Clinical Microscopy: Lecture

Week 1: Safety, Quality Assessment and Laboratory Operation intro

LEARNING OBJECTIVES:
 Discuss the components and purpose of chemical hygiene plans and MSDS.
 State the purpose of Standard precautions policy and describe the guidelines
 Describe the acceptable methods for handling and disposing of biologic waste and sharp objects in the urinalysis
laboratory.
 List of 6 components of the chain of infection and the laboratory safety precautions that break the chain.
 Discuss the importance of QC and QA in urinalysis and POCT.
 Recognize the regulatory agencies in clinical laboratories in Philippines
POINT OF VIEW:
Urinalysis and Body Fluid analysis are performed in the clinical Laboratory, which is a part of the Healthcare
organization.
Both health care organizational and Clinical laboratories have differing organizational configurations and offer a
variety of services to physicians and patients with the goal of providing the best possible patient care.

REGULATORY AGENCIES GOVERNING THE CLINICAL LABORATORY IN PHILIPPINES

1. Bureau of Licensing and Regulation (BLR): now became Bureau of Health Facilities and Service Regulatory
Bureau (HFSRB).
 Sets Standards for Regulation of health facilities and services
 Disseminates regulatory policies and standards for information and compliance
 Issues permit to construct (PTC), license to operate (LTO), clearance to operate (CTO), Health
 Maintenance Organizations (HMOs), and certificate of accreditation (COA)
 Ensures sustainability of health facilities compliance with regulatory standards
 Provides consultation and advisory services to stakeholders regarding health facilities regulation.
2. Department of Health (DOH): principal health agency in the Philippines.
 Responsible for ensuring access to basic public health services, through the provision of quality health
care and regulation of providers of health goods and services.
3. Food and Drug Administration (FDA): Responsible for the approval of medical and diagnostic equipment,
pharmaceuticals, reagents and diagnostic tests before these can be marketed.
4. National Reference Laboratory (NRL): Responsible for the External Quality assessment and monitoring
proficiency test of clinical laboratories.
Other accreditation government agency
5. Philippine Association of Medical Technologist (PAMET): NGO of medical technologist.
 As of today, one of most influential in terms of Continuing Professional Development (CPD)
provider.
6. Philippine Society of Medical Laboratory Scientist (PSMLS): New NGO of medical technologist.

NATIONAL AGENCIES FOR THE LABORATORY STANDARDS:

1. National Committee for Clinical Laboratory Standards (NCCLS): Is a non-profit, private educational
organization that develops and publishes national and international laboratory standards on a variety of clinical
laboratory testing procedures and policies.
LEGAL AND ETHICAL CONCERNS:
Informed consent: for certain complex procedures or procedures with important risks, the patient should know what test
to be perform.
Standard Operating Procedures: Laboratory employees have the responsibility to know and follow the accepted
standards of care

DAYLE DANIEL G. SORVETO, RMT 1

Clinical Microscopy: Lecture
Week 1: Safety, Quality Assessment and Laboratory Operation intro
 An acceptable Standard of Care for the laboratory is the care that a reasonable laboratory professional would
provide.
Confidentiality: Privacy of patient information, the tests they are having done and the laboratory results, must be kept
strictly confidential.
 Confidential information is not be shared with insurance companies, lawyers, or relatives of the patient
unless they are authorized to have this information.
Specimens for Legal Cases: when a specimen is collected for a case that may involve litigation, special safeguards are
recommended to protect the rights of all those involved
 Chain of Custody the specimen must be collected and handled in a particular manner.
Example legal cases specimens: 1. Blood-alcohol levels. 2. Drug test specimen. 3. Specimens for rape cases. 4
medical examiner’s specimens. 5

LABORATORY SAFETY
 Laboratory personnel must learn what hazard exist, basic safety precautions associated.
 Apply the basic rules of common sense required for everyday safety for patients, co-workers, and themselves.

1. BIOLOGIC HAZARDS
 Sources of potentially harmful microorganisms.
 Those microorganisms frequently present in the specimens received in the clinical lab.
 “Chain of Infection” must be controlled and monitor.
 The chain of infection requires a continuous link between (infectious agent, reservoir, portal of exit,
transmission, portal of entry, susceptible to host.

“All Blood, other body fluids and any unfixed tissue samples are considered potentially INFECTIOUS for various
pathogens”. -- universal precaution—

DAYLE DANIEL G. SORVETO, RMT 2

Clinical Microscopy: Lecture
Week 1: Safety, Quality Assessment and Laboratory Operation intro
Standard precautions in laboratory:

1. Hand Hygiene: proper handwashing and use of alcohol-based antiseptic cleanser, sanitize hands after touching
blood, body fluids, secretions, excretions and contaminated items
2. Wear gloves: Clean, non-sterile gloves are adequate when touching any types of specimen
3. Mouth, nose and eye protection: used to protect from any foreign
substances.
4. Wear gown:
5. Patient care equipment:
6. Enviromental control
7. Linen
8. Occupational health and blood-borne pathogens
9. Patient placement
10. Respiratory hygiene/cough etiquette FIGURE 1 BIOHAZARD SYMBOL

BIOLOGIC WASTE DISPOSAL

 Urine may be discarded by pouring it into a laboratory sink under a Plexiglas

countertops shield
 Disinfect the sink using a 1:5 or 1:10 dilution of sodium hypochlorite.
o Stored in plastic bottles are effective for 1 month and protected from light
after preparation
 Empty urine containers can be discarded as non-biologically hazardous FIGURE 2 SHARP HAZARD SYMBOL
waste.
 1st to wear PPE in the lab: Lab gown > Gloves > Mask > Goggles
 1st to remove PPE in the Lab: Gloves > Lab gown > Goggles > Mask

SHARP HAZARDS

 All sharp objects must be disposed in puncture-resistant, leak-proof container with biohazard symbol.

CHEMICAL HAZARDS

 Chemical spills and Exposure:

o In skin, flush the area with large amount of water for atleast 15 mins, then seek for medical attention.
o Contaminated clothes should be removed as soon as possible.
o Do not attempt to neutralize the chemicals that come in contact to skin.

DAYLE DANIEL G. SORVETO, RMT 3

Clinical Microscopy: Lecture
Week 1: Safety, Quality Assessment and Laboratory Operation intro
o Acid first before water in terms of mixing both chemicals to avoid sudden splashing by the rapid generation
of heat
o Prepare the reagents under the fume
hood.
o “CHEMICAL LABELING”
Developed by NFPA. Diamond-shaped,
color coded symbol and each category is
graded on scale 0-4.
 “NEVER STORE CHEMICAL ABOVE
HEAD HEIGHT!!!!!!”

MATERIAL SAFETY DATA SHEET (MSDS)

 All employees have a right to know about

all chemical hazards present in their
workplace.
 The information contained in an MSDS
includes the following
o Physical and chemical characteristics FIGURE 3: NFPA HAZARDOUS MATERIAL SYMBOLS.
o Fire and explosion potential
o Reactivity potential
o Health hazards and emergency first aid procedures
o Methods for safe handling and disposal
o Primary routes of entry
o Exposure limits and carcinogenic potential

RADIOACTIVE HAZARD FIGURE 4: A) POISON, B) CORROSIVE, C) RADIOACTIVE SYMBOLS

 Radioactivity may be encountered in clinical lab performing

a precedures using Radioisotopes
 The effects of radiation are cumulative related to the amount of exposure.
 Pregnant women is at risk in radiation exposure.
 Radiation monitoring:
o Film Badge or Survey meter
o Exposure limits (maximum permissible dose equivalent – 5000mrem/yr: whole body)
o Wipe Test (leak test): laboratory surfaces wiped w/ moistened absorbent material radiation contained in
each wipe counted.
Chemical spill (what to do)

C- ontain the spill

ELECTRICAL HAZARD
L- eave the area
 Laboratory setting contains a large amount of electrical equipment w/ which
workers have frequent contact. E- mergency: eye wash
 Equipment should not be operated with wet hands shower & medical care.
 Electrical safety:
1. Lock out/ tag out malfunctioning electrical or mechanical equipment A - Ccess MSDS
serviced.
2. Report any small shocks; unplug and tag equipment until serviced N- otify Supervision
3. Replace all frayed wires and plugs.

DAYLE DANIEL G. SORVETO, RMT 4

Clinical Microscopy: Lecture
Week 1: Safety, Quality Assessment and Laboratory Operation intro
4. If a severely shocked person cannot let go instrument, unplug it (without touching it) or knock person loose
w/ nonconductive material, such as wood.
5. If the shock victim stops breathing perform CPR (Cardiopulmonary Resusitation)

FIRE HAZARD

 When fire is discovered, all employees are expected to take the actions in the acronym RACE.
“NEVER USE WATER ON FLAMMABLE
LIQUID OR ELECTRICAL WIRES” How to use fire extinguisher: R- rescue injured
A- activate alarm
P- pull C- contained fire close door
OTHER THINGS SHOULD BE AVOIDED INSIDE A-Aim E- extinguish fire
THE LABORATORY: S- squeeze
1. Mouth pipetting
S- sweep
2. Eating/ consumption of food
3. Smoking
4. Applying cosmetics
5. Needle prick situations
6. Storing of food in refrigerator in lab
7. Tantrums in lab

DAYLE DANIEL G. SORVETO, RMT 5

Clinical Microscopy: Lecture
Week 1: Safety, Quality Assessment and Laboratory Operation intro
QUALITY ASSESSMENT:
Terminologies
1. Quality Assessment: refers to the overall process of guaranteeing quality care and is regulated throughout the
total testing system.
2. Quality system: refers to all of the laboratory policies, process, procedures and resources needed to achieve in
quality test
3. Quality control: control and calibration of materials, reagents used and methods
4. Proficiency Testing: testing of unknown samples received from outside agency i.e., Reference lab and provides
unbiased validation of quality of patient test results.

POLICY FOR HANDLING MISLABELED SPECIMENS:./

 Do NOT assume any information about the specimen or patient.

 Do NOT relabel an incorrectly labeled specimen.
 Do NOT discard the specimen until investigation is complete.
 Leave specimen EXACTLY as you receive it; put in the refrigerator for preservation until errors can be resolved.
 Notify floor, nursing station, doctor’s office, etc. of the problem and why it must be corrected for analysis to
continue.
 Identify problem on specimen requisition with date, time, and your initials.
 Make person responsible for specimen collection participate in solution of problem(s). any action taken should be
documented on the requisition slip.
 Report all mislabeled specimens to the appropriate supervisor

REAGENT STRIPS
Criteria for urine specimen rejection
 All reagents and reagent strips must be properly labeled with
 Unlabeled date of opened, expiry, and appropriate safety information.
 Nonmatching labels on request form  Should check daily.
 Contaminated w/ feces, diapers, toilet paper.  Should not be stored in refrigerator.
 Insufficient amount  RECAPPED IMMEDIATELY AFER REMOVING EACH
 Improperly transported or preserved STRIP.
 Delay of time collection and receipt in the lab
QUALITY CONTROL COMMONLY CHECKED IN LAB:
 Personnel evaluation: monthly
 CPE: Monthly
 Laboratory fire extinguisher: yearly/annually
 Accidental written report: within 24 hrs
 Centrifuge: 3 months
 Automatic pipettes: 2-3 months
 Machines analyzer: every week

Reporting of critical Results in Urinalysis:

 POSITIVE KETONES ( Child age 2 years and younger)

 POSITIVE CLINITEST ( Child age 2 years and younger)
 STRONGLY POSITIVE FOR GLUCOSE
 POSITIVE FOR CYSTEINE, LUECINE, TYROSINE CRYSTALS

DAYLE DANIEL G. SORVETO, RMT 6

Clinical Microscopy: Lecture
Week 1: Safety, Quality Assessment and Laboratory Operation intro
HISTORY OF URINALYSIS:
Analyzing urine was actually the beginning of laboratory medicine.
1. Edwin smith surgical papyrus, Pictures of early physicians commonly showed them examining a bladder-shaped
flask of urine.
2. Hippocrates: Wrote the book of “Uroscopy”
3. By 1140 CE: color charts had been developed which describes of 20 different colors
4. “ant testing” and “taste testing” for glucose
5. Frederick dekkers discover of albuminuria by boiling urine.
6. 17th century: Thomas addis, developed a method of quantitating the microscopic sediment.
7. Richard bright: Introduced the concept of urinalysis as a part of a doctor’s routine patient examination in 1827.

WHY URINE IS VERY ACCESSIBLE?

 Urine is readily available and easily collected specimen.

 Urine contains information, which can be obtained by inexpensive lab test.

According to CLSI, urinalysis defines as “the testing of urine with procedures commonly performed in an
expeditious, reliable, accurate, safe and cost-effective manner”

URINE COMPOSITION:  The major inorganic solid dissolved in urine

 Urine consist of urea, creatinine, uric acid,
chloride, sodium, potassium, and inorganic
chemicals.
 Urine is normally 95% water and 5% solutes
is CHLORIDE. Followed by sodium and
potassium.
 Normal daily urine output: (1200 to 1500mL)
 Normal range of urine output: ( 600 to 2000mL)
 Oliguria- decrease urine output.
o Infant: <1ml/kg/hr
o Child: <0.5ml/kg/hr
o Adult: < 400mL/kg/hr
 Anuria- Cessation of urine flow
o Result of serious damage to the kidney
or from decrease flow of blood to the
kidney.
 Nocturia- increase urine excretion during night.
 Polyuria- Increase in daily urine output.
o >2.5L/day = adults.
o >2.5-3.0ml/kg/hr in children
o Often associated with diabetes mellitus
and Insipidus.
o Can be artificially induced by diuretics.
 The kidney do not reabsorb excess glucose,
necessitating excretion of increased amounts of
water to remove the dissolved glucose from the
body.
 Polydipsia- increased ingestion of water

DAYLE DANIEL G. SORVETO, RMT 7

Clinical Microscopy: Lecture
Week 1: Safety, Quality Assessment and Laboratory Operation intro
o If urine sample is for culture test
recommended is refrigeration.
 The ideal preservative should be bactericidal
 Inhibit urease.
 Preserve formed elements in the sediments.
 Should not interfere with chemical tests.

TYPES OF SPECIMEN:

SPECIMEN COLLECTION:

 Container must be collected in clean, dry, leak-

proof containers.
 It should be made in clear container to allow for
determination of color and clarity.
 Recommended capacity of container is 50mL.
o 12ml for microscopic analysis.
o Remaining for repeat analysis

SPECIMEN INTEGRITY:

 Specimens should be delivered to the laboratory

and tested within 2hrs.
 A specimen cannot be delivered and tested
within 2 hours should be refrigerated (2-8°C) or
appropriate chemical preservative added.

SPECIMEN PRESERVATION

 Refrigeration- most routinely used preservation

in laboratory.
o Decrease bacterial growth and
metabolism

DAYLE DANIEL G. SORVETO, RMT 8