St.

Paul University Philippines

College of Medical Technology
1st Semester, AY 2020-2021 AUBF
Chapter 1: Safety and Quality Assesment
September 14, 2020

CONTENTS LEARNING OBJECTIVES

I. Learning Objectives  State the purpose of the Standard Precautions policy and describe
II. Safety its guidelines.
A. Acronyms
III. Safety Procedure Manuals  Describe the types of personal protective equipment that
IV. Universal Precautions laboratory personnel wear, including when, how, and why each
V. Body Substance Isolation article is used.
VI. Standard Precautions
VII. Hand Hygiene  Correctly perform hand hygiene procedure following CDC
A. Info Gloves guidelines.
B. Mouth, Nose and Eye Protection  Describe the acceptable methods for handing and disposing of
C. Gown
D. Patient Care Equipment
biologic waste and sharp objects in the urinalysis laboratory.
E. Environmental Control  Describe precautions that laboratory personnel should take with
F. Linen regard to chemical, radioactive, electrical and fire hazards.
G. Occupational Health and Blood-Borne Pathogens
H. Patient Placement
 Define the pre-examination, examination and post-examination
I. Respiratory Hygiene/Cough Etiquette components of quality assessment.
VIII. Occupational Exposure to Blood-Borne Pathogens Standard
A. Engineering Controls SAFETY
B. Work Practice Controls
C. Personal Protective Equipment  To work safely in this environment, laboratory personnel must
D. Medical learn what hazards exist, the basic safety precautions associated
E. Documentation with them, and how to apply the basic rules of common sense
IX. Hazards in The Laboratory
A. Biologic Hazards
required for everyday safety for patients, co-workers, and
1. Chain of Infection themselves.
2. Hand Hygiene
3. Personal Protective Equipment ACRONYMS
4. Biologic Waste Disposal
B. Sharp Hazards  CDC – Center for Disease Control and Prevention
C. Chemical Hazards  OSHA – Occupational Safety and Health Administration
1. Chemical Handling  CLSI – Clinical Laboratory Standards Institute
2. What to Do When There Is A Chemical Spill
3. Chemical Hygiene Plan o Nagbibigay ng guidelines for writing procedure and policies
4. MSDS  HICPAC – Healthcare Infection Control Practices Advisory
5. Chemical Labeling Committee
D. Electric Hazards
E. Xi. Fire/Explosive Hazard
1. Actions When Fire Is Discovered SAFETY PROCEDURE MANUALS:
2. Steps to Operate Fire Extinguisher  must be readily available in the laboratory that describes the
3. Types of Fire Extinguisher
4. NFPA Hazards Identification System
safety policies mandated by CDC and OSHA
F. Physical Hazards  must be updated and reviewed manually by the laboratory
G. Radioactive Hazards director
H. Types of Safety Hazard Summary
 SPM – readily available provided by CLSO
X. Quality Assessment
A. Quality System  In 1996, CDC and HICPAC combined features of UP and BSI
B. Accreditation Agencies guidelines and called the new guideline – Standard Precautions.
C. Urinalysis Procedure Manual
XI. Pre-Examination Variables
A. Pre-Examination Errors UP (UNIVERSAL PRECAUTIONS):
B. Requisition Form  all patients are considered to be possible carriers of blood-borne
C. Tat pathogens.
D. Policy for Handling Mislabeled Specimens
E. Criteria for Urine Specimen Rejection  The CDC excluded urine and body fluids not visibly contaminated
XII. Examination Variables by blood.
A. Reagents  Focused in blood specimens and body fluid contaminated by
B. Instrumentation and Equipment
XIII. Quality Control
blood.
A. External Quality Control
1. Proficiency Testing BSI (BODY SUBSTANCE ISOLATION):
2. How to Conduct Proficiency Testing?
 Consider all body fluids and moist body substances to be
3. Interpretation of The Results
B. Internal Quality Control potentially infectious
1. Proficiency Testing  Personnel should wear gloves at all times when encountering body
XIV. Post-Examination Variables substances.
A. Reporting Results
XV. Summary of Quality Assessment Errors  blood+other body fluids. 
XVI. Microscopic Quantitation  Disadvantage: does not recommend handwashing after removing
of gloves unless usual contamination is present

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Fronda, J. Mansibang, M.
Mora, O. Pinson, M.
Vargas, L.
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STANDARD PRECAUTIONS:
 Combination of major features of UP and BSI guidelines
o Combined by CBC and HICPAC
1. Hand Hygiene
2. Gloves
3. Mouth, nose and eye protection
4. Gown
5. Patient care equipment
6. Environmental control
7. Linen
8. Occupational health and blood-borne pathogens
9. Patient placement
10. Respiratory hygiene/cough etiquette
1. Hand Hygiene
 Wash hands after touching blood, bod fluids, secretions,
excretions, and contaminated items, whether or not gloves are
worn.
 it includes both handwashing and the use of alcohol-based
antiseptic cleansers.
o Sanitize after using gloves
2. Gloves
 Clean, nonsterile gloves are adequate
 Wear gloves when touching body fluids, secretions, excretions and
contaminated items.
 Put on gloves just before touching mucous membranes and
nonintact skin.
 Latex consideration in gloves
3. Mouth, Nose and Eye Protection
 Wear a mask and eye protection or a face shield to protect mucous
membranes of the eyes nose and mouth during procedures and
patient care activities that are likely to generate splashes or sprays
of blood, body fluids, secretions and excretions.
 N95 is used during patient care activities related to
mycobacterium exposure.
4. Gown
 Clean, nonsterile gown is adequate
 Wear a gown to protect skin and to prevent soiling of clothing
during procedures that are likely to generate splashes.
5. Patient Care Equipment
 Ensure that reusable equipment is not used for the care of another
patient until it has been cleaned and reprocessed appropriately.
 Ensure that single-use items are discarded properly
6. Environmental Control
 Ensure that the hospital has adequate procedures for the routine
care, cleaning, and disinfection of environmental surfaces, beds,
bedrails, bedside equipment, and other frequently touched
surfaces
7. Linen
 Handle, transport, and process linen soiled with blood, body fluids,
secretions, and excretions in a manner that prevents skin and
mucous membrane exposures and contamination clothing and
that avoids the transfer of microorganisms to other patients and
environments.
8. Occupational health and blood-borne pathogens
 Take care to prevent injuries when using needles, scalpels, and
other sharp instruments or devices; when handling sharp
instruments. After procedure; when cleaning used instruments;
when disposing used needles.
 Main rule: Never recap used needles
9. Patient Placement
 Place a patient who contaminates the environment or who does
not (or cannot be expected to) assist in maintaining appropriate
hygiene or environment control in a private room.
 If a private room is not available, consult with infection control
professionals regarding patient placement or other alternatives.
10. Respiratory hygiene/cough etiquette
OCCUPATIONAL EXPOSURE TO BLOOD-BORNE PATHOGENS
STANDARD
Engineering Controls
1. Providing sharps disposal containers and needles with safety
devices.
2. Requiring discarding of needles with the safety device activated and
the holder attached.
3. Labelling all biohazardous materials and containers.
Work Practice Controls
1. Requiring all employees to practice Standard Precautions and
documenting training on an annual basis.
2. Prohibiting eating, drinking, smoking and applying cosmetics in the
work area.
3. Establishing a daily work surface disinfection protocol
Personal Protective Equipment
1. Providing laboratory cats, gowns, face shields and gloves to
employees and laundry facilities for non-disposable protective
clothing.
Medical
1. Providing immunization for the hepatitis B virus free of charge.
2. Providing medical follow up to employees who have been
accidentally exposed to blood-borne pathogens.
Documentation
1. Documenting annual training of employees in safety standards.
2. Documenting evaluations and implementation of safer needle
devices
3. Involving employees in the selection and evaluation of new devices
and maintain a list of those employees and the evaluations.
4. Maintaining a sharp injury log inducing the type and brand of safety
device, location and description of the incident and confidential
employee follow-up.
HAZARDS IN THE LABORATORY
Biologic hazards
 Infection Control – procedures to control and
monitor infections occurring the facilities.
 chain of Infection – process of how
microorganisms are transmitted. It requires a
continuous link between 6 components.

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Mora, O. Pinson, M.
Vargas, L.
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Chain of Infection

 Originally 3 factors:
o source (contaminated spx);
o MOT (direct contact, airborne and droplet, inhalation)
o susceptible host
Hand Hygiene
 Hand contact is the primary method of infection transmission.
 Alcohol-based cleansers
o When using alcohol-based cleansers, apply the cleanser to the
palm of one hand.
o Rub your hands together and over the entire cleansing area,
including between the fingers and thumbs.
o Continue until the alcohol dries.
o Used when hands are not visibly contaminated
 Handwashing is the single most effective way to prevent the
spread of infections.
 Antimicrobial soap is used for handwashing
 15-20 seconds when rubbing with soap
 Handwashing songs:
o HBD – 2 rounds
o Twinkle-twinkle – 1 round
o Alphabet – 1 round
 Ignaz Semmelweis – father of handwashing
 Dr. Didier Pitter – father of modern handwashing
Personal Protective Equipment
 Protects you from the spread of infection.
 a crucial constituent of infection control system.
 Donning: kung meron si hainet, 2nd siya.
o Gown
o Mask or respirator (3rd if hairnet is included)
o Goggles or face shield
o Gloves
 Doffing:
o Gloves
o Goggles or face shield
o Gown
o Mask or respirator
o Wash hands
Biologic Waste Disposal
 All biologic waste, except urine must be placed in appropriate
containers labeled with the biohazard symbol.
 Urine may be discarded by pouring it int0 a laboratory sink.
 Disinfection of the sink is using a 1:5 or 1:10 dilution of sodium
hypochlorite should be performed daily.
 Empty urine containers can be discarded as nonbiologically
hazardous waste.
 1:10 sodium hypochlorite can kill HIV within 2 mins and Hepa B
within 10 mins – effective for 1 month
 Sodium hypochlorite dilutions stored in plastic bottles are
effective for 1 month if protected from light after preparation.
 The waste is decontaminated following institutional policy:
o Incineration;
o Autoclaving; or
o Pick up by a certified hazardous waste company.

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Notify the supervisor

Sharp Hazards Chemical Hygiene Plan
 All sharp objects must be disposed in puncture-  OSHA requires all facilities that use hazardous chemicals to have a
resistant, leak-proof container with biohazard written chemical hygiene plan (CHP) available to employees.
symbol.  Purpose:
 The biohazard sharp containers should not be 1. Appropriate work practices
overfilled and must always be replaced when 2. Standard operating procedures
the safe capacity mark is reached. 3. PPE
 #1 rule: never recap used needles 4. Engineering controls, such as fume hoods and flammables
safety cabinets.
5. Employee training requirements
Chemical Hazards 6. Medical consultation guidelines
 When skin contact occurs, the best first aid it to  Chemical hygiene officer - is responsible for implementing and
flush the area with large amount of water for at documenting compliance with the plan.
least 15 minutes, then seek for medical attention.
 Acid should always be added to water. Material Safety Data Sheet
o If water is added to acid = boom sabog!
1. Physical and chemical characteristics
 Pipetting by moth is unacceptable in the laboratory 2. Fire and explosion potential
 Symbol- Skull with 2 crossed bones 3. Reactivity potential
 Every chemical in the workplace should be presumed hazardous. 4. Health hazards and emergency first aid procedures
5. Methods for safe handling and disposal
Chemical Handling 6. Primary routes of entry
 Chemicals should never be mixed together unless specific 7. Exposure limits and carcinogenic potential
instructions are followed, and they must be added in the order
specified Chemical Labeling
 Acid should always be added to water to avoid the possibility of
sudden splashing caused by the rapid generation of heat in some
chemical reactions
 Chemicals should be used from containers that are of an easily
manageable size.
 Pipetting by mouth is unacceptable in the laboratory
 State and federal regulations are in place for the disposal of  Hazardous chemicals should be labeled with a description of their
chemicals and should be consulted. particular hazard, such as poisonous, corrosive, flammable,
explosive, teratogenic, or carcinogenic
Alkali splashes on the skin
Electrical Hazards
a. Wash thoroughly and repeatedly with water.  Equipment should not be operated with wet
b. Bathe the affected skin with cotton soaked with 5% acetic acid or hands.
undiluted vinegar.
 Equipment should be unplugged before cleaning.
Alkali splashes in the eye  If electrical shock occurs, the electrical source
a. Wash immediately with large quantities of water sprayed from a wash must be removed immediately. Never touch the
bottle. Squirt the water into the corner of the eye near the nose. person or the equipment involved.
b. After washing with water, wash the eye with a saturated solution of  Turning off the circuit breaker, unplugging the equipment, or
boric acid. moving the equipment using a nonconductive glass or wood
Acid splashes on the skin object are safe procedures to follow.
a. Wash thoroughly and repeatedly with water.  All electrical equipment must be grounded with three-prolonged
b. Bathe the affected skin with cotton wool soaked in 5% aqueous plugs.
sodium carbonate.
Acid splashes in the eye Fire/explosive Hazards
a. Wash the eye immediately with large quantities of water sprayed from  JCAHO (Joint Commission on Accreditation of Healthcare
a wash bottle. Squirt the water into the corner of the eye near the Organization) requires that all healthcare institutions post
nose. evacuation routes and detailed plans follow in the event of a fire.
b. After washing, put 4 drops of 2% aqueous sodium bicarbonate into the
eye. When a fire is discovered, all employees are expected to take actions:
c. Refer the patient to a physician. Continue to apply bicarbonate R- Rescue – rescue anyone in danger
solution to the eye while waiting for the doctor. Alternatively, hold the A- Alarm – activate the institutional fire alarm system
eye under the running tap. C- Contain – close all doors to potentially affected     areas
E- Extinguish/Evacuate – attempt to extinguish the fire, if possible or
What to do when there is a chemical spill? evacuate, closing the door
Contain the spill Steps on how to operate the fire extinguisher:
Leave the area P- Pull pin
Emergency (eyewash, shower, medical care) A- Aim at the base of the fire
Access the MSDS S- Squeeze handle

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S- Sweep nozzle side to side Types of Safety Hazards Summary

Types of Fire Extinguishers

 Class A – Class C are dry chemicals

NFPA Hazards Identification System

 NFPA – National Fire Protection Association
 NFPA has developed the Standard System for the Identification of
the Fire Hazards of Materials, NFPA 704. This symbol system is
used to inform firefighters of the hazards they may encounter with
fires in a particular area.
 Diamond shaped, color-coded symbol contains information
relating go health flammability, reactivity and personal
protection/special precautions.
 Each category is graded on a scale of 0-4, based on the extent of
concern.
QUALITY ASSESSMENT
 It refers to the overall process of guaranteeing quality patient care
and is regulated throughout the total testing system.
 It is the continual monitoring of the entire test process from test
ordering and specimen collection through reporting and
interpreting results.
Quality System
 It refers to all laboratory’s policies, processes, procedure, and
resources needed to achieve quality testing.

 NOSMSX Documentation of QA procedures is required by all laboratory

- 0 - NO – no hazard ACCREDITATION AGENCIES
- 1 – S – slight hazard  Joint Commission (JC)
- 2 – M – Moderate hazard  College of American Pathologists (CAP)
- 3 – S – Serious hazard  American Association of Blood Banks (AABB)
- 4 – X – Extreme hazard  American Osteopathic Association (AOA)
 American Safety of Histocompatibility and Immunogenetics
 SUVSM – Reactivity (ASHI)
- S – stable if heated  Commission on Laboratory Assessment (COLA)
- UV – violent chemical change
- S – shock and heat Urinalysis Procedure Manual:
- M – may deteriorate  Principle and purpose of the test
 Clinical significance
Physical Hazards  Patient preparation
 Avoid running in rooms and hallways  Specimen type and method of collection
 Watch for wet floors  Specimen acceptability and criteria for rejection
 Bend the knees when lifting heavy objects  Reagents, standards and controls
 Keep long hair pulled back  Instrument calibration and maintenance protocols and schedules
 Avoid dangling jewelry  Step-by-step procedure
 Maintain a clean, organized work area  Calculations, frequency and tolerance limits for controls and
 Fall – most common physical hazard corrective actions
 Reference values and critical values
Radioactive Hazards  Interpretation of results
 Radioactivity may be encountered in the clinical  Specific procedure notes
laboratory when procedures using radioisotopes are  Limitations of the method
performed.  Method validation
 The amount of radioactivity present in the clinical  Confirmatory testing
laboratory is very small and represents little danger; however, the  Recording of results
effects of radiation are cumulative related to the amount of  References
exposure. (combination of time, distance, and shielding.).  Effective date
 Exposure to radiation during pregnancy presents a danger to the  Author
fetus; personnel who are pregnant or think they may be should
 Review schedule
avoid areas with this symbol.

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PRE-EXAMINATION VARIABLES
 Occur before the actual testing of the specimen
 Include test requests, patient preparation, timing, specimen
collection, handling, storage and transport

Pre-examination Errors:
 Improper patient orientation
 Patient misidentification
 Wrong container
 Mishandled specimen
 Delayed transport
 Incorrect storage or preservative of urine
 Insufficient volume
EXAMINATION VARIABLES
Requisition form includes:  are the process that directly affect the testing of specimens.
 Actual date and time of specimen collection  Include reagents, instrumentation and equipment, testing
 Whether the specimen was refrigerated before transporting procedure, QC, preventive maintenance (PM), access to procedure
 The time the specimen was received in the laboratory and the manuals, and competency of personnel performing the tests.
time the test was performed  Standard container: 50 mL
 Test requested  Capacity of urine: 12 mL
 Specific instruction that might affect the result of the analysis
 Patient identification information (name, date of birth, sex) Reagents
 all reagents and reagent strips must be properly labeled with the
Turn Around Time (TAT) date of preparation or opening, purchase and received date,
 amount of time required from the point at which a test is ordered expiration date, and appropriate safety information.
by the health-care provider until the results are reported to the  Reagent strips should be checked against known negative and
health-care provider positive control solutions on each shift or at a minimum once a
o for both STAT and routine test day, and whenever a new bottle is opened.
 Results of all reagent checks are properly recorded.
 Reagent strips must be refrigerated, and must be recapped
immediately after removing each strip.
 Reagent strip should not be exposed to light
o Reagent bottle: colored

Instrumentation and Equipment

 the one who should correct the misspelled identification is the one
who delivered the specimen
Policy for Handling Mislabeled Specimens
 Refractometers are calibrated on each shift.
o Deionized water (1.000)
o 5% saline (1.022 ± 0.001) or 9% sucrose (1.0334 ± 0.001)
 Temperatures of refrigerators and water baths should be taken
daily and recorded.
o Calibrated every 3 months
o Disinfected on a weekly basis
 Microscopes should be kept clean at all times and have an annual
professional cleaning.
 Deionized water used for reagent preparation is quality controlled
by checking pH and purify meter resistance on a weekly basis
 The bacterial count is checked on a month schedule

QUALITY CONTROL
 Refers to the materials, procedures, and techniques that monitor
the accuracy, precision, and reliability of a laboratory test.
 It is performed to ensure that acceptable standards are met during
the process of patient testing.
 It is performed at scheduled times, such as at the beginning of
each shift or before testing patient samples, and it must always be
performed if reagents are changed, an instrument malfunction has
occurred, or if test results are questioned by the health-care
provider

 label must be written at the body of the container

External Quality Control

Criteria for Urine Specimen Rejection

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 Also known as Interlab Quality Control  Aka Intralab Quality Control

 Used to verify the accuracy and of a test and are exposed to the  Consists of internal monitoring systems built in to the test system
same conditions as the patient samples and are called internal and procedural controls.
 Documentation of QC includes dating and initialing the material  Monitors the sufficient addition of a patient specimen or reagent,
when it is first opened and recording the manufacturer’s lot the instruments/reagents interaction and for lateral flow test
number and the expiration date each time a control is run and the methods, whether the sample migrated through the test strip
test result is obtained. properly
 This is important in long term accuracy  Important for daily monitoring of accuracy and precision on
analytical methods.
Proficiency Testing (External Quality Assessment)
 testing of unknown samples received from an outside agency and Proficiency Testing (External Quality Assessment)
provides unbiased validation of the quality of patient test results.  Testing of unknown samples received from an outside agency and
How to conduct proficiency testing? provides unbiased validation of the quality of patient test results
1. A series of unknown samples are sent to the laboratory from the  Proficiency testing is also for accreditation
reference laboratory or authorized program provider.  Different samples will be given to different laboratory; CAP will
2. Unknown samples must be tested by the laboratorians who regularly detect if there are error
perform analysis of patient specimens using the same reagents and  CAP - agency which assess if the process/ procedure is successfully
equipment for actual patient specimens, and the results are submitted to done
the program provider, preferably as soon as every analysis is done.
3. analysis of unknown samples should be completed within the usual time POST-EXAMINATION VARIABLES
as for the routine samples.  Are processes that affect the reporting of result and corrected
4. unknown samples should be treated like a patient specimen to interpretation of data.
determine the true essence of accuracy
5. results of the proficiency testing must be shared with other laboratories Reporting Results
“during the testing period” – comparison studies can be made after the  Electronic Transmission
testing cycle to identify areas of improvement. - most common method for reporting results
 CLIA – mandates proficiency testing  Delta check
Interpretation of the Results of the Proficiency Testing: - compares a patient’s test results with his/her previous results
 Difference or greater than 2SD in the results indicated that a - for counterchecking
laboratory is not agreement with the rest of the laboratories  Telephone
included in the program. - frequently used to transmit results of stat tests and critical values
 In case a clinical laboratory failed to identify or resolve an error or 1. time of telephone call
discrepancy in the test process, the facility is at risk of continuous 2. initial of the person making the call
preparation and may be recommended for closure. 3. name of the person receiving the telephone call
o STAT – from the word statim means immediate
 Control mean
- average of all data points
SUMMARY OF QUALITY ASSESSMENT ERRORS
 Standard Deviation (SD)
– a measurement statistic that describes the average distance
each data point in a normal distribution is from the mean.
- measure the dispersion range of the mean
 Coefficient of Variation (CV)
- is the SD expressed as a percentage of the mean
- indicates whether the distribution of values about the mean is in
a narrow versus broad range and should be less than 5%.
- index of precision
- CV (Total percent error)
- CV=SD/Mx100
 Control Ranges
– are determined by setting confidence limits that are within ±2
SD or ±3 SD of the means, which indicated that 95.5% to 99.7% of
the values are expected to be within that range.
 Levey-Jennings Chart – most common chart
 Trend
– a gradual changing in the mean in one direction
- slow change
- either increase or decrease
- main cause: deterioration of reagent
 Shift
– an abrupt change in the mean
- fast change
- main cause: improper calibration of the instrument MICROSCOPIC QUANTITATIONS
Internal Quality Control

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Additional Notes/Reminders:
1. Book notes are in BLACK.
2. Lecture notes are in RED.
3. PPT are in BLUE.

References
Reyes, L. (2020). Chapter 1: Safety and Quality Assessment
Strasinger, S. Urinalysis and Body Fluids idk edition

Remember to cite your sources using APA format

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● Redefined Hippocrates ideas, theorizing that urine represented is not a

filtrate of the four humors and overall condition but rather, a filtrate of
CONTENTS
the blood.
I. History Middle Ages
II. Urinalysis ● Physicians concentrated on the art of uroscopy.
A. Importance Of Urinalysis
III. Urine ● They received instruction in urine examination as part of their training
A. Characteristic of Urine Specimen
B. Urine Formation 1140 CE
C. Urine Composition
D. Urine Volume
● Color charts has been developed that describes the significance of 20
E. Test to identify Urine different colors..
IV. Specimen Collection
V. Specimen Rejection Protospatharius
VI. Specimen Handling
A. Specimen Integrity ● Invented the first documented laboratory technique heat would
B. Specimen Preservation precipitate proteins causing proteinuria to manifest through
VII. Methods of Urine Collection cloudiness.
A. Bottle Method
B. Gauze-pad Method o Protospatharius - manifested through “cloudiness”
C. Midstream Clean-Catch Method
D. Catheterized Method Frederik Dekkers
E. Suprapubic Aspiration Method
VIII. Types of Urine Specimen ● In 1694, he made laboratory findings of albuminuria by boiling urine,
A. Single/Random Specimen which means remain a useful diagnostic indicator today.
B. First Morning Specimen
C. 24 hours (or timed) Specimen
D. 12 hour urine sample
Paracelsus
E. Early afternoon specimen ● Used vinegar to bring cloudiness
F. Fasting Specimen ● Acid will precipitate or cook proteins
G. Glucose Tolerance Test
H. Catheterized Specimen
I. Midstream Clean-Catch Specimen 17th century
J. Suprapubic Aspiration Specimen ● 17TH century, the uses of uroscopy had spiralled far beyond the edge of
K. Prostatitis Specimen reason. Physicians and leeches started telling fortunes and predicting
L. Pediatric Specimen
M. Drug Specimen Collection
the future with urine, a practice known as “uromancy”. Witch hunters
mixed urine with nails to distinguish witches from non-witches. The
abuses of urine finally caused a backlash.

I. HISTORY Thomas Bryant

Edwin Smith
● An Egyptian hieroglyphic used for urinalysis reference
● Early physicians were able to obtain diagnostic information from such
basic observations as: color, turbidity, odor, viscosity, volume, and
sweetness (by noting that certain specimens attracted ants or tasted
sweet)
● Led a medical rebellion against all uses of uroscopy over the centuries.
● In 1627, he published the Pisse Prophets, a book that devastated
uroscopy.
o Pisse prophets- urine of diagnosis
⮚ The book was inspired of the passing of medical licensure exam in
England

Sumerian and Babylonian Physicians of 400 BC Thomas Addis

● Recorded their assessment of urine on clay tablets
o Urine characteristics were altered with different diseases
Sanskrit medical works from 100 BC
● Describe 20 different types of urine
● Developed methods for quantitating the microscopic sediment.
Richard Bright
● Introduced the concept of urinalysis as part of a doctor's routine
examination in 1827

Hindu Culture 1930s

● Urine tasted sweet and that black ants were attracted to sweet
urine , a characteristic of the disease now known as diabetes
mellitus.
Hippocrates
● In the fourth century, BC, Hippocrates hypothesized that urine was a
filtrate of the humors, which came from the blood and was filtered
through the kidneys.
o 4 humors - blood, black bile, yellow bile, phlegm
● describes bubbles that lay on the surface of fresh urine as an indication
of long-term kidney
● Bubbles on the surface of urine are in fact often owing to proteinuria
Galen
● Urinalysis began to disappear from routine examinations.
II. URINALYSIS
● Clinical Laboratory Standards Institute
o Defines urinalysis as “the testing of urine with procedures commonly
performed in an expeditious, reliable, accurate, safe, and cost-
effective manner.”
o Reasons for performing urinalysis identified by CLSI:
⮚ Aiding in the diagnosis of disease.
⮚ Screening asymptomatic populations undetected
⮚ Monitoring progress of disease and the effectiveness of therapy.
A. Importance of Urinalysis
● Useful in ascertaining evidence of disease or disturbed functions of the
kidneys and the pathological lesions of the uterus, bladder, and uterus
for males lesions of prostate and seminal vesicles.

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● Its chemical changes can indicate early disease. of these inorganic compounds, making it difficult to establish normal
III. URINE levels.
● A complex aqueous solution of organic and inorganic constituents ● The major inorganic dissolved in urine (in order):
resulting from the active metabolism of the body or directly from food 1. Chloride
taken in. 2. Sodium
● Urine - ultrafiltrate of plasma 3. Potassium
o easily collected
o It is tested within 2 hours 6. Sulfate -2.5g/L
● “Uroscopia” - scientific examination of urine 7. Phosphate -2.5g/L
o From the latin word: “uros”, urine 8. Ammonium -0.7g/L
“Copia” - to be examined or inspect 9. Phosphorous -2g/L
10. Total sulfur -1.5g/L
A. Characteristics of a Urine specimen
1. Urine is a readily available and easily collected specimen,
2. Urine contains information, which can be obtained by inexpensive
laboratory tests, about many of the body’s metabolic functions.

B. Urine Formation
● The kidneys continuously form urine as an ultrafiltrate of plasma.
Reabsorption of water and filtered substances essential to body
function converts approximately 170,000 mL of filtered plasma to the D. Urine Volume
average daily urine output of 1200 mL.
● Depends on the amount of water that the kidneys excrete.
C. Urine Composition ● Water- major constituent of the body, therefore the amount excreted
● 95% water(liquid) and 5% solute (Solid) is usually determined by the body’s state of hydration.
● Although variations in the concentrations of solutes can occur due to ● Factors that influence urine volume:
influence factors: o Fluid intake
o Dietary intake, physical activity, body function, state of the kidney, o Fluid loss from nonrenal sources
and endocrine functions. o Variations in the secretion of ADH
o Need to excrete increased amount of dissolved solids (glucose or
Chiefly Organic salts)
1. Urea- 25-35 g/L
● 1200 to 1500 mL- normal daily urine output.
o A metabolic waste product produced in the liver from the breakdown
● 600 to 2000 mL- considered normal.
of proteins and amino acids.
o Accounts for nearly half the total dissolved solids in urine.
o Major organic component Oliguria
2. Creatinine -1.5g/L ● Decrease in urine output.
o Derived from creatine, a nitrogeneous substance in muscle tissue. o Infants- <1mL/kg/hr
3. Uric Acid -0.4-10g/L o Children- <0.5 mL/kg/hr
o common components of kidney stones, derived from the catabolism o Adults- <400 mL/day 
of nucleic in food and cell destruction ● Commonly seen when the body enters a state of dehydration as a
4. Hippuric Acid -0.7g/L result of excessive water loss from vomiting, diarrhea, perspiration, or
5. Undetermined N2 -0.6g/L severe burns.

6. Ketones 9. Pigments 12. Hormones Anuria

7. Carbohydrates 10. Mucin 13. Sugar 2.9 g/L ● After Oliguria.
8 . Bicarbonates 11. Fatty acids 14. Enzyme ● Cessation of urine flow.
o May be present in small amount depending on diet ● May result from any serious damage to the kidneys or from a decrease
in the flow of blood to the kidneys.
Inorganic Compound ● Kidneys excrete 2-3x more during the day than during the night.
1. Chloride -10g/L
2. Sodium -5g/L Nocturia
3. Potassium -3.3g/L ● Increase in the nocturnal excretion of urine.
4. Calcium -0.3g/L Occurs as chloride, sulphate and
5. Magnesium -0.1/L phosphate salts
● Potassium-serves Polyuria
as a buffer in the ● Increase in daily urine volume.
blood o Adults- >2.5 L/day
● Dietary intake o Children- >3 mL/kg/day
greatly influences ● Often associated with diabete mellitus and insipidus
the concentrations ● May be artificially induced by diuretics, caffeine, or alcohol→
suppressors of ADH
● Diabetes mellitus and insipidus cause polyuria.

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● Following collection, spx should be delivered to the laboratory and

Diabetes mellitus tested within 2 hours. If this is not possible, it should be refrigerated or
● Caused by a defect either in the pancreatic production of insulin or in have an appropriate chemical preservative added
the function of insulin→ increased body glucose concentration. o  11 most significant changes that may occur in a specimen allowed to
● The kidneys do not reabsorb excess glucose, necessitating excretion remain unpreserved at room temperature for longer than 2 hours
of increased amounts of water to remove the dissolved glucose from
the body.
● Though the urine appears to be dilute, urine from a patient with DM
has a high specific gravity because of the increased glucose content.

Diabetes Insipidus
● Results from a decrease in the production or function of ADH, thus the
water necessary for adequate body hydration is not reabsorbed from
the plasma filtrate.
● Urine is truly dilute and has a low specific gravity.

E. Test to identify Urine

● Presence of considerable amounts of urea nitrogen and creatinine
o Test to identify urine:
⮚ Urea nitrogen - 600 mg/dL
⮚ Creatinine - 50 mg/dL
⮚ Urea nitrogen and B. Specimen Preservation
creatinine must have  ● Urine specimen must be examined immediately for accurate result of
higher concentration (50% tests and for proper evaluation. Examination may be delayed if
of plasma) specimen can be ideally preserved.
● Most routinely used method of preservation is refrigeration, realible in
IV. SPECIMEN COLLECTION preventing bacterial decomposition of urine.
1. Specimen must be collected in clean, dry, leak-proof containers ● If the urine is not refrigerated use a proper preservative on it.
2. Disposable containers are recommended ● If the urine is culture, it should be refrigerated for up to 24 hours.
3. Properly applied screw-top lid ● Constant room temp: 20-24 degree Celsius
4. Clear, wide mouth container with wide flat bottom \
5. Recommended capacity of container is 50mL.
6. All specimens must be properly labelled.
7. Specimen sample should be accompanied with a properly labelled
laboratory request form

● The label should be on the body of the container to prevent

misidentification  and it includes the ff: Purpose of Urine Preservation
o Patient’s name ● To suppress bacterial growth by;
o Date and time of collection o Preventing conversion of urea to ammonia
o Identification number o Preventing degradation of glucose by bacteria or yeast
o 12ml needed amount of urine o Interference of bacterial proteins
o To prevent instability of urinary solutes
V. SPECIMEN REJECTION o To prevent degeneration of organized sediments such as pus
● Unacceptable situations include: casts,etc
o Spx in unlabeled containers
o Non Matching labels and requisition forms Ideal Preservatives
o Spx with contaminated feces or toilet paper
● Bactericidal - it destroys bacteria.
o Containers with contaminated exteriors
● Inhibit urease
o Spx of insufficient quantity o Urease- enzyme  that catalyzes hydrolysis of urea--- leads to
o Spx that have been improperly transported breakdown of CO2 and Ammonia--- leads to the elevation of pH
urine producing alkaline urine
● Preserve formed elements in the sediment
● Should not interfere with chemical tests

VI. SPECIMEN HANDLING

● Changes in urine composition take place not only in vivo but also in
vitro.

A. Specimen Integrity

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● Rubber tubed which has been cleaned and sterilized is inserted through
the urethral orifice to the urethral canal, then finally to the bladder to
collect a presumably pure urine specimen.
● Not recommended anymore because it is painful

E. Suprapubic Aspiration Method

● Direct puncturing of the suprapublic region for collection of urine the
urinary bladder
o Since urinary bladder is sterile under normal conditions, SAM
provides a sample for bacterial culture that is completely free of
extraneous contamination  

VIII.TYPES OF URINE SPECIMENS

A. Single/Random Specimen
● Most commonly received spx due to its ease of collection.
● May be collected at any time.
● Actual time of voiding should be recorded on the container.
● Useful for routine screening tests to detect obvious abnormalities.
o advantage: allow detection pathologic postprandial conc. of solutes
(e.g., sugar and proteins)
o Disadvantage: variation in dilution and conc. of solute

B. First Morning Specimen

● Voided upon rising or waking
● Ideal screening spx.
● For evaluating proteinuria (excessive protein in urine).
● Essential for preventing false-negative pregnancy tests 
● Refrigeration - it is a physical preservative. It is the most routinely ● Most preferred sample because the night urine sample is less variable in
method of preservation dilution.
● Chemical preservatives are not recommended ● FMS is concentrated
● Pag may tinetake na drug/medicine si patient, hindi magandang
gamitin si boric acid as preservative dahil magkakaroon ng interfere sa C. 24 Hour (or Timed) Specimen
result . ● Used to produce accurate quantitative results.
● Advantage of refrigeration: Prevents bacterial growth for 24 hours.  ● required when the concentration of the substance to be measured
● For culture, boric acid and thymol are best preservatives for urine changes with diurnal variations and with daily activities such as
specimens.  exercise, meals and body metabolism
● Commercial preservative - refrigeration is not possible ● Solutes exhibit diurnal variations 
o Catecholamines, 
Special Preservatives o 17-hydroxysteroids, and 
● 10mL 40% Formalin -Addis count o Electrolytes (low concentration in the morning, high in the
● 10mL conc. HCI -epinephrine, cathecholamines, vanilymandelic acid afternoon)
(VMA)
● 10mL Glacial HAc, pH 2.0 –aldosterone
● H2SO4 -preserves calcium and other inorganic constituents
● NaF or Benzoic acid -ideal for glucose analysis; prevents glysoclysis

VII. METHODS OF URINE COLLECTION

A. Bottle Method
● A method that uses any receptacles to collect the specimen provided
that it is dry, clean and sterile.

B. Gauze-pad Method
● A gauze pad is used to collect the urine and then centrifuge tube
containing a golf tee.

C. Midstream Clean Catch Method

● Collection of urine specimen for examination at the middle part of a single
continued normal urination.
o bawal ang pahintu-hinto na pag-ihi, lalo na sa girls dahil maraming
epithelial cells sa vagina. Pag nagstop, may tendency na sumama
yung epithelial cells sa sample

D. Catheterized Method

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D. 12-hour Urine Sample

● urine is collected within 12 hours (8am-8pm)
● usually used for Addis count
● if any of these cells changes was noted, it indicates a disease process
o Casts>5,000
o RBCt>500,000
o WBC>2,000,000
● For a 12 hour urine specimen, the best preservative is formalin (10%). 

E. Early Afternoon Specimen

● For urobilinogen determination
● Early afternoon specimen - correlates with typical alkaline type 

F. Fasting Specimen (Second Morning)

● Second voided specimen after a period of fasting
● Recommended for glucose monitoring

G. Glucose Tolerance Test

● Provides a sample for bacterial culture that is completely free of
● Collected to respond with the blood samples drawn during an OGTT
extraneous contamination.
● Tested for glucose and ketones and results are reported along with the
● Spx can be used for cytologic examination.
blood test results as an aid to interpret the patient’s ability to
metabolize a measured amount of glucose.
K. Prostatitis Specimen (Three-Glass Collection
● For prostatic collection
● Procedure:
1st specimen -first portion of urine
2nd specimen -midstream
3rd specimen -massage prostate
⮚ Quantitative cultures are performed on all specimens.
⮚ Prostatic Infection: 3rd specimen have a WBC/HPO and bacterial count
10x that of the first specimen

o 1st & 3rd - for microscopic examination

o 2nd - Control for bladder and kidney infection

H. Catheterized Specimen
● Collected under sterile conditions by passing a catheter through the
urethra into the bladder.
● Used to measure function of an individual kidney
● Bacterial culture- most requested test on a catheterized spx.

I. Midstream Clean-Catch Specimen

● Alternative of catheterized spx.
● Provides a safer, less traumatic method for obtaining urine for bacterial
culture and routine urinalysis.
● Spx is less contaminated with epithelial cells and bacteria.
● Strong bacterial agents (hexachlorophene or povidone-iodine) should
not be used as cleansing agents.
● Mild antiseptic towelettes are recommended.
L. Pediatric Specimens
● Used soft, clear plastic bags with hypoallergenic skin adhesive to attach
to the genitalia of both boys and girls.
● Sterile spx may be obtained by catheterization or by suprapubic
aspiration.
● For routine spx analysis, make sure that the area is free of
contamination.
o Avoid the anus when attaching the bag over the genital area.
● For microbiology spx, clean the area with soap and water and sterilely
dry the area.
o Firmly apply a sterile bag then transfer collected spx into a sterile
container.

J. Suprapubic Aspiration Specimen M. Drug Specimen Collection

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● Urine spx collection is the most vulnerable part of a drug-testing

program
● Chain of Custody (COC)- process that provides the documentation of
proper sample identification from the time of collection to the receipt
of laboratory results.
● Collection may be “witnessed” for suspected donors that might tamper
results or “unwitnessed” for non-suspects.
● For witnessed specimen collection, a same-gender collector will
observe the collection of 30-45 mL of urine.

Drug Urine Specimen

o Urine temperature must be taken within 4 minutes from collection to
make sure that it has not been adulterated.
o Temperature must be between 32.5 to 37.7 degrees celsius. If the spx
is not within this range, it should be recorded and the supervisor or
employer must be contacted.
o Color is also inspected to identify any signs of contaminant.
⮚ Bluing agent- the hospital use to prevent specimen adulteration.

Additional Notes/Reminders:
1. PPT notes are in BLACK.
2. Lecture notes are in BLUE.
3. Information retrieved from book are in RED.

References
● Reyes, L. (2020). Chapter 2: Introduction to Urinalysis
● Strasinger, S. K., & Schaub, D. L. (2021). Urinalysis and body fluids.
Philadelphia: F.A. Davis Company.

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