AMT Lab/Phleb basics Flashcards
Centrifugal force depends on 3 variables…
and separates based on…
mass, speed, radius
density
speed expressed as…
force generated express as…or…
angular velocity value…
r=
revolutions/min(rpm)
relative centrifugal force/RCF or gravity (g)
1.118x10*-5
r=radius in cm from center of axis to bottom
Equation for speed of centrifuge related to RCF/RCF=
1.118x10*-5 x r x (rpm)’2
*10 to neg 5
*2=squared
CLSI
clinical and lab standards institute
CLSI recommend blood be centrifuged at an RCF of…or…for…min
1,000-1200xg
OR
3500 rpm
for 10-15 min
…or… centrifuge where tubes are horizontal position when spinning and in a vertical position when stopped
Horizontal head or swinging bucket
…or…centrifuge where tubes are at angle in sample bucket, allowing small particles to sediment faster
fixed angle or angle head
Centrifuges that separate small liquid samples of <=2mL in plastic conical shaped containers w/integral snap cap
microcentrifuges
High speed centrifuge up to 150,000rpm to separate chylomicrons from serum
ultracentrifuge
strobe light determines…
speed
Check speed of centrifuge with…or….
every…
tachometer or strobe light, every 6mths
NIST
national institute of standards and technology
Check time with…timer, every…
NIST traceable timer, 6mths
centrifuge used to sediment small particles faster
fixed angle/angle head
centrifuge used to separate chylomicrons from serum
ultra
Glassware/plasticware must fall into class…or….
Institute that recommends tolerance limits…
Preferred glassware class…
Usually made of… …
Class A, B
NIST recommended
Preferred is A and made of borosilicate glass
Pipette that is electronic, prepare multiple samples…
Pipette that are handheld, disposable tips w/air displacement or positive displacement
Automatic pipette
semi-automated pipette
Mechanism of action which relies on a piston for creating suction to draw the sample into a disposable tip that’s changed after use
A certain volume of air remains between the piston and the liquid.
air displacement
ie. pipettes used in lab
Mechanism of action which has a moving piston in pipepette tip or barrel much like a hypodermic syringe, doens’t require a different tip and is used as a dispenser.
The piston is in direct contact with the liquid.
Positive displacment
ie. osmo pipette
Which pipete requires recalibration…
how often per year…
Two methods used to calibrate…
automatic pipettes, 4x/yr
Semiautomatic also uses this method
gravimetric and volumetric
Calibration that verifies accuracy by the amt of water dispensed by pipette.
Weight of water is proportional to the volume dispensed.
Weight=volume
Accuracy of volume is dispensed and adjusted accordingly to the weight
Gravimetric
Calibration that verifies accuracy of amt of dye thats pipetted into a specific volume of water and is read spectrophotometrically.
absorbance=amount
volumetric
Which class of glassware doesn’t need to be recalibrated
A
Handheld that require bulb to apply suction
manual
…or… is glass pipette that has a bulb in the middle w/tapered delivery tip
accuracy is 1:….
transfer or volumetric
1:1000
..or…Pipette thats uniform in diameter w/tapered delivery tip
measuring or graduated
Pipettte with two frosted bands
Last drop blown outb after pipette drains
Pipete must be rinsed w/solvent after first liquid has drained
To contain, TC
Pipette filled and allowed to drain by gravity. Held vertically, tip placed against side of vessel
To deliver, TD
Pipette filled, drained and remaining fluid in tip blown out, has two frosted bands at top
blow out
Pipette held in vertical position w/tip against vessel and drained by gravity
self draining, ie. TD
Organization that maintains standards for temps
NIST
national institute of standards and tech
Thermistor probe is also called
an electronic probe
3 types of thermometers
mercury/liquid in glass
digital
electronic/themistor probes
Gold/platinum thermometer calibrated on international temp scale w/lead wires and sheath
NIST
Standard ref material
(SRM)
All NIST certified thermometers come with a…
NIST traceable thermometers come with
NIST cert of calibration
NIST cert of traceability.
certificate issued by manufacturer
Temp for incubators, heat blocks, water baths
36-38C
RT
20-24C
Lab fridge…
BB fridge…
lab 2-8C
BB 1-6C
Lab freezer…
BB freezer…
lab <= -20C
BB <=-65C
Sln can use as alternative to lens sln…
sln not to use…
can use methanol, not xylene
Absorbance can be calculated easily from percent transmission using which calculation?
2 – log10 %T
Absorbance can be calculated easily from percent transmission using 2 – log10 %T. If all the light passes through a solution without any absorption, absorbance is zero and the %T is 100%. If all the light is absorbed, %T is zero, and absorption is infinite.
Most common microscope, white light illuminates sample from below…
limitation…
brightfield
low contrast of biological samples
Which immunoassay methodology is the emission of light by molecules in an excited state with a limited amount of heat as the result of a chemical reaction?
Chemiluminescence is the emission of light by molecules in an excited state with a limited amount of heat (luminescence) as the result of a chemical reaction. Chemiluminescent assays are ultrasensitive and are widely used in automated immunoassays and DNA probe assay systems. Chemiluminescence has excellent sensitivity and dynamic range. Chemiluminescent labels can be attached to an antigen or an antibody. Most chemiluminescent reagents and conjugates are stable and relatively nontoxic.
Microscopy improves contrast of unstained, transparent. Quantity of unscatted light/directly transmitted is minimized collecting only light scattered by sample… the field around the specimen (i.e., where there is no specimen to scatter the beam) is generally dark.
Good to view…
Darkfield
spirochetes
Uses electrons to illuminate and creates enlarged image.
Creates higher resolving power and higher magnification.
Uses electrostatic and electromagnetic lenses.
Focuses on a specific plane…
Good to view…or… …
Electron
tissue or tumor markers
Uses fluorescense. High energy light illuminates, emits light of lower frequency.
Dyes used to stain structures…
Good to view…
Fluorescent
ANA
Small phase shifts in the light passing thru transparent specimen showing differences in refractive index as diff in contrast…
An optical microscopy technique that converts phase shifts in light passing through a transparent specimen to brightness changes in the image. Phase shifts themselves are invisible, but become visible when shown as brightness variations.
Good to view…
phase contrast
manual PLT cts
Only transmits polarized light
good to view…
polarized
crystals
Gives 3D image. brightfield can be modified into this. Two split beams of light are polarized and recombined by objective prism.
Recombination gives 3D
Differential interference contrast
Differential Interference Contrast (DIC) is a phase contrast technique that allows transparent structures to be visualized by exploiting changes in refractive index. In contrast to conventional phase contrast techniques, which are based on changes in optical path length, DIC is based on the gradient of the optical path length (rate of change in wavefront shear). Steep gradients produce the high contrast and 3-D relief effect that is characteristic of DIC.
Magnification of:
eyepiece..
low power objective…
high power objective…
oil immersion objective…
eyepiece: 10X
low: 10x
high:40x
oil: 100x
Knob to move slide right and left…
knob to move stage forward and backward…
slide right/left:
x axis motion knob
stage forward/backward:
y axis
Rotating disk under stage to vary intensity/size of cone of light
iris diaphram
Focuses light onto specimen
condenser lens
part that connects the eyepiece to the revolving nosepiece/lenses
tube
holds objective lenses
nosepiece
focuses light onto specimen, can move up and down
condenser lens
English units of measurement
3 for length..
1 mass..
4 for volume…
length: inch,foot, yard
mass: lb
volume: cup, pint, quart, gallon
Metric system is based on decimal system, multiples of ten
length…
mass..
volume…
length: meter
mass: gram
volume: liter
luminous intensity in SI
candela
International System of Units/SI worldwide standardized system, recommended by CLSI
Length:
Mass:
Time:
amt sub:
temp:
electric current:
luminous intensity:
Length: meter
Mass: kg
Time: sec
amt sub: mole
temp: Kelvin
electric current: ampere
luminous intensity: candela
Deka
Deka…10*1
Hecto
Hecto…10*2
Kilo….
Kilo….10*3
Mega..
mega: 10 *6
giga
giga 10*9
Deci
Deci: 10*-1
centi..
Centi:10*-2
milli
milli: 10*-3
micro
micro: 10*-6
Nano:
Nano: 10*-9
pico
pico: 10*-12
femto
femto: 10*-15
Celcius from farenheit
5/9x (F-32)
Farenheit from Celcius
(9/5)C +32
Kelvin from Celsius
C+273
95F to C
5/9x(95-32)=35C
95C to F
(9/5x95)+32=203F
95C to Kelvin
95+273=368K
BUN/Creatinine ratio
BUN 24.0
Creatinine 2.4
Give ratio
10:1
CHOL/HDL ratio
TC 200
HDL 40
5:1
Which cell lines aren’t included in the Myeloid part of M:E calculation
Which cell line is included in Erythroid ratio
Lymphs and Monos
Normoblasts
Write fraction, 1 pt solute to 1 part diluent
1/2
2 is total volume
pt:pt is
pt analyze + total parts (including diluent)
1:1 dilution=
1:2
1:5
1 pt serum+0 pt diluent
1:2 1 pt serum + 1 pt diluent
1:5 1 pt serum + 4 pt diluent
1:2, 1:4, 1:8 etc is a
1:5, 1:25, 1:125 is a
1:10, 1:100 is a
two fold, x2
five fold, x5
ten fold x 10
5% w/w sln equals how much solute to total solution
How much diluent is added
5g solute per 100g total solution
95g diluent added to 5g making 100g sln
Make 100g of 5% w/w sln of NaCl
5g/100g is 5% w/w,
5/100x 100g wanted=need 5g NaCl to 95g diluent to make a total of 100g sln
10% w/v sln equals how much solute to total sln
10g of solute to 100mL of total sln
Make 1,000 ml of 10% w/v of NaOH
10% w/v = 10g/100ml
x 1000mL= 100g of NaOH to add to 900ml diluent to get 1000mL total
2% v/v equals how much solute to sln
2ml/100ml
Make 50mL of a 2% v/v of HCl
2% v/v = 2ml/100ml
x50ml=1ml of HCl added to 49ml diluent equals total of 50ml
Molarity/M
Have g/L, covert to mole/L by get gmw
g/L x mole/L= M
40g NaOH/L, what is molarity?
1 mole NaOH is 40 GMW,
40g/L x 1 mole/40 =1mol/L=1M
Nomality (N)
N=Equivalent/L
1 Equivalent=gmw/valence
Valence is # of H
Osmolality=mOsmol/kg of H2O
Normal range…
calculation…
Normal range 275-295 mOsm/kg
1.86(NA) + GLU/18 + BUN/2.8
Osmolality of
NA 150
Glu 180
BUN 14
294 mOsmol/kg H2)
Osmolar gap
measured-calculated
Concentrated Slns
C1V1=C2V2
1 is, 2 is
1 is known
2 is unknown
PT has 350 PLT ct, how many mL of it needed to get 7mL of with concentration of 250
350x?mL=250x7=5mL
Ratio of SD of a distribution to its arithmetic mean.
Used to express precision and reproducibility of an assay
Coefficient of Variation, CV
Coefficient of Variation, CV used to express…and…
Acceptable CV is…
Used to express precision and reproducibility of an assay
Less than 5% for most analytical systems
/X is
mean
CV formula
Mean is 200, SD is 5, calculate CV
SD/Mean x 100
5/200 x 100 =2.5%
Gives an estimated degree of uncertainty. Probability of estimated range…
expressed as..
Confidence interval
percentage
Mean +- 1 SD=
Mean +- 2 SD=
Mean +- 3 SD=
1SD 68%
2SD 95%
3SD 99%
Given mean (/X) is 9.8, 1 SD is 0.2, calculate 95% confidence limits for control run with mean +- 2SD
1SD= 9.8 +- 0.2
2SD=9.8 +- 0.4, 9.4-10.2
pH formula
pH=pKa +log (base)(acid)
(salt)(acid)
(HCO3)(H2CO3)
Diff between cations and anions…
cations..
anions…
calculation
anion gap
cations: Na, K
anions: Cl, CO2
Na+K - Cl+CO2
Law that states concentration of sub is directly proportional to amt of radiant energy absorbed or inversely proportional to the logarithm of the transmitted radiant energy
2 formulas:
proportional to absorbed
versus
indirectly proportional to transmitted…
Beers Law
A=abc
A=2-log%T
Con unk/Con std = Abs unk/Abs std
Formula for known/unknown absorbance…
Concentration of unknown=
AbsUn/AbsStd x ConcenStd
Abs of 6.0g std is 0.40, abs of unknown is 0.350, concentration of unknown?
0.350/0.40 x 6.0
5.25g
Chain of custody things needed…
PT consent, security seal, to addresee only
store in locked area
Examples of chain of custody
alcohol levels for DUI
DOT drug testing
paternity, DNA
Rape
Medical examiner
Digital version of patient medical history/date
EMR
electronic medical record
Series of computer network that interconnects computers in a limited area like hospital, using network media
LAN
local area network
A computer network that interconnects computers in a broad area such as international, using private or public network trainsports
WAN
wide area network
Comprehenstive integrated info system to manage medical, admin, financial, and legal aspects of a hospital/services
HIS
Hospital info system
Computer software providing services to software apps beyond those available to the operating system
Software that lies between an operating system and the applications running on it. Essentially functioning as hidden translation layer, enables communication and data management for distributed applications.
Middleware
Computerized process for healthcare providers to electronically enter and order medical procedures/lab tests based on predetermined logarithm
CPOE
computerized provider order entry
CLIA stands for
clinical laboratory improvement amendments
CDC stands for
centers for disease control
CMS stands for
centers for medicare/medicaid services
Program that establishes quality standards for all labs…
Published by…and…
CLIA
plublished by CDC and CMS
Organization that categorizes and grades testing based on the complexityof testing
FDA
Two criteria to be waived test
cleared by FDA for home use
simple/accurate as to pose no reasonable risk if performed incorrectly
Examples of waived
blood glucose/cholesterol
urine prego, dipstick/tablet urinalysis
ovulation
nonautomated ESR
spun HCT
Hmg copper sulfate
Hmg by single analyze instruments
Who determines if a test meets criteria for being a waived test
HHS
Dept of Health and Human Services
Complexity?
-manual procedures w/limited steps
-microscopy of urine sediment
-automated heme w/out diff
-primary culture set up
-urine culture/colony ct kits
-gram
moderate
To be categorized as PPM, provider performed microscopy, must meet criteria
-physician, supervised midlevel practioner, dentist
-moderately complex
-main instrument is a microscope
-control materials not available
-specimen is labile, delay would affect results
-need limited handling/processing
Examples of PPM tests
-direct wet mt preps, qualitative semen
-KOH preps
-pinworm, fern
-postcoital direct, qualitative
-urine sediment
-nasal smears wbc, fecal wbc
3 criteria for high complexicity
-any modified FDA cleared test
-lab developed test/LDT
-cytology
Complexity?
-serogrouping/typing
-manual procecures w/multiple steps/reagent prep
-concentration/diff staining
-antimicrobial testing
-gel immunochemical
-electrophoresis, flow
-pap smear
high
These two can conduct an inspection of any accredited lab that’s issued a certificate of accreditation…
How often CLIA requires…
CMS, dept of HHS
2yrs
External quality control to verify accuracy of lab test methods
PT
proficiency testing
Proficiency testing is required by… under…
Usually done …times per year
Not required for…
CMS, under CLIA
3 times per year
not required for waived tests
Approves the PT program that must be enrolled in
HHS
Must maintain copy of PT related forms for minimum of….from the date of PT event
2 yrs
Satisfactory performance on PT testing is…for each analyze
except with immunoheme, some are..
80%
100%
Unsatisfactory PT
same analyte in 2 consecutive
OR
2 out of 3 testing events
Alternate/Split sample testing can be done for PT if…
approved PT isn’t available
SPLIT SAMPLES w/other or ref lab, established in house method, clinical validation by chart review, participation in ungraded/educational PT program
Examples of pre analytical testing
lab req, id, collection, storage, transportation, specimen adequacy, aliquoting, centrifugation
Oral requests can be made if…
and within…
followed by written authorization
within 30 days
Standard that requires the use of at least 2 pt ids…
3 examples of ids
Joint Commision
National Patient Safety Standard
-name, bday, med rec
How long keep records of test reqs/authorizations (can be patients chart/medical record)…
Who may request records…
2 yrs
HHS
Examples of analytical testing
reagents, calibration, QC, temps
recording results
verify normal range
competency of personell
Process of testing and adjusting an instrument/kit to provide a known relationship between the measurement response and the value of the substance being measured by the test
Contains a known amount of analyte being tested
used to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure.
calibration
Records of patient testing kept for at least…
BB records kept for…
Blood/products…
Pathology kept for..
-PT 2yrs
-BB 5yrs
-Blood/products: 5yrs or 6mths after exp which ever is later
-path 10yrs
How long must a copy of each procedure w/dates and initial use/discontinuance be kept
2 yrs after discontinuence
Post analytic examples
verifying calculations
reporting results
ID/notify panic
filing
data retrieval
Most errors occur in what two phases…
pre and post
percentage of error:
pre…
analytical..
post…
pre 46%
analytical 8%
post 47%
Term used to describe monitoring/evaluating all aspects of testing and all phases.
Uses the QC data and conducted over a period of time
QA
Term that is one component of QA, involves mostly the analytical phase, ensures accuracy, and performed daily
QC
standard that where concentration is determined by dissolving weighted amt of std in solvent and diluting to a stated volume/mass.
Accuracy based on purity of std/solvent not analytical method.
primary calibration std
Standard where concentration is determined by an analytical method of stated reliability.
Prepared from pure substances of known composition.
Secondary std
Process that sets the instrument to a specific parameter, also called standards
calibration
Substances that are patient like used to validate run after calibration and tests the accuracy and precision of the method
Can use sera/BF thats stable for at least…
controls
a year
Control reqs
should be pt like
run at lease 2 levels
stable
never used to calibrate
Term that is the agreement between the measured quanitity and its true value
How close the value is to the true value
accuracy
Material prepared/purchased w/stated or expected value
assay control
Material whose value is not known except when assayed w/in lab by repeated testing
unassayed control
Aggrement among replicate measurements. How close the single values are to one another. The repeatability or reproducibility
precision
The more precise the method, the…the SD among replicate results
smaller
Actual middle value
median
value that occurs the greatest frequency
mode
average of all values, included in control material, represented by /x
mean
dispersion of control values about the mean.
repeatability, reproducibility, precision
SD
If data have a normal distrubution,
the mean/mode/median are…
about the same
Difference between highest and lowest values
range
average squared distance of data points from the mean
variance
square root of the variance
SD
SD expressed as percentage of the mean
CV
coefficient of variation
CV formula….
acceptable CV is less than…% for most analytical systems
SD/mean x 100
1SD
…% will fall to the right and left of the mean, so…% of all data fall within 1SD
34.1% fall to right and left
68.2% of all data fall within 1SD
2SD
…% of all data will fall between 2 SD
95.5% of all data fall within 2SD
3SD
…% of all data will fall within 3SD
99.6% of all data fall within 3SD
The lab normally runs within …or…% confidence limit to be considered accurate and precise
2SD, 95%
A chart with a normal distrubution curve on its side. Used to determine if a run is acceptable/quality of run.
Values within…on each side are accepted as being accurate and precise
Accurate test results fall w/in acceptable limits of +/-…SDs….% of the time
Levey Jennings chart
2SD
Signal of errors
…consecutive results fall on…side of mean
…consecutive results fall outside…
…result falls outside….
5 consecutive results fall on 1 side of mean
2 consecutive results fall outside 2SD
1 result falls outside 3SD
6 steps in finding source of signal errors
- clerical
- reagent
- procedural/maintainence
- retest ctrl
- recalibrate instrument/new ctrl
- call tech
Error thats unpredicable, no obvious pattern and almost always preventable.
Large deviation from mean.
Random error
3 Random error causes…
Remedy…
operator error (pipetting etc)
electronic fluctuation in instrument
interfering substances
Remedy: repeat test with fresh reagents, good working pipettes
Error that happens over a period of time, data points are not evenly distributed about the mean.
This can be described as…or….
Systemetic error
shift or trends
Error where data pts gradually drift from the mean.
Gradual loss of reliability.
When seven points in a row in an upward or downward direction are seen on a quality control graph
trend
Error with abrubt change in data pts from mean.
Shift
2 causes of trend
-deterioration/aging of reagents, ctrl, light
-accumulation of debris cuvette window
4 causes of shift
-change in reagent lot/without calibration
-failure of calibration
-instrument maintence
-change in room temp
Set of rules/decision criteria to decided whether an analytical run is in control or out of control..
Westgard Multirules
A…is an interval w/in which the accuracy and precision of testing system are expected to be stable but cannot be greater than 24hrs or less the frequency stated by m2anufacturer.
run
Multirule where you accept the run/is a warning
1 ctrl exceeds mean by +/-2SD
1-2S
Multirule where you reject, 1 ctrl exceeds mean by +/-3SD
1-3S
Rule where you rejct, 2 consecutive exceeds mean by +-2SD.
May be beginning of systemic error
2-2S
Rule where you reject, two consecutive is greater than +/- 4SD
May be due to random error
R-4S
Rule where you reject, 4 consecutive exceed by +/-1SD in the same direction.
May be systematic error
4-1S
Rule where you reject, 10 consecutive exceed in same direction.
May be systematic
10x
Normal range, normal value, ref range also called…
Refer to a normal grp of individuals free from disease and represent…% of the population
reference interval
95%
If no existing analyze or methodology exists to do comparative studies, need ….to… people
If method already in place, ref interval is validated by using method comparision.
Most common ref interval study used in lab is as few as…test subjects
120-700
40
Parameters categorized as sensitivity, specificity and predicitive value are broadly defined as…
diagnostic efficiency
A predicitive value of a methods ability to detect patients with a disease is called the…
Probability of correctly classifying diseased patient as disease
sensitivity of a test
the test that has 100% sensitivity can detect the disease in question in every patient who has the disease is called
true positive
Diagnostic sensitivity formulas
diseased w/+ result/total diseased x100%
or
true pos/# true pos + # false neg x 100%
The abilty to predict the value of a method to exclude a patient without disease is called…
Correctly classifying a nondiseased person as nondiseased
specificity
The test that has 100% specificity will always be negative, and a patient who tests negative does not have the disease
true negative rate
Diagnositic specificity formulas
nondiseased w/neg result/
total #nondiseased x 100%
or
true neg/# true neg + # false pos x100%
positive predictive value formula…
% of the time a positive test will be true
true pos/#true pos +#false pos x100%
negative predictive value formula…
% of the time a negative test will be true
true neg/#true neg+#false neg x100%
Differences between repeated and successive test results…
delta check
Delta check can be usesd as a form of …
quality assurance
4 parameters delta checks can be based on…
-current result minus previous
-current-previousx100%/previous
-delta diff/delta time
-delta % change/delta time
Any test performed at the time a rapid decision can be made that leads to treatment w/immediate pt outcome
POCT
point of care testing
What category of testing involves microscopic evaluation (i.e., wet mount, Potassium hydroxide preparation, fern test, etc.) by a physician in the office for their own patient?
To meet the criteria for inclusion in the Provider-Performed Microscopy (PPM) category, procedures must follow these specifications: The examination must be personally performed by the practitioner (defined as a physician), a midlevel practitioner (defined as a physician, a midlevel practitioner under the supervision of a physician), or a dentist. The procedure must be categorized as moderately complex. The primary test instrument is the microscope (limited to brightfield or phase-contrast microscopy). The specimen is labile. Control materials are not available. Specimen handling is limited. Proficiency testing is not required; however, twice-yearly verification of accuracy is required. Those with a PPM certificate can also perform waived testing.
5 POCT classifications
-off site
-alternate sit
-physican office
-near patient
-beside
POCT devices have these characteristics
-portable
-easy to use, mininal steps
-results w/in mins
-flexible test menus
-reagent at RT
-built in cal/QC
Ensures the electronics of the device are performing as expected
internal QC
Tests the system in the same manner as a patient sample
external QC
Tests the system and its operators blindly by providing unknown samples
PT
Examples of POC device principles
-reflectance
-electrochem/impedance
-spectrophotometry
-fluorescen
-PCR
Most POCT classified as…
POCT is… …. than conventional lab testing
moderate complexicity tests
more expensive
Testing personell req…
-On/B4 April 1995 highschool, clinical training
-Until Sep 1997 high school, clinical exp
-After 1997 AS
-AS or equivalent education/training
-licensed physician (doctor,master,bacherlor in chem/phy/bio, or CLS/MT accredited)
CLIA reg to evaluate/document performance for high complexicity testing at least…during the first year, then at least….
semiannually the first year then annually
Lab must document/assess problems during quality assurance reviews and take corrective action to prevent reoccurance
performance improvement projects
Lab must keep docs of quality assurance activities for….
2 yrs
Incidents which involves risk of injury or actual injury must be reported to risk management within
48hrs
Event which facility personell could exercise control and which is associated in whole or in part with the facility’s intervention, rather than the condition for which such intervention occured.
An event in which care resulted in an undesirable clinical outcome-an outcome not caused by underlying disease-that prolonged the patient stay, caused permanent patient harm, required life-saving intervention, or contributed to death.
adverse incident
Name of term where risk management must report serious adverse incidients to the state within 15 days
code 15
an occurence that results in unanticipated death or major loss of functions not related to the natural course of patients illness or underlying condition.
sentinel event
A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called “sentinel” because they signal the need for immediate investigation and response. The terms “sentinel event” and “medical error” are not synonymous; not all sentinel events occur because of an error and not all errors result in sentinel events.
Process variation for which a recurrence carries a significant chance of serious adverse event
near miss
A near miss is something that you instinctively recognize at the moment. It usually comes with a surge of adrenaline and relief. We also know it as a “close call,” a “narrow escape,” or a “near accident.”
In fact, “near accident” is probably the best general definition of “near miss.”
In depth analysis of an occurence by a multidisciplinary team of involved employees.
It is a structured facilitated team process to identify root causes of an event that resulted in an undesired outcome and develop corrective actions.
root cause anaysis
OSHA..
is part of…
and a…agency
occupational safety and health admin
the US dept of labor
federal agency
Fed agency that issues regulations to ensure employee workplace safety with employers with 1+ employees
OSHA
In addition to having id, severity of hazard, nature/degree, and recommended measures to minimize adverse effects,
label of hazardous materials should have these 3 things
-name
-address
-phone
of manufacterer
Standard that requires pictograms on labels to alert users of chemical hazards
hazard communication standard
6 chemical hazard classifications for pictogram labels
-carcinogen
-corrossive
-flammable
-irritant
-toxic
Pictogram with skull and crossbones for what 1 hazard
acute toxicity
Pictogram of environment for what 1 hazard
aquatic toxicity
Pictogram of flame over circle for what 1 hazard
oxidizers
Pictogram of exploding bomb for what 3 hazards
-explosives
-self reactives
Self reactive substances are thermally unstable liquids or solids liable to undergo a strongly exothermic thermal decomposition even without participation of oxygen (air).
-organic perioxides:
organic peroxides supply both the oxygen and the fuel source.
Pictogram of corrosion (test tubes dripping on hand)
for what 3 hazards
-skin corrosion/burn
-corrosive to metals
-eye damage
Pictogram of gas cylinder for what 1 hazard
gases under pressure
Pictogram of exclamation mark for what 6 hazards
Skin, irritants:
-skin sensitizer
-irritant(skin, eye, respiratory tract)
-acute toxicity
-narcotic effects
-hazardous to ozone layer
Pictogram of flame for what 6 hazards
-flammables
-pyrophorics: Pyrophoric materials are substances that ignite instantly upon exposure to oxygen.
-self heating
-emits flammable gas
-self reactives
-organic peroxides
Pictogram of health hazard(person) of what 6 hazards
-carcinogen
-mutageniticity
-reproductive toxicity
-target organ toxicity
-aspiration toxicity
-respiratory sensitizer
Safety training required by…every…
kept for…
OSHA, year
3yrs
A written program to set forth procedures, equipment, PPE, and work practices to help protect employees from health hazards by hazardous chemicals
Chemical hygiene plan
Plan required by OSHA concerning bloodborrne pathogens that describes potential risks and measures taken to protect/if exposed
exposure control plan
Term that all samples are infectious and also contaminated w/HIV, HBV and all sharps are contaminated
Universal precautions/Standard Precautions
Common sources of HIV, HepB,C include blood and body fluids such as these…
-semen, vaginal secretions
-CSF, snynovial, pleural, peritoneal, amniotic
-saliva in dental settings
-unfixed tissues/organs
-cell, tissue organ cultre
Primary transmission modes for HIV, HBV, HCV are these 3
-puncture wound contaminated objects
-skin contact with infectious fluid/tissue thru broken skin
-mucous membrane contact (eye, nose, mouth)
Hepatitis that is fecal oral,foodborne, vaccine available
Hep A
Hep A lab
elevated…and…
two ab and correlation…
done with…
elevated ALT, bili
IgM=disease
IgG=immunity
done with EIA
Hep B transmitted thru these 3
-sex
-needs/IV drug
-transfusion
Hep B incubation period…
95% are…or…
5% are..
asymptomatic or acute
chronic
Order of apperance of HepB markers
-HBV DNA
-HBsAg
-HBeAg
-anti-HBc
-anti-HBe
-anti-HBs
First detectable Hep B marker…
detected using…
HBV DNA
NAT
Two Hep B antigens in acute phase, very infectious
HBsAg
HBeAg
Hep B marker indicating viral replication and most infectious
HBeAg
Marker that is marker for previous infection and is in recovery phase and remains throughout persons life
anti-HBc
Marker where infection is resolving and patient is immune; is protective against future
Anti-HBs
Marker due to immunity due to vaccination
anti-HBs
Two Hepatitis with vaccines
Hep A and B
Hep similar to Hep B, sex/iv use/trans;
7-8wk incubation;
elevated ALT
Hep C
Hep C tests:
EIA for…
RT-PCR for…
EIA: antibody to HCV
RT PCR: HCV RNA
Hep virus that needs HBV, IV drug/hemophiliacs
Hep D
Hepatitis thats cause of epidemic and sporadic heptatis in developing countries;
resemebles Hep A, fecal oral
Hep E
HIV spreads thru…or….
It infects…
sex, IV drug
CD4+ T cells
Opportunisitc pathogens in HIV:
3 Parasites…
4 viruses…
2 fungi…
1 bacteria….
Opportunisitc pathogens in HIV:
Parasites
-crytosporidium
-pneumocystis
-toxoplasma
viral
-HBV, CMV, EBV, HSV
Fungal
-candida
-Cryptococcus
Bacteria
-mycobacterium
Two types of HIV…
Dominant one worldwide…
which one is slower…
HIV1,2
Dominant HIV1
Slower HIV2
Groups in HIV1
M,N,O
Incubation period for HIV…
full blown AIDS when CD4 drows below…
18mths
200 cell/microL
Reversal of T Helper to suppresor CD4:CD8,
what is normal ratio, ratio in HIV
normal >1.5
HIV <0.5
Name of therapy that interferes with any aspect of HIV rep/spread
HAART
hightly active antiretroviral therapy
Technique used for qualitative detection of antibodies and antigens to both HIV1,2
ELISA
No further testing for HIV is required for…on the…immunoassay
nonreactive on initial
Specimens with reactive ag/ab or repeatedly reactive should do a test that….from…
differentiates HIV1 ab from HIV2 ab
Specimens reactive at initial and nonreactive on HIV1/2 ab differentiation should be tested using
HIV1 NAT
High risk tasks
needles, shaprs usage
invasive procedures w/bleeding
large amount of blood
spill,splatter, splashes
Plan name that establishes procedures and utilizes appropriate materials and equipment to minimize exposure to bloodborne pathogens
exposure control plan
Enginerring controls
hand wash, sharps containers, leakproof containers, protective shields
Work practice controls
-hand wash
-handle needles appropriatly, no double handed recap, not overfilled, no hands in sharp container
-leaking/puntured in second container
-closed b4 disposed of
-no mouth pipette
-no food etc in lab
Labels not required if .. .. or … .. are used
red bags or red containers
Hep B vaccine must be made available within…days of initial employment
10 days
OSHA requires exposed person be tested after initial exposure then at…,…, and…months.
If person refuses testing, blood should be drawn and saved for…days
3, 6, 12 months
90 days
How often does OSHA require blood borne pathogen training
yearly
When there’s potential to generate aerosols of M.tb or large concentrations used BSC class…
2
BSC class that allows unsterlized room air into cabinet and around area/material and only sterilizing the air that is exhausted outside by… …
BSC class 1
negative pressure
BSC class with a sash that sterilizes the air that flows over the infectious material as well as the air that is exhausted.
BSC class 2
BSC class 2 also called
laminar flow BSC
Category/Subcategory of BSC… which is self contained and 70% of air is recirculated by passing thru HEPA filter
BSC 2A
Category/Subcategory of BSC…used by radioisotopes, toxic chemicals, or carcinogens
BSC 2B
BSC completely enclosed and has negative pressure. Most protection. Air is sterilized while infectious material is handled with gloves.
BSC 3
Most clinical micro labs use class…BCSs
Certified once installed, then…..
BSC 2A
annually
Code 15
Name of term where risk management must report serious adverse incidients to the state within 15 days
Markers in convalescent/recovery phase of hepB
AntiHBc, antiHBe
Marker for previous infection hepb
AntiHBc
% of the time a positive test will be true
positive predictive value
% of the time a negative test will be true
negative predictive value
BSL not known to consistently cause disease in humans and used in standard micro practices
examples are nonpathogenic ie. Ecoli, B.subtilis
BSL 1
BSL with agents associated with human disease aquired thru percutaneous injury,ingestion, or mucous membrane.
BSL 1 practice and limited access, biohazard warnings, sharps precausings
ie. S.aureus, E.coli 157, K.pneumo, HBV, HIV
BSL 2
BSL with indigenous agents may cause serious or lethal disease thru inhalation.
BSL2 practice and controlled access, decontamination
M.tb, B.abortus, Y.pestis. B.antracis, C.immitis
BSL 3
BSL with dangerous agents which cause individual risk of aerosol transmitted lab infections, fatal, no vaccines/treatment
BSL3 practice and clothing change, shower, decontamination
Ebola, Lassa, Marburg
BSL 4
BSL used with most standard microbiological practices not known to cause issues
BSL 1
BSL used thats most fatal, no vaccine/treatment, risk of aerosol
BSL 4
BSL used with limited access, biohard signs, and sharps precaustions, most common pathological pathogens seen
BSL 2
BSL used for agents that are generally inhaled and lethal, decontamination
BSL 3
B.subtilis, E.coli used BSL
1
ebola, lassa, marburg use BSL
4
m.tb, B.aborus, Y.pestis, B.anthracis, C.immitis use BSL
3
S.aureas, E.coli 157, K.pneumo, HBV, HIV use BSL
2
How must a laboratory operate to handle TB sputum and TM materials?
Question 2Answer
Biosafety level of 2+ or 3
BSL-3 builds upon the requirements of BSL-2. Organisms that can cause serious or potentially lethal disease through respiratory transmission are typically worked with in a BSL-3 laboratory. Example: Mycobacterium tuberculosis.
3 Categories for bioterrorism agents…
A, B,C
What category are agents anthrax, botulism, plague, smallpox, tularemia, filoviruses, and arenaviruses classified as?
Category A are pathogens that are rarely seen in the United States. These agents have the highest priority; organisms in this category pose a risk to national security because they can be easily disseminated or transmitted from person to person and result in high mortality rates and have the potential for major public health impact.
Category with emerging pathogens and could be used for mass dissemination due to ease of production/dissemination and high morbidity…
Two types…
C
Nipah virus, hanta virus
Category moderately easy to dissemniate, moderate morbidity,
low mortality
and need specific enhancements of CDCs diagnostic capacity/enhanced surveillance
B
Category B examples
Brucellosis, C.perf
Salmonella, Shigella, Ecoli
B.mallei, C.psittaci, Coxiella burnetii
Typhus fever/Rickettsia pro
vibrio cholerae, crypto parvum
Category that pose risk to national security because they are easily disseminated,
high mortality rates, might disrupt public/panic
Category A
category A agents
anthrax, plague, smallpox
tularermia
botulism
ebola, marburg, lassa
3 types of gas stored in cylinders…and examples
liquefied: chlorine, propane, CO2
nonliquefied: helium, nitrogen
dissolved gases: acetylene
…is lowest temp which vapor of a flammable liquid can be ignited in air
Flashpoint
A flammable liquid is any liquid with a flashpoint below …F/C
Stored in…
100F/37C
flammable liquid safety cabinet
Safety color coding:
red means 3 things…
yellow means…
orange means..
fluorescent orange…
Color is contrasted with…
red: fire, danger, stop
yellow: caution
orange: warning
fluorescent orange: bio hazard
black
Fire pull alarms, bio med waste containers, and emergency stop are color…
red
Radiation signs are
yellow
Color biological hazard signs used to signify potential prescence of biohazardous infectious agent posing potential risk is color
fluorescent orange
Organization that sets color coded scheme for hazards
NFPA
national fire protection agency
Blue diamond…
0-4…
health hazard
normal to deadly
Red diamond…
0-4…
fire hazard
won’t burn to flash pt below 73F
White diamond…
6 specific hazards…
specific hazard
-ACID
-ALK (alkali)
-COR (corrosive)
-OXY (oxidizer)
-radioactive symbol
-W crossed out: don’t use water
Yellow diamond
0-4
reactivity
stable, may detonate
Fire with ordinary combustible material…
Such as…
Class A
paper, wood, cloth
some rubber, plastic
Fire w/flammable or combustible liquid….
Such as…
Class B
gasses, greases
some rubber, plastic
Fire w/energized electric equipment
Class C
Fire w/combustible metal…
such as…
Class D
mag,sodium,lithium, potassium
Class extinguisher ordinary combustible materials such as wood, paper, cloth
Class A
Class extinguisher flammable or combustible liquid such as acetone, ethanol etc
Class B
Class extinguisher w/energized electrical
Class C
Class extinguisher w/combustible metal
Class D
Fire acrynom
Remove people from danger
Activate alarm, call
Confine fire
Extinguish or evacuate
Extinguisher acroynym
Pull pin
Aim at base
Squeeze handle
Sweep side to side
Electrical safety checked… … and then…
upon install, annually
Requirements for radiation safety 4 reqs
-employee gets motoring equiment to monitor exposure
-records and checkins annually
-post sign radition caution symbol, caution, radiation area
-keep radiation as low as reasonably achievable (ALARA) per NRC
NRC, ALARA
Nuclear regulatory commision
as low as reasonably achievable
Federal agency regulates disposal of toxic/bio hazardous waste
EPA
environmental protection agency
Act that gives EPA authority to control hazardous waste such as generation, trans, treatment, storage, disposal
RCRA
resouce conservation and recovery act
Hazardous waste def…
RCRA def…
any waste w/properties that make it dangerous or potentially harmful to environment or public health
RCRA: waste that appears on one of the four hazardous waste lists or exhibits at least 1 of 4 characteristics (ignitablity,corrosivity,reactivity,toxicity)
Fed agency regulates packing, labeling, trans of hazardous.
National safety by air/rail/highway/water
DOT
dept of trans
IATA..
purpose…
international air transport association
regulate packing,shipping by air
DOT training req within… and every…
90 days
3yrs
DOT requires markings on hazardous with these 4
-shipping name
-UN id #
-inhalation hazard if necessary
-name/address cosignee
DOT Hazard has how many classes
9 stupid classes I won’t remember
ICAO:
international civil aviation organization
instructions for safe transport by air
IMO:
international maritime organization
by water
…
DOTs HMR has two categories… and …
…capable of causing permanent disability/fatal
…not in a form to generally be capable of permanent disability or fatal
…which category does clinical lab specimens fall
Category A, B
A: harm
B: not generally harmful, most lab specimens
Not subject to packing and shipping reqs…
-blood/plasma from uninfected
-dried blood spots, fecal occult blood on material
-PT samples for research,diag,investigational
Category B is triple packaged
….,…., and …
primary receptacle
secondary packaging
outer packaging
LAW that prohibits discrimination of disabilities either presently,past, perceived to, or associated with someone
ADA
american disablities act
Def of ADA disability…
Def of qualified employee…
physical or mental
limits major life activity
can perform the essential functions of the job or without a reasonable accommodaiton
FEDREAL AGENCY enforces employment , discrimination laws, protects from discrimination such as age, disability, equal pay, race, religion,sex,etc
EEOC
equal employment opportunity
commission
EEOC
equal employment opportunity
commission
Federal law that defines min wage, overtime, how to be paid…
classfied into…and…
FLSA
fair labor standards act
nonexempt: hourly
exempt: salaried
FLSA
fair labor standards act
ACT of 1963 prohibiting discrimnation on race,color,creed,religion,sex etc which now includes disabilities, veterans, 40-70
title 7 civil rights act
Form of insurance providing compensation medical care who are injured on job in exchange for mandatory relinquishment of right to sue, also called compensation bargain
workmans comp
Payments made by goverment to unemployed; proportional to their previous earned salary
unemployment comp
Requires employers with more than 50 employees up to …weeks of unpaid job proteced leave in any…mth period to care for baby,kid,spouse,parent or serious health
can also leave intermittently or reduced schedule when medically necessary without employee permission, can still get benefits and right to return
FMLA
12 weeks unpaid job leave in 12mth period
FMLA
family and medical leave act
Act that provide health insurance for…or…mths after retiring,resigning,laid off, full time to part time, or discharged except for… ….
COBRA
consolidated omnibus budget reconcilation act
18 or 36mths
expect for gross misconduct
Act that
-enables workers to keep health insurance protection when changing jobs
-establishes electronic healthcare trans standards for HHS
-maintain privacy etc health info
HIPAA
HIPAA
health insurance
portability and accountability act
PHI
examples
protected health info
med rec
appt schedule
billing
med list
eval of tecnicial skills..
done…
competency eval
annually
eval of knowledge, skills, attitudes and beliefs…
done…
performance eval
anually
voluntary process non government grants recognition to an individual who has met certain education reqs and has entry level competency by examination
certification
mandatory process some states grant permission to engage in an occupaiton
licensure
voluntary process non government agency grants recognition to an organization that achieved a set predetermined standards
accreditation
Budget items such as salaries and benefits changed based on previous years budget, based on # of tests
forecast budget
Budget with fixed amount of money granted for fixed period of time, 1-2yrs.
Usually government bodies
Appropriation budget
Budget with fixed(overhead) and variable expenses(reagents) are itemilzed.
Usefull when test volume subject to change, thus able to adjust variable portion
Flexible budget
Budget used for continuous managment of ogranization used by lab managers
operational budget
Budget designed for purchase of equipment, expansion of program or remodeling
capital budget
Budget where historical budget is disregarded and new costs/items are made.
Eliminates dead wood
Zero based budget
Budget prepared quarterly and more accurate than annual
Rolling quarter budget
Budget made monthly to anticipate cash flow, received/spent. Predicts timing/amt of cash flow
Cash budget
Cost directly assigned to production of product, billable test, consumables, labor
direct
costs not directly involved in production, personell costs, supervisor,phleb
indirect costs
costs that change with production volume, ie reagents
variable costs
costs that don’t change with production volume, lease on equipement, techs needed
fixed
Fringe benefits can be …% to …%
examples
20-25% of salary
SS tax,FICA
unemployment, workmans comp
health/life/disability insurance
retirement,vacation
sick,maternity
Standardized descriptions of 5 character, alpha numeric codes w/text descripter
coders/billers use to report healthcare services/procedures for reimbursement
CPT
current procedural terminology
CPT
current procedural terminology
Category of CPT describes procedure/service with 5 digits
Category 1 CPT
Category of CPT supplemental tracking for performance measurement
Category II CPT
Category of CPT that is temporary tracking for new and emerging technologies
Category III CPT
Term when procedure was modified but code/def was not changed
examples
CPT code modifier
serum electropho
PLT agg
BF crystals
ie. 91 repeat clinical diag lab test
ICD
ICD-10-CM
international classificaition of diseases
clinical modifications
Oldest method of tracking diseases and mortality in the world. Tabular list with disease code #s, index of disease entries, classification system for procedures
ie. R31.0 asymptomatic hematuria
ICD, International Classification of Diseases
ICD-10-CM
HCPCS codes
healthcare common procedure coding system
Standard HIPAA code set for reporting supplies, orthotic/prostetic devices, durable med equip.
Report healthcare provider and services.
ie.G0001 routine venipuncture for collection of blood
HCPCS
healthcare common procedure
coding system
Acquisition or improvement of work related skills by people already in the workforce. Keeps people up to date on skills etc.
CE
continuing education
Old name for CLSI that develop accredited consensus clin lab standards
NCCLS
national committee for clinical lab standards
Accredits labs under CMS, proficiency testing, and is member based physician organization
CAP
college of american pathologists
Agency that approves new test methodologies/instruments/reagents before consumers can use
FDA
Biosafety hoods inspected…
annually
Federal legislation that regulates most labs
CLIA
Nonprofit that accredits healthcare organizations and programs in the US
JCAHO
joint commision on accreditation of healthcare organization
Labs must have inspections every…
Required by..
2yrs
CLIA
Proficiency testing that doesn’t meet CLIA is
failed SAME analyze in two consecutive PT events or 2 out of 3 testing events
4 examples of alternate PT testing
-split samples sent to other lab or ref lab
-split sample w/established in house method, assayed material or regional pool
-clinical validation by chart review
-participation in ungraded/educational PT program
Split sample
Split sample comparison is performed by splitting a single sample into two aliquots. One aliquot is tested using the primary test method while the second aliquot is tested on by the same or an alternate test method at another acceptable laboratory.
transcription error entering manual result is an example of
post analytical
Most common analytical error
not checking specimen integrity, HIL
Most common post analytical error
clerical error
review procedure…and…
upon implementation and substantial revisians
thermometers must be check against NIST …
annually
Centrifuge speed, timers checked
every 6 mths
Check quarterly
automatic pippetes 4x/yr
CTRL outside 3SD due to
random error
CTRL with 2 consecutive outside 4SD due to
random error
If only one CTRL is out of 2SD/95% what do you do
repeat same CTRL
4 docs req to keep in employee file
-job competency training checklist
-annual peformance appraise
-CE docs
-remedial action docs
CEUs are…by CAP
not mandated
CEUs 3 facts
-required by some states/organizations
-help learn about new stuff
-help with networking
-customer complaints
-monitoring trends for corrected reports are part of
QA
Federal law that requires competency of lab to be documented
CLIA
OSHA reqs safety training at…and then…
orientation, annually
3 OSHA TB plan req
-must get PPD skin tests
-pos PPD must have annual chest xray
-any PT contact must get fit for respirators
fire protocol
Rescue
Alarm, call operator
Contain
Extinguish/evacuate
agency regulate disposal of biohazard waste
EPA
Fed agency regulates facilities that use radioisotopes
NRC
nuclear regulatory commisson
Federal law defines min wage and OT
FLSA
fair labor standards act
Agency enforces equal pay for equal work
EEOC
equal employment
opportunity commision
Title VII, prohibits discrimination in this labor law
civil rights act
HIPAA law requires….to establish standards for PHI
dept of HHS
molecules in solution=undissolved molecules
A homogeneous mixture in which the dissolved substance (solute) is in dynamic equilibrium with its undissolved form.
A…solution contains the maximum concentration of its solute. This maximum concentration is the solute’s solubility limit.
saturated
Another term for analytical precision and repeatability
Coefficiant of variation
QC is a measure of…
reliability
Random due to these two
CTRL outside 3SD
CTRL with 2 consecutive outside 4SD
99.95% purified chemical that can be measured directly
primary standard
derived from the primary and is less pure
Secondary standard
NCCLS
NCCLS
national committee
for clinical lab standards
COBRA
COBRA
consolidated omnibus
budget reconcilation act
laminar flow BSC is BSC #
2
What hazard communication pictogram defines a skin/eye and respiratory irritant?
Exclamation mark
Semi automated calibration method…
Gravimetric
OSHA safety training…
Records kept..
Training annually
Records kept 3yrs
Water ph
7.0
Coefficient of variation tests for…
QC tests for…
CV: analytical precision
QC: reliability
60g NaOH in 1L, normality?
1 Equivalent=40gmw for every 1 valence
60g/L x 1 Equivalent/40g =1.5N
Used as external QC, test accuracy of test methods
Proficiency testing
Under CLIA these two monitor proficiency testing, one requires
CMS requires
Joint commission monitors also
4 Common causes of failed proficiency testing
-Clerical errors
-instrument/method codes
-calibration bias
-not returning on time
An alternative performance assessment to determine reliability of analytical testing.
Split sample testing, alternate proficiency testing
What hazard communication pictogram defines oxidizers
Flame over circle
What hazard communication pictogram defines aquatic toxicity
Environment
What 2 hazard communication pictograms defines acute toxicity
Skull and cross bones
Exclamation mark
What hazard communication pictogram defines explosives, self reactives, organic peroxides
Exploding bomb
What hazard communication pictogram defines eye damage
Corrosion
What hazard communication pictogram defines gases under pressure
Gas cylinder
What hazard communication pictogram defines narcotic effects and hazardous to ozone layer
Exclamation mark
What 2 hazard communication pictogram defines self reactives and organic peroxides
Flame
Exploding bomb
What hazard communication pictogram defines aspiration/target organ/reproductive toxicity
Health hazard
BSL, how many levels
Biosafety levels, 4
BSL1: doesn’t cause disease, most micro practices
BSL 2: disease thru cut, ingest, mucous mem
BSL 3: lethal, serious thru inhalation
BSL 4: risk of aerosol, fatal, no vaccines
BSL 1: standard micro practices
BSL2: standard plus signs, precautions, manual
BSL 3: BSL 2 plus controled access and decontamination
BSL 4: BSL 3 plus change clothes, shower, decontamination
A: paper, wood, cloth
B: combustible liquid
C: energized electrical
D: combustible metals
…
Category of CPT codes:
I: procedure or service
II: supplemental tracking performance measurement
III: temp set of tracking new and emerging technology
ICD codes: tracking diseases, mortality, R##.#
HCPCS: reporting supplies, orthotic/prosthetic medical equipment
G####
The GHS pictogram with an exclamation mark is used on substances that are harmful or irritating.
The health effects are acute (set in quickly), but they’re less severe than something marked with the toxic symbol.
Chemical classes include:
-Skin, eye, or respiratory tract irritants
-Skin sensitizers, which cause an allergic response
-The lowest level of acutely toxic chemicals
-Materials with narcotic effects (drowsiness, lack of coordination, and dizziness)
-ozone
The health hazard pictogram is used for substances that present a health hazard over time.
Chemical classes include:
-Carcinogens, which cause cancer
-Mutagenic chemicals that cause genetic defects
-Agents with reproductive toxicity that affects fertility or in utero development
-Chemicals with target organ toxicity
-Respiratory sensitizers
-Substances with aspiration toxicity
Primary standard is what percent of a purified chemical that can be measured directly
99.95% purified chemical
Oversees FDA, CMS, CDC
Dept HHS
Major bacteria in HIV infection
Mycobacterium
3 parasites with HIV
Pneumocystis
Toxoplasma
Cryptosporidium
2 fungi in HIV
Cryptococcus
Candida
4 viruses in HIV
CMV
EBV
HBV
HSV
Min # standards needed for standard curve
3
Inspections for lab every…
Required by..
2 yrs
CLIA
Molarity calc
gmw/L
Normality calc
1 equ (Each H is 1)/gmw
Centrifuge inspection: time, speed every
6mths
BSA hoods, thermometer every
Year
Lab inspection every
2yrs
Pipettes every
Quarter
QA competency done… Then…
Twice a year then annually
Rule to report to state serious incident
Code 15
Report injury within
48hrs
Passing PT for main lab…
Passing PT for BB…
Fail…
Lab: 80%
BB: 100%
Fail: 2 consecutive PT events for one analyte
QA Records kept
2 years
RCF calc
1.118x 10^-5 x r x rpm^2
RCF NV
Rpm NV
Time
RCF 1-1200
Rpm 3500
10-15 min
Most accurate pipette for Ctrl…
Concentration…
Transfer, volumetric
1:1000
C to F
5/9 x (F-32)
F to C
(9/5 x C) +32
Normal osmolality
275-295
Osmal gap calc
Measured- calculated
CV calc, how much ok
SD/mean x 100
5%
1SD..
2SD…
3SD…
1: 68
2: 95
3: 99
pH calc…
Normal pH…
bicarb/acid…
pH= pKa + log (salt/A)(acid/HA)
7.4
20:1
Beers law con/abs calc
Concen unk/Concen std
Abs unk/Abs std
Copy of Proficiency testing and patient records kept…
BB records kept…
BB products kept..
Pathology kept…
Copy of Proficiency testing and patient records kept…2yrs
BB records kept…5yrs
BB products kept..6mths after expire or whatever is later
Pathology kept…10yrs
QC tests
Reliability
Two rules that indicate random error, no pattern, due to pipetting, electronics, HIL
1-3SD and R4S
2-2S, 4-1S, and 10x indicate…errors that happen…
Systematic happen over time
Gradual loss, accumulation and aging can lead to this systematic error leads to drift from mean on one side
Trend
This is a systematic error that is an abrupt change due to reagent change without Cal, new lot, maintenance or room temp
Shift
Error that’s a warning
1-2S
Deka:
Deci:
Deka: 10*1
Deci: 10^-1
95F is what C
35C
95C is what F
203F
Post exposure, how often tested…
Save blood..
Initial, 3, 6, 12
Blood 90 days
How many BSC…
Which one most micro…
1,2,3
2A
How many BSL
1,2,3,4
Pictogram of exclamation mark for what 6 hazards
Skin, irritants:
-skin sensitizer
-irritant(skin, eye, respiratory tract)
-acute toxicity
-narcotic effects
-hazardous to ozone layer
Pictogram of health hazard(person) of what 6 hazards
-carcinogen
-mutageniticity
-reproductive toxicity
-target organ toxicity
-aspiration toxicity
-respiratory sensitizer
TLA
Total laboratory automation
The move toward total laboratory automation is being driven by forces outside the clinical laboratory, such as healthcare reform and managed care. Developments in automation within the three phases of laboratory testing, robotics, data management, and workflow integration are making the move toward TLA possible.
How must a laboratory operate to handle TB sputum and TM materials?
Biosafety level of 2+ or 3
BSL-3 builds upon the requirements of BSL-2. Organisms that can cause serious or potentially lethal disease through respiratory transmission are typically worked with in a BSL-3 laboratory. Example: Mycobacterium tuberculosis
Absorbance can be calculated easily from percent transmission using which calculation?
2 – log10 %T
Absorbance can be calculated easily from percent transmission using 2 – log10 %T. If all the light passes through a solution without any absorption, absorbance is zero and the %T is 100%. If all the light is absorbed, %T is zero, and absorption is infinite.
What category are agents anthrax, botulism, plague, smallpox, tularemia, filoviruses, and arenaviruses classified as?
Category A are pathogens that are rarely seen in the United States. These agents have the highest priority; organisms in this category pose a risk to national security because they can be easily disseminated or transmitted from person to person and result in high mortality rates and have the potential for major public health impact.
How many points up or down in a row is a trend
A trend is seven points in a row in an upward direction or seven points in a row in a downward direction. With a trend, it doesn’t matter if the centerline is crossed.
Which category of bioterrorism agents include emerging pathogens that could be engineered for mass dissemination in the future because of availability, ease of production and dissemination?
Category C
Bioterrorism agents are a concern to laboratories. These agents are divided into categories A, B and C. The agents that have the third-highest priority are in the Category C and include emerging pathogens. Category C bioterrorism agents have the potential to be engineered for mess dissemination.
What category of testing involves microscopic evaluation (i.e., wet mount, Potassium hydroxide preparation, fern test, etc.) by a physician in the office for their own patient?
Provider-Performed Microscopy (PPM)
To meet the criteria for inclusion in the Provider-Performed Microscopy (PPM) category, procedures must follow these specifications: The examination must be personally performed by the practitioner (defined as a physician), a midlevel practitioner (defined as a physician, a midlevel practitioner under the supervision of a physician), or a dentist. The procedure must be categorized as moderately complex. The primary test instrument is the microscope (limited to brightfield or phase-contrast microscopy). The specimen is labile. Control materials are not available. Specimen handling is limited. Proficiency testing is not required; however, twice-yearly verification of accuracy is required. Those with a PPM certificate can also perform waived testing.
Which three veins are most frequently used for a venipuncture?
Cephalic, basilic, and median cubital
In the arm, the three veins that are typically used for venipuncture are the cephalic, basilic, and median cubital.
In the more common spectrophotometer, the electronic measuring device consists of a ____________ and a galvanometer.
photoelectric cell
The amount of light transmitted by the solution in the cuvette is measured by a photoelectric cell, a sensitive instrument producing electrons in proportion to the amount of light hitting it. The electrons are passed on to a galvanometer, where they are measured.
What is the order of draw for multiple evacuated tubes?
Blood culture (aerobic), blood culture (anaerobic), blue, red, green stopper, lavender, and gray
When collecting multiple tubes of blood, a specified “order of draw” protocol needs to be followed to diminish the possibility of cross contamination between tubes caused by the presence of different additives. Errors in the order of draw can affect laboratory test results.
What category of bioterrorism agents have the highest priority and pose a risk to national security because they can be easily disseminated or transmitted from person to person, result in high mortality rates and have the potential for major public health impact?
Category A
Bioterrorism agents are a concern to laboratories. These agents are divided into categories A, B and C. Category A agents have the highest priority. Anthrax and Smallpox are examples of Category A agents
Which term is defined as blood and blood products, contaminated sharps, pathology waste products, and microbiological waste?
Infectious waste
Infectious waste is to be packaged for disposal in color-coded containers and should be labeled as such with the universal symbol for biohazards.
What category of bioterrorism agents include pathogens that are moderately easy to disseminate, result in moderate and low morbidity rates, and require specific enhancements of the CDC’s diagnostic capacity and enhanced disease surveillance?
Category B
Bioterrorism agents are a concern to laboratories. These agents are divided into categories A, B and C; and Category B agents have the second highest priority. Category B agents have moderate morbidity (suffering from the disease) with low mortality (death) rates. Ricin toxin is an example of Category B agent.
Which category of bioterrorism agents include emerging pathogens that could be engineered for mass dissemination in the future because of availability, ease of production and dissemination?
Category C
Bioterrorism agents are a concern to laboratories. These agents are divided into categories A, B and C. The agents that have the third-highest priority are in the Category C and include emerging pathogens. Category C bioterrorism agents have the potential to be engineered for mess dissemination.
What category are agents anthrax, botulism, plague, smallpox, tularemia, filoviruses, and arenaviruses classified as?
Category A
Category A are pathogens that are rarely seen in the United States. These agents have the highest priority; organisms in this category pose a risk to national security because they can be easily disseminated or transmitted from person to person and result in high mortality rates and have the potential for major public health impact.
In the calculation of MCV = HCT x 10/___?
RBC
MCV is calculated manually by dividing the volume of packed red cells (hematocrit) by the number of red cells, using the formula: MCV= HCT X 10/RBC.
A 200-mg/dL solution was diluted 1:10. This diluted solution was then additionally diluted 1:5. What is the concentration of the final solution?
4 mg/dL
200 mg/dL x 1/10 x1/5 = 200/50 = 4 mg/dL
What demonstrates an abrupt change from the established average value of the control for three days in a row?
Shift
Assaying control specimens and standards along with patient specimens serves several major functions. A shift is defined as a sudden and sustained change in one direction in control sample values. A common cause of a shift is the failure to calibrate reagent when changing lot numbers.
Which substance is employed to produce a chemical reaction?
A reagent is defined as any substance employed to produce a chemical reaction. In highly automated clinical laboratories, very few reagents are prepared by laboratory staff. In many cases, only water or buffer needs to be added to a prepackaged reagent.
3 LAYERS of anticoagulated blood and they’re components/%
Top:
middle:
bottom:
3 LAYERS of anticoagulated blood and they’re components/%
Top: 55%
plasma
-90% water
-10% solutes
middle: 1%
buffy coat
-WBC,PLT
bottom: 45%
rbc
