Laboratory Operations Flashcards
recognition granted by non-governmental agency to institutions that meet certain standards; voluntary
accreditation
examples: AABB, CAP, JCAHO, NAACLS
recognition granted by non-governmental agency to individuals who meet education requirements and demonstrate entry-level competency by passing exam; voluntary
certification
examples: AAB, ASCP, AMT
permission granted by state to individuals/organizations to engage in certain professions/businesses; mandatory; illegal to practice/operate in that state without license
licensure
examples: licensure of lab personnel is required in CA, FL, HI, LA, MT, NV, NY, MD, RI, TN, WV
technical standards and accreditation of blood banks
AABB (formerly American Association of Blood Banks)
standards on all aspects of lab practice developed through voluntary consensus
CLSI (Clinical Laboratory & Standards Institute), formerly NCCLS
standards to facilitate international exchange of goods and services; developed through voluntary worldwide consensus
ISO (international organization for standards)
defines standards for quality management in medical labs
ISO 15189
writes regulations for and enforces CLIA ‘88
Centers for Medicare and Medicaid Services (CMS)
interprets and implements federal regulations related to health care
Department of Health and Human Resources (HHS)
oversees CDC, CMS, FDA, SAMSHA
HHS
regulates packaging, labeling, and transportation of biological products
Department of Transportation (DOT)
regulates disposal of toxic chemicals and biohazardous wastes
Environmental Protection Agency (EPA)
regulates market entry of instruments/reagents and production of donor blood and components; licenses blood banks
Food and Drug Administration (FDA)
licenses labs that use radionucleotides
Nuclear Regulatory Commission (NRC)
regulates employee safety in the workplace
OSHA
certifies laboratories to conduct forensic drug testing for federal agencies
Substance Abuse and Mental Health Services Administration (SAMHSA)
requires employers to inform employees about hazardous substances in workplace and educate them in safe handling
Hazard Communication Standard (OSHA 1983) “Right-to-Know Law”
regulates all lab testing (except research) performed on humans in U.S. Requirements for personnel and quality assurance determined by test complexity; administered by CMS
Clinical Laboratory Improvement Amendments of 1988 “CLIA ‘88”
requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in the lab
Occupation Exposure to Hazardous Chemicals in Laboratories (OSHA 1990) “Laboratory Standard”
mandates work practices and procedures to minimize worker exposure to bloodborne pathogens
Bloodborne Pathogens Standard (OSHA 1991)
requires monitoring of formaldehyde exposure
Formaldehyde standard (OSHA 1992)
regulates use and disclosure of protected health information (PHI)
Health Insurance Portability and Accountability Act of 1996 “HIPAA”
tests cleared by the FDA for home use, negligible likelihood of erroneous results, or no reasonable risk of harm to patient if performed incorrectly
waived
QC of waived tests
none required other than to follow manufacturers guidelines
proficiency testing of waived tests
not required
testing personnel minimum qualifications of waived tests
none specified
certain microscopic exams performed by provider during patient’s visit (e.g., direct wet mount, KOH prep, urine sediment)
Provider-Performed Microscopy (PPM)
QC of PPM
required when controls are available; otherwise reference materials (e.g., photomicrographs) fulfill requirement
PT of PPM
PT not specifically required, but labs must verify accuracy of testing twice annually; can be through PT, split sampling, or blind testing
testing personnel minimum requirements for PPM
physician, midlevel provider, or dentist
score <= 12 on 7 criteria
(knowledge, training/experience, reagent/material prep, characteristics of operational steps, calibration/quality control/proficiency testing materials, test system troubleshooting, interpretation/judgment)
moderate complexity
QC for moderate complexity testing
2 levels of external controls each day of testing
PT for moderate complexity testing
required
testing personnel minimum qualifications for moderate complexity testing
high school diploma or equivalent and training for testing provided
score >12 on 7 criteria
(knowledge, training/experience, reagent/material prep, characteristics of operational steps, calibration/quality control/proficiency testing materials, test system troubleshooting, interpretation/judgment)
high complexity
QC for high complexity testing
2 levels of external controls each day of testing
PT for high complexity testing
required
testing personnel minimum qualifications for high complexity testing
associate degree in medical laboratory technology or equivalent
standard to protect health-care workers from occupational exposure to bloodborne pathogens
Bloodborne pathogens standard of 1991
primary requirements of the Bloodborne Pathogens Standard
- exposure control plan
- universal precautions
- engineering controls
- work practice controls
- personal protective clothing and equipment
- housekeeping
- training
- medical surveillance
- hep b vaccine
- hazard communications
- sharps injury log
blood
potentially infectious
tissues
potentially infectious
semen
potentially infectious
vaginal secretions
potentially infectious
CSF
potentially infectious
synovial fluid
potentially infectious
pleural fluid
potentially infectious
peritoneal fluid
potentially infectious
pericardial fluid
potentially infectious
amniotic fluid
potentially infectious
saliva in dental procedures
potentially infectious
feces
usually not infectious unless visibly bloody
nasal secretions
usually not infectious unless visibly bloody
sputum
usually not infectious unless visibly bloody
sweat
usually not infectious unless visibly bloody
tears
usually not infectious unless visibly bloody
urine
usually not infectious unless visibly bloody
vomitus
usually not infectious unless visibly bloody
packaging of biologics for shipping
- primary container - test tube, vial, etc containing etiologic agent; must be securely closed, watertight, surrounded by absorbent material and placed in secondary container
- secondary container - must be watertight, sealed, and placed in approved mailing container
- mailing container - must be made of fiberboard
- labeling - biohazard label required on primary and mailing containers
- training - employees must be trained and retrained every 2-3 years or when regulations change
also known as “Right-to-Know Law”; “HAZCOM”
Hazard Communication Standard (HCS)
standard to inform employees about chemical hazards in workplace and protective measures
Hazard Communication Standard (HCS)
primary requirements of HCS
- written hazard communication plan
- inventory of hazardous chemicals on site
- hazard labeling
- material safety data sheets (MSDS) for each chemical readily accessible to employees on each shift
- training on initial assignment and when new hazard introduced
also known as “Laboratory Standard”; “Chemical Hygiene Standard”
Occupational Exposures to Hazardous Chemicals in Laboratories Standard
standard to limit employee exposure to hazardous chemicals to levels at or below permissible exposure levels (PELs)
Occupational Exposures to Hazardous Chemicals in Laboratories Standard
primary requirements for the Occupational Exposures to Hazardous Chemicals in Laboratories Standard
1.
visible destruction of human tissue on contact; can cause injury on inhalation or contact
corrosives
e.g., glacial acetic acid, hydrochloric acid, sodium hydroxide
interfere with metabolic processes when ingested, inhaled, or absorbed through skin
toxic substances
e.g. cyanides, sulfides
capable of causing cancer
carcinogens
e.g., benzidine, formaldehyde
induce genetic mutations; cause defects in embryo
mutagens and teratogens
e.g., benzene, lead, mercury, radioactive material, toluene
capable of causing fire
ignitables
e.g., acetone, alcohols, ether, xylene
lowest temperature that produces ignitable vapor
flashpoint
capable of causing an explosion
reactives
e.g., ether, perchloric acid, picric acid, sodium azide
forms explosive peroxides on exposure to air or light; store in explosion-proof refrigerator
ether
may react explosively with organic compounds; separate from other acids
perchloric acid
shock sensitive when dehydrated; more powerful than TNT
picric acid
solutions can form explosive lead or copper azides in drains
sodium azide
Describe the safety diamond.
Blue diamond (left) - health 0 = no hazard 1 = can cause sig. irritation 2 = can cause temp. incapacitation or residual injury 3 = can cause serious or permanent injury 4 = can be lethal
Red diamond (top) - flammability 0 = will not burn 1 = flashpoint above 200*F (must be preheated before ignition can occur) 2 = flashpoint below 200*F (must be heated or high ambient temp. to burn) 3 = flashpoint below 100*F (can be ignited under almost all ambient temps.) 4 = flashpoint below 73*F (will vaporize and readily burn at normal temperatures)
Yellow diamond (right) - instability 0 = stable 1 = normally stable; high temps. make unstable 2 = violent chemical change at high temps. or pressures 3 = may explode at high temps. or shock (shock + heat may detonate) 4 = may explode at normal temps. and pressures (may detonate)
White diamond (bottom) - special hazards ALK = alkaline ACID = acidic COR = corrosive OX = oxidizing Radioactive symbol = radioactive W with line through it = reacts violently or explosively with water W with line through it and OX = reacts violently or explosively with water and oxidizing
storage of acids
(1) store below counter level or in acid cabinets
(2) separate from flammable and combustible material, bases and active metals (e.g., sodium, potassium, magnesium)
(3) separate organic acids from inorganic acids
(4) separate oxidizing acids from organic acids
storage of bases
(1) separate from acids
(2) store inorganic hydroxides in polyethylene containers
storage of flammables
(1) limit amount in work area
(2) store in approved safety cans or cabinets
(3) separate from oxidizing acids and oxidizers
storage of oxidizers
(1) separate from reducing agents (e.g., zinc, alkaline metals, formic acid), flammable, and combustible materials
storage of water-reactive chemicals
(1) keep away from water
(2) store in a dry, cool place
examples of organic acids
formic, glacial acetic, citric
examples of inorganic acids
hydrochloric, nitric, sulfuric
examples of oxidizing acids
chromic, nitric, perchloric, sulfuric
examples of bases
ammonium hydroxide, potassium hydroxide, sodium hydroxide
examples of flammables
acetone, alcohols, xylene
examples of oxidizers
nitric acid, perchloric acid, sulfuric acid, acetic acid, potassium chloride, hydrogen peroxide
examples of water-reactive chemicals
sodium, potassium
Class A fires
combustible material: cloth, wood, paper
extinguishers to use: pressurized water (A) , dry chemical (ABC)
comments: do not use water on electrical fires or burning liquids
Class B fires
combustible material: flammable or combustible liquids
extinguishers to use: dry chemical (ABC), CO2 (BC)
Class C fires
combustible material: electrical equipment
extinguishers to use: dry chemical (ABC), CO2 (BC)
comments: never use water; dry chemical may damage electrical equipment; CO2 leaves no residue; good choice for analyzers, computers
Class D fires
combustible material: combustible metals
extinguishers to use: leave to professional firefighters
What additive/anticoagulant is in a lavendar topped tube?
EDTA
What is the mode of action of EDTA?
prevents clotting by chelating calcium
Which colored tube should be at least 1/2 full?
lavendar
Which anticoagulant/additive prevents platelets from clumping?
EDTA
What is the benefit of using EDTA as an anticoagulant/additive in tubes for CBCs and differentials?
EDTA causes minimal morphologic changes to WBCs
What additive/anticoagulant is in a light green tube?
heparin
What is the mode of action of heparin?
prevents clotting by neutralizing thrombin
What types of tests can be done using tubes with EDTA?
CBC, diff, sed rate
What is the best anticoagulant, additive for prevention of hemolysis?
heparin
Why can’t you use heparin tubes for differentials?
because it creates a blue background
What additive/anticoagulant is in a light blue tube?
sodium citrate
What is the mode of action of sodium citrate?
prevents clotting by binding calcium
What type of tests can be done using tubes with heparin?
many chemistries, osmotic fragility, plasma hemoglobin, blood gases
What type of tests can be done using tubes with sodium citrate?
most coagulation tests
Which additive/anticoagulant preserves labile clotting factors?
sodium citrate
Why should sodium citrate tubes be full (of blood)?
so that a 9:1 blood-to-anticoagulant ratio can be obtained; if NOT, then coag results will be falsely increased
What happens to coagulation results if sodium citrate tubes are not full (of blood)?
the results will be falsely increased
What type of additive/anticoagulant is in a gray topped tube?
sodium fluoride
What is the mode of action of sodium fluoride?
inhibits glycolysis (not an anticoagulant)
Which tube would you use if you wanted to preserve glucose for 24 hours?
gray-top (sodium fluoride)
What is added to a sodium fluoride tube if anticoagulation is needed?
potassium oxalate
What is the mode of action of oxalate?
binds calcium
What is the recommended order for drawing evacuated tubes and filling tubes from a syringe?
1) blood culture [yellow (SPS)] or blood culture bottles
2) coagulation (citrate) [light blue]
3) serum (with/without clot activator; with/without gel) [red, gold, speckled]
4) heparin (with/without gel) [green]
5) EDTA [lavendar, pink, white]
6) glycolytic inhibitor (Na fluoride/K oxalate) [gray]
Why should blood culture tubes/bottles be drawn first?
avoids bacterial contamination from needle that has pierced other stoppers
Why should citrate (light blue) tubes be drawn before other anticoagulant and clot activator tubes?
avoids contamination with additives that can affect coag results
Why should serum (red, gold, speckled) tubes be drawn before green tubes?
avoids contamination with sodium heparin (increased sodium) or lithium heparin (increased lithium)
Why should serum (red, gold, speckled) tubes be drawn before lavendar tubes?
avoids contamination from K2EDTA (decreased calcium, magnesium; increased potassium)
Why should serum (red, gold, speckled) tubes be drawn before gray tubes?
avoids contamination with sodium fluoride/potassium oxalate (decreased calcium; increased sodium; increased potassium; interference with some enzyme assays)
What results would be affected by drawing a green tube before a serum tube?
sodium (increased)
lithium (increased)
What results would be affected by drawing a lavender tube before a serum tube?
calcium (decreased)
magnesium (decreased)
potassium (increased)
What results would be affected by drawing a gray tube before a serum tube?
calcium (decreased)
sodium (increased)
potassium (increased)
interference with some enzyme assays
Why should green tubes be drawn before lavender tubes?
avoids contamination from K2EDTA (decreased calcium, magnesium; increased potassium)
Why should green tubes be drawn before gray tubes?
avoids contamination with sodium fluoride/potassium oxalate (decreased calcium, increased sodium, increased potassium)
What results would be affected by drawing a lavender tube before a green tube?
calcium (decreased)
magnesium (decreased)
potassium (increased)
What results would be affected by drawing a gray tube before a green tube?
calcium (decreased)
sodium (increased)
potassium (increased)
Why should lavender tubes be drawn before gray tubes?
avoids contamination with oxalate, which alters cellular morphology
What would be altered if gray tubes were drawn before lavender tube?
cellular morphology would be altered due to the oxalate
What is the recommended order of filling microcollection tubes from capillary punctures?
1) blood gases - minimizes air exposure
2) EDTA - minimizes clumping of platelets
3) other additive tubes - minimizes clotting
4) serum tubes - clotting is not a concern
What should you do if a phlebotomy patient has an IV?
1) use opposite arm or perform fingerstick
2) have nurse turn off IV for 2 minutes, apply tourniquet below IV site, use different vein if possible; document location of IV and venipuncture, type of fluid
What should you do if a phlebotomy patient has a fistula?
draw from opposite arm
What should you do if a phlebotomy patient has indwelling lines and catheters, heparin locks, cannulas?
1) usually not drawn by lab
2) first 5 mL drawn should be discarded
3) lab may draw below heparin lock if nothing is being infused
What should you do if a phlebotomy patient has sclerosed veins?
select another site
What should you do if a phlebotomy patient has a hematoma?
draw below hematoma
What should you do if a phlebotomy patient has streptokinase/tissue plasminogen activator (TPA)?
1) minimize venipunctures
2) hold pressure until bleeding has stopped
What should you do if a phlebotomy patient has edema?
select another site
What should you do if a phlebotomy patient has scars, burns, or tattoos?
select another site
What should you do if a phlebotomy patient has had a mastectomy?
draw from opposite arm
What should you do if a phlebotomy patient refuses a blood draw?
1) try to persuade
2) if unsuccessful, notify nurse