MT ASSESSMENT PROGRAM - LABORATORY MANAGEMENT

QA & QC: CLINICAL MICROSCOPY

Lecturer:

KEY TERMS

Biological hazard - A biological material or an entity contaminated with biological material that is potentially capable
of transmitting disease

Chemical Hygiene Plan - An established protocol developed by each facility for the identification, handling, storage, and
disposal of all hazardous chemicals
- The Occupational Safety and Health Administration established the plan in January 1990 as a
mandatory requirement for all facilities that deal with chemical hazards

Critical value - A patient test result representing a life threatening condition that requires immediate attention
and intervention

Decontamination - A process to remove a potential chemical or biological hazard from an area or entity (e.g.,
countertop, instrument, or materials) and render the area or entity "safe."
- May use various processes such as:
● Autoclaving incineration
● Chemical neutralization
● Disinfecting agents

Documentation - A written record. Includes written policies and procedures quality control and maintenance records
- May encompass the recording of any action performed or observed, including verbal
correspondence, observations, and corrective actions taken

External quality assurance - The use of materials (e.g., specimens and kodachrome slides) from an external unbiased source to
monitor and determine if quality goals (i.e., test results) are being achieved
- Results are compared with the results from other facilities performing the same function
- Proficiency surveys are one form of external quality assurance

Infectious waste disposal policy - A procedure outlining the equipment, materials, and steps used in the collection storage, removal,
and decontamination of infectious material and substances

Material Safety Data Sheet - A written document provided by the manufacturer or distributor of a chemical substance listing
(MSDS) information about the characteristics of that chemical
- Includes:
● The identity and hazardous ingredients of the chemical
● Its physical and chemical properties including reactivity
● Any physical or health hazards
● Precautions for the safe handling, storage, and disposal of the chemical

Occupational Safety and Health - Established by Congress (1970) OSHA is a division of the U.S. Department of Labor that is
Administration (OSHA) responsible for:
● Defining potential safety and health hazards in the workplace
● Establishing guidelines to safeguard all workers from these hazards
● Monitoring compliance with these guidelines
- The intent is to alert, educate, and protect all employees in every environment to potential safety
and health hazards

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Preventive maintenance - The performance of specific tasks in a timely fashion to eliminate equipment failure
- These tasks vary with the instrument and include:
● Cleaning procedures
● Inspection of components
● Component replacement when necessary

Procedure manual - A written document describing in detail all aspects of each policy and procedure performed in the
laboratory
- For example, the manual includes:
● Supplies needed ● Technical procedures
● Reagent preparation procedures ● Quality control criteria
● Specimen requirements ● Reporting formats
● Mislabeled & unlabeled spx protocols ● References
● Procedures for storage and disposal of wastes

Protective barriers - Items used to eliminate exposure of the body to potentially infectious agents
- These barriers include:
● Protective gowns ● Biosafety cabinets (fume hoods)
● Gloves ● Splash shields
● Eye and face protectors ● Specimen transport containers

Quality assurance - An established protocol of policies and procedures for all laboratory actions performed to ensure
the quality of services (i.e., test results) rendered

Quality control materials - Materials used to assess and monitor the accuracy and precision (i.e, analytical error) of a method

Technical competence - The ability of an individual to perform a skilled task correctly

- Includes the ability to evaluate results, such as recognizing discrepancies and absurdities

Test utilization - The frequency with which a test is performed on a single individual and how it is used to evaluate a
disease process
- Repeat testing of an individual is costly and may not provide additional or useful information.
Sometimes a different test may provide more diagnostically useful information

Turnaround time - To the laboratorian, the time that elapses from receipt of the spx → reporting of the test results
- Physicians and nursing personnel assign a broader time frame

Universal Precautions - A policy describing the procedures to use when obtaining, handling, storing, or disposing of all
blood, body fluid, or body substances regardless of patient identity or patient health status
- All body substances should be treated as potentially infectious

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 QUALITY ASSURANCE

- A program of checks and balances designed to ensure the - To achieve these goals, a commitment by all lab personnel,
quality of a laboratory's services administration and management, is necessary
- All laboratorians must be aware of the effect their services • Must be evident in management decisions, including the
have on the diagnosis and treatment of patients allocation of laboratory space, the purchase of equipment
- These services must be monitored to ensure that they are and supplies, and the budget. Without adequate
appropriate and effective and that they meet the established resources, the quality of laboratory services is
standards for laboratory practice compromised
- The QA program must involve a mechanism for the detection • Properly educated and experienced laboratory personnel
of problems and provide an opportunity to improve services with a high level of evaluative skills are essential to
- In essence, “quality assurance is a broad spectrum of plans, ensure the quality of laboratory results
policies, and procedures that together provide an ‣ Many studies have shown that the standards of
administrative structure for a laboratory's efforts to achieve specimen collection technique and analytical
quality goals" performance are generally inferior to those obtained
- On a larger scale, all components of health care, including by skilled laboratorians
physicians, nurses, clinics, hospitals, and their services, are ‣ It is imperative that laboratorians have access to
involved in QA. The laboratory is only part of a larger program reference books and opportunities for continuing
to ensure quality health care education to assist them in skill maintenance and
- QA has been an important part of the clinical laboratory since development
the first laboratory surveys of the 1940s ‣ Continuing education opportunities provide
• Revealed that not all laboratories reported the same intellectual stimulation and challenges, facilitate the
results on identical blood specimens submitted for development of quality employees, and ensure that
hematological and chemical analyses the maintenance of the urinalysis laboratory is kept
• Since then, all sections of the clinical laboratory have abreast of technological advances
become involved in assuring the quality, accuracy, and - A QA program for the urinalysis laboratory consists of three
precision of the laboratory results they generate. The principal aspects:
urinalysis laboratory is no exception (1) Preanalytical components: occur before testing
- A QA program encompasses all aspects of the urinalysis (2) Analytical components: directly affect to testing
laboratory. Specimen collection, storage, and handling; (3) Postanalytical components: procedures and policies that
instrumentation use and maintenance; reagent quality and affect result reporting and interpretation
preparation; and the laboratorian's knowledge and technical - An error in any component will directly affect the quality of
skills must meet specific minimum criteria to ensure the results, each component must be monitored, evaluated, and
quality of the results generated maintained

PREANALYTICAL COMPONENTS OF QUALITY ASSURANCE

- Involve numerous laboratory and ancillary staff and in many - The definition of turnaround time differs:
instances, multiple departments • Laboratorian: The time from receipt of the spx in the lab
- Bcs of the importance of cost-effective practices in test → reporting of results to a patient care area or into a
ordering, the laboratory plays a role in monitoring test data information system
utilization, that is, avoiding duplicate testing and ensuring test • Physicians: The time from when they write the order for
appropriateness the test → result is communicated to them for action
- Each laboratory is unique and procedures to intercept and • Nursing personnel: The time that elapses from actual
eliminate unnecessary testing must be designed to fit the specimen collection → results are communicated to them
workflow of each laboratory - To monitor and address potential delays that directly involve
- The importance of timely result reporting cannot be the lab, a policy for the documentation of spx collection,
overemphasized. A delay in spx transport and processing receipt, & result report times is necessary
directly affects spx turnaround time

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- Spx collection techniques differ, often controlled by medical - The processing of urine spxs within the lab is another potential
personnel outside of the lab → direct effect on lab source of preanalytical problems
- Numerous factors can affect the urine spx obtained (e.g., diet, - One should process routine urinalysis specimens immediately
exercise, hydration, and medications), and appropriate patient to prevent changes in specimen integrity
preparation may be needed • If delay is unavoidable: Protect the specimens from light
• Collection instructions (including special precautions and and refrigerate them
appropriate labeling) must be well written and - Timed urine collections require a written protocol to ensure
distributed to and used by all personnel involved in adequate mixing, volume measurement, recording, aliquoting,
specimen collection and preservation if the specimen testing is to be delayed
- Laboratory staff who receive specimens must be educated to - With a written procedure for specimen processing in place, all
identify and handle inappropriate or unacceptable specimens personnel will perform these tasks consistently, eliminating
• They must document any problems encountered, so that unnecessary variables
it can be addressed and corrected
- The procedure the staff should follow involves:
(1) Correlation of the patient's name on the request slip with
the patient's name on the specimen container
(2) The evaluation of the elapsed time between the
collection and the receipt of the specimen in the lab
(3) The suitability of specimen preservation, if necessary
(4) The acceptability of the specimen (e. g., the volume
collected, the container used, its cleanliness, and any
evidence of fecal contamination)
- Bcs of the multitude of variables and personnel involved in
- If the specimen is not acceptable, a procedure must be in
urine specimen collection and processing, adequate training
place to ensure that the physician or nursing staff is informed
and supervision are imperative
of the problem
• Written procedures must be available
• The problem or discrepancy is documented, and
• Personnel must adhere to equipment manuals and
appropriate action is taken
maintenance schedules
• Written guidelines that give the criteria for specimen
• Personnel must have had appropriate education regarding
rejection, as well as the procedure for the handling of
universal blood and body fluid precautions
mislabeled specimens, are required to ensure consistent
• Communication to the personnel of all procedure changes
treatment by all personnel
or introductions of new procedures must be consistent

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 ANALYTICAL COMPONENTS OF QUALITY ASSURANCE

- Variables that are involved directly in laboratory testing

- Include reagents & supplies, instrumentation, analytical methods, monitoring analytical methods, & lab personnel's technical skills

1. Equipment - All equipment—such as glassware, pipettes, analytical balances, centrifuges, refrigerators, freezers,
microscopes, and refractometers—requires routine monitoring to ensure appropriate function, calibration, and
adherence to prescribed minimal standards
- Preventive maintenance schedules to eliminate equipment failure and downtime should be included in the
laboratory procedure manual
- Use of instrument maintenance sheets for documentation
• provides a visual format to remind the staff of maintenance requirements and to record the performance
of periodic maintenance
- Bcs the bench technologist is the first individual to be aware of an instrument failure, troubleshooting and
"out-of-control" protocols including service and repair documentation should be readily available in the
urinalysis laboratory
- Frequency of maintenance differs depending on the equipment used, and the protocol should meet the
minimal standards set forth by the Joint Commission on Accreditation of Healthcare Organizations or the
College of American Pathologists (CAP) guidelines

lists equipment found in the urinalysis laboratory with the frequency and types of performance checks that one should perform
- Temperature-dependent devices, refractometers and osmometers: monitored and recorded daily
- Centrifuges: cleaned daily, the accuracy of their timers and speed (revolutions per minute) can be performed
periodically
- Automatic pipettes, analytical balances, and fume hoods: require periodic checks, which are determined by the
individual laboratory and often vary based on usage
- Microscopes: require daily cleaning and sometimes adjustments (e.g., illumination and phase ring alignment) to
ensure optimal viewing
- Microscopes and balances: should have annual preventive maintenance and cleaning by professional service
engineers to avoid potential problems and costly repairs

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 - A current CAP inspection checklist is an excellent resource for developing an individualized procedure for
performing periodic checks and routine maintenance on the equipment and for providing guidelines on the
documentation necessary in the urinalysis laboratory

2. Reagents - Reliable analytical results obtained in the urinalysis laboratory require the use of quality reagents
- The laboratory must have an adequate supply of distilled or deionized water
• Each urinalysis procedure should specify the type and quality of water required for tasks such as reagent
preparation or reconstitution of lyophilized materials
• Water quality requires periodic monitoring that varies with the source quality and the needs of the
laboratory
- Routinely, resistivity (conductivity) and bacterial counts are performed and documented. In addition, because
water loses its resistivity on storage, it should be obtained fresh daily
- Water quality tolerance limits and the action to be taken when these quality limits are exceeded also must be
available in a written policy
- Standard laboratory practice is to check all newly prepared standards and reagents before using them
• Done by performing the assay on a control material using the new and old reagents or standards
• If the new standard/reagent performs equivalent to the old = it is acceptable & dated as approved for use
• if it performs inadequately: it should be discarded and the reagent or standard remade.
- New lot numbers of commercially prepared reagents and standards, as well as different bottles of a current lot
number, must be checked against the old and proven reagents before placing them into use.
- Documentation of these reagent and standard checks must be maintained in the urinalysis laboratory.
- All standards, reagents, reagent strips, and tablets, whether made in the laboratory or commercially prepared,
must be dated when prepared or received and when they are checked out
- Reagent-grade or analytical reagent
• Grade rgts should be used when preparing reagent solutions for qualitative or quantitative procedures
• Primary standards, if necessary for quantitative methods, must be made from chemicals of the highest
grade available
‣ These can be purchased from agencies such as the National Bureau of Standards or CAP and can be
accurately weighed to produce a standard of a known concentration
‣ From these primary standards, secondary standards or calibration materials can be made
‣ Any solvents used should be of sufficient purity to ensure appropriate reactivity and prevent
interfering side reactions

3. Procedure - Must be available in the urinalysis laboratory and should comply with the National Committee for Clinical
Manuals Laboratory Standards approved guideline GP2-A4 Clinical Laboratory Technical Procedure Manual
- Each manual should be comprehensive, including:
• Details of all procedures performed • Step-by-step performance procedures
• Proper spx collection and handling procedures • Calculations
• Test principles • Reporting of results
• Reagent preparation • References
• Control materials and acceptance criteria
- The manual must show documentation of any procedural changes and must be reviewed annually
- A well-written procedure manual provides a ready and reliable reference for the veteran technologist, as well as
an informational training tool for the novice
- Uniform performance of testing methods = accurate & reproducible results regardless of changes in personnel
- A routine urinalysis incorporates methods to ensure consistent quality in each of its components
- The laboratory procedure manual details all examinations—physical, chemical, microscopic—and includes
quality control checks, acceptable terminology, and tolerances for each
- The manual also provides steps to follow when tolerances are exceeded or results are questionable
- Procedures include criteria for the correlation of the physical, chemical, and microscopic examinations, as well
as follow-up actions if discrepancies are discovered. (For instance, if the blood reagent strip test is negative and
the microscopic examination reveals red blood cells, one should check for ascorbic acid)
- Reference materials such as textbooks, atlases, and charts must be available for convenient consultation

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4. Monitoring - The microscopic examination requires the standardization of technique and adherence to the established
procedure by all technologists to ensure consistency in results and reporting
• This requires written step-by-step instructions of the volume of urine used, the centrifuge speed, the time
of centrifugation, the sediment concentration, and the volume of sediment examined, as well as reporting
format, terminology, and grading

- Several standardized urinalysis systems (e.g., KOVA and Urisystem) are available commercially; all are superior
to the traditional glass slide and coverslip technique
- Because many of the procedures performed in the urinalysis laboratory are manual, it is imperative to monitor
technical competence
- Uniformity of technique by all personnel is necessary and can be achieved through:
• Proper training
• Adherence to established protocols
• Performance of quality control checks
- New technologists should have their technical performance evaluated before they perform routine clinical tests
- New procedures introduced into the laboratory should be properly researched, written, and proven before
being placed into use
- Before reporting results, technologists must be able to evaluate the results obtained, recognize absurdities or
discrepancies, and seek answers or make corrections for those discrepancies encountered.
- Performing and recording results obtained, even when they differ from those expected or desired, is
paramount
- Test results have a direct effect on patient diagnosis and treatment, so the highest level of ethical behavior is
required. Documentation of errors or problems and the action taken to correct them is necessary to:
1. Ensure communication to staff and supervisory personnel
2. Prevent the problem from recurring
3. Provide a paper trail of actual circumstances and corrective actions taken as a result
- These policies should be viewed as a means of guaranteeing the quality of the laboratory results
- Accurate results depend not only on the knowledge and technical competence of the technologist, but
also on the technologist's integrity in reporting what actually is obtained
- Circumstances can arise in laboratory testing that appear to contradict expected test results. When
these circumstances are appropriately investigated, legitimate explanations that expand the
technologist's scope of experience can be obtained
• For example, a patient's test results can differ greatly from those obtained previously. Investigation
can reveal that a specimen mix-up occurred or that a drug the patient recently received is now
interfering with testing
• This highlights the need for good communication among all staff and supervisory personnel, as well
as the need for a vehicle such as staff meetings or “quality circles" to ensure the dissemination of
new information

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 MONITORING ANALYTICAL COMPONENTS OF QUALITY ASSURANCE

- For internal QA of testing methods, quality control (QC) - The tolerance limits for these results must be defined,
materials are used to assess and monitor analytical error, that documented, and readily available in the laboratory
is, the accuracy and precision of a method. • If exceeded, corrective action must be taken and
- QC materials documented.
• Serve to alert the laboratorian of method changes that - Whether the urinalysis laboratory performs quantitative urine
directly affect the quality of the results obtained. procedures (e.g., total protein or creatinine) depends on the
• Can be prepared by the laboratory personnel or facility.
purchased from commercial suppliers - In some settings the urinalysis laboratory performs only the
• Mimic patient samples in their physical and chemical manual quantitative procedures, whereas the chemistry
characteristics section performs those procedures that are automated.
• For some QC materials the manufacturer determines and - The value assigned to commercial or homemade QC materials
assigns the expected values. These values should be is determined in the laboratory by performing repeated
confirmed and adjusted if necessary to reflect the analyses over different days.
method and conditions of each laboratory. • This enables variables such as personnel, reagents, and
- Some control materials monitor only the status of the supplies to be represented in the data generated.
qualitative chemical examination of urine using reagent strips - After analyses are complete, the QC data are tabulated and
whereas other control materials include microscopic entities the control limits are determined using the mean and standard
that can monitor the microscopic examination and the steps deviation (SD).
involved in processing urine specimens (e.g., centrifugation). - Initial control (or tolerance) limits can be established using a
- The microscopic elements present vary with the manufacturer. minimum of 20 determinations
• Quantimetrix Corporation (DipandSpin, QuanTscopics): • As more data is accumulated, the limits can be revised.
stabilized human red blood cells, white blood cells, and • Because the error distribution is gaussian, control limits
crystals. are chosen such that 95% to 99% of the control values
• Hycor Biomedical Inc. (KOVATrol): stabilized red blood will be within tolerance. This corresponds to the mean
cells, organic particles (mulberry spores) to simulate value ± 2 SD or + 3 SD, respectively.
white blood cells, and crystals. - Graphs of the QC values obtained over time are plotted and
- Although commercial control materials may be more costly are known as Levey-Jennings control charts.
than controls made in the laboratory, they are readily available • Provide an easy, visual means of identifying changes in
and do not demand the time and expertise required to make accuracy and precision.
good, stable control solutions. - Changes in accuracy are evidenced by a shift in the mean,
- Another means of monitoring the entire urinalysis procedure whereas changes in precision (random error) are manifested
is to prepare an aliquot of a well-mixed urine specimen and by an increase in scatter or a widening of the distribution
have each technologist or one from each shift of workers about the mean (standard deviation).
perform the procedure. - External quality assurance measures monitor and evaluate a
• Provides an intralaboratory or in-house quality laboratory's performance as compared with other facilities. It
assessment. may be in the form of:
• Results should be recorded independently and evaluated. • proficiency testing
• When multiple laboratory sites within a facility provide • participation in programs in which each laboratory uses
urinalyses, personnel at each site can test an aliquot of the same lot of QC materials.
the same urine specimen and compare results. ‣ used primarily with quantitative urine methods.
• If commercial control materials with sediment - Monthly, the results obtained by each laboratory are reported
constituents are not used to evaluate the microscopic to the manufacturer of the QC material.
examination, this in-house duplicate testing can be - Within weeks, reports summarizing the analytical methods
instrumental in detecting subtle changes in the used and the results obtained by each laboratory are
processing procedure. distributed
• The time and effort involved in intralaboratory testing • Useful in detecting small continuous changes in
ensures that each laboratory and all staff are consistently systematic error in quantitative methods that may not be
obtaining equivalent results. evident with internal quality assurance procedures.
- Results are recorded daily in a tabular or graphic form.

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- For a laboratory to be accredited, periodic interlaboratory - One approach used to evaluate these slides is for each
comparison testing in the form of proficiency surveys is technologist in the laboratory independently to identify the
required by the Clinical Laboratory Improvement Act of 1988 sediment component.
• Involves the performance of routine tests on survey - Results are shared and only one answer can be submitted to
samples provided to all participating laboratories. the survey agency.
• Each laboratory independently performs and submits • Although limited, this format does allow evaluation of
results to the survey agency (e.g., CAP, Centers for competence in microscopic identification. In addition, if
Disease Control and Prevention) for assessment and the process of arriving at an answer by consensus is used,
tabulation. it provides an opportunity to maintain and improve the
• Before the distribution of these survey samples, selected competence of personnel.
or reference laboratories analyze and establish the target - Although QC materials help to detect decreased quality in
value for each sample. laboratory testing, they do not pinpoint the source of the
• Using the reference laboratory results and the survey problem, nor do they solve it.
participant results, the survey agency prepares extensive - Only with good communication and documentation can
reports and charts for each analyte assessed, the method analytical problems be pursued and continuing education
used, and the values obtained. programs developed.
• These surveys provide valuable information on laboratory - Some problems encountered in the laboratory may be
performance and testing methods: individually, by approached best by the development of a quality circle.
specific method, and as a whole. - The involvement of laboratorians in a problem-solving team
- Some urinalysis proficiency surveys include photographic reaffirms the technologists' self-worth and enhances their
slides for the identification of urine sediment components, commitment to quality goals.
such:
• Casts
• Epithelial cells
• Blood cells
• Diaper fibers

POSTANALYTICAL COMPONENTS OF QUALITY ASSURANCE

- Urinalysis results can be communicated efficiently and • Each institution must establish its own list of critical values
effectively using a standardized reporting format and • For example, the list might include as critical the presence
terminology of pathological urine crystals (e.g., cystine, leucine, or
- The report should include reference ranges and the opportunity tyrosine); a strongly positive test for glucose and ketones;
to add additional informative statements if warranted and the presence of a reducing substance, other than
• For example, "glucose oxidase/ reducing substances glucose or ascorbic acid, in an infant
questionable owing to the presence of ascorbic acid" or - Quality assurance measures, whether internal (QC materials) or
"clumps of white blood cells present." external (proficiency surveys), require documentation and
- Results should be quantitative (e.g.y 100 mg/dL or 10 to 25 evidence of active review
RBCs/HPF [red blood cells per high-power field)) wherever - When acceptable tolerances are exceeded, they must be
possible, and all personnel should use standardized terminology addressed and corrective action must be taken
(e.g., color or clarity terms) - Documentation is crucial, because an action that was not
- The laboratory procedures should describe in detail the documented essentially has not been performed
appropriate reporting format and also provide criteria for the - The goal of an effective QA program is consistently accurate and
reporting of any critical values reproducible results. In achieving this goal, test results reflect a
• Critical values are significantly abnormal results that patient's condition, rather than procedural or personnel
exceed the upper or lower critical limit and are variations
life-threatening. These results need to be relayed
immediately to the physician for appropriate action
• The laboratorian is responsible for recognizing critical
values & communicating them in a timely fashion

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 SAFETY IN THE URINALYSIS LABORATORY

- For years the healthcare industry has been at the forefront in • Written safety manuals that define specific policies and
developing policies and procedures to prevent and control procedures for all potential hazards are required in
the spread of infection in all areas of the hospital to ensure laboratories as a result
patient and employee safety. • Guidelines for developing this written policy are provided
- Clinical laboratory employees are exposed to numerous in the National Committee for Clinical Laboratory
workplace hazards in various forms—biological, chemical, Standards approved document GP5-A2, Clinical
electrical, radioactive, compressed gases, fires, etc. = safety Laboratory Waste Management
policies are an integral part of the laboratory. - An additional requirement of the law is that all employees
- With the passage of the Occupational Health and Safety Act document annual review of the safety manual
in 1970, formal regulation of safety and health for all - Next section discusses those hazards frequently encountered
employees, regardless of employer, officially began in the clinical laboratory when working with urine and body
• Administered through the US Department of Labor by the fluids (e.g., feces, amniotic fluid, and cerebrospinal fluid) and
Occupational Safety and Health Administration (OSHA) the policies and procedures necessary to ensure a safe and
healthy working environment

BIOLOGICAL HAZARDS

- Biological hazards abound in the clinical laboratory. One must • Although these body fluids may be unlikely sources of
treat any patient specimen or body substance (e.g., body fluid, hepatitis B virus or human immunodeficiency virus, they
fresh tissue, excretions, secretions, sputum, drainages, and can be a reservoir for other infectious agents → therefore,
nonintact skin) as infectious, regardless of patient diagnosis. most clinical laboratories use UP when working with all
- Primary concern to healthcare workers: transmission of body fluids
diseases, esp HBV and HIV - Three primary routes of infection
- All personnel must adhere to Universal Precautions (UP) to 1. Inhalation
prevent cross-transmission and exposure to potentially - Aerosols → can be created when liquids (e.g., body
infectious agents fluids) are poured, pipetted, or spilled
• Initially published as recommendations by the Centers for - Other sources of airborne transmission: removal of
Disease Control and Prevention in 1987 tight-fitting caps from specimen containers and
• Describes the potential sources of infectious agents, the centrifugation
methods to be used when handling and disposing of these
agents, and the precautions and techniques for working 2. Ingestion
directly with patients - Occurs when infectious agents are taken into the
• Although most institutions have an infection control mouth and swallowed, such as from mouth pipetting;
department, the responsibility to educate, implement, and eating, drinking, or smoking in the laboratory; or
monitor employee compliance to UP resides in the hand-to-mouth contact following failure to
laboratory appropriately wash one's hands
• Must be documented and available for reference in the
laboratory 3. Direct inoculation/skin contact
- Although urine, feces, and vomitus are body fluids, the 1988 - Involves parenteral exposure to the infectious agent as
Centers for Disease Control revision of these guidelines for the a result of a break in the technologist's skin barrier or
safety of laboratory workers excludes them from the contact with the mucous membranes
requirement of UP unless the specimens are bloody - includes skin punctures with needles, cuts or scratches
• Identifying and separating specimens based on the from contaminated glassware, and splashes of
presence of visible blood is time consuming and specimens into the eyes, nose, and mouth
subjective, requires procedural variations, and may
promote laxity in processing and handling other specimen - Although it is impossible to eliminate all sources of infectious
types transmission in the laboratory, the use of protective barriers
and adherence to UP can minimize transmission

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 - When contact with urine or other body fluids is - Protective laboratory coats must be worn in the
anticipated, appropriate protective barriers must be used. laboratory
Gloves should be worn when: • Should be changed daily or more often if soiled
• Assisting patients in collecting specimens • Should not be worn outside of or be removed from
• Receiving and processing specimens the laboratory area
• Performing any testing procedure • If splashing of large volumes of urine or other body
• Cleaning equipment or work areas fluids is anticipated, a moisture-resistant apron or
• Should be worn at all times in the laboratory where gown should be worn
countertops, chairs, and other surfaces are exposed to - Eyewear/headgear
these specimens • Should be used to protect the eyes, nose, and
• If involved directly with patients, one should change mouth
gloves after each patient • Processing and performing procedures on urine
- In the laboratory and body fluids can often result in sprays or
• Gloves are changed when they are visibly soiled or splatters
physically damaged • Eyeglasses are usually sufficient for most
• Gloves used in the laboratory should not be worn situations in the laboratory; however, plexiglass
outside of the area shields, safety goggles, or hood sashes may be
• Whenever gloves are removed or when contact with necessary for protection, depending on the
urine or other body fluids has occurred, hands should procedure being performed and the substance
be washed with an appropriate antiseptic soap being handled

Specimen Processing

- All specimens should be transported to the lab in sealed - When removing lids or caps from specimens, the
plastic bags, with the request slip placed on the outside of technologist should work behind a protective shield or
the bag cover the specimens with gauze or disposable tissues to
- If the outside of the specimen container is obviously prevent sprays and splatters
contaminated bc of leakage or improper collection - During centrifugation, specimens should be capped or
technique, placed in covered trunnions
• Exterior of the container can be cleaned using an • Centrifuges should not be operated with their tops
appropriate disinfectant before processing open, nor stopped by hand
• Or it should be rejected and a new specimen requested - If a specimen needs to be aliquoted, the technologist
should use transfer pipettes or protective barriers if
pouring from the specimen container

Disposal of Waste

- Adherence to an infectious waste disposal policy is necessary • Urine → may be discarded directly down a sink or toilet,
to protect all lab personnel (including custodial staff) with caution taken to avoid splashing
• Because all biological specimens and materials exposed to ‣ Sink should be well-rinsed with water and 0.5% bleach
them (e.g., contaminated needles and glassware) are (at least daily) when discarding urine
considered infectious → must be disposed of properly - Contaminated sharps such as needles, broken glass, or
- Disposal requirements: leakproof, well constructed transfer pipettes must be placed into puncture resistant
receptacles clearly marked with the universal biohazard containers for disposal
symbol and available in all laboratory areas (Figure 2-1) • Containers should not be overfilled
• Biohazard containers should not be overfilled • Should be sealed securely and enclosed in a clean
• Should be sealed adequately and enclosed within a clean infectious waste disposal bag to protect custodial
biohazard bag before removal from the laboratory area by personnel before removal from the laboratory area
custodial staff • Considered infectious → must be incinerated or
- All biological specimens (except urine) must be sterilized or autoclaved before disposal
decontaminated before disposal - Noninfectious glass such as empty reagent bottles and
• Incineration and autoclaving are acceptable, with the latter nonhazardous waste such as emptied urine containers are
usually being the most cost-effective considered normal waste and require no special precautions
for disposal

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Decontamination

- Several agents are available for the daily decontamination of

laboratory surfaces and equipment • If an absorbent powder is used → liquid will
• Bleach or a phenolic disinfectant is used most often in the solidify and can be scooped up and placed into an
clinical laboratory infectious waste receptacle
• 0.5% bleach solution • If disposable towels are used → allow the spill to
‣ Prepared by adding 1 part bleach to 9 parts water be absorbed and pour 0.5% bleach over the towels
‣ Stable for 1 week • Carefully pick up the bleach-soaked towels and
• Phenolic disinfectant transfer them to an infectious waste container
‣ Combination of phenolic compounds and detergents • Decontaminate the spill area again using 0.5%
‣ Purchased commercially bleach and clean it with a phenolic detergent if
‣ Make appropriate dilutions according to the desired
manufacturers' recommendations • All disposable materials used to clean the spill area
- When spills occur, decontaminants are used to must be placed in infectious waste receptacles
neutralize the biological hazard and to facilitate its
removal
• Decontaminants are less effective in the presence
of large amounts of protein → body fluid spill
should first be absorbed with a solid absorbent
powder (e.g., Zorbitrol) or disposable towels

CHEMICAL HAZARDS

- Chemicals are ubiquitous in the clinical laboratory - Labeling of chemicals → fundamental to a laboratory safety
• Many are caustic, toxic, or flammable program
• Must be specially handled to ensure the safety and • Hazardous chemicals can be classified into several
well-being of laboratory employees categories:
- OSHA rule of January 1990: requires each facility to ‣ Caustic/corrosive materials, poisons, carcinogens,
have a Chemical Hygiene Plan flammables, explosives, mutagens, and teratogens
• Defines the safety policies and procedures for all • Each must be appropriately labeled to ensure proper
hazardous chemicals used in the laboratory and handling
includes: • All chemicals are required to have descriptive warning
‣ ID of a chemical hygiene officer labels on their shipping containers
‣ Policies for the handling, storage, and use of ‣ Color-coded and include a pictorial representation of
chemicals the hazard
‣ Use of protective barriers • However, when a chemical is removed from its original
‣ Criteria for monitoring over-exposure to shipping container, its hazard identity is lost unless the
chemicals laboratory appropriately relabels it
‣ Provisions for medical consultations or • Although OSHA requires the labeling of hazardous
examinations chemicals, it does not mandate the type of labeling system
- Educating personnel about chemical safety policies and to use
procedures is mandatory and requires a documented • By using a consistent identification system, hazards can be
annual review readily identified and appropriate precautions taken
- By developing and using a comprehensive Chemical
Hygiene Plan, chemical hazards are minimized and the
laboratory becomes a safe environment in which to
work

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 • 704-M Hazard Identification System
‣ Developed by the National Fire Protection Association ‣ Available for each chemical, include the identity
‣ Uses bright, color-coded labels divided into quadrants information, hazardous ingredients, physical and
‣ Labels are highly visible and identify the health (blue), chemical characteristics, physical hazards, reactivity,
flammability (red), and reactivity (yellow) hazard for health hazards, precautions for safe handling and use,
each chemical, as well as any special considerations and regulatory information of the chemical (see
(white) example in Appendix B)
‣ Also uses numbers from 0 to 4 to classify the hazard ‣ Whereas an MSDS for each hazardous chemical used in
severity, with 4 representing extremely hazardous all laboratory areas must be available on site, each
laboratory section should retain copies of the MSDS for
- To limit employee exposure, appropriate usage and handling chemicals frequently used in their areas for quick
guidelines for each chemical type must be described in the reference
laboratory safety manual
- General rules such as prohibiting pipetting by mouth or
sniffing of chemicals are mandatory.
- Greatest hazard encountered in the clinical laboratory:
splattering of acids, alkalis, and strong oxidizers
• Appropriate use of protective barriers is required
• Use of gloves, gowns, goggles, and a fume hood or safety
cabinet will reduce the potential of injury
- Chemical safety tips
1. Never grasp a reagent bottle by the neck or top
2. Always add acid to water
- Safety equipment such as an eyewash or shower must be
readily available and accessible in case of accidental exposure
- Goal of the OSHA hazardous communication rule: to ensure
that all employees are aware of potential chemical hazards in
their workplace
• This employee 'right to know" requires chemical
manufacturers and suppliers to provide material safety
data sheets (MSDSs)

Handling Chemical Spills

- In the event of a spill, the MSDS for the chemical should be - For emergency treatment of personnel affected by chemical
consulted to determine the appropriate action to take splashes or injuries, clear instructions should be posted in the
- Each laboratory should have available a chemical spill kit that laboratory
includes: - Chemical spills of hazardous substances must be reported to
• Absorbent, appropriate protective barriers (e.g., gloves supervisory personnel and appropriately documented
and goggles), cleanup pans, absorbent towels or pillows, • Permits a review of the circumstances and facilitates
and disposal bag changes to prevent recurrence of the incident
- Frequently, liquids are contained by absorption using a spill • Any injury or illness resulting from the spill/exposure also
compound (absorbent) such as ground clay or a sodium requires documentation and follow-up
bicarbonate and sand mixture
• The latter is generally appropriate for acid, alkali, or
solvent spills
• Following absorption, the absorbent is swept up and
placed into a bag or sealed container for appropriate
chemical disposal and the spill area is thoroughly washed

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Disposal of Chemical Waste

- All chemicals must be disposed of properly to ensure safety in the workplace and in the environment in general
- Chemical disposal differs based on the chemical type, the amount to be discarded, and the local laws
• Each laboratory must maintain its own policies for disposal
• Ff the performance of laboratory procedures, chemicals often are diluted adequately or neutralized such that disposal in the
sewer system is satisfactory
• Flushing sinks and drains with copious amounts of water following the disposal of aqueous reagents is a good laboratory
practice
• Appropriate steps to be followed must be available in a general laboratory policy or in the laboratory procedure that uses the
chemical

OTHER HAZARDS

- Organic solvents used in the clinical laboratory represent - Other potential fire hazards in the laboratory include:
health and fire hazards electrical hazards or hazards from flammable compressed
• As a result, these flammable substances require special gases
considerations regarding storage, use, and disposal - Laboratory personnel should report any deteriorations
- Appropriately vented storage cabinets → necessary to store discovered in equipment (e.g., electrical shorts) or their
solvents connections (e.g., a frayed cord)
- Availability of the cabinets dictates the volume of flammables - If a liquid spill occurs on electrical equipment or its
that are allowed to be stored on the premises. connections, appropriate action must be taken to dry the
- Fume hood → mandatory d/t potentially toxic vapors = equipment thoroughly before placing it back into use
adequate ventilation is needed during solvent use - Compressed gases
- Small amounts of water-miscible solvents may be disposed of • Must be secured at all times, regardless of their
in the sewer system with copious amounts of water contents or the amount of gas in the tank
• However, disposal of flammable solvents in this fashion is • Valve caps should be in place except when in use
dangerous • Procedure for the appropriate transporting, handling,
• All solvent waste should be recovered following and storage of compressed gases is necessary to ensure
procedures in glass or other appropriate containers proper usage
• Written laboratory protocol listing acceptable solvent • All laboratory personnel must be aware of the location
combinations → necessary bc not all solvents can be of all fire extinguishers, alarms, and safety equipment;
mixed together be instructed in the use of a fire extinguisher; and be
- After collection, each solvent waste container must be marked involved in laboratory fire drills, at least annually
clearly with the solvent type and relative amount present and
must be properly stored until disposal

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