URINALYSIS AND BODY FLUIDS LECTURE

LECTURE: SAFETY AND QUALITY MANAGEMENT

Safety Biological Chain of Infection

Identification of hazards
Precautions to adhere to
Applying “common sense”

Safety Hazards

Transmission of microorganisms
Continuous link

• Infectious agent
Mandated Safety Policies
Agencies involved in developing guidelines • Reservoir
Centers for Disease Control and
• Portal of exit
Prevention (CDC)
Occupational Health and Safety • Means of transmission
Administration (OSHA) • Portal of entry
Clinical Laboratory Standards Institute
(CLSI) • Susceptible host

Infection Control Infectious Agents

Monitors infections in the facility Bacteria
Infection control procedure development Fungi
Primary objective of biological safety is Parasites
preventing completion of the chain of Viruses
infection
Reservoirs
Location of potentially harmful
microorganisms

•Humans

• Animals

• Fomites
VENN IRISH OREL| BMLS III-2
 Means of Transmission Standard Precautions (SP) (continued_2)
Airborne Occupational health and blood-borne
Direct contact pathogens
Droplet
• No needle recapping
Vector
Vehicle Patient placement

Portal of Entry • Isolation if needed

Often same as reservoir portal of exit
Respiratory hygiene/cough etiquette
Mucous membranes of the nose, mouth,
and eyes • Prevent droplet and fomite transmission
Breaks in the skin of respiratory pathogens
Open wounds Occupational Exposure to Blood-Borne
Pathogens Standard
Susceptible Host
Law monitored and enforced by OSHA
Other patients
Controls are required by OSHA to be
Visitors
Health-care personnel provided by or mandated by the employer
for all employees
Standard Precautions (SP)
• Engineering controls
Hand hygiene • Work practice controls
Immediately after removing gloves
• Personal protective equipment
Between patient contacts
• Medical
Gloves
Blood, body fluids, secretions, excretions, Postexposure Prophylaxis (PEP)
contaminated items Report accident immediately to
Mouth, nose, and eye protection supervisor
Mucous membrane protection, sprays, Prompt testing of source patient
aerosols and employee for HIV, HBV, HCV
Follow CDC updated guidelines for
Gown the management of exposures and
Appropriate when soiling of scrubs is recommended PEP
imminent
Personal Protective Equipment (PPE)
Standard Precautions (SP) (continued_1) Report accident immediately to supervisor
Patient-care equipment
Prompt testing of source patient and
• Dispose or sterilize as per protocol employee for HIV, HBV, HCV
Environmental control Follow CDC updated guidelines for the
management of exposures and
• Clean and disinfect surfaces recommended PEP

Linen Gloves:
not a substitute for hand hygiene
•Prevent exposure when handling
 Types: Before going to designated break areas
sterile and nonsterile, powdered and Before and after using bathroom facilities
nonpowdered, latex and nonlatex Includes hand washing and using alcohol-
based antiseptic cleansers
Latex allergy
Report any symptoms to supervisor; Disposal of Biological Waste
reactions can be fatal Specimens and contact materials
Alternative nitrile or vinyl glove is Waste containers have biohazard
recommended symbol
Fluid-resistant lab coats Containers disposed of per protocol
Protect skin and clothing Empty containers go in no
Must be worn completely buttoned, biohazardous waste
gloves pulled over wrist cuffs Urine can be poured down the sink, no
Wear when working with specimens, splashes
remove when leaving lab Flush sink with water
Change when visibly soiled Daily 1:5 or 1:10 sodium hypochlorite
Discard disposable as biohazardous waste flush
and non-disposable in designated laundry • Also use on countertops
bins
• Store protected from light
Face protection
Goggles, full-face plastic shields, Plexiglas Decontamination
countertop shields Needed for:
Splashes and aerosols caused by Contaminated no disposable equipment
uncapping, pouring, transferring, and • Blood spills
centrifuging
Never centrifuge uncapped specimens • Areas that process blood and body fluids

• Daily use of 1:10 sodium hypochlorite

• Do not wipe or mop a spill

Contaminated specimen container exteriors

• Disinfect exterior -Use absorbent powder or paper

towels
• Request new specimen as per protocol
‒ Disinfect the area with bleach or
Foot protection
phenol solution
• Closed-toed and covers the entire foot
Sharp Hazards
Hand Hygiene Needles
Hand contact is the primary method of Lancets
infection transmission Broken glassware
Sanitize hands Puncture-resistant containers
Before patient contact Leak proof
After gloves are removed • Conveniently located in work area
Before leaving the work area
At any time when hands have been
knowingly contaminated Chemical Hazards
Similar to biohazard rules
Avoid ingesting, getting on body, clothes,
and work area
Presume all chemicals are hazardous

Chemical Spills
Skin/eye contact
• Flush 15 minutes with water

• Then seek medical attention

• Know location of eyewash and showers

• Remove contaminated clothing

immediately
• Do not try to neutralize with other
chemicals
‒ Acid contact—do not use a base, just
water
Hazard labels
Poison, corrosive, flammable, explosive,
Chemical Handling teratogenic, carcinogenic
Follow specific instructions for mixing of National Fire Protection Association
chemicals (NFPA)
Acid to water-based liquid Standard System for the Identification of
Wear eye protection the Fire Hazards of Materials, NFPA 704
Utilize fume hood Symbol on doors, cabinets, containers
No mouth pipetting Fire hazards
Chemical Hygiene Plan Safety Data Sheet (SDS)
Written plan required by OSHA includes OSHA Federal Hazard Communication
• Appropriate work practices Standard

• Standard operating procedures • Employee’s right to know

• PPE Must have file available

• Engineering controls, hoods, safety Vendors supply but facility is responsible

to collect and maintain file
cabinets
SDS Information
• Employee training Information content required

• Medical consultation guidelines • Physical and chemical characteristics

Chemical Hygiene Officer required • Fire and explosion potential

• Reactivity potential

• Health hazards and emergency first aid

Chemical Labeling procedures

• Methods for safe handling and disposal • Must be nonconductive

• Primary routes of entry Fire/Explosive Hazards

The Joint Commission (TJC) requires
• Exposure limits and carcinogenic potential
evacuation routes and a detailed plan to be
Globally Harmonized System posted and followed in case of a fire for all
Classification and Labeling of Chemicals health-care facilities
Includes criteria for the classification of RACE acronym
health, physical, and environmental •Rescue: anyone in danger
hazards
All employees trained on the new label • Alarm: activate

elements and SDS format • Contain: close affected area doors

Increases awareness and understanding of
• Extinguish/Evacuate: if possible, or exit
hazards in the workplace

Chemical Waste Disposal Fire Extinguisher Operation

State and federal regulations in place for PASS acronym
proper disposal • Pull pin
Chemicals must be disposed following SDS
• Aim at base of fire
directions
Sinks and drains must be flushed with • Squeeze handles
large amounts of water • Sweep nozzle side to side
Radioactive Hazards
Radioisotopes in lab Physical Hazards
Slight danger in lab General precautions
Symbol on doors • Avoid running in rooms and hallways
Radiographers wear badges to measure • Watch for wet floors
Exposure • Bend the knees when lifting heavy
Pregnancy: avoid areas with this symbol objects
• Keep long hair pulled back
Electrical Hazards
Avoid water and fluid contact • Avoid dangling jewelry
Do not operate equipment with wet hands • Maintain a clean, organized work area
Observe for frayed cords, overloads; report
Unplug and dry wet equipment • Wear supportive, closed-toe shoes

Unplug equipment before cleaning

Equipment grounded with three-prong Quality Management (QM)
plugs The overall process of guaranteeing quality
patient care
Electrical Shock Accident Quality system
Do not touch person
• The laboratory’s policies, processes,
Remove electrical source
Turn off circuit breaker procedures, and resources needed to
Unplug equipment achieve quality testing
Move equipment using wood or glass
Testing controls Commission on Laboratory Assessment
(COLA)
• Quality control
Urinalysis Procedure Manual
Preexamination variables
Must be available in the work area
• Specimen collection, handling, and Each procedure must include
storage
• Principle or purpose of the test
Examination variables
• Clinical significance
•performance,
Reagent and test
• Patient preparation
instrument calibration and maintenance,
personnel requirements, and technical • Specimen type and method of collection
competence
• Specimen acceptability and criteria for
Post examination variables rejection
• Reporting of results and interpretation • Reagents, standards, and controls

• Instrument calibration and maintenance

Quality Assessment Documentation
Guidelines published by College of protocols and schedules
American Pathologists (CAP) and the CLSI
• Step-by-step procedure, calculations
provide complete instructions for
documentation • Frequency and tolerance limits for
controls and corrective actions
•Procedure manuals
• Reference values and critical values
• Internal and external quality control
• Interpretation of results
• Standardization and equipment
• Specific procedure notes
maintenance
• Proficiency testing and record-keeping • Limitations of the method

• Safety programs • Method validation Confirmatory testing

• Recording of results
• Training, education, competency
assessment • References

• Scheduled, documented review • Effective date, author, and review

processes
Schedule
• Required by accrediting agencies

Accrediting Agencies Evaluating Procedures and New

The Joint Commission (TJC) Methodology
Ongoing process
College of American Pathologists (CAP)
American Association of Blood Banks Current methods reviewed annually
Procedure manual changes should be
(AABB)
reviewed, referenced, and signed by a
American Osteopathic Association (AOA)
person with designated authority
American Society of Histocompatibility and
All personnel notified of changes
Immunogenetics (ASHI)
 Preexamination Variables • Adequate amount of specimen
Variables occurring before testing
• Non-contaminated specimen
• Test requests
• Tightly closed container
• Patient preparation and timing
Must have documented rejection
• Specimen collection procedures
• Specimen handling, transport, and Internal Laboratory Quality Improvement
storage
Form
Requires communication and adequate
training among health-care personnel
outside the clinical laboratory

Turnaround Time (TAT)

TAT is defined as the amount of time
required from when a test is ordered by the
health-care provider until the results are
reported to the health-care provider
TATs for stat and routine tests
Process improvement using cause and
effect

Procedure Manual Specimen Collection

and Handling
Requisition and computerized entry forms

•Patient identification information

‒ Name, sex, age, date of birth, hospital ID

number
• Test requested

• Type of urine specimen to be obtained

(voided, clean catch, catheterized)
• Requested date and time of collection

• Actual collection information (time, Summary of Preexamination Variables

storage/transport condition) Patient misidentification
Wrong test ordered
• Received and tested time
Incorrect urine specimen type collected
Insufficient urine volume
Specimen acceptability
Delayed transport of urine to laboratory
• Matching patient information on Incorrect storage or preservation of urine
specimen and requisition form
Examination Variables
• Properly labeled specimen Processes that directly affect the testing of
• Timely transport or refrigeration specimens

• Reagents
• Instrumentation and equipment Specimen and reagent stability
Calculation formulas
• Testing procedure
Health and safety precautions
• QC Sources of error and interference
• Preventive maintenance Clinical situations influencing test,
alternate procedures
• Access to procedure manuals
Helpful hints
• Competency of personnel performing Turnaround time for STATs
the tests
Quality Control (QC)
Reagents The materials, procedures, and techniques
Manufacturer, name, and chemical that monitor the accuracy, precision, and
formula reliability of a laboratory test
Instructions for preparation QC procedures ensure that acceptable
•Type of water used in preparation standards are met during the process of
patient testing
‒ Clinical Laboratory Reagent Water
QC is performed at scheduled times
(CLRW)
Must always be performed if reagents
Storage requirements changed, instrument has malfunctioned, or
-Procedures for reagent quality control test results are questioned by the provider
Test results cannot be reported until the QC
-Label with date of opening or preparation is verified

• Check reagent strips daily or External QC

Verifies accuracy and precision
each shift and when a new bottle is
opened and record results • Exposed to the same condition as a
patient sample
Safety and health precautions • Medically significant
Instrumentation and Equipment • Run two levels of control material
Operation, calibration, limitations, dilution
procedures, recording • Record date of opening, manufacturer’s
Calibration and control of refractometers, lot number, expiration date each time
osmometers, reagent strip readers control is run
Temperatures of refrigerators and water • Same person running controls must run
baths patient samples
• Recorded daily • Free of communicable disease (HIV,
Hepatitis C, Hepatitis B)
Calibration and disinfection of centrifuges
Prepare a routine preventive maintenance
schedule
Document all routine and non-routine
Calculate mean and standard deviation for
maintenance
control for each test
Testing Procedure -Gaussian distribution
Specimen preparation: time and speed of
centrifugation
-Mean: average of the results from ‒ Verifies functional ability only
repeat testing of the control sample
Proficiency Testing/External Quality
Standard deviation: average distance each Assessment
value is from the mean PT/EQA: Unbiased validation of the quality
Coefficient of variation: standard deviation of patient test results
expressed as a percentage from the mean Testing of unknown samples provided by
Control range: ±2 SD or ±3 SD from the an external agency
mean (95.5% to 99.7%) Vendors supply materials to laboratory
Laboratory tests materials and returns
Corrective Actions results to vendor
Accuracy is evaluated and compared with
other laboratories using the same method
of analysis
Vendor statistically rates answer from all
participating labs and returns report to lab
director
Corrective actions performed and
documented

Individualized Quality Control Plan

Alternative option that provides quality
testing to meet CLIA regulations
IQCP considers entire testing process
Requires risk assessment, a QC control
plan and quality assessment
Involves selecting quality monitors which
include QC and PT records, patient results,
specimen rejection logs, TAT reports,
preventive measures, corrective action,
and follow-up records, and personnel
Must be taken when control values are competency records
outside the tolerance limits
Personnel and Facilities
Must be documented Personnel assessment includes education
Internal QC and training, continuing
education,
Internal monitoring included in the test competency assessment, and performance
system appraisals
Document training
• Internal and procedural: monitors
• Checklist of procedures
addition of patient specimen and
reagents, instrument and reagent Documentation of continuing education
interaction, test completion
Current reference materials must be
Electronic: electrical components of available
instruments in place of liquid control Safe working area with adequate space
medium Standard precautions followed at all times
 Postexamination Variables
Processes that affect the reporting of
results and correct interpretation of data

- Use standardized reporting formats to

minimize health-care provider confusion
• Reference ranges included

Electronic transmissions are the most

common
Auto verification is often programmed into
many laboratory analyzers
Correct erroneous results in a timely
manner
• Do not erase original result from chart

• Document errors

When telephoning results, confirm that the

results are being reported to the
appropriate person

• “Read Back” adopted by TJC

Written procedures should be available for

the reporting of critical values

Interpretation of Results
Include specificity and sensitivity of tests in

procedure manual
List all interfering substances in manual
A well-documented QA program ensures
quality test results and patient care