Review Cards - Lab Operations, Management, & Education Flashcards
Recognition granted by nongovernmental agency to institutions that meet certain standards; voluntary
A. Certification
B. Accreditation
C. Licensure
D. None of the above
B. Accreditation
Examples: AABB, CAP, JCAHO, NAACLS
Recognition granted by nongovernmental agency to individuals who meet education requirements and demonstrate entry-level competency by passing the exam; voluntary
A. Certification
B. Accreditation
C. Licensure
D. None of the above
A. Certification
Examples: ASCP, AAB, AMT
Permission granted by the state to individuals/organizations to engage in certain professions/businesses; mandatory
A. Certification
B. Accreditation
C. Licensure
D. None of the above
C. Licensure
Examples: states
Technical standards & accreditation of blood banks
A. Food & Drug Administration (FDA)
B. Centers for Disease Control (CDC)
C. Association for the Advancement of Blood and Biotherapies (AABB)
D. Environmental Protection Agency (EPA)
C. Association for the Advancement of Blood and Biotherapies (AABB)
Standards and guidelines primarily related to infection control and safe work practices
A. Food & Drug Administration (FDA)
B. Centers for Disease Control & Prevention (CDC)
C. Association for the Advancement of Blood and Biotherapies (AABB)
D. Environmental Protection Agency (EPA)
B. Centers for Disease Control & prevention (CDC)
Standards on all aspects of lab practice developed through voluntary consensus
A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
B. Clinical Laboratory & Standard Institute (CLSI, formerly NCCLS)
Standards to facilitate international exchange of goods & services; developed through voluntary worldwide consensus; ISO 15189 defines standards for quality management in medical labs
A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
A. International Organization for Standardization (ISO)
Writes regulations for and enforces Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88)
A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
C. Centers for Medicare & Medicaid Services (CMS)
Interprets & implements federal regulations related to healthcare; oversees CDC, CMS, FDA, SAMSHA
A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. Department of Health & Human Services (HHS)
D. Department of Health & Human Services (HHS)
Regulates packaging, labeling, & transportation of biological products
A. Environmental Protection agency (EPA)
B. Department of Transportation (DOT)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
B. Department of Transportation (DOT)
Regulates disposal of toxic chemical & biohazardous wastes
A. Environmental Protection Agency (EPA)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
A. Environmental Protection Agency (EPA)
Regulates market entry of instruments/reagents & production of donor blood & components; licenses blood banks
A. AABB
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. Food and Drug Administration (FDA)
D. Food & Drug Administration (FDA)
Licenses labs that use radionucleotides
A. International Organization for Standardization (ISO)
B. Nuclear Regulatory Commission (NRC)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
B. Nuclear Regulatory Commission (NRC)
Regulates employee safety in the workplace
A. Substance Abuse and Mental Health Services Administration (SAMSHA)
B. Centers for Disease Control & Prevention (CDC)
C. Centers for Medicaid and Medicare Services (CMS)
D. Occupational Health & Safety Administration (OSHA)
D. Occupational Health & Safety Administration (OSHA)
Certifies laboratories to conduct forensic drug testing for federal agencies
A. Substance Abuse and Mental Health Services Administration (SAMSHA)
B. Centers for Disease Control & Prevention (CDC)
C. Centers for Medicaid and Medicare Services (CMS)
D. Occupational Health & Safety Administration (OSHA)
A. Substance Abuse and Mental Health Services Administration (SAMSHA)
Requires employers to inform employees about hazardous substances in workplace & educate them in safe handling
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above
B. Hazard Communication Standard (OSHA 1983)
“Right-to-know Law”
Regulates all lab testing (except research) performed on humans in the USA; requirements for personnel & quality assurance determined by test complexity; administered by CMS
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above
A. Clinical Laboratory Improvement Amendments of 1988
“CLIA ‘88”
Requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in labs
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990)
D. Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990)
“Laboratory Standard”
Mandates work practices & procedures to minimize worker exposure to bloodborne pathogens
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above
C. Bloodborne Pathogens Standard (OSHA 1991)
Requires monitoring of formaldehyde exposure
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Formaldehyde Standard (OSHA 1992)
D. None of the above
C. Formaldehyde Standard (OSHA 1992)
Regulates use & disclosure of protected health information (PHI)
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Health Insurance Portability and Accountability Act of 1996
D. None of the above
C. 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 tests
Quality control for waived tests
None required other than to follow manufacturers directions
Certain microscopic exams performed by provider during patient’s visit (e.g., direct wet mount, KOH prep, urine sediment)
Provider-Performed Microscopy (PPM)
(It is a subcategory of moderate complexity)
Quality control for PPM
Required when controls are available; otherwise, reference materials (e.g., photomicrographs) fulfill requirement
Criteria for moderate complexity tests
Score </=12 on 7 criteria
Quality control for moderate complexity tests
2 levels of external controls per 24 hours
Is proficiency testing required for 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 requirements for PPM
Physician, mid level provider, or dentist
Testing personnel requirements for moderate complexity tests
High school diploma or equivalent & training for testing performed
Criteria for high complexity tests
Score >12 on 7 criteria
Quality control for high complexity tests
2 levels of external controls per 24 hours (except coagulation testing, which requires 2 levels every 8 hours, and blood gases, which require 3 levels every 24 hours)
Testing personnel requirements for high complexity tests
Associates degree in medical laboratory technology or equivalent
Standard published in 1991 (revised in 2001) to protect healthcare workers from occupational exposure to bloodborne pathogens
bloodborne pathogens standard
Primary requirements of the Bloodborne Pathogens Standard (BBPS)
Exposure control plan
Universal precautions
Engineering controls
Work practice controls
Personal protective clothing & equipment
Housekeeping
Training
Medical surveillance
Hepatitis B vaccine
Hazard communication
Sharps injury log
Determination of employees risk of exposure & implementation to control exposure; plan must be reviewed & updated annually to reflect new technologies; Documentation of evaluation &adoption of safer devices is required.
Exposure control plan (BBPS)
All blood & certain body fluids are to be handled as if known to be infectious for bloodborne pathogens
Universal precautions (BBPS)
Control measures that isolate or remove a hazard from the workplace, e.g., sharps containers, self-sheathing needles, plastic capillary tubes, Plexiglass shields
Engineering controls (BBPS)
E.g., hand washing, disposal of needles with safety device activated & holder attached, ban on eating/drinking/smoking in lab
Work practice controls (BBPS)
E.g., proper disposal of biohazardous waste, decontamination of work surfaces
Housekeeping (BBPS)
E.g., lab coats, gloves, face shields
Must be provided by employer.
Personal protective equipment & clothing
BBPS training requirements
On assignment and annually thereafter
Postexposure evaluation & follow-up at no cost to the employee
Medical surveillance (BBPS)
BBPS Hepatitis B vaccine requirements
Provided by employer within 10 days of assignment at no cost to employees
E.g., biohazard labels, red bags
Hazard communication (BBPS)
BBPS sharps injury log requirements
Must include description & location of incident, device involved. Employee privacy must be protected.
Specimens that are potentially infectious
Blood
Tissues
Semen
Vaginal secretions
CSF
Synovial fluid
Pleural fluid
Peritoneal fluid
Pericardial fluid
Amniotic fluid
Saliva in dental procedures
Specimens that are usually NOT infectious (unless visibly bloody)
Feces
Nasal secretions
Sputum
Sweat
Tears
Urine
Vomitus
Packaging requirements of biologics for shipping
Primary container - test tube, vial, etc containing etiologic agent - securely closed, watertight, surrounded by absorbent material and placed in secondary container
Secondary container - watertight, sealed & placed in approved mailing container
Mailing container - made of fiberboard
Labeling - biohazard label on primary & mailing containers
Training - every 2-3 years or when regulations change
Issued by OSHA in1983; written for the manufacturing industry, but courts expanded jurisdiction to clinical labs
Hazard Communication Stands (HCS)
(Also known as the “Right-to-Know” law; “HAZCOM”)
Primary requirements of the Hazard Communication Standard
1.) written hazard communication plan
2.) inventory of hazardous chemicals on site
3.) hazard labeling
4.) material safety data sheet (MSDS) for each chemical readily accessible to employees on each shift
5.) training on initial assignment & when new hazard introduced
Issued by OSHA in 1990; extension of the hazard communication standard written specifically for labs
Occupational Exposures to Hazardous Chemicals in Laboratories Standard
(Also known as “Laboratory Standard”; “Chemical Hygiene Standard”)
Purpose of the Occupational Exposures to Hazardous Chemicals in Laboratories Standard
To limit employee exposure to hazardous chemicals to levels at or below permissible levels (PELs)
Purpose of the Hazard Communication Standard
To inform employees about chemical hazards in workplace & protective measures
Primary requirements of the Occupational Exposures to Hazardous Chemicals in Laboratories Standard
1.) written chemical hygiene plan outlining SOPs for use, storage, exposure control, & disposal of hazardous chemicals
2.) designation of chemical hygiene officer
3.) hazard ID and labeling
4.) MSDS for each chemical
5.) use of PPE
6.) proper maintenance of file hoods & other protective equipment
7.) monitoring employee exposure
8.) medical exams at no cost to employee
9.) training on initial assignment & before assignments involving new exposures
Causes visible destruction of human tissue on contact; can cause injury on inhalation or contact
Corrosives (glacial acetic acid, hydrochloric acid, sodium hydroxide)
pH of corrosives
Chemicals with pH <2 or >12
Should inorganic acids be separated from organic acids?
Yes
What happens when concentrated acids or bases are mixed with water?
It can generate large amounts of heat.
Substances that interfere with metabolic processes when ingested, inhaled, or absorbed through the skin
Toxic substances (cyanides, sulfides)
What are threshold limit values (TLVs)?
Safe level of exposure
Substances capable of causing cancer
Carcinogens (Benzidine, formaldehyde)
Mutagens
Induce genetic mutations
Teratogens
Cause defects in the embryo
Examples of mutagens & teratogens
Benzene, lead, mercury, radioactive material, toluene
Ignitables
Substances that cause fire
Examples of ignitables
Acetone, alcohols, ether, xylene
Lowest temperature that produces ignitable vapor
Flashpoint
Flashpoint for flammables
<37.7C
Flashpoint of combustibles
> =37.7C
Chemicals that cause explosions
Reactives (ether, perchloric acid, sodium azide)
Storage of ether
Ether forms explosive peroxides on exposure to air or light; store in explosion-proof refrigerator
Storage of perchloric acid
It may react explosively with organic compounds; separate from other acids
A reactive that is shock sensitive when dehydrated and more powerful than TNT
Picric acid
A solution that can form explosive lead or copper azides in drains
Sodium azide
NFPA Hazmat Diamond - Blue
(Left)
Hazard: health
0 - no hazard
1 - can cause significant irritation
2 - can cause temporary incapacitation or residual injury
3 - can cause serious or permanent injury
4 - can be lethal
NFPA Hazmat Diamond - Red
(Top)
Hazard: Flammability
0 - will not burn
1 - must be preheated for ignition to occur
2 - must be heated or in increased ambient temp to burn
3 - can be ignited under almost all ambient temps
4 - will vaporize & burn at normal temps
NFPA Hazmat Diamond - Yellow
(Right)
Hazard: Instability
0 - stable
1 - increased temp makes unstable
2 - violent chemical change at increased temp or pressures
3 - May explode from increased temp or shock
4 - May explode at normal temp & pressures
NFPA Hazmat Diamond - White
(Bottom)
Hazard: special hazards
W = unusual reactivity with water
OX = oxidizer
ALK = alkaline
How should acids be stored?
Store below counter level or in acid cabinets.
Separate from flammable & combustible material, bases, & active metals (e.g., sodium, potassium, & magnesium).
Separate organic acids from inorganic acids.
Separate oxidizing acids from organic acids.
Is formic acid an organic, inorganic, or oxidizing acid?
Organic acid
Is glacial acetic acid an organic, inorganic, or oxidizing acid?
Organic acid
Is citric acid an organic, inorganic, or oxidizing acid?
Organic acid
Is hydrochloric acid an organic, inorganic, or oxidizing acid?
Inorganic acid
Is nitric acid an organic, inorganic, or oxidizing acid?
Inorganic acid and oxidizing acid
Is sulfuric acid an organic, inorganic, or oxidizing acid?
Inorganic acid and oxidizing acid
Is chromic acid an organic, inorganic, or oxidizing acid?
Oxidizing acid
Is perchloric acid an organic, inorganic, or oxidizing acid?
Oxidizing acid
How should bases be stored?
Separate from acids.
Store inorganic hydroxides in polyethylene containers.
Examples of bases.
Ammonium hydroxide, potassium hydroxide, sodium hydroxide
How should flammable chemicals be stored?
Limit amount in work area.
Store in approved safety cans or cabinets.
Separate from oxidizing acids & oxidizers.
Examples of flammable chemicals used in the lab
Acetone
Alcohols
Xylene
How should oxidizers be stored?
Separate from reducing agents (e.g., zinc, alkaline metals, formic acid), flammables & combusting materials
Examples of oxidizers
Nitric acid
Perchloric acid
Sulfuric acid
Acetic acid
Potassium chloride
Hydrogen peroxide
How do you store water-reactive chemicals?
Keep away from water. Store in a dry, cool place.
Examples of water-reactive chemicals
Sodium
Potassium
Class A fire - combustible material
Cloth, wood, paper
What extinguisher(s) should be used in class A fires?
Pressurized water (A)
Dry chemical (ABC)
Class B fire - combustible material
Flammable or combustible liquids
What type of fire extinguisher(s) would you use on a class B fire?
Dry chemical (ABC)
CO2 (BC)
Class C fire - combustible material
Electrical equipment
What type of fire extinguisher(s) would you use for class C fires?
Dry chemical (ABC)
CO2 (BC)
Dry chemical can damage computers, analyzers.
Class D fires - combustible material
Combustible metals
What type of fire extinguisher would you use on class D fires?
Leave to professional firefighters
Anticoagulant in a lavender tube
EDTA
EDTA - mode of action
Prevents clotting by chelating Ca2+
EDTA - examples of use
CBC
Diff
Sed rate
Why are EDTA (lavender) tubes used?
Prevents platelets from clumping.
Minimal morphologic changes to WBCs.
EDTA tube - special requirements
Tube should be at least 1/2 full
Anticoagulant/additive in a green tube
Heparin
Heparin - mode of action
Prevents clotting by neutralizing thrombin
Tube used for most chemistries
Green (heparin)
Tube used for osmotic fragility
Green (heparin)
Tube used for plasma hemoglobin
Green (heparin)
Tube used for blood gases
Green (heparin)
Tube used for CBC, diff, and sed rate
Lavender (EDTA)
Best anticoagulant for prevention of hemolysis
Heparin (green tube)
Why would you NOT use a heparin tube for diffs?
Blue background
Anticoagulant/additive in a blue tube
Sodium citrate
Sodium citrate - mode of action
Prevents clotting by binding Ca2+
Tube used for most coagulation tests
Light blue (sodium citrate)
Why should a sodium citrate tube be used for coagulation tests?
Preserves labels clotting factors
Sodium citrate tube - special requirements
Tube must be full for 9:1 blood-to-anticoagulant ratio or coagulation results will be falsely increased.
How can you ensure that a 9:1 blood-to-anticoagulant has been achieved when drawing a sodium citrate tube using a butterfly?
Use a discard tube to clear the air from the tubing
When should you reduce sodium citrate?
When hematocrit is >55%
Anticoagulant/additive in a gray tube
Sodium fluoride
Sodium fluoride - mode of action
Inhibits glycolysis (not an anticoagulant)
Sodium fluoride - examples of use
Glucose
Lactic acid
Blood alcohol
How long does sodium fluoride preserve glucose?
24 hours
What can be added to sodium fluoride if anticoagulation is needed?
K oxalate - binds Ca2+
Order of draw
Blood culture (yellow [SPS] or bottle)
Coagulation (light blue)
Serum (red, gold, speckled)
Heparin (green)
EDTA (lavender, pink, white)
Glycolytic inhibitor (gray)
Why should a blood culture be drawn first?
Avoids bacterial contamination from the needle that has pierced other stoppers
Why is a coagulation tube (light blue) drawn before other anticoagulant & clot activator tubes?
Avoids contamination with additives that can affect coagulation results.
When should a royal blue tube (no additive) be drawn?
Before a coag tube (light blue)
Why should a serum tube be drawn before a heparin tube?
Avoids contamination with sodium heparin (increased sodium) or lithium heparin (increased lithium).
Why should a serum tube be drawn before a lavender tube?
Avoids contamination from K2EDTA (decreased magnesium and calcium; increased potassium)
Why should a serum tube be drawn before a gray top tube?
Avoids contamination with sodium fluoride/potassium oxalate (decreased calcium; increased sodium and potassium)
Why should an EDTA tube be drawn before a gray tube?
Avoids contamination with oxalate, which alters cellular morphology
Order for filling microcollection tubes from capillary punctures
Blood gases - minimizes exposure to air
EDTA - minimizes clumping of platelets
Heparin - fill after EDTA if CBC needed
Other additive tubes - minimizes clotting
Serum tubes - clotting is not a concern
Phlebotomy - IV - course of action
Use opposite arm or perform fingerstick, if possible; otherwise, have nurse turn of IV for 2 minutes, apply tourniquet below IV, use different vein (if possible).
Document location of IV & venipuncture, type of fluid.
Phlebotomy - fistula - course of action
Draw from opposite arm
Phlebotomy - indwelling lines & catheters, heparin locks, cannulas - course of action
Usually it drawn by lab.
First 5 ml drawn should be discarded.
Lab May draw below heparin lock of nothing is being infused.
Phlebotomy - sclerosed veins - course of action
Select another site
Phlebotomy - hematoma - course of action
Draw below
Phlebotomy - streptokinase/tissue plasminogen activator (TPA) - course of action
Minimize venipunctures.
Hold pressure until bleeding has stopped.
Phlebotomy - edema - course of action
Select another site
Phlebotomy - scars, burns, tattoos - course of action
Select another site
Phlebotomy - mastectomy - course of action
Draw from opposite arm
Phlebotomy - patient refuses - course of action
Try to persuade. If unsuccessful, notify nurse. Never draw without consent; could lead to charges of assault & battery.
Phlebotomy - unidentified patient - course of action
Ask nurse to identify before drawing.
Phlebotomy - fasting
Nothing to eat or drink (except water) for at least 8 hours
fasting blood sugar, triglycerides, lipid panel, gastric, insulin
Phlebotomy - chilling
Place in slurry of crushed ice & water. Do not use ice cubes alone because RBCs may lyse.
ACTH, acetone, ammonia, gastric, glucagon, lactic acid, pyruvate, PTH, renin
Phlebotomy - warming
Use 37*C heat block, heel warmer, or hold in hand
cold agglutinins, cryoglobulins
Phlebotomy - protection from light
Wrap in aluminum foil
bilirubin, carotene, erythrocyte protoporphyrin, vitamin A, vitamin B12
Phlebotomy - chain of custody
Chain of custody form. Lock box may be required.
any test used as evidence in legal proceedings; e.g., blood alcohol, drug screens, DNA analysis
Phlebotomy - misidentification of patient - possible effect
Treatment errors
Transfusion fatality
Phlebotomy - drawing at incorrect time - possible effect
Treatment errors if samples for certain tests aren’t drawn at appropriate time, e.g., therapeutic drug monitoring, analytes that exhibit diurnal variation, analytes that are affected by recent eating/drinking
Phlebotomy - improper skin disinfection - possible effect
Infection at site of puncture.
Contamination of blood cultures & blood components.
Isopropyl alcohol wipes can contaminate samples for blood alcohol.
Phlebotomy - drawing from edematous site - possible effect
Dilution of sample with tissue fluid
Phlebotomy - fist pumping during venipuncture
Increased potassium, lactic acid, calcium, phosphorus
Decreased pH
Phlebotomy - tourniquet >1 minute - possible effect
Increased potassium, total protein, lactic acid
Phlebotomy - IV fluid contamination - possible effect
Increased glucose, electrolytes (depending on IV)
Phlebotomy - expired collection tubes - possible effect
Decreased vacuum - failure to obtain a specimen
Phlebotomy - incorrect anticoagulant or contamination from incorrect order of draw - possible effect
K2EDTA before serum or heparin tube = decreased calcium and magnesium; increased potassium
Contamination of citrate tube with clot activator = erroneous coagulation results
Phlebotomy - failure to hold bottom of tube lower than top during collection - possible effect
Carryover from one tube to another = possible additive contamination
Phlebotomy - short draws - possible effect
Incorrect blood:anticoagulant ratio affects some results, e.g., coagulation tests
Phlebotomy - inadequate mixing of anticoagulant tube - possible effect
Micro-clots, fibrin, platelet clumping can lead to erroneous results
Phlebotomy - hemolysis from alcohol contamination, “milking” site of capillary puncture, probing with needle, vigorous shaking of tubes, exposure of samples to extremes of temperature - possible effect
Increased potassium, magnesium, LD, iron
Phlebotomy - how long should you allow serum & gel separator tubes to clot to avoid fibrin strands?
30-60 minutes
What is the timeframe to centrifuge after collection?
Within 2 hours
How long and for what RCF should you spin citrate tubes to produce platelet-poor plasma?
1500 RCF for 15 minutes
How long to spin most tubes and at what RCF?
1,000-3,000 RCF for 10-15 minutes
How do you avoid loss of CO2 , change in pH, evaporation, or aerosol formation during centrifugation?
Keep tubes capped
Why should primary tubes not be re-spun?
It can cause hemolysis.
What should you do if you must re-Alina primary tube?
Transfer serum/plasma to another tube
Why should serum separator tubes not be re-spun?
Serum in contact with RBCs under gel can be expressed & increase potassium
What is the timeframe for separating serum or plasma from cells?
Within 2 hours of collection (exception: centrifuged gel tubes)
How long can serum/plasma be kept at room temperature?
8 hours
How long can serum/plasma be kept at 2-8*C?
48 hours
Can whole blood be frozen?
No
Tubes are in horizontal position when rotating; produces a tightly packed, flat sediment surface; recommended for serum separator tubes
Horizontal-head centrifuge (swinging bucket)
Tubes are at fixed angle (25-40*C) when rotating; capable of higher speeds; produces a slanted sediment surface that isn’t tightly packed; decantation is not recommended
Angle-head centrifuge
High-speed centrifuge; capable of 100,000 rpm; refrigerated to reduce heat
Ultra centrifuge
Types of glass - high resistance to thermal shock & chemical attack; heavy walls to minimize breakage; used for most beakers, flasks, & pipets; minimal contamination of liquids by elements in glass; can be heated and autoclaved
Borosilicate glass (Kimax, Pyrex)
Types of glass - 6 times stronger than borosilicate; better able to resist clouding due to alkali & scratching
Aluminosilicate glass (Corex)
Types of glass - used for highly alkaline solutions; alkali resistant; poor heat resistance
Boron free
Types of glass - heat, chemical, & electrical tolerance; excellent optical properties; used for high-precision analytic work, optical reflectors, mirrors
High silica
Types of glass - soda-lime glass containing oxides of sodium, silicon, & calcium; least expensive but poor resistance to high temperatures & sudden changes of temperature; only fair resistance to chemicals; can release alkali & affect some determinations; used for some disposable glassware
Flint glass
Types of glass - amber or red; used to decrease exposure to light, e.g., bilirubin standards
Low actinic
Types of plastic - relatively inert chemically; resistant to most acids, alkalis, & salts; can be autoclaved; used for piper tips, test tubes
Polypropylene
Types of plastic - relatively inert chemically; resistant to most acids (except concentrated H2SO4), alkalis, & salts; used for test tubes, bottles, disposable transfer pipets, test tube racks; can’t be autoclaved
Polyethylene
Types of plastic - stronger than polypropylene & better temp tolerance, but chemical resistance not as good; clear; resistant to shattering; used for centrifuge tubes, graduated cylinders
Polycarbonate
Types of plastic - rigid, clear; shouldn’t be autoclaved; will crack & splinter; used for test tubes, graduated tubes
Polystyrene
Types of plastic - soft & flexible but porous; frequently used as tubing
Polyvinyl chloride
Types of plastic - extremely inert; excellent temp tolerance & chemical resistance; used for stir bars, stopcocks, tubing
Teflon
Glassware inscription - Class A; meets high standards for accuracy
A
Glassware inscription - temp of calibration; temp glassware & solutions should be for maximum accuracy
20*C
Glassware inscription - to contain; vessel calibrated to hold specified volume (e.g., volumetric flask)
TC
Glassware inscription - to deliver; vessel calibrated to deliver specified volume (e.g., graduated cylinder)
TD
Volumetric glassware - wide-mouthed, straight-sided jar with pouring spout; not accurate enough for critical measurements
Beaker
Volumetric glassware - sloping sides; graduated markings; used to hold liquids, mix solutions, measure noncritical volumes
Erlenmeyer flask
Volumetric glassware - pear shaped; long neck with single calibration mark; manufactured to strict standards; glassware & solutions should be at RT; used to prepare standards & reagents; shouldn’t be used to store solutions
Volumetric flask
Volumetric glassware - upright, straight-sided tube with flared base; used for noncritical measurements; most are TD; shouldn’t be used to measure <5mL or <10% of capacity; use graduate closest in size to volume to be measured
Graduated cylinder (graduates)
Glass pipets - transfer pipet; single calibration mark; calibrated to accurately deliver fixed volume of nonviscous samples & standards; touch off last drop against wall of receiving vessel
Volumetric pipet
Glass pipets - transfer pipet; similar to volumetric pipet, but bulb closer to tip; etched rings means blowout; used for accurate measurement of viscous fluids, e.g., whole blood; not widely used
Ostwald-Folin
Glass pipets - graduated or measuring pipet; graduation marks down to tip; etched ring means blowout; can use for serial dilutions & measuring reagents; not accurate enough for measuring samples or standards
Serological pipet
Glass pipets - graduated or measuring pipet; doesn’t have graduation marks all the way to the tip or frosted band near upper end; delivery is made “point to point;” not widely used
Mohr pipet
Glass pipets - disposable pipet for volumes ranging from 1-1,000 uL; single calibration mark; filled by capillary action; TC; must be rinsed out with diluent to deliver exact amount; small pipetting bulb is used
Micropipet
Glass pipet - programmable and used with disposable plastic tips; aliquots of liquid dispensed can range from 0.1 uL to 10 mL or larger; the device aspirates a predefined volume when its plunger is moved through a complete cycle; good for reducing cross-contamination between samples
Semiautomatic & automatic pipettes
Pipets - verify accuracy & precision on receipt, after service or repair, & on regular schedule; most accurate method for calibration is gravimetric method (weight of distilled water delivered); secondary method is spectrophotometric (absorbance of potassium dichromate or p-nitrophenol delivered).
calibration
Grades of chemicals - very high purity; meets specifications of American Chemical Society; recommended for qualitative & quantitative analysis.
analytic reagent grade
Grades of chemicals - spectrograde, nanograde, or HPLC grade; used for gas chromatography, HPLC, fluorometry, & trace metal determination
ultra pure
Grades of chemicals - spectrograde, nanograde, or HPLC grade; used for gas chromatography, HPLC, fluorometry, & trace metal determination
ultra pure
Grades of chemicals - limits of impurities not specified; may be acceptable for some lab applications when higher purity chemicals are not available
chemically pure
Grades of chemicals - for industrial use; not of sufficient purity to use as analytic reagents
practical, technical, or commercial grade
Grades of chemicals - meet specifications of U.S. Pharmacopeia or National Formulary; not injurious to health; not necessarily of sufficient purity to use as analytic reagents
USP or NF grade
Purified water - meets CLSI specifications for ionic, microbiological, & organic impurities, particulate & colloid content; pure enough for most routine testing; replaces previously designated type I and type II water; no single purification method can produce water of this quality; purification systems use various combinations of distillation, deionization, reverse osmosis, & filtration; lab must test at regular intervals for resistivity (the higher the resistivity, the lower the ion concentration), microbial content, & total organic carbon (TOC).
Clinical laboratory reagent grade (CLRW)
Purified water - for applications that require water of different purity than CLRW, e.g., DNA/RNA analysis, trace metals; must meet specifications of assay
Special reagent water (SRW)
Purified water - feed water for autoclaves & dishwashers; impurities that could contaminate washed labware or solutions in autoclave are removed; replacement for previously designated type III water
autoclave & wash water
CAP Reagent Labeling Requirements
Content
Concentration
Storage requirements
Date prepared or reconstituted
Expiration date
Lot #, if applicable
(Not required - date received, date opened)
Brightfield microscopy - least expensive objective; partially corrects for chromatic & spherical aberrations
achromatic objective
Brightfield microscopy - controls angle & amount of light sent to objective
aperture diaphragm
Brightfield microscopy - microscope with 2 oculars
binocular microscope
Brightfield microscopy - used to eliminate yellow color emitted by tungsten
blue filter
uses transmitted light & lenses; objects appear dark against white background; used for most routine clinical work
Brightfield microscope
Brightfield microscopy - microscope with 2 lens systems - objectives & oculars
compound microscope
Brightfield microscopy - focuses light on specimen
condenser
Brightfield microscopy - distance throughout which all parts of specimen are in focus simultaneously
depth of focus
Brightfield microscopy - limits area of specimen that can be seen
field of view
Brightfield microscopy - limits are of illumination to image field
field of diaphragm
Brightfield microscopy - used to help objective gather light from a wide numerical aperture; provides high resolution; type B (high viscosity) is commonly used.
immersion oil
Brightfield microscopy - method of focusing & centering light path & spreading light uniformly; ensures optimum contrast & resolution
Kohler illumination
Brightfield microscopy - magnification of ocular x magnification of objective; 1,000x is highest magnification achievable with brightfield microscope
magnification, total
Brightfield microscopy - mathematical expression of light admitted by lens
numerical aperture (NA)
the higher the NA, the greater the resolution
Brightfield microscopy - lenses attached to revolving nosepiece; most commonly used are low power (10x), high power (40x), & oil immersion (50x or 100x)
objectives
Brightfield microscopy - eye piece, usually 10x
ocular
Brightfield microscopy - object in center of field at 1 magnification will be in center of field at other magnifications
parcentric
Brightfield microscopy - object remains in focus from 1 magnification to another
parfocal
Brightfield microscopy - more expensive objective that corrects for curvature of field; results in flat field with uniform focus
planachromatic objective
Brightfield microscopy - ability to reveal fine detail & distinguish between 2 close points
resolution
Brightfield microscopy - light control knob; light intensity should not be regulated by condenser or diaphragms
Rheostat
Brightfield microscopy - type of bulb used for brightfield microscopy
Tungsten-halogen bulb
Brightfield microscopy - image seen through microscope; upside down & reversed
virtual image
Brightfield microscopy - distance between slide & objective; decreases with higher magnification objectives
working distance
Brightfield microscope with one special condenser; objects appear white against black background
Darkfield microscope
microscope used in the identification of live Treponema pallidum & other microorganisms
Darkfield microscope
Brightfield microscope with 2 special filters; fluorescent dyes absorb light of 1 wavelength & emit light of longer wavelength; objects appear green, yellow, or orange against black background
Fluorescent microscope
microscope used for direct & indirect fluorescent antibody stains in microbiology & immunology
Fluorescent microscope
Brightfield microscope with special slit aperture below condenser, polarizer, & special amplitude filter (modulator) in back of each objective; gives 3D effect to unstained specimens
Interference contrast microscope
microscope used for wet mounts
Interference contrast microscope
Brightfield microscope with phase condenser & phase objectives; subtle differences in refractive index converted to clear-cut variations of light intensity & contrast; good for living cells, unstained specimens
Phase contrast microscope
microscope used for manual platelet counts, urine sediments (good for hyaline casts)
Phase contrast
Brightfield microscope with 2 crossing filters - polarizing filter below condenser, analyzer between objective & eyepiece; objects that can refract light (birefringent) appear white against black background
Polarizing microscope
microscope used in identification of crystals in urine & synovial fluid; confirmation of fat or oval fat bodies in urine sediment
Polarizing
2 types of electron microscopes
Transmission & Scanning
Electron microscopes - beam of electrons passes through specimen, focused onto fluorescent screen or photographic plate; magnification >100,000x
Transmission electron microscope
electron microscope used for virology, cells (organelles)
Transmission
Electron microscopes - beam of electrons strikes surface of specimen, focused onto photographic film or cathode ray tube; 3D image; magnification >1,000x
Scanning electron microscope
electron microscope used for virology, cells (surface)
Scanning
science (information science) of processing data for storage, retrieval, & use
informatics
the use of computers & information systems to process & communicate information generated in the clinical lab
laboratory informatics
computerized medical record
Electronic medical record (EMR)
Information systems - system of hardware, software, connections, & communication protocols to handle all informational needs of the lab, from intake of requests to delivery of results; can provide patient information, test information, collection lists, work lists, test results, financial functions, productivity/workload monitoring, quality management, & interface with other computer systems
Laboratory information system (LIS)
Information systems - information system to handle all informational needs of hospital, both clinical & administrative
Hospital information system (HIS)
Information systems - hardware & software that allow for electronic communication between 2 computer systems, even if they use different programming languages; the LIS is typically interfaced to HIS & automated analyzers
Interface
Information systems - interface that transmits electronic information in 1 direction, e.g., a point-of-care analyzer downloads test results to the LIS
unidirectional interface
Information systems - interface that transmits electronic information in 2 directions, e.g., the LIS downloads orders from the HIS & uploads results to the HIS
bidirectional interface
Information systems - interface between the analyzer and LIS; can apply rules to automate processes, e.g., autoverification (automatic release of results without tech review when certain criteria are met).
Middleware
Information systems - documentation that the LIS functions as expected; required by regulatory agencies
system validation
Computer networks - computer network that connects computers in close geographic proximity (e.g., building, campus)
Local area network (LAN)
Computer networks - computer network that connects computers over larger geographic area (e.g., multisite health-care facility, internet)
Wide area network (WAN)
Computer networks - global system of interconnected computer networks
Internet
Computer networks - computer network within an organization; access is usually restricted to employees
Intranet
Computer networks - extension of a private network onto the internet where it can be accessed by authorized clients, suppliers, etc.
Extranet
Computer networks - common set of signals & rules that network uses for communication
Protocol
Computer networks - one of the first protocols developed for connecting computers
Ethernet
Computer networks - transmission control protocol/internet protocol; originally developed as transfer protocol for Internet; adapted for transmission in LANs
TCP/IP
Computer networks - standardized message protocol that facilitates exchange of medical data among computer systems
Health level 7 standard (HL7)
Process by which a lab ensures quality results by closely monitoring preanalytical, analytical, & postanalytical stage of testing
Quality assessment or quality assurance (QA)
Everything that precedes test performance, e.g., test ordering, patient preparation, patient ID, specimen collection, specimen transport, specimen processing.
Preanalytical QA
Everything related to assay, e.g., test analysis, quality control (QC), reagents, calibration, preventive maintenance
Analytical QA
Everything that comes after test analysis, e.g., verification of calculations & reference ranges, review of results, notification of critical values, result reporting, test interpretation by physician, follow-up patient care
Postanalytical QA
All of the lab’s policies, processes, procedures, & resources needed to achieve quality testing
Quality system
Part of the analytical phase of quality assurance; process of monitoring results from control samples to verify accuracy of patient results
QC
A sample that is chemically & physically similar to an unknown specimen & is tested in exactly the same manner; Monitors precision of the test system and covers the dynamic linear range of the assay; for non-waived tests, CLIA requires at least 2 levels of controls assayed every 24 hours, provided the manufacturer’s requirements are not greater (except coag requires 2 levels every 8 hours; blood gases requires 3 levels every 24 hours); for qualitative tests, pos & neg controls must be included with each run
Control material
Testing control material not built into the test system; term also used for QC that extends beyond the lab, e.g., participation in proficiency testing program
External QC
Electronic, internal, or procedural controls that are built into the test system
Internal monitoring systems
Statistical parameters describing spread of data about the mean, e.g., standard deviation, coefficient of variation, range; Measurements of precision
Measures of dispersion
Difference between the highest & lowest values in data set
Range
Sum of all observations divided by number of observations; average of all observations
Mean
Statistical expression of dispersion of values around the mean; requires a minimum of 20 values.
Standard deviation (SD)
Expressed standard deviation as a percentage
Coefficient of variation (CV)
CV % = (SD/Mean) x 100
The lower the CV = the higher the precision.
The difference between the means of two methods.
Bias
The student’s t test is used to determine if bias is significant.
QC Statistics - Normal distribution
The Gaussian bell-shaped curve:
*68% of values fall within +/-1 SD of mean
*95% of values fall within +/-2 SD of mean
*99.7% of values fall within +/-3 SD of mean
The range within which control values must fall for the assay to be considered valid. Many labs use mean +/-2 SD. 1 determination in 20 will fall outside +/-2 SD. This is an anticipated part of normal variation
Control Limits
A normal distribution curve lying on its side, marked with mean, +/-1, +/-2, +/-3.
Levey-Jennings chart
A control result outside established limits.
Outlier
(May be due to chance or may indicate a problem in the test system. If it occurs more than once in 20 successive runs, an investigation must be carried out.)
6 consecutive control values on the same side of the mean
Shift
Control values increasing or decreasing for 6 consecutive runs
Trend
*Often caused by unstable reagent, calibrator, or instrument condition
An error that doesn’t recur in a regular pattern, e.g., error due to dirty glassware, use of wrong pipet, voltage fluctuation, sampling error, anticoagulant or drug interference.
Random error
Indication of random error
indicated by a control value significantly different from others on a Levey-Jennings chart, OR violation of the 13S or R4S Westgard rules.
-usually a one time error, & controls and samples can be rerun with success
A recurring error inherent in test procedure, e.g., dirty photometer, faulty ISE, evaporation or contamination of standards or reagents; affects all results
Error, systematic
Indication of a systematic error
Indicated by a trend or shift on a Levey-Jennings chart, OR violation of 22S, 41S, or 10x Westgard rules.
-requires an investigation to determine cause
Rejection of a run because QC results indicate a problem when none is present.
False rejection
How can false rejections of runs be minimized?
Use of Westgard rules
Westgard - 1 control is >+/-2s from mean
1:2S rule
Westgard rule that is a warning flag of a possible change in accuracy or precision; initiates testing of other rules.
1:2S
Westgard - 1 control is >+/-3s from the mean
1:3S rule (rejection)
1:3S rule - type of error?
Random error
Westgard - 2 consecutive controls >2s from the mean on the same side
2:2S rule (rejection)
2:2S rule - type f error?
Systematic error
Westgard - 2 consecutive controls differ by >4s
R:4S rule (rejection)
R:4S rule - type of error?
Random error
Westgard - 4 consecutive controls >1s from mean on the same side
4:1S rule (rejection)
Westgard - 10 consecutive controls on same side of mean
10x rule (rejection)
4:1S rule - type of error?
Systematic error
10x rule - type of error?
Systematic error
Control out of acceptable range - (Step 1) hold patient results until problem is resolved - rationale?
if a control value is inaccurate, patient values might be inaccurate.
Control out of acceptable range - (Step 2) rerun control (1 time only) - rationale?
Value might have been due to expected random error (1 in 20 results will be outside +/-2 SD)
Control out of acceptable range - (Step 3) if control is still out after 1 rerun, run a new vial of control or another lot # - rationale?
control might have been outdated, improperly stored, or contaminated
Control out of acceptable range - (Step 4) if control is still out, look for & correct any problems, then run control - rationale?
Consider reagents (low, outdated, improperly stored, contaminated, change in lot #), preventive maintenance (overdue), mechanical problems, clots, etc.
Control out of acceptable range - (Step 5) if control is still out, recalibrate, then run control - rationale?
calibration may have shifted
Control out of acceptable range - (Step 6) If control is still out, get assistance - rationale?
Supervisor or service rep may be able to determine the problem
Control out of acceptable range - (Step 7) once resolved, document corrective action - rationale?
Provides a record for future reference, points out repetitive problems
Control out of acceptable range - (Step 8) evaluate all patient results in rejected run & since last run with acceptable QC; repeat tests & issue corrected reports, as needed - rationale?
Ensure accuracy of reported results.
The process of testing & adjusting analyzer’s readout to establish correlation between measured & actual concentrations
Calibration
Reference material with known concentration of analyte; programmed into analyzer’s computer for use in calculating concentration of unknowns; formerly called standard.
Calibrator
Testing materials of known concentrations (calibrators, controls, proficiency testing samples, patient specimens with known values) to ensure accuracy of results throughout reportable range.
Calibration verification (validation study)
Calibration verification requirements
- test 3 levels - high, midpoint, & low
- every 6 months, when lot # of reagents changes, following preventive maintenance or repair, & when controls are out of range
how close a measurement is to its true value
accuracy
Verification of accuracy
lab tests samples of known values (controls, calibrators, proficiency samples, previously tested patient specimens) to see how close results are to known value
reproducibility; how close results are when the same sample is tested multiple times
Precision
Verification of precision
lab repeatedly tests the same samples (on same day & different days) to see how close the results are
CV is used to compare the precision of samples.
Range of values over which the lab can verify accuracy of the test system; also known as linearity
Reportable range
Verification of reportable range
lab tests samples with known values at highest & lowest levels claimed to be accurate by the manufacturer
formerly called normal value; can vary for different patient populations (age, gender, race); established testing minimum of 120 healthy subjects & determining range in which 95% fall (Note: 5% of healthy population falls outside of reference range)
Reference interval
Verification of reference interval
If manufacturer’s or published reference ranges are used, the lab must test specimens from normal subjects to verify ranges; ranges may need to be adjusted to fit the lab’s patient population.
same as detection limit; lowest concentration of substance that can be detected by test method
Analytical sensitivity
*high sensitivity means decreased false negatives.
*high value desirable in screening tests
Verification of analytical sensitivity
determined by manufacturer; for unmodified FDA-approved test, verification isn’t required
Ability of method to measure only analyte it’s supposed to measure & not other related substances
Analytical specificity
*high specificity means decreased false positives and decreased cross-reactivity
*high value desirable in confirmatory tests
Verification of analytical specificity
determined by manufacturer; for unmodified FDA-approved tests, verification is not required
Diagnostic value of a test - True positive (TP)
Positive result in a patient who has the disease
Diagnostic value of a test - False positive (FP)
Positive result in a patient who does not have the disease
Diagnostic value of a test - True negative (TN)
Negative result in a patient who does not have the disease
Diagnostic value of a test - False negative (FN)
Negative result in a patient who does have the disease
Diagnostic value of a test - Diagnostic sensitivity
% of population with the disease that test positive
TP/(TP+FN) x 100
Diagnostic value of a test - Diagnostic specificity
% of population without the disease that test negative
TN/(TN+FP) x 100
Diagnostic value of a test - Positive predictive value (PPV)
% of time that a positive result is correct
TP/(TP+FP) x 100
Diagnostic value of a test - Negative predictive value (NPV)
% of time that a negative result is correct
TN/(TN+FN) x 100
Study to verify accuracy of a new method
Correlation study
*split patient samples are analyzed by existing method and new method
*requires a minimum of 40 patient samples representing a wide range of concentrations
*reference values (existing method) are plotted on x axis, values from new method are plotted on y axis.
perfect correlation is straight line passing through zero at 45 angle
*the correlation coefficient (r) can be derived mathematically
*values range from -1 to +1
*0 = no correlation between methods
*+1 = perfect direct correlation
*>=0.95 = excellent correlation
Schedule of maintenance to keep equipment in peak operating condition
Preventive maintenance
*must be documented and follow manufacturer’s specifications & frequencies
Procedures specified by manufacturer to evaluate critical operating characteristics of the test system, e.g., stray light, background counts
function checks
*must be within manufacturer’s established limits before patient testing is conducted
*documentation required
Comparison of patient data with previous results; detects mislabeled specimen & other errors
Delta checks
*when limit is exceeded, must determine if due to medical change in patient or lab error
Test results that indicate a potentially life-threatening situation
Critical values
*patient care personnel must be notified immediately
*Joint Commission requires “read-back” policy
*person receiving critical values must record & read back patient’s name & critical values
*lab must document person who received information & time of notification
List tests with critical values
Glucose
Sodium
Potassium
Total CO2
Calcium
Magnesium
Phosphorus
Total bilirubin (neonates)
Blood gases
CLIA requires documentation of competency assessment on hire, at 6 months, & then annually
Personnel competency assessment
Testing of unknowns submitted by an outside agency, e.g., CAP
PT
Set of instructions for methods used in the laboratory; also known as a procedure manual
Standard operating procedure (SOP)
the right of a patient to have his/her medical information kept private; restriction of access to information to those who have authorization and a need to know
Confidentiality
all individually identifiable health information, including lab results; HIPAA requires HCP to establish extensive security measures to ensure privacy; unauthorized disclosure of medical information could lead to charges of breach of confidentiality or invasion of privacy
Protected Health Information (PHI)
the wrongful intrusion into a person’s private affairs, e.g., unauthorized disclosure of confidential medical information
Invasion of privacy
consent for a medical procedure given by patient after procedure & possible risks have been explained; may be expressed or implied
Informed consent
written or verbal consent
Expressed consent
consent that is inferred from action or signs; e.g., a patient sits in phlebotomy chair & extends arm; action implies consent for venipuncture
Implied consent
patients have a right to refuse medical treatment/procedures
Informed consent
violation of duty to exercise reasonable skill & care
Negligence
misconduct or negligence that results in injury to patient
Malpractice
touching another person without his/her consent; e.g., drawing blood against a patient’s wishes
Assault & battery
procedure to guarantee integrity of specimen to court, e.g., legal blood alcohol, drug test
Chain of custody
*each person handling specimen must sign a chain-of-custody form that accompanies specimen & documents custody of specimen at all times
*specimen may be transported in a locked box to prevent tampering
Prefix - Deci-
10^-1
Prefix - Centi-
10^-2
Prefix - Milli-
10^-3
Prefix - Micro-
10^-6
Prefix - Nano-
10^-9
Prefix - Pico-
10^-12
Prefix - Femto
10^-15
Prefix - Femto
10^-15
*C to *F
F = (1.8 x *C) + 32
*F to *C
C = (*F - 32)/1.8
If the temperature of a refrigerator is 4*C, what is the temperature in *F?
F = (1.8 x 4C) + 32 = 39.2
If the room temperature is 73*F, what is the temperature in *C?
*C = (73 - 32)/1.8 = 22.8
Mean formula
Mean = Ex/n
E = sum
x = individual values
n = number of values
Calculate the mean of the following data set:
2, 6, 7, 8, 9, 10
Standard Deviation formula
Calculate the standard deviation of the following data set:
23, 19, 24, 47, 23, 20
Coefficient of variation formula
Calculate the coefficient of variation for the following:
Dilution formula
Dilution = (Vol. of specimen)/(Vol. of specimen + vol. of diluent)
What is the dilution if 0.1 mL of serum is diluted with 0.4 mL of saline?
(0.1)/(0.1 + 0.4) = 0.1/0.5 = 1/5
How would you prepare a 1:10 dilution of urine?
1 part urine + 9 parts diluent
Correcting for a dilution formula
Value obtained for diluted specimen x reciprocal of dilution
A specimen for glucose is diluted 1:5. The value of the diluted specimen is 100 mg/dL. What value should be reported?
100 mg/dL x 5 = 500 mg/dL
Ability to apply management process, systematize workflow, make decisions, communicate with coworkers.
Organizational skills
Understanding theories of human needs & work motivation
People skills
Effective use of & accounting for a company’s monetary assets
Financial skills
Skills to transform resources into products/services
Technical skills
Manager makes all decisions without input from others; quick decision-making; least acceptance & commitment from staff; poorest quality decisions
Authoritarian style
Manager makes decisions after polling staff; better quality & acceptance; decisions take longer; those in minority might feel ignored.
Democratic style
Manager tries to get at least partial agreement from all staff; everyone has input; highest quality decisions; good acceptance & commitment; time-consuming
Consensus style
Manager leaves decision to staff; least effective approach; manager abdicates responsibility
Laissez-faire style
Manager leaves decision to staff; least effective approach; manager abdicates responsibility
Laissez-faire style
organization’s purpose
mission
organization’s broad, long-term ambitions
goals
directive’s that describe how a goal will be achieved - should be SMART
Objectives
SMART
-Specific
-Measurable
-Achievable
-Realistic
-Time-bound
establishing goals & objectives, formulating policies to carry out objectives
planning
coordinating resources to achieve plans; defining working relationships, including line of authority & workflow
organizing
communicating, motivating, delegating, & coaching; creating a climate that meets the needs of individuals & the organization
directing
defining standards of performance, developing a reporting system, & taking corrective action when necessary
controlling
Lab Management - establishes goals & priorities; broad policy making - title and focus?
Director
Focus - organizational goals
Lab Management - runs organization within framework of policies given to him/her - title and focus?
Administrator
Focus - Organizational goals
Lab Management - oversees activity to achieve goal or purpose - title and focus?
Manager
Focus - Work environment
Lab Management - oversees activities of others to help them accomplish specific tasks - title and focus?
Supervisor
Focus - People, operations
Maslow’s Hierarchy of Needs - Physiological - definition & workplace counterpart(s)?
Survival needs - food, water, air, rest
Workplace - Income
Maslow’s Hierarchy of Needs - Safety - definition & workplace counterpart(s)?
Physical & psychological security
Workplace - Insurance, safe work environment, job security
Maslow’s Hierarchy of Needs - Social - definition & workplace counterpart(s)?
Sense of belonging, acceptance, affection
Workplace - social relationships with coworkers
Maslow’s Hierarchy of Needs - Esteem - definition & workplace counterpart(s)?
Respect, independence, appreciation, recognition
Workplace - Job title, privileges, respect of colleagues
Maslow’s Hierarchy of Needs - Self-actualization - definition & workplace counterpart(s)?
Realization of full potential
Workplace - challenging work, autonomy, professional growth
Personnel required in high-complexity labs under CLIA-‘88
- lab director
- technical supervisor
- clinical consultant
- general supervisor
- general supervisor
- testing personnel
Responsibilities - overall operation & administration of lab
lab director
Responsibilities - technical & scientific oversight of lab; must be available on as-needed basis to provide on-site, telephone, or electronic consultation
technical supervisor
Responsibilities - consultation regarding appropriateness & interpretation of tests
clinical consultant
Responsibilities - general supervisor
day-to-day supervision of lab
Responsibilities - specimen processing, test performance, & reporting of test results
testing personnel
Employee performance appraisal - job description
basis for evaluation
Employee performance appraisal - standards/criteria
what is expected; should be objective & measurable
Employee performance appraisal - measurement instrument
instrument to compare actual performance with desired performance
Employee performance appraisal - evaluator
person trained in use of instrument, familiar with intricacies of job, time to dedicate to process
Employee performance appraisal - feedback mechanism
plan for sharing results of review, taking corrective action, planning for future
Evaluation errors - everyone is rated toward middle of scale
error of central tendency
Evaluation errors - an individual is rated lower than justified because of comparison with another exceptional individual. (the opposite may also occur)
contrast error
Evaluation errors - everyone is rated high (opposite may also occur)
error of leniency
Evaluation errors - good performance in one are influences evaluation in other areas
halo effect
Evaluation errors - poor performance in one area influences evaluation in other areas
reverse halo effect
Evaluation errors - judgments are made based on recent events or unusual incidents
recency phenomenon
frequency of testing personnel competency assessment
Semiannually during 1st year, annually thereafter, & whenever there’s a change in test methodology or instrumentation
Lab operating costs - expenses that don’t fluctuate when volume of work changes over short term
Fixed costs
-instrument leases, maintenance contracts, computer services, equipment costs, facilities upkeep, management salaries, custodial salaries, employee benefits, depreciation, lease payments, rent, taxes
Lab operating costs - expenses that fluctuate directly with change in work load
variable costs
-labor costs, supplies, reagents, disposables
Lab operating costs - costs associated with performance of a test
direct costs
-supplies, reagents, controls, standards, disposables, equipment costs, equipment maintenance contracts, equipment depreciation, technical & supervisory labor
Lab operating costs - overhead
indirect costs
-administration, plant maintenance, security, utilities, building depreciation, rent, taxes, insurance, housekeeping, purchasing, billing, regulatory expenses, laboratory information system (LIS) expenses
Lab operating costs - total of direct & indirect expenses of producing a test result
unit cost/cost per test
Break-even price per test - formula?
(annual fixed costs + variable costs)/test volume
Break-even test volume - formula?
total fixed costs/(average revenue per test - variable cost per test)
Break-even revenue - formula?
total fixed costs/[(average revenue per test - variable cost per test)/average revenue per test]
Quality management system developed by CLSI to organize all policies, processes, & procedures for preanalytic, analytic, & postanalytic activities; based on 12 quality systems essentials (QSEs); similar to ISO 15189
GP26-A4: Quality Management System: A Model for Laboratory Services
List the 12 QSEs that form the basis of GP26-A4.
- Organization
- Customer focus
- Facilities & safety
- Personnel
- Purchasing & inventory
- Equipment
- Process management
- Documents & records
- Information management
- Nonconforming event management
- Assessments
- Continual improvement
Quality management system developed specifically for clinical labs by the ISO; based on ISO 17025 and ISO 9001; accreditation is mandatory in some countries but currently voluntary in the US
ISO 15189: Medical laboratories-Particular requirements for quality & competence
General requirements for the competence of testing and calibration laboratories - ISO?
ISO 17025
Quality management systems - Requirements - ISO?
ISO 9001
System developed by Toyota to improve quality by improving workflow & eliminating waste; focuses on equipment layout, standardization of processes, cross-training, inventory management; turnaround times are improved by grouping automated analyzers in core lab & replacing batch processing with single-piece flow
Lean
System developed by Motorola to improve quality by determining & eliminating causes of defects/errors & reducing variability in processes; Uses DMAIC methodology to improve processes & statistical methods to measure quality improvements
Six Sigma
Six sigma = only 3 errors per million tests
DMAIC methodology
Define
Measure
Analyze
Improve
Control
Quality improvement system that combines principles of Lean & Six Sigma
Lean Six Sigma
Internal audit tool to evaluate quality of patient care by following a specimen through preanalytic, analytic, & postanalytic phases of testing; used by The Joint Commission (TJC) & CAP as part of acrediation
Tracer methodology
Sentinel events: TJC
Definition?
Example?
Goals?
Definition: unexpected event involving death or serious physical or psychological injury, or risk thereof
Example: Administration of ABO-incompatible blood
Goals: improve patient care
Sentinel events: TJC
Requirements?
Reporting?
Requirements:
1. Root cause analysis - analysis of why even happened; examines proximate causes, e.g., personnel equipment, environment, leadership, corporate culture, communication, external factors; focuses on systems/processes, not individuals
2. Action plan - establishes risk reduction strategies & measures of effectiveness; should delineate responsibilities for implementation/oversight & establish time lines
3. Implementation
4. Monitoring
Reporting - reporting to TJC is optional but encouraged so that event can be added to database & used as educational tool to help others avoid similar events; confidentiality is maintained
POCT - definition?
testing performed at site of patient care; also known as decentralized, bedside or near-patient testing
POCT - goal?
provide rapid results where immediate medical action is required, e.g., emergency department, ICUs
POCT - common tests?
urine reagent strips
glucose
electrolytes
blood gases
activated clotting time (ACT)
PT
APTT
hemoglobin
POCT - regulations?
determined by test complexity; may operate under clinical lab’s CLIA certificate or separate CLIA certificate
POCT - optimal staffing - director?
MLS or pathologist responsible for administrative, financial, & technical decisions
POCT - optimal staffing - Point-of-Care Coordinator?
oversees testing & responsible for compliance, training, QC, proficiency testing (if required)
POCT - optimal staffing - Designated contact/trainer at each testing site?
liaison between POCC & testing personnel; assists with training/competency assessment
POCT - optimal staffing - testing personnel?
qualifications determined by test complexity of testing; usually phlebotomists, lab assistants, nurses, respiratory therapists
POCT - considerations?
Cost
Performance specifications
Ease of use
Turnaround time
Impact on quality & cost of patient care
Data management
Data connectivity
Data interface capabilities
ABCs of writing behavioral objectives
A - audience - who?
B - behavior - what?
C - criteria - under what conditions? When? How?
D - degree - expected standard of performance; How many? How much? How well?
VAK learning style model
Visual - Seeing - reading assignments, pictures, slides, diagrams, drawings, graphs, videos, demonstrations
Auditory - Hearing - lectures, tapes, discussions; stimulated by changes in vocal tone, pitch, pacing
Kinesthetic - Doing - laboratories, role-play, group work
Domains of Learning - Cognitive
Elements?
Knowledge level?
Application level?
Problem solving level?
Elements - facts, knowledge
Knowledge level - recall & comprehend facts/information
Application level - apply information in concrete situations
Problem-solving level - manipulate information in new situations or contexts; analyze, synthesize, evaluate
Domains of Learning - Psychomotor
Elements?
Knowledge level?
Application level?
Problem solving level?
Elements - physical skills
Knowledge level - observe & imitate a skill
Application level - practice a skill
Problem-solving level - adapt existing skills to meet new demands or originate new procedures
Domains of Learning - Affective
Elements?
Knowledge level?
Application level?
Problem solving level?
Elements - attitudes, feelings, values
Knowledge level - receive & respond to information about attitudes/feelings
Application level - assess attitudes/feelings
Problem-solving level - organize & internalize values into system that guides behavior
Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Knowledge
Ability to?
Examples of verbs for objectives at different levels?
Ability to: recall specific facts
Examples: cite, define, identify, label, list, match, state
Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Comprehension
Ability to?
Examples of verbs for objectives at different levels?
Ability to: grasp meaning of material
Examples: change, describe, explain, give examples, illustrate, interpret, paraphrase, rephrase, summarize
Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Application
Ability to?
Examples of verbs for objectives at different levels?
Ability to: use material in new & concrete situations
Examples: apply, classify, compute, demonstrate, predict, prepare, present, show, solve, utilize
Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Analysis
Ability to?
Examples of verbs for objectives at different levels?
Ability to: break down material into component parts
Examples: analyze, associate, conclude, determine, diagnose, diagram, differentiate, discriminate, distinguish, examine, infer, outline
Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Synthesis
Ability to?
Examples of verbs for objectives at different levels?
Ability to: put elements together to form new whole
Examples: combine, compile, compose, create, design, develop, devise, generalize, invent, modify, originate, plan, propose, project, revise, rewrite, synthesize, theorize
Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Evaluation
Ability to?
Examples of verbs for objectives at different levels?
Ability to: judge value of material for given purpose
Examples: appraise, assess, compare, conclude, contrast, critique, deduce, evaluate, judge, weigh
Testing at Different Cognitive Levels - Recall
Definition?
Example?
Recognizing or remembering isolated information
Example: which enzymes are elevated with liver disease?
Testing at Different Cognitive Levels - Application
Definition?
Example?
Interpreting or applying limited data
Example: 15 nucleated RBCs per 100 WBCs were observed on a differential. The automated analyzer reported the total WBC as 15 x 10^6/L. What is the corrected WBC count?
Testing at Different Cognitive Levels - Analysis
Definition?
Example?
Evaluating data, solving problems, or fitting together a variety of elements into a meaningful whole
Example: A patient’s RBCs agglutinated in anti-A, but not in anti-B. His serum agglutinated A1 cells & B cells. What might account for these results & how should you proceed?
Which anticoagulant is best for the prevention of hemolysis and therefore utilized when analyzing many chemistry analytes?
A. EDTA
B. Heparin
C. Sodium fluoride
D. Sodium citrate
B. Heparin
Which type of error is recurring and indicated by a trend or shift on a Levey-Jennings chart?
A. Random
B. Linear
C. Systematic
D. Proportional
C. Systematic
Which type of error is recurring and indicated by a trend or shift on a Levey-Jennings chart?
A. Random
B. Linear
C. Systematic
D. Proportional
C. Systematic
Which of the following components of a QC program is most useful to detect sample misidentification?
A. Critical limits
B. Delta check
C. Function check
D. Personal Competency Assessment
B. Delta check
Which measurement can be calculated as TP/(TP + FN) x 100?
A. Sensitivity (Diagnostic)
B. Specificity (Diagnostic)
C. Positive Predictive Value
D. Negative Predictive Value
A. Sensitivity (Diagnostic)
Attitude, feelings, and judgment refer to which domain of learning?
A. Cognitive
B. Psychomotor
C. Affective
D. Competency
C. Affective
Performing a calculation to determine the corrected WBC count is an example of which level of cognitive testing?
A. Recall
B. Application
C. Analysis
D. Evidence-based
B. Application
Which of the following is an example of an indirect cost when calculating costs for laboratory tests?
A. specimen collection supplies
B. abnormal control material
C. labor cost for performing the test
D. insurance
D. insurance
Under CLIA ‘88, testing personnel with an associate degree and approved laboratory training may perform which level of testing complexity?
A. waived only
B. moderate complexity only
C. waived and moderate-complexity tests
D. waived, moderate, and high-complexity tests
D. waived, moderate, and high-complexity tests
The goal of POCT is:
A. to reduce the need for quality control
B. to improve sensitivity and specificity over central lab assays
C. to provide rapid test results when immediate medical action is required
D. to reduce the training needed to perform lab assays
C. to provide rapid test results when immediate medical action is required
Which of the following is true of the “Six Sigma” method?
A. The goal of Six Sigma is to improve test quality by reducing errors
B. Refers to an error rate of only 3 errors per million tests
C. Process consists of five steps (define, measure, analyze, improve, and control)
D. All of the above are true of Six Sigma
D. All of the above are true of Six Sigma
