LABORATORY SAFETY AND WASTE MANAGEMENT, QUALITY ASSURANCE AND SPECIMEN COLLECTION Flashcards
A program that is important in order to protect the lives of students and teachers, to protect the laboratory equipment and facilities, and to protect the environment.
Laboratory safety
A method of infection control in which all human blood and other body fluids containing visible blood are treated as if infectious.
Universal Precautions
A set of comprehensive safety guidelines designed to protect patients and healthcare workers by requiring that all patients and all body fluids, body substances, organs, and unfixed tissues be regarded as potentially infectious.
Standard Precautions
Established procedure to be followed for a given operation or in a given situation with the purpose of ensuring that a procedure is always carried out correctly and in the same manner.
Standard Operating Procedure (SOP)
Is the removal of microorganisms to a certain level as not to be able to infect humans and cause disease.
10% of sodium hypochlorite solution (dilute household bleach by mixing 1-part bleach to 9 parts of distilled water) it must be prepared daily and labeled with agent name, concentration, and date of preparation.
Decontamination
Is the absolute removal of all microorganisms.
Sterilization
Is a technical bulletin providing detailed hazard and precautionary information.
Material Safety Data Sheet (MSDS)
Businesses are required to provide to their costumers the MSDS for all chemicals they manufacture or distribute.
TRUE
The MSDS provides:
a. products information
b. fire and explosion precautions
c. toxicology
d. health effects
e. recommended PPE
f. storage recommendations
g. leaks and spills
h. waste disposal recommendations; EQUIPMENT
i. first aid
The most effective at reducing hazards yet often the most difficult to implement.
Elimination
Used as control organism with less pathogenic.
Substitution
Favored over administrative and personal protective equipment (PPE) for controlling existing worker exposures in the workplace because they are designed to remove the hazard at the source, before it comes contact with the worker.
Engineering controls
Bench top acrylic splash shield to protect the worker from aerosols, fine mist of liquid, biohazard containers, disinfectants, hand antiseptics, puncture-resistant sharps containers, safety needles, biosafety cabinet, fume hood, laminar flow.
Engineering controls
Include the protocols or changes to work practices, policies, or procedures. They can be relatively inexpensive to establish but, over the long term, can be very costly to sustain.
Administrative controls
Authorization/approval written biosafety procedures required for the experimental procedures and equipment including inventory of biological agents or materials, laboratory personnel biosafety training, medical surveillance (BSL 2 and above), health history, medical screening, immunization, serum storage, post-exposure, prophylaxis.
Administrative control
The use of special clothing and equipment to protect staff and patients who maybe exposed to known or suspected pathogens.
Personal Protective Equipment (PPE)
These are compulsory in all instances in the physical containment level 2 laboratory.
Be aware of the composition of fabrics, as some might be highly flammable.
A disposable laboratory coat is compulsory in physical containment level 3 laboratories or in specific instances such as collection when highly dangerous pathogens can be involved, such as suspected cases of H5N1 avian influenza or SARS.
Laboratory coats
Serve as a barrier when splashes or sprays occur during specimen collection or handling.
Masks
Protection of eyes is strongly recommended as a routine procedure to prevent contact with these droplets.
Goggles
Should be worn in all instances, and should be available to laboratory staff on a routine basis.
Gloves
Hazards occur by physical agents like fire, electrical, noise, radiation, high voltage, machinery with moving parts, sharp material.
Physical Hazards
R.A.C.E?
Rescue or remove: rescue or remove any persons from the immediate scene
Alert or activate: pull the nearest alarm
Confine: close all doors to the hazard or fire area
Extinguish/evacuate: extinguishing using the closest fire extinguisher if the fire impedes your evacuation. Evacuate to your designated meeting location.
Ordinary combustibles such as woods, papers, and plastics.
Pressurized water-based extinguishers
Class A
Flammable liquids (i.e., ethanol, xylene) and electrical fires.
Carbon dioxide extinguisher
Class B/C
Ordinary combustibles, flammable liquids, and electrical fires.
Multipurpose dry chemical agent extinguisher
Class ABC
Combustible metals (i.e., magnesium, powdered aluminum).
Sodium chloride or copper based dry powder
Class D
Kitchen fires, cooking oils, and fats.
Potassium bicarbonate or wet chemical fine mist
Class K
P.A.S.S.
Pull the pin
Aim the base of the fire.
Squeeze the handle.
Sweep from side to side.
Hazards occurred by biological agents like blood, body fluids, and experimental animals, allergens, infectious agents, experimental agents, microbes, viral vectors
Biological hazards
Hazards occurred by chemicals cleaning agents, disinfectants, solvents, and compressed gases.
Chemical hazards
This is the major route.
Inhalation
May produce systemic poisoning.
Absorption through skin
Generally due to poor hygiene practices, such as eating or smoking in the laboratory.
Ingestion
Health hazard?
Blue quadrant
Flammable Hazard
Red quadrant
Reactivity/Stability Hazard
Yellow quadrant
Other special information
White quadrant
100% non filtered air
Non volatile - yes
Volatile - yes
Chemical fume good
100% HEPA filtered supply air
Non-volatile - no
Volatile - no
Clean bench
Type of BSC that 100% of HEPA filtered exhaust air
Non-volatile - yes
Volatile - Yes, in minute quantities while canopy connected
Class I
60% HEPA filtered exhaust air, 40% recirculated HEPA filtered air
Non-volatile - yes
Volatile - yes, but in small amounts towards rear of cabinet
Class II Type B1
100% HEPA filtered exhaust air
Non-volatile - Yes
Volatile - Yes
Class II Type B2
HEPA filtered supply and exhaust air ( varies depending on configuration)
Non-volatile - yes
Volatile - yes, if connected to building exhaust. Concentrations vary.
Class II Type C1
100% HEPA filtered supply and exhaust air
Non-volatile - yes
Volatile - yes
Class III
Velocity at the face of the wood (with sash on normal operating position) should be
100 to 120 ft per minute and fairly uniform across the opening
It removes the particles that may be harmful to the employee who is working with potentially infectious biologic specimens.
Biosafety Cabinets (BSCs)
Is a type of mechanical air filter that works by forcing the air through a fine mesh that traps a harmful particles at 99.99%
High Efficiency Particulate Air (HEPA)
Modern American Convention HEPA:
99.99% at 0.3 microns
Modern American Convention ULPA:
99.99% at 0.12 microns
Major sources of health care wastes
Hospitals and other health facilities
Laboratories and research center
Mortuary and autopsy centers
Animal research and testing laboratories
Blood banks and collection services
Nursing homes for the elderly
Is a solid, liquid, or gaseous material that displays either a “hazardous characteristic” or specifically listed by name as hazardous waste.
Hazardous waste
True or False
Hazardous chemicals must never poured down the drain as a method of disposal
True
Applies to waste that are liquids with a flash point less than 140 degrees Fahrenheit.
Solid that are capable of spontaneous combustion under normal temperature and pressure.
ex: ethanol, sodium nitrate, hydrogen gas, xylene, acetone
Ignitability
Applies to waste that aqueous solutions with less than or equal to 2% or greater than or equal to 12.5
This does not apply to solid or non-aqueous materials
ex: hydrochloric acid, nitric acid, sodium hydroxide
Corrosive
Refers to the materials that react violently or generate toxic fumes when mixed with water
Materials that are normally unstable or explosive
Reactivity
Refers to the characteristics applies to the wastes that have potential to contaminate ground water if improperly disposed
Toxicity
Waste contaminated with blood and other body fluids, cultures, and stocks of infectious agents from laboratory work or waste from patients with infections.
Infectious waste
Human tissues, organs or fluids, body parts and contaminated animal carcasses.
Pathological waste
Types of waste that contains syringes, needles, disposable scalpels and blades.
Sharps waste
Waste that contains of solvent and reagents for laboratory preparations, disinfectants, sterilant and heavy metals contained medical devices and batteries.
Chemical waste
Expired, unused, contaminated drugs and vaccines.
Pharmaceutical waste
Waste containing substances with genotoxic properties highly hazardous substances that are mutagenic, teratogenic, carcinogenic such as cytotoxic drugs used in cancer treatment and their metabolites
Cytotoxic waste
Products contaminated by radionuclides including radioactive diagnostic material or radiotherapeutic materials
Radioactive waste
Waste that does not pose any particular biological, chemical, radioactive.
Non hazardous or General waste
Non infectious dry waste
Black
Sharps and pressurized
Red
Infectious and pathologic wet waste
Yellow
Non-infectious wet waste
Green
Chemical wastes
Yellow with black band
Systemic actions necessary to provide adequate confidence that laboratory services will satisfy given medical needs for patient care.
Quality assurance
What is the primary goal of quality assurance?
To deliver quality service and products to costumer
Refers to the planned and systemic activities implemented in a quality system so that the quality requirements for a product or service will be fulfilled
Quality assurance
What are the two principles involved in QA?
Fit for purpose
Right first time
Mistakes should be eliminated
Right first time
Product should be suitable for the intended purpose
Fit for purpose
Test ordering
Specimen collection, transport, and processing
Preservatives used
Entering patient information
Pre analytical phase
Test processing and analysis
QC data
Record keeping
Analytical phase
Reporting out of specimen results
Physician contact
Reference range
Post Analytical phase
True or False?
QA monitors quality performance starting from the ordering of a laboratory determination to its reporting, the interpretation of the results, and then application to patient care.
True
A system used to monitor the analytical process to detect and prevent errors that would impact on the accuracy and precision of laboratory results.
Quality control
What is the goal of QC?
To detect the errors and correct them before patient’s results are reported
It is concerned with the analytic phase of QA
Quality control
Objectives of Quality Control?
To check the stability of the machine
To check the quality reagents
To check the technical errors
Also known as Intralaboratory QC
Performed by laboratory personnel using control materials of know values and comparing the control values to established acceptable ranges
Internal QC
Also known as Interlaboratory QC, Proficiency testing
Performed by labor personnel when analyzing specimens sent to the laboratory by an external agency and the results generated are submitted to the agency for assessment.
External QC
It detects both random and systematic errors
Internal QC
The purpose is to maintain the accuracy of the analytical methods
External QC
NRL
Hematology
National Kidney and Transplant Institute (NKTI)
Clinical Chemistry
Lung Center of the Philippines
Bacteriology, Clinical Microscopy, Blood banking, Mycology, Parasitology
Research Institute for Tropical Medicine (RITM)
HIV/AIDS and other Sexually Transmitted Infections
San Lazaro Hospital - STD AIDS Cooperative Central Laboratory (SLH/SACCL
The nearness or closeness of the assayed value to the target or true value.
Accuracy
The ability of an analytical method to give repeated results on the same sample that agree with one another.
Precision
The degree by which the method is easily repeated.
Practicability
The ability of an analytical method to maintain the accuracy and precision over an extended period of time during the equipment, reagents, and personnel may change.
Reliability
The ability of an analytical method to measure the smallest concentration of the analyte of the interest.
Sensitivity
Ability of the test to detect the proportion of individuals with that disease who test positively with the test
Diagnostic sensitivity
Indicates the ability of the test to generate more true-positives and few false-negative.
Diagnostic sensitivity
True or False
Screening tests require high sensitivity so that no case is missed.
True
Ability of an analytical method to measure only the analyte of interest (no interfering substance)
Specificity
Ability of the test to detect the proportion of individuals without the disease who test negatively for the disease.
Diagnostic of Specificity
It reflects the ability of the method to detect true-negatives with very few false-positives.
Diagnostic of the Specificity
True or False
Confirmatory tests require high specificity to be certain in diagnosis.
True
A quality management technique and symbols logic flow charts used by management information system to chart specific process of information flow.
It serves as a disruption to the exact sequence of work task and ways.
Flow Chart
Also known as trend charts.
They are designed to show patterns of performance.
A unique graph used to display over a period of time.
Run Charts
Used to plot control measurements against standards.
It is used to identify whether the process is in or out of control.
Control Charts
It is a term assigned to a bar chart that is designed to illustrate the classical Pareto principle, which states that 80% of all the problems can be attributed to 20% of the possible causes.
Pareto charts
Also known as Ishikawa diagrams and Fishbone diagrams.
This method identifies possible causes or contributing factors on quality defects.
The problem is placed in the head of the diagram, with possible causes branching out of the backbone, in the work flow direction.
Cause and Effect Diagrams
This method used to show relationship between one variable and another.
A big advantage of this diagram is that all data points, not just the summary statistical indexes are plotted on the graph.
Scatter Diagram
A technique of using a practical sequence on a flip chart or other visual aid to “tell the story”
Story Boards
Extent which the test value is close to the true value.
Refers to the correctness of the value obtained to the actual value of analyte.
Accuracy
True or False
The accuracy of the method is reflected by its ability to reproduce the value of reference samples of known concentration.
True
True or False
To achieve accuracy, we also use blank.
True
Used to set the absorbance (OD) to zero.
Blank
Used when reagent is colorless
Water blank
Used when reagent is colored
Reagent blank
Also the Reference Material or Calibrator
It is used as a basis or reference for the calculation of the value of the unknown.
Standard
It has highest purity
Can be measured directly.
Primary standard
It has lowest purity.
Concentration is determined by comparison to a primary standard and this is less expensive.
Secondary standard
Refers to the average of values.
Measure the central tendency.
Mean
Refer to the most common value.
Mode
The middle value and the 50th centile
Median
Refers to the nearness of the obtained value to each other.
It is the “reproducibility” of a laboratory determination when it is run repeatedly under identical conditions.
Precision
Substance having a known or determined range of values.
Control
Values stated by the manufacturer
More expensive but can be used as external checks for accuracy.
Assayed commercial control
Values not given, determined by the user.
Unassayed commercial control
Shortcomings include increased for exposure to pathogens, deterioration, contamination and loss of potency.
Pooled control sera
True or False
Bovine-based QC material is not the choice for immunochemistry, dye binding, and certain bilirubin assays.
True
This refers to the control range
Range of values within which control result must fall.
Confidence interval
Most common unit of precision
Measure of dispersion of the values around the mean
Standard Deviation
Percentile express of the mean
Coefficient of Variation
A measure of variability.
Variance
Bell shaped curve
It is obtained by plotting the values from multiple analyses of sample.
Gaussian Distribution Curve
It is occurs when data elements are centered around the mean with most elements close to the mean.
It focuses on the distribution of errors from the analytical method rather than the values from a healthy or patient population
Gaussian Distribution Curve
Refers to the degree of flatness or sharpness in the peak of a set values having a Gaussian distribution.
Kurtosis
It calculates the difference between QC results and the target means.
This plot will give the earliest indication of systemic errors (trend) and can be with the 13s rule.
Cumulative Sum Graph (CUSUM)
True or False?
When a systemic error is present the CUSUM values steadily increase.
True
Used to compare results obtained on a high and low control serum from different laboratories.
Youden/Twin plot
Compares most recent patient result with previous results.
Most commonly used patient based-QC technique
Delta Check
Most common and most widely used in QC chart in the laboratory.
Shewhart Levey-Jennings Chart
Is a graph wherein quality control data is plotted on to give a visual indication whether a laboratory test is working well.
Shewhart Levey-Jennings Chart
It is formed by control values that either increase or decrease for 6 consecutive days.
Trend
What is the main cause of trend?
Deterioration of Reagents
It is formed by control values that distribute themselves on one side or either side of the mean for 6 consecutive days.
Shift
What is the main cause of shift?
Improper calibration of the instrument
Refers to the sample values that are widely scattered in an unusual and unexplained pattern around the mean.
Dispersion
Causes of dispersion
Operators inattention
Clerical errors
Interfering substances in the reagent
Electronic or optical variation in instrument
Are control values that are far from the main set of values.
Are highly deviating values caused by random or systemic errors.
Outliers
It is recognized that the use of simple upper and lower control limits is not enough to identify analytical problems.
Used to accept or reject a “run” of samples.
Westward Multi-rules
What are random errors?
1:3S and R:4S
What are systematic errors?
2:2S
4:1S
10:x
Is due to chance
Basis for varying differences between repeated measurements
Random error
Unable to predict because they are no pattern
Random error
Random errors are caused by:
Pipetting errors (incorrect volume)
Mislabeling of the specimen
Voltage/Temperature fluctuation
Improper mixing of the sample and reagent
Analytical result is assigned to a wrong specimen
Sample error (lipemia, drug interference, hemolysis)
Is an error that influences observations consistently in one direction (constant difference)
Predictable
Usually analytical errors
Systematic error
Systematic error are often related to:
Calibration problems
Deterioration of reagents and control materials
Contaminated solutions
Unstable and inadequate reagent blanks
Dirty photometer
Leaky ion selective electrode (ISE)
Failing instrumentation
Poorly written procedures
Highest frequency of clerical errors with the use of handwritten labels and request forms.
Online computer input is the most error-feee means of requesting laboratory tests.
Clerical errors
Also the reference limit/interval/value or normal value
Range in which a certain percentage of the population is expected to fall
Reference Range
Factors to be considered when establishing reference intervals
Composition of the reference population
Criteria used for excluding and including the individuals from the reference population
Physiologic and environmental conditions
Specimen collection, including preparation for testing
Analytical method used
FBS
8-10 hours
Lipid profile
10-14 hours
BMP (Na, K, Cl, CO2, Glu, BUN, CRT, Ca:
10-12 hours
A process by which blood is obtained from a patient vein
Venipuncture
Is the deoxygenated blood with a dark red color.
Venous blood
What are the advantages of the venipuncture?
Collect large amount of blood
Repeated and additional blood tests can be made
Can be stored for future use
Ideal for blood chemistry determination
Outpatient/Ambulatory patient:
Verbally ask the name
DOB
Ask for an ID card conscious
In patient/Hospitalized patients
Verbally ask the full name
Verify the name using ID/bracelet
Sleeping patients
Must be awakened before blood collection
Verbally ask full name
Verify the name using ID/bracelet
Unconscious, mentally incompetent patients
Ask the attending nurse or the relative verify using ID/bracelet
Infants/children
A nurse or relative may identify the patient verify using ID bracelet
What is the proper patient positioning in venipuncture
The patient is lying supine or sitting in a phlebotomy chair
Position patient’s arm using the phlebotomy wedge or patient’s fist
Torniquet application
Should not be pinched
Should be flat around the arm and not rolled or twisted
Should be applied 3 to 4 inches or 3 fingers above the venipuncture site
Remain in place for 1 minute
Should be released for 2 minutes before being reapplied
Blood pressure cuff
Inflated 40 mm/hg
Site selection
Select a vein that is large and does not roll
Exam in antecubital area first
Ask the patient to hold arm still and make a fist
Palpate the vein using the tip of your index finger not the thumb
Use a warm, moist compress for 3 to 5 minutes to increase vein sized if needed
Cleansing the site
Circular motion, starting inside of the venipuncture site and working outward in widening concentric circles about 2 to 3 inches
Cleaning the site with an antiseptic (70% isopropyl alcohol) helps prevents contamination
Be sure to allow the alcohol to dry before attempting the venipuncture procedure
Never blow on the site/never wipe it dry
Performing the venipuncture
Reapply the tourniquet
Visually confirm the venipuncture site
Anchor the below the venipuncture site, place the thumb of the non dominant hand 1-2 inches below the puncture site and pulling the skin taut.
Insert the needle at a 15 degrees to 30 degrees angle.
Insert the evacuate tube and allow it to fill.
Calcium A
5x
Na Citrate
3-4x
Heparin
8x
EDTA
8x
NaF
8x
Bruising or skin discoloration
Ecchymosis
Collection of blood into the surrounding tissue and skin layer
Hematoma
Following information that needs to be fill up in collecting specimen
Patient’s name
Identification number
Date and Time of collection
Phlebotomist initial
Test maybe included
Do NOT draw blood in the following areas
Edematous or has a lesion
IV site
Arm on the side of a mastectomy
Underside wrist
Lower extremities
Feet
Ankle
True or False
The gauge of the needle is inversely related to the size of the needle
True
21 gauge
Standard for venipuncture
23 gauge
Children
23 or 25 gauge
Winged infusion set
23 gauge butterfly
For small and difficult veins
25 gauge
Collection from scalp or other tiny veins of infants
Sites to be avoided for venipuncture
Burned areas
Areas with hematoma
Thrombosed veins
Edematous arms
Mastectomy on one or both arms
Arms with AV shunt
Casts
IV therapy lines in both arms
Procedures in collecting below the IV
Turn off the IV at least 5 minutes before venipuncture
Apply the torniquet below the IV site
Select a vein other than the one with the IV
Draw 5 ml of blood and discard before drawing the specimen tubes for testing
Common causes of hematoma
Vein is fragile or too small for the needle size
Needle penetrates all the way through the vein
Needle is partly inserted in to the vein
Needle is removed while the torniquet is still on
Pressure is not adequately applied after venipuncture
Liquid that remains when clotting is prevented with the addition of an anticoagulant
Plasma
Density is 1.025 g/ml
Plasma
Liquid that remains after the blood has clotted.
Serum
Obtain after the centrifuging whole blood containing anticoagulant
Plasma
Contain clotting factors
Plasma
Obtain after centrifuging clotted blood
Serum
Does not contain clotting factors
Serum
Yellow colored serum due to increase bilirubin pigment interfere with albumin, Chol, TP and glucose.
Cause: increase bilirubin
Icteric
Reddish due to the rupture of RBC membrane releasing hemoglobin and other red cell components
Caused: Rupture of RBCs
Hemolyzed
White colored serum due to high fat content
Causes: TAG levels exceed 400 mg/dL, alcoholism, steroids
Lipemic
Are substances which prevent blood coagulation
They inhibit coagulation process by eliminating calcium or by binding with thrombin.
Anticoagulants/Blood anticoagulants
EDTA, Citrate, Calcium binds with
Calcium
Heparin binds with
Thrombin
Tubes containing sodium and potassium anticoagulants are not use in measuring concentration of electrolytes
False positive result
Tubes contain sodium oxalate are not used for measuring calcium level because oxalate will react with calcium and precipitated as calcium oxalate
False negative result
Tubes with EDTA and citrate are not suitable for enzymatic assays because it binds with calcium ion that is a cofactor for enzymes like alkaline phosphates
False Negative Result
Order of Draw
Blood cultures
Light blue stopper tubes
Red/gray
Green/Light green
Lavender
Gray
Yellow/Orange
Ideal temperature for storing serum (long term)
Rapid freezing in liquid nitrogen
Short term storage of serum (6 weeks)
Store at -200 degrees Celsius
Specimen retention
Clinical samples
1 year at -80 degrees Celsius
Serum/Plasma
48 hours
CSF/Body fluid
7 days
Grounds of rejecting a specimen
Unlabeled or mislabeled specimen
Insufficient volume of specimen collected
Clots in an anti coagulated tube
Hemolysis
Improper transport
Wrong blood collection tube
Discrepancies between requisition and specimen label
Non-fasting if required
