1.10.24basic Flashcards
Centrifugal force depends on 3 variables…and separates based on…
mass, speed, radiusdensity
speed expressed as…force generated express as…or…angular velocity value…r=
revolutions/min(rpm)relative centrifugal force/RCF or gravity (g)1.118x10*-5r=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)’210 to neg 5*2=squared
CLSI
clinical and lab standards institute
CLSI recommend blood be centrifuged at an RCF of…or…for…min
1,000-1200xgOR3500 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, BNIST recommendedPreferred 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 pipettesemi-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 useA certain volume of air remains between the piston and the liquid.
air displacementie. 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 displacmentie. osmo pipette
Which pipete requires recalibration…how often per year…Two methods used to calibrate…
automatic pipettes, 4x/yrgravimetric 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
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 tipaccuracy is 1:….
transfer or volumetric1:1000
..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
NISTnational institute of standards and tech
Thermistor probe is also called
an electronic probe
3 types of thermometers
mercury/liquid in glassdigitalelectronic/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 calibrationNIST cert of traceability.certificate issued by manufacturer
Temp for incubators, heat blocks, water baths
36-38C
RT
20-24C
Lab fridge…BB fridge…
lab 2-8CBB 1-6C
Lab freezer…BB freezer…
lab <= -20CBB <=-65C
Sln can use as alternative to lens sln…sln not to use…
can use methanol, not xylene
Most common microscope, white light illuminates sample from below…limitation…
brightfieldlow contrast of biological samples
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…
Darkfieldspirochetes
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… …
Electrontissue or tumor markers
Uses fluorescense. High energy light illuminates, emits light of lower frequency. Dyes used to stain structures…Good to view…
FluorescentANA
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 contrastmanual PLT cts
Only transmits polarized lightgood to view…
polarizedcrystals
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 contrastDifferential 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: 10Xlow: 10xhigh:40xoil: 100x
Knob to move slide right and left…knob to move stage forward and backward…
slide right/left: x axis motion knobstage 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 measurement3 for length..1 mass..4 for volume…
length: inch,foot, yardmass: lbvolume: cup, pint, quart, gallon
Metric system is based on decimal system, multiples of tenlength…mass..volume…
length: metermass: gramvolume: liter
luminous intensity in SI
candela
International System of Units/SI worldwide standardized system, recommended by CLSILength:Mass:Time:amt sub:temp: electric current: luminous intensity:
Length: meterMass: kgTime: secamt sub: moletemp: Kelvinelectric current: ampereluminous 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 ratioBUN 24.0Creatinine 2.4Give ratio
10:1
CHOL/HDL ratioTC 200HDL 40
5:1
Which cell lines aren’t included in the Myeloid part of M:E calculationWhich cell line is included in Erythroid ratio
Lymphs and MonosNormoblasts
Write fraction, 1 pt solute to 1 part diluent
1/22 is total volume
pt:pt is
pt analyze + total parts (including diluent)
1:1 dilution=1:21:5
1 pt serum+0 pt diluent1:2 1 pt serum + 1 pt diluent1:5 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, x2five fold, x5ten fold x 10
5% w/w sln equals how much solute to total solutionHow much diluent is added
5g solute per 100g total solution95g 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/100mlx 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/100mlx50ml=1ml of HCl added to 49ml diluent equals total of 50ml
Molarity/M
Have g/L, covert to mole/L by get gmwg/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/L1 Equivalent=gmw/valenceValence is # of H
Osmolality=mOsmol/kg of H2ONormal range…calculation…
Normal range 275-295 mOsm/kg1.86(NA) + GLU/18 + BUN/2.8
Osmolality of NA 150Glu 180BUN 14
294 mOsmol/kg H2)
Osmolar gap
measured-calculated
Concentrated SlnsC1V1=C2V21 is, 2 is
1 is known2 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 assayLess than 5% for most analytical systems
/X is
mean
CV formulaMean is 200, SD is 5, calculate CV
SD/Mean x 1005/200 x 100 =2.5%
Gives an estimated degree of uncertainty. Probability of estimated range…expressed as..
Confidence intervalpercentage
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 +- 0.22SD=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 gapcations: Na, K anions: Cl, CO2Na+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 energy2 formulas:proportional to absorbedversusindirectly proportional to transmitted…
Beers LawA=abcA=2-log%T
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 6.05.25g
Chain of custody things needed…
PT consent, security seal, to addresee onlystore in locked area
Examples of chain of custody
alcohol levels for DUIDOT drug testingpaternity, DNARapeMedical examiner
Digital version of patient medical history/date
EMRelectronic medical record
Series of computer network that interconnects computers in a limited area like hospital, using network media
LANlocal area network
A computer network that interconnects computers in a broad area such as international, using private or public network trainsports
WANwide area network
Comprehenstive integrated info system to manage medical, admin, financial, and legal aspects of a hospital/services
HISHospital info system
Computer software providing services to software apps beyond those available to the operating systemSoftware 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
CPOEcomputerized 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…
CLIAplublished 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 usesimple/accurate as to pose no reasonable risk if performed incorrectly
Examples of waived
blood glucose/cholesterolurine prego, dipstick/tablet urinalysisovulationnonautomated ESRspun HCTHmg copper sulfateHmg by single analyze instruments
Who determines if a test meets criteria for being a waived test
HHSDept 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 HHS2yrs
External quality control to verify accuracy of lab test methods
PTproficiency testing
Proficiency testing is required by… under…Usually done …times per yearNot required for…
CMS, under CLIA3 times per yearnot 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 analyzeexcept with immunoheme, some are..
80%100%
Unsatisfactory PT
same analyte in 2 consecutiveOR2 out of 3 testing events
Alternate/Split sample testing can be done for PT if…
approved PT isn’t availableSPLIT 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 authorizationwithin 30 days
Standard that requires the use of at least 2 pt ids…3 examples of ids
Joint CommisionNational 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 yrsHHS
Examples of analytical testing
reagents, calibration, QC, tempsrecording resultsverify normal rangecompetency 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
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 calculationsreporting resultsID/notify panic filingdata 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 methodCan use sera/BF thats stable for at least…
controlsa year
Control reqs
should be pt likerun at lease 2 levelsstablenever used to calibrate
Term that is the agreement between the measured quanitity and its true valueHow 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
CVcoefficient 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 left68.2% 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 preciseAccurate test results fall w/in acceptable limits of +/-…SDs….% of the time
Levey Jennings chart2SD
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 mean2 consecutive results fall outside 2SD1 result falls outside 3SD
6 steps in finding source of signal errors
- clerical2. reagent3. procedural/maintainence4. retest ctrl5. recalibrate instrument/new ctrl6. 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 instrumentinterfering substancesRemedy: 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 errorshift or trends
Error where data pts gradually drift from the mean.Gradual loss of reliability.
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 warning1 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 +/- 4SDMay 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 interval95%
If no existing analyze or methodology exists to do comparative studies, need ….to… peopleIf 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
120-70040
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%ortrue 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%ortrue 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
POCTpoint of care 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 testsmore 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 eventA 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 missA 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 adminthe US dept of laborfederal 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 reactivesSelf 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
-irritant(skin, eye)-skin sensitizer-respiratory tract irritant-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, year3yrs
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 labelevated…and…two ab and correlation…done with…
elevated ALT, biliIgM=diseaseIgG=immunitydone with EIA
Hep B transmitted thru these 3
-sex-needs/IV drug-transfusion
Hep B incubation period…95% are…or…5% are..
asymptomatic or acutechronic
Order of apperance of HepB markers
-HBV DNA-HBsAg-HBeAg-anti-HBc-anti-HBe-anti-HBs
First detectable Hep B marker…detected using…
HBV DNANAT
Two Hep B antigens in acute phase, very infectious
HBsAgHBeAg
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 HCVRT 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 drugCD4+ T cells
Opportunisitc pathogens in HIV:3 Parasites…4 viruses…2 fungi…1 bacteria….
Parasites-crytosporidium-pneumocystis-toxoplasmaviral-HBV, CMV, EBV, HSVFungal-candida-CryptococcusBacteria-mycobacterium
Two types of HIV…Dominant one worldwide…which one is slower…
HIV1,2Dominant HIV1Slower HIV2
Groups in HIV1
M,N,O
Incubation period for HIV…full blown AIDS when CD4 drows below…
18mths200 cell/microL
Reversal of T Helper to suppresor CD4:CD8,what is normal ratio, ratio in HIV
normal >1.5HIV <0.5
Name of therapy that interferes with any aspect of HIV rep/spread
HAARThightly 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 usageinvasive procedures w/bleedinglarge amount of bloodspill,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 months90 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 1negative 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…BCSsCertified once installed, then…..
BSC 2Aannually
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 practicesexamples 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 precausingsie. 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, decontaminationM.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/treatmentBSL3 practice and clothing change, shower, decontaminationEbola, 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
3 types of gas stored in cylinders…and examples
liquefied: chlorine, propane, CO2nonliquefied: helium, nitrogendissolved 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/CStored in…
100F/37Cflammable liquid safety cabinet
Safety color coding:red means 3 things…yellow means…orange means..fluorescent orange…Color is contrasted with…
red: fire, danger, stopyellow: cautionorange: warningfluorescent orange: bio hazardblack
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
NFPAnational fire protection agency
Blue diamond…0-4…
health hazardnormal to deadly
Red diamond…0-4…
fire hazardwon’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
reactivity0-4stable, may detonate
Fire with ordinary combustible material…Such as…
Class Apaper, wood, clothsome rubber, plastic
Fire w/flammable or combustible liquid….Such as…
Class Bgasses, greasessome rubber, plastic
Fire w/energized electric equipment
Class C
Fire w/combustible metal…such as…
Class Dmag,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 dangerActivate alarm, callConfine fireExtinguish or evacuate
Extinguisher acroynym
Pull pinAim at baseSqueeze handleSweep 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 commisionas low as reasonably achievable
Federal agency regulates disposal of toxic/bio hazardous waste
EPAenvironmental protection agency
Act that gives EPA authority to control hazardous waste such as generation, trans, treatment, storage, disposal
RCRAresouce conservation and recovery act
Hazardous waste def…RCRA def…
any waste w/properties that make it dangerous or potentially harmful to environment or public healthRCRA: 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
DOTdept of trans
IATA..purpose…
international air transport associationregulate packing,shipping by air
DOT training req within… and every…
90 days3yrs
DOT HMR…requires…
Hazardous material regulationsshipper to adhere to pretrans reqs
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
ICAOIMO
international civil aviation organizationinstructions for safe transport by airinternational maritime organizationby 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, BA: harmB: 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 receptaclesecondary packagingouter packaging
LAW that prohibits discrimination of disabilities either presently,past, perceived to, or associated with someone
ADAamerican disablities act
Def of ADA disability…Def of qualified employee…
physical or mentallimits major life activitycan 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
EEOCequal employment opportunitycommission
EEOC
equal employment opportunitycommission
Federal law that defines min wage, overtime, how to be paid…classfied into…and…
FLSAfair labor standards actnonexempt: hourlyexempt: 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 healthcan also leave intermittently or reduced schedule when medically necessary without employee permission, can still get benefits and right to return
FMLA12 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… ….
COBRAconsolidated omnibus budget reconcilation act18 or 36mthsexpect 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
PHIexamples
protected health infomed recappt schedulebillingmed list
eval of tecnicial skills..done…
competency evalannually
eval of knowledge, skills, attitudes and beliefs…done…
performance evalanually
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 salarySS tax,FICAunemployment, workmans comphealth/life/disability insuranceretirement,vacationsick,maternity
Standardized descriptions of 5 character, alpha numeric codes w/text descriptercoders/billers use to report healthcare services/procedures for reimbursement
CPTcurrent 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 changedexamples
CPT code modifierserum electrophoPLT aggBF crystalsie. 91 repeat clinical diag lab test
ICDICD-10-CM
international classificaition of diseasesclinical modifications
Oldest method of tracking diseases and mortality in the world. Tabular list with disease code #s, index of disease entries, classification system for proceduresie. R31.0 asymptomatic hematuria
ICD, International Classification of DiseasesICD-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
HCPCShealthcare common procedurecoding system
Acquisition or improvement of work related skills by people already in the workforce. Keeps people up to date on skills etc.
CEcontinuing education
Old name for CLSI that develop accredited consensus clin lab standards
NCCLSnational committee for clinical lab standards
Accredits labs under CMS, proficiency testing, and is member based physician organization
CAPcollege 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
JCAHOjoint commision on accreditation of healthcare organization
Labs must have inspections every…Required by..
2yrsCLIA
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
RescueAlarm, call operatorContainExtinguish/evacuate
agency regulate disposal of biohazard waste
EPA
Fed agency regulates facilities that use radioisotopes
NRCnuclear regulatory commisson
Federal law defines min wage and OT
FLSAfair labor standards act
Agency enforces equal pay for equal work
EEOCequal employmentopportunity 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 moleculesA 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 3SDCTRL 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
NCCLSnational committee for clinical lab standards
COBRA
COBRAconsolidated omnibus budget reconcilation act
laminar flow BSC is BSC #
2
What hazard communication pictogram defines a skin irritant?
Exclamation mark
What hazard communication pictogram defines a skin irritant?
Exclamation mark
What hazard communication pictogram defines a skin/eye and respiratory irritant?
Exclamation mark
Semi automated calibrated with
GravimetricAccuracy of volume is dispensed and adjusted accordingly to the weight
OSHA safety training…Records kept..
Training annuallyRecords kept 3yrs
Water ph
7.0
Coefficient of variation tests for…QC tests for…
CV: analytical precisionQC: 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 bonesExclamation 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
FlameExploding 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 practicesBSL 2: disease thru cut, ingest, mucous mem BSL 3: lethal, serious they inhalation BSL 4: right of aerosol, fatal, no vaccines
BSL 1: standard micro practices BSL2: standard plus signs, precautions, manualBSL 3: BSL 2 plus controled access and decontamination BSL 4: BSL 3 plus change clothes, shower, decontamination
A: paper, wood, clothB: combustible liquidC: energized electricalD: 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 equipmentG####
