PRELIM: LABORATORY SAFETY AND QUALITY ASSESSMENT

BSMLS TERM
AUBF311 ANALYSIS OF URINE
LABORATORY
AND BODY FLUIDS 3 01
OUTLINE

I. Introduction: LAB VIII. Chemical Hazards

SAFETY IX. MSDS
II. Biological Hazards X. Quality Assessment
III. Biological Hazards XI. Urinalysis procedure
Definition manual
IV. PPE XII. Preexamination
V. Hand hygiene Variable
VI. Biologic waste XIII. Examination
disposal Variables Chain of infection and safety practices related to
VII. Sharp Hazards XIV. Post examination the biohazard symbol.
Variable (From Strasinger, SK, and DiLorenzo, MA: The
Phlebotomy
Textbook, FA Davis, Philadelphia, 2011, with
permission.)
Introduction: LAB SAFETY

 The clinical laboratory contains a variety of safety

hazards, many of which are capable of producing
serious injury or life-threatening disease.
 To work safely:
 learn what hazards exist
- saan ba siya galing, maari ito manngaling sa
ating specimen or sa patient.
 the basic safety precautions
- is one of the primary components to work
safely in the laboratory
 apply the basic rules of common sense
- be attentive
- identified all the different hazard
- following the precaution
 Safety procedure manuals
 must be readily available in the laboratory
 describe the safety policies
 updated and reviewed annually by the
laboratory director or pathologist
• mandated by the Centers for Disease
Control and Prevention (CDC) and the
Occupational Safety and Health
- The etiologic agent is coming from the
Administration (OSHA)
infectious agent meaning those
• The Clinical and Laboratory Standards
microorganisms
Institute (CLSI)
- Paki tignan po yung break the link ng bawat
 provides the guidelines for writing these biohazard
procedures and policies.

Biologic Hazards
Biologic Hazards Definition: Universal Precaution
 Proper hand hygiene, correct disposal of  In 1987 the CDC instituted Universal Precautions
contaminated materials, and wearing personal (UP).
protective equipment (PPE) are of major
 It states that all patients are considered to be
importance in the laboratory.
possible carriers of bloodborne pathogens.

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  Same sa statement sa ating laboratory “All guidelines and called the new guidelines Standard
specimen considered are considered Precautions.
infectious”  Standard Precautions are as follows:
 The guideline recommends 1. Hand hygiene
 wearing gloves when collecting or handling 2. Gloves
blood and body fluids contaminated with blood 3. Mouth, nose, and eye protection
 wearing face shields when there is danger of 4. Gown
blood splashing on mucous membranes and 5. Patient care equipment
when disposing of all needles and sharp objects 6. Environmental control
in puncture-resistant containers. 7. Linen
 The CDC excluded urine and body fluids not 8. Occupational health and blood-borne pathogens
visibly contaminated by blood from UP. 9. Patient placement
- Yung mga visible lang ng contamination ng 10. Respiratory hygiene/cough etiquette
blood yung kasama sa recommended
guidelines. Personal Protective Equipment (PPE)
 PPE used in the laboratory includes gloves, fluid-
resistant gowns, eye and face shields, and Plexiglas
countertop shields.
- For the laboratory urine section, we use the
Plexiglas countertop shield
 Gloves should be worn when in contact with
patients, specimens, and laboratory equipment or
fixtures.
 Wearing gloves is not a substitute for hand
hygiene, and hands must be sanitized after gloves
are removed.

Hand Hygiene

 Hand hygiene includes both hand washing and

using alcohol based antiseptic cleansers.
 The CDC has developed hand washing guidelines to
Biologic Hazards Definition: be followed for correct hand washing.
BSI (Body Substance Isolation) Guidelines

 BSI guidelines are not limited to blood- borne

pathogens
 According to BSI guidelines, personnel should wear
gloves at all times when encountering moist body
substances.
 A major disadvantage of BSI guidelines is that they
do not recommend handwashing after removing
gloves unless visual contamination is present.

Biologic Waste Disposal

 All biologic waste, except urine, must be placed in
Biologic Hazards Definition: Standard Precaution appropriate containers labeled with the biohazard
symbol.
 In 1996 the CDC and the Healthcare Infection  Urine may be discarded by pouring it into a
Control Practices Advisory Committee (HICPAC) laboratory sink under a Plexiglas countertop shield.
combined the major features of UP a n d BSI

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 Care must be taken to avoid splashing, and he sink 4. Health hazards and emergency first aid
should be flushed with water after specimens are procedures
discarded. 5. Methods for safe handling and disposal
 Disinfection of the sink using a 1:5 or 1:10 dilution of 6. Primary routes of entry
sodium hypochlorite should be performed daily. 7. Exposure limits and carcinogenic potential
 Empty urine containers can be discarded as non- -beyond that pwede mag cause ng injury or
biologically hazardous waste. severe damage w/ the workers kung meron siya
carcinogenic potential
Sharp Hazards
 All sharp objects must be disposed in puncture-
resistant, leak-proof container with the biohazard
symbol.

Chemical Hazards
 Every chemical in the workplace should be
presumed hazardous.
 Chemical Labeling
 Hazardous chemicals should be labeled with a
description of their particular hazard, such as
poisonous, corrosive, flammable, explosive,
teratogenic, or carcinogenic.

Quality Assessment
 It refers to the overall process of quality patient care
and is regulated throughout the total testing system.
 Chemical Spills and Exposure  Quality system refers to all of the laboratory’s
 When skin contact occurs, the best first aid is to policies, processes, procedures, and resources
flush the area with large amounts of water for at needed to achieve quality testing.
least 15 minutes, then seek medical attention.  In a clinical laboratory, a quality assessment
 all laboratory personnel should know the program includes not only testing controls, referred
location and proper use of emergency showers to as quality control (QC), but also encompasses:
and eye wash stations  Preexamination variables (e.g., specimen
 Contaminated clothing should be removed as collection, handling, and storage)
soon as possible.  Examination variables (e.g., reagent and test
performance, instrument calibration and
maintenance, personnel requirements, and
technical competence)
 Postexamination variables (e.g., reporting of
results and interpretation)
 Documentation that the program is being
meticulously followed.

Quality Assessment Program

 Procedure manuals
 Internal quality control
Material Safety Data Sheets  External quality control
 Electronic quality control
 Information contained in an MSDS includes the
following:  Calibration or calibration verification
1. Physical and chemical characteristics  Standardization
2. Fire and explosion potential  Proficiency testing or External quality assessment
3. Reactivity potential (EQA),

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  Record keeping  Requisition forms and computerized entry forms
 Equipment maintenance and safety programs should designate the type of urine specimen to be
-meron tayo guidelines dito on how to conduct collected and the date and time of collection.
equipment maintenance hindi natin antayin na  The form should include space for recording
magkakaron ng trouble sa ating equipment, if your 1. The actual date and time of specimen collection,
equipment is in a good condition so must probably note whether the specimen was refrigerated
safe yung mga workers (electrical, function ng before transporting.
centrifuge hindi siya tumatalon hindi nagkakaron ng 2. The time the specimen was received in the
other mechanical or electrical problem) laboratory and the time the test was performed
 Training, education and competency assessment of 3. Tests requested
personnel -ex; pregnancy test, urinalysis
 Scheduled and documented review process. 4. An area for specific instructions that might affect
the results of the analysis
Urinalysis Procedure Manual 5. Patient identification information must be
 A procedure manual containing all the procedures complete.
performed in the urinalysis section must be -ex; requisition form complete patient
available for reference in the working area and identification and data. sometimes we include
must comply with the CLSI guidelines. the time of the collection, time received in the
-CM section – Clinical Microscopy Section laboratory and the time of the examination, from
-for example; double checking parang nag consult there we identify also yung tinatawag natin na
tayo turn around time
 The following information is included for each  Patient preparation, type and volume of specimen
procedure: required, and the need for sterile or opaque
1. Principle or purpose of the test containers must be included with the specific
2. Clinical significance procedure.
3. Patient preparation  All urine specimens should be examined within 2
-kung kailangan mag fasting ng patient or hours.
abstinence or some other examination na pwede  If this is not possible, written instructions for
yung routine preserving the specimen must be available.
4. Specimen type and method of collection  procedures for collecting clean-catch and timed
5. Specimen acceptability and criteria for rejection specimens,
6. Reagents, standards and controls  specimen processing, and printed instructions
7. Instrument calibration and maintenance that are given to patients, are also included in
protocols the manual.
8. Step by step procedure
-magiging basis po natin ng part din ng accuracy  Criteria for specimen rejection for both physical
of result characteristics and labeling errors
9. Reference values and critical values
10. Interpretation of results
11. Limitations of the method
-must be read within 5 mins beyond that ex;
reagent strip may kanya kanyang time per
interpretation
12. Method validation
13. Confirmatory testing
-if it’s needed kasi minsan ex; bilirubin
determination of level
14. Recording of results
15. References

Preexamination Variables
 before the actual testing of the specimen
 test requests, patient preparation, timing,
specimen collection, handling, and storage.

Specimen Collection and Handling

 Specific information on specimen collection and
handling should be stated at the beginning of each
procedure listed in the manual.

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 -kailangan basahin to add information, magka-iba
Examination Variables yung written procedure sa laboratory sa
 the processes that directly affect the testing of Manufacture’s package inserts
specimens.
 reagents Quality Control
 instrumentation and equipment,  Quality control refers to the materials, procedures,
 testing procedure, and techniques that monitor the accuracy,
 QC, precision, and reliability of a laboratory test.
 preventive maintenance (PM),  to ensure that acceptable standards are met during
 access to procedure manuals, the process of patient testing.
 competency of personnel performing the tests
External Quality Control
Reagents  to verify the accuracy and precision of a test and are
exposed to the same conditions as the patient
 All reagents and reagent strips must be properly
samples.
labeled with the date of preparation or opening,
-kung paano ginawa yung quality control testing
purchase and received date, expiration date, and
ganon din sa patient sample.
appropriate safety information.
 Reliability is the ability to maintain both precision
 Reagent strips should be checked against known
and accuracy.
negative and positive control solutions on each shift
or at a minimum once a day, and whenever a new
Internal Quality Control
bottle is opened.
-each shift natin – in every shifting in the lab, kung  it consists of internal monitoring systems built in to
may 3 shifts pwede 3x mo siya ginagawan ng the test system and are called internal or
negative and positive control procedural controls.
 Results of all reagent checks are properly recorded.  Internal controls monitor the sufficient addition of a
patient specimen or reagent, the
 Reagent strips must never be refrigerated, and must
instruments/reagents interaction, and, for lateral flow
be recapped immediately after removing each strip.
test methods, whether the sample migrated through
the test strip properly.
Instrumentation and Equipment
-one of the good example ng mga internal quality
 refractometers,
control ay yung mga rapid tests, ex.pregnancy test
-for the specific gravity
 osmometers, Electronic Controls
 automated reagent strip readers, and  External quality control (EQC) uses a mechanical or
 automated microscopy instruments. electrical device in place of a liquid QC specimen.
 point of care (POC) instrument.
 Common Equipment -ang good example is yung glucometer, yung
- refrigerators, centrifuges, microscopes, and water yung ginagamit nung merong diabetes, theres a
baths. strip control wherein we have to insert it to the
 Temperatures of refrigerators and water baths electrical device.
should be taken daily and recorded.  EQC verifies the functional ability of a testing device
-ni-ccheck ng DOH pag nag visit sila sa laboratory.  but it does not verify the integrity of the testing
 Calibration of centrifuges is customarily performed supplies.
every 3 months, and the appropriate relative
centrifugal force for each setting is recorded. Proficiency Testing (External Quality Assessment)
-tachometer yung ginagamit.  PT or EQA is the testing of unknown samples
- Centrifuges are routinely disinfected on a weekly received from an outside agency, and provides
basis. unbiased validation of the quality of patient test
results.
Testing Procedure -dito sa Philippines meron tayong proficiency testing,
 Detailed, concise testing instructions are written in a ang nagbibigay ng unknown sample ay yung mga
step by-step manner. nasa reference laboratory (NRL), hindi pwedeng
 Instructions should begin with specimen preparation, hindi sumali ang isang laboratory because it is a
such as time and speed of centrifugation, and requirement for the renewal of the Lab license under
include types of glassware needed, time limitations R.A 4688 for the clinical laboratory act.
and stability of specimens and reagents, calculation  Laboratories subscribing to these programs receive
formulas and a sample calculation, health and safety lyophilized or ready-to-use specimens for routine
precautions, and procedures. urinalysis and Kodachromes or color plates for
 sources of error and interfering substances sediment constituent identification.
 Reference sources should be listed.
 Manufacturer’s package inserts may be included but
cannot replace the written procedure.

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  The laboratory accuracy is evaluated and compared
with other laboratories using the same method of
analysis.
 Corrective action must be taken for unacceptable
results.
 The Clinical Laboratory Improvement
Amendments (CLIA) mandates comparison testing
for laboratory accreditation.

Personnel and Facilities

 Personnel assessment includes education and
training, continuing education, competency
assessment, and performance appraisals.
 Each new employee must have documentation of
training during orientation to the laboratory.
 Up-to-date reference materials and atlases should
be readily available, and documentation of
continuing education must be maintained.
 An adequate, uncluttered, safe working area is also
essential for both quality work and personnel
morale. Standard precautions for handling body
fluids must be followed at all times.

Postexamination Variables
 processes that affect the reporting of results and
correct interpretation of data.

Reporting Results
 Standardized reporting formats
 A written procedure for reporting, reviewing, and
correcting errors must be present.
 Electronic transmission
 Errors may be discovered in the laboratory through a
QA procedure known as the delta check that
compares a patient’s test results with the previous
results.
 Erroneous results must be corrected in a timely
manner.
 Erroneous results must be corrected in a timely
manner to assure that the patient does not receive
treatment based on incorrect results.
 Errors can occur in patient identification,
specimen labeling, or result transcription.
 The patient’s record should be corrected as soon as
the error is detected

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