CHAPTER

2 
Quality Assurance and Safety

LEARNING OBJECTIVES
After studying this chapter, the student should be able to:
1. Define and explain the importance of quality 6. Define and give an example of the following terms:
assurance in the laboratory. • Biological hazard
2. Identify and explain preanalytical, analytical, and • Chemical hazard
postanalytical components of quality assurance. • Decontamination
3. Differentiate between internal and external quality • Personal protective equipment (PPE)
assurance and discuss how each contributes to an 7. Describe a Standard Precautions policy and state its
overall quality assurance program. purpose.
4. Define and discuss the importance of the following: 8. Discuss the three primary routes of transmission of
• Critical values infectious agents and a means of controlling each
• Documentation route in the clinical laboratory.
• Ethical behavior 9. Describe appropriate procedures for the handling,
• Preventive maintenance disposal, decontamination, and spill control of
• Technical competence biological hazards.
• Test utilization 10. Discuss the source of potential chemical and fire
• Turnaround time hazards encountered in the laboratory and the
5. Discuss the relationship of the Occupational Safety procedures used to limit employee exposure to them.
and Health Administration to safety and health in the 11. State the purpose of and the information contained in
workplace. a material safety data sheet.

CHAPTER OUTLINE
Quality Assurance Monitoring Analytical Safety in the Urinalysis Laboratory
Quality Assurance: What Is It? Components of Quality Biological Hazards
Preanalytical Components of Assurance Chemical Hazards
Quality Assurance Postanalytical Components of Other Hazards
Analytical Components of Quality Assurance
Quality Assurance

KEY TERMS
biological hazard A biological critical value A patient test result documentation A written record. In
material or an entity representing a life-threatening the laboratory, documentation
contaminated with biological condition that requires includes written policies and
material that is potentially immediate attention and procedures, quality control, and
capable of transmitting disease. intervention. maintenance records.
Chemical Hygiene Plan An decontamination A process to Documentation may encompass
established protocol developed by remove a potential chemical or the recording of any action
each facility for the identification, biological hazard from an area or performed or observed, including
handling, storage, and disposal of entity (e.g., countertop, verbal correspondence,
all hazardous chemicals. The instrument, materials) and render observations, and corrective
Occupational Safety and Health the area or entity “safe.” One actions taken.
Administration established the may use various processes in external quality assurance The use
plan in January 1990 as a decontamination, such as of materials (e.g., specimens,
mandatory requirement for all autoclaving, incineration, Kodachrome slides) from an
facilities that deal with chemical chemical neutralization, and external unbiased source to
hazards. disinfecting agents. monitor and determine whether

21
22 CHAPTER 2  Quality Assurance and Safety

quality goals (i.e., test results) are personal protective equipment Items Precautions from the Healthcare
being achieved. Results are used to eliminate exposure of the Infection Control Practices
compared with results from other body to potentially infectious Advisory Committee (HICPAC)
facilities performing the same agents. These barriers include and the Centers for Disease
function. Proficiency surveys are protective gowns, gloves, eye Control and Prevention (CDC)
one form of external quality and face protectors, biosafety that describes procedures to
assurance. cabinets (fume hoods), and prevent transmission of infectious
infectious waste disposal policy A splash shields. agents when obtaining, handling,
procedure outlining the preventive maintenance The storing, or disposing of all blood,
equipment, materials, and steps performance of specific tasks in a body fluid, or body substances,
used in the collection, storage, timely fashion to eliminate regardless of patient identity or
removal, and decontamination of equipment failure. These tasks patient health status. All body
infectious materials and vary with the instrument and fluids including secretion and
substances. include cleaning procedures, excretions should be treated as
material safety data sheet (MSDS) inspection of components, and potentially infectious.
A written document provided by component replacement when technical competence The ability of
the manufacturer or distributor necessary. an individual to perform a skilled
of a chemical substance listing procedure manual A written task correctly. Technical
information about the document describing in detail all competence also includes the
characteristics of that chemical. aspects of each policy and ability to evaluate results, such as
An MSDS includes the identity procedure performed in the recognizing discrepancies and
and hazardous ingredients of laboratory. For example, the absurdities.
the chemical, its physical and manual includes supplies needed, test utilization The frequency with
chemical properties including reagent preparation procedures, which a test is performed on a
reactivity, any physical or specimen requirements, single individual and how it is
health hazards, and precautions mislabeled and unlabeled used to evaluate a disease
for safe handling, storage, and specimen protocols, procedures process. Repeat testing of an
disposal of the chemical. for the storage and disposal of individual is costly and may not
Occupational Safety and Health wastes, technical procedures, provide additional or useful
Administration (OSHA) quality control criteria, reporting information. Sometimes a
Established by Congress in 1970, formats, and references. different test may provide
OSHA is a division of the U.S. quality assurance An established more diagnostically useful
Department of Labor that is protocol of policies and information.
responsible for defining potential procedures for all laboratory turnaround time To the
safety and health hazards in the actions performed to ensure the laboratorian, the time that elapses
workplace, establishing guidelines quality of services (i.e., test from receipt of the specimen in
to safeguard all workers from results) rendered. the laboratory to reporting of test
these hazards, and monitoring quality control materials Materials results on that specimen.
compliance with these guidelines. used to assess and monitor the Physicians and nursing personnel
The intent is to alert, educate, accuracy and precision (i.e., assign a broader time frame.
and protect all employees in every analytical error) of a method.
environment from potential safety Standard Precautions One tier of the
and health hazards. Guidelines for Isolation

QUALITY ASSURANCE
together provide an administrative structure for a labo-
ratory’s efforts to achieve quality goals.”1 On a larger
Quality Assurance: What Is It?
scale, all components of health care, including physi-
Quality assurance (QA) is a program of checks and bal- cians, nurses, clinics, hospitals, and their services, are
ances designed to ensure the quality of a laboratory’s involved in QA. The laboratory is only part of a larger
services. All laboratorians must be aware of the effects program to ensure quality health care.
that their services have on the diagnosis and treatment Quality assurance has been an important part of the
of patients. These services must be monitored to ensure clinical laboratory since the first laboratory surveys of
that they are appropriate and effective, and that they the 1940s. These early surveys revealed that not all labo-
meet established standards for laboratory practice. ratories reported the same results on identical blood
The QA program must involve a mechanism for the specimens submitted for hematologic and chemical anal-
detection of problems and must provide an opportunity yses. Since the time of those first surveys, all sections of
to improve services. In essence, “quality assurance is a the clinical laboratory have become involved in ensuring
broad spectrum of plans, policies, and procedures that the quality, accuracy, and precision of the laboratory
 CHAPTER 2  Quality Assurance and Safety 23

results they generate. The urinalysis laboratory is no laboratorian as opposed to physicians or nursing per-
exception. sonnel. For example, a laboratorian defines turnaround
A QA program encompasses all aspects of the urinaly- time as the time from receipt of the specimen in the
sis laboratory. Specimen collection, storage, and han- laboratory to reporting of results to a patient care area
dling; instrumentation use and maintenance; reagent or into a data information system. In contrast, physi-
quality and preparation; and the laboratorian’s knowl- cians view turnaround time as the time from when they
edge and technical skills must meet specific minimum write the order for the test until the result is commu-
criteria to ensure the quality of the results generated. To nicated to them for action. To nursing personnel, turn-
achieve the goals set forth in a QA program, a commit- around time is the time that elapses from actual
ment by all laboratory personnel, including those in specimen collection until the results are communicated
administration and management, is necessary. This dedi- to them. To monitor and address potential delays that
cation must be evident in management decisions, includ- directly involve the laboratory, a policy for the docu-
ing the allocation of laboratory space, the purchase of mentation of specimen collection, receipt, and result
equipment and supplies, and the budget. Without ade- report times is necessary.
quate resources, the quality of laboratory services is Specimen collection techniques differ, are often con-
compromised. Properly educated and experienced labo- trolled by medical personnel outside of the laboratory,
ratory personnel with a high level of evaluative skills are and can have a direct effect on laboratory results. In
essential to ensure the quality of laboratory results. addition, numerous factors can affect the urine specimen
“Many studies have shown that the standards of speci- obtained (e.g., diet, exercise, hydration, medications),
men collection technique and analytical performance are and appropriate patient preparation may be needed. To
generally inferior to those obtained by skilled laborato- ensure an appropriate specimen, collection instructions
rians.”2 Because of the dynamic environment of clinical (including special precautions and appropriate labeling)
laboratory science, it is imperative that laboratorians must be well written and must be distributed to and used
have access to reference books and opportunities for by all personnel involved in specimen collection.
continuing education to assist them in skill maintenance Laboratory staff who receive specimens must be edu-
and development. Not only do continuing education cated to identify and handle inappropriate or unaccept-
opportunities provide intellectual stimulation and chal- able specimens. In addition, they must document any
lenges for laboratorians, they also facilitate the develop- problems encountered, so that these problems can be
ment of quality employees and ensure that maintenance addressed and corrected. The procedure the staff should
of the urinalysis laboratory is kept abreast of technologi- follow involves (1) correlation of the patient’s name on
cal advances. the request slip with the patient’s name on the specimen
A QA program for the urinalysis laboratory consists container; (2) evaluation of elapsed time between collec-
of three principal aspects: (1) preanalytical components— tion and receipt of the specimen in the laboratory; (3)
procedures that occur before testing; (2) analytical the suitability of specimen preservation, if necessary; and
components—aspects that directly affect testing; and (3) (4) the acceptability of the specimen (e.g., the volume
postanalytical components—procedures and policies collected, the container used, its cleanliness, any evidence
that affect reporting and interpretation of results. Because of fecal contamination). If the specimen is not accept-
an error in any component will directly affect the quality able, a procedure must be in place to ensure that the
of results, each component must be monitored, evalu- physician or nursing staff is informed of the problem,
ated, and maintained. the problem or discrepancy is documented, and appro-
priate action is taken. Written guidelines that give the
criteria for specimen rejection, as well as the procedure
Preanalytical Components  
for handling of mislabeled specimens, are required to
of Quality Assurance
ensure consistent treatment by all personnel (Box 2-1
The preanalytical components involve numerous labora- and Table 2-1).
tory and ancillary staff and, in many instances, multiple Processing of urine specimens within the laboratory
departments. Because of the importance of cost-effective is another potential source of preanalytical problems.
practices in test ordering, the laboratory plays a role in
monitoring test utilization, that is, avoiding duplicate
BOX 2-1 Criteria for Urine Specimen Rejection
testing and ensuring test appropriateness whenever pos-
sible. Each laboratory is unique, and procedures to inter- • Insufficient volume of urine for requested test(s)
cept and eliminate unnecessary testing must be designed • Inappropriate specimen type or collection
to fit the workflow of each laboratory. • Visibly contaminated (e.g., by fecal material, debris) specimen
The importance of timely result reporting cannot • Incorrect urine preservative
be overemphasized. A delay in specimen transport • Specimen not properly preserved for transportation delay
• Unlabeled or mislabeled specimen or request form
and processing directly affects specimen turnaround
• Request form incomplete or lacking
time. The definition of turnaround time differs for the
24 CHAPTER 2  Quality Assurance and Safety

TA B L E 2- 1 Definitions and an Example of Policy for Handling Unlabeled or Mislabeled Specimens

Definitions
Unlabeled No patient identification is placed directly on the container or tube containing the specimen. To place the label on
the plastic bag that holds the specimen is inadequate.
Mislabeled The name or identification number on the specimen label does not agree with that on the test request form.
Policy Features
Notification Contact the originating nursing station or clinic and indicate that the specimen must be recollected. Document
the name of the individual contacted.
Document Order the requested test and write CANCEL on the document with the appropriate reason for the cancellation,
that is, specimen unlabeled or specimen mislabeled, identification questionable.
Initiate an incident report and include names, dates, times, and all circumstances.
Specimen Do not discard the specimen. Process and perform analyses on those specimens that cannot be saved, but do not
report the results. Properly store all other specimens.
On specimens that cannot be recollected (e.g., cerebrospinal fluid):
1. The patient’s physician must:
• contact the appropriate laboratory supervisor and request approval for tests on the “questionable” specimen
• sign documentation of the incident
2. The individual who obtained the specimen must come to the laboratory to:
• identify the specimen
• properly label the specimen or correctly label the test request form
• sign documentation of the incident
Reporting Results All labeling and signing of documentation must take place before results are released (except in cases of
life-threatening emergencies, for example, cardiac arrest, when verbal specimen identification is acceptable
and the documentation is completed later).
All reported results must include comments describing the incident. For example, “Specimen was improperly
labeled, but was approved for testing. The reported value may not be from this patient.”
Quality Assurance Report Forward a copy of the incident to the Quality Assurance committee and to the patient care unit involved (e.g.,
nursing station, clinic, physician’s office).

One should process routine urinalysis specimens imme- reagents and supplies, instrumentation, analytical
diately to prevent changes in specimen integrity; if delay methods, monitoring of analytical methods, and the
at the reception area is unavoidable, one must protect laboratory personnel’s technical skills. Because each
the specimens from light and refrigerate them. Timed component is capable of affecting test results, procedures
urine collections require a written protocol to ensure must be developed and followed to ensure acceptable
adequate mixing, volume measurement, recording, ali- quality.
quoting, and preservation if specimen testing is to be Equipment.  All equipment—such as glassware, pipet­
delayed. With a written procedure for specimen pro- tes, analytical balances, centrifuges, refrigerators, freez-
cessing in place, all personnel will perform these tasks ers, microscopes, and refractometers—requires routine
consistently, thereby eliminating unnecessary variables. monitoring to ensure appropriate function, calibration,
Because of the multitude of variables and personnel and adherence to prescribed minimal standards. Pre­
involved in urine specimen collection and processing, ventive maintenance schedules to eliminate equipment
adequate training and supervision are imperative. Written failure and downtime are also important aspects of a
procedures must be available; personnel must adhere QA program and should be included in the laboratory
to equipment manuals and maintenance schedules; per- procedure manual. Use of instrument maintenance
sonnel must have had appropriate education regarding sheets for documentation provides a visual format
universal blood and body fluid precautions; and com- to remind the staff of maintenance requirements and
munication to personnel regarding all procedure changes to record the performance of periodic maintenance.
or introduction of new procedures must be consistent. Because the bench technologist is the first individual to
Preanalytical components are a dynamic part of the clini- be aware of an instrument failure, troubleshooting and
cal laboratory and require adherence to protocol to “out-of-control” protocols including service and repair
ensure meaningful test results. documentation should be readily available in the uri-
nalysis laboratory.
The required frequency of maintenance differs depend-
Analytical Components   ing on the equipment used; the protocol should meet the
of Quality Assurance minimal standards set forth in guidelines provided by
Analytical components are those variables that are The Joint Commission (TJC) (formerly the Joint Com-
involved directly in laboratory testing. They include mission on Accreditation of Health Care Organizations
 CHAPTER 2  Quality Assurance and Safety 25

TA B L E 2 - 2 Urinalysis Equipment Performance Checks

Equipment Frequency Checks Performed
Automatic pipettes Initially and periodically thereafter; Check for accuracy and reproducibility.
varies with usage (e.g., monthly)
Balances, analytical Periodically (e.g., quarterly) Check with standard weights (National Bureau of Standards
Class S).
Annually Service and clean.
Centrifuges Daily Clean rotor, trunnions, and interior with suitable disinfectant.
Periodically (e.g., annually) Check revolutions per minute and timer.
Periodically Change brushes whenever needed; frequency varies with
centrifuge type and usage.
Fume hoods (i.e., biosafety cabinets) Periodically (e.g., annually) Airflow
Microscopes Daily Clean and adjust if necessary (e.g., Köhler illumination, phase
ring adjustment).
Annually Service and clean.
Osmometers Daily Determine and record osmolality of control materials.
Reagent strip readers Daily Calibrate reflectance meter with standard reagent strip.
Daily (or periodically) Clean mechanical parts and optics.
Refractometers Daily Read and record deionized water (SG 1.000) and at least one
standard of known SG. For example, NaCl 3% (SG 1.015),
5% (SG 1.022), 7% (SG 1.035); or sucrose 9% (1.034).
Acceptable tolerance: target ± 0.001.
Temperature-dependent devices, Daily (or when used) Read and record temperature.
(e.g., refrigerators, freezers, water
baths, incubators)
Thermometers Initially and annually thereafter Check against NIST-certified thermometer.

NIST, National Institute of Standards and Technology; SG, Specific gravity.

[JCAHO]) or the College of American Pathologists water (CLRW). Each urinalysis procedure should specify
(CAP). Table 2-2 lists equipment often present in the the type and quality of water required for tasks such as
urinalysis laboratory along with the frequency and types reagent preparation or reconstitution of lyophilized
of performance checks that should be performed. For materials. The quality of CLRW requires periodic moni-
example, temperature-dependent devices are monitored toring for ionic and organic impurities as well as for
and recorded daily, as are refractometers and osmome- microbial contamination3 In addition, because CLRW
ters. Whereas centrifuges should be cleaned daily, the absorbs carbon dioxide, thereby losing its resistivity on
accuracy of their timers and speed (revolutions per storage, it should be obtained fresh daily. CLRW quality
minute) can be checked periodically. Automatic pipettes, tolerance limits and the actions to be taken when these
analytical balances, and fume hoods also require peri- quality limits are exceeded must also be available in a
odic checks, which are determined by the individual written policy.
laboratory and often vary according to usage. Micro- Reagent-grade or analytical reagent–grade reagents
scopes require daily cleaning and sometimes adjustments should be used when reagent solutions are prepared for
(e.g., illumination, phase ring alignment) to ensure qualitative or quantitative procedures. Primary stan-
optimal viewing. Microscopes and balances should dards for quantitative methods, must be made from
undergo annual preventive maintenance and cleaning chemicals of the highest grade available. These can be
by professional service engineers to avoid potential purchased from manufacturers or agencies such as the
problems and costly repairs. A current CAP inspection National Institute of Standards and Technology (NIST)
checklist is an excellent resource for developing an indi- (formerly the National Bureau of Standards [NBS]) or
vidualized procedure for performing periodic checks and CAP and can be accurately weighed to produce a stan-
routine maintenance on equipment, and for providing dard of a known concentration. From these primary
guidelines on the documentation necessary in the uri- standards, secondary standards or calibration solutions
nalysis laboratory. can be made. Any solvents used should be of sufficient
Reagents.  Reliable analytical results obtained in the purity to ensure appropriate reactivity and to prevent
urinalysis laboratory require the use of quality reagents. interfering side reactions.
The laboratory must have an adequate supply of distilled Standard laboratory practice is to check all newly
water, deionized water, or clinical laboratory reagent prepared standards and reagents before using them. This
26 CHAPTER 2  Quality Assurance and Safety

is done by analyzing a control material using new and BOX 2-2 Guidelines for Standardizing
old standards or reagents. If performance of the new Microscopic Urinalysis
standard or reagent is equivalent to performance of the
old, it is acceptable and dated as approved for use; if it Procedural Factors
performs inadequately, it should be discarded and the 1. Volume of urine examined (10, 12, 15 mL)
reagent or standard remade. New lot numbers of com- 2. Speed of centrifugation (400× g, 600× g)
3. Length of centrifugation (3, 5, 10 minutes)
mercially prepared reagents and standards, as well as
4. Concentration of sediment (10 : 1, 12 : 1, 15 : 1)
different bottles of a current lot number, must be checked 5. Volume of sediment examined (0.4, 0.5, 1.0 mL)
against older, proven reagents before they are placed
into use. Documentation of standard and reagent checks Reporting Factors
1. Each laboratory should publish its own normal values (based on
must be maintained in the urinalysis laboratory. All
system used and patient population).
standards, reagents, reagent strips, and tablets, whether 2. All personnel must use same terminology.
made in the laboratory or commercially obtained, must 3. All personnel must report results in standard format.
be dated when prepared or received, and when their 4. All abnormal results should be flagged for easy reference.
performance is checked and determined to be acceptable.
Ensuring the quality of commercial reagent strips and From Schweitzer SC, Schumann JL, Schumann GB: Quality assurance guide-
lines for the urinalysis laboratory. J Med Technol 3:570, 1986.
tablet tests used in the urinalysis laboratory is discussed
in Chapter 7.
Procedure Manuals.  Procedure manuals must be avail-
able in the urinalysis laboratory and should comply with Monitoring.  The microscopic examination requires
the Clinical and Laboratory Standards Institute (CLSI) standardization of technique and adherence to the estab-
(formerly the National Committee for Clinical Labora- lished procedure by all technologists to ensure consis-
tory Standards [NCCLS]) approved guideline GP02-A5 tency in results obtained and in their reporting. Preparing
Laboratory Documents: Development and Control.4 urine for manual microscopy requires written step-by-
Each manual should be comprehensive and should step instructions that detail the volume of urine to use,
include details of all procedures performed, proper speci- the centrifuge speed, the time of centrifugation, the
men collection and handling procedures, test principles, sediment concentration, and the volume of sediment
reagent preparation, control materials and acceptance examined, as well as the reporting format, terminology,
criteria, step-by-step performance procedures, calcula- and grading criteria (Box 2-2). Several standardized
tions, reporting of results, and references. Because the manual microscopic slides (e.g., KOVA [Hycor Biomedi-
procedure manual is vital to the laboratory, it must be cal Inc, Garden Grove, CA], Urisystem [Fisher Scientific,
reviewed continually, updated, and adhered to in the Waltham, MA]) are commercially available, and all are
performance of all tests. The manual must show docu- superior to the traditional glass slide and coverslip tech-
mentation of any procedural changes and must be nique.5 In contrast, automated microscopy instruments
reviewed annually. A well-written procedure manual such as the iQ200 (Iris Diagnostics, Chatsworth, CA)
provides a ready and reliable reference for the veteran and the UF1000i (bioMérieux, Marcy l’Etoile, France)
technologist, as well as an informational training tool require minimal specimen preparation and have good
for the novice. The importance of procedure manuals accuracy and precision; their performance is easily moni-
cannot be overemphasized, because uniform perfor- tored and documented using quality control materials.
mance of testing methods ensures accurate and repro- Because many of the procedures performed in the
ducible results, regardless of changes in personnel. urinalysis laboratory are done manually, it is very impor-
A routine urinalysis incorporates methods to ensure tant to monitor technical competence. Uniformity of
consistent quality in each of its components. The technique by all personnel is necessary and can be
laboratory procedure manual details all examinations— achieved through (1) proper training, (2) adherence to
physical, chemical, and microscopic—and includes established protocols, and (3) performance of quality
quality control checks, acceptable terminology, and tol- control checks. New technologists should have their
erances for each. The manual also provides steps to technical performance evaluated before they perform
follow when tolerances are exceeded or results are routine clinical tests. Similarly, new procedures intro-
questionable. In addition, procedures include criteria for duced into the laboratory should be properly researched,
the correlation of physical, chemical, and microscopic written, and proven before they are placed into use.
examinations, as well as follow-up actions if discrepan- Before reporting results, technologists must be able to
cies are discovered. (For instance, if the blood reagent evaluate the results obtained, recognize discrepancies or
strip test is negative and the microscopic examination absurdities, and seek answers or make corrections for
reveals red blood cells, the specimen should be checked those encountered. Performing and recording the results
for ascorbic acid.) Reference materials such as textbooks, obtained, even when they differ from those expected or
atlases, and charts must be available for convenient desired, is paramount. Because test results have a direct
consultation. effect on patient diagnosis and treatment, the highest
 CHAPTER 2  Quality Assurance and Safety 27

level of ethical behavior is required. Documentation of Another means of monitoring the entire urinalysis
errors or problems and the actions taken to correct them procedure is to select a well-mixed urine specimen
is necessary to (1) ensure communication with staff and and have each technologist or one from each shift of
supervisory personnel, (2) prevent the problem from workers perform the procedure. This provides an intra-
recurring, and (3) provide a paper trail of actual circum- laboratory or in-house quality assessment. Results should
stances and corrective actions taken as a result. These be recorded and evaluated independently. When multiple
policies should be viewed as a means of guaranteeing the laboratory sites within a facility perform urinalysis
quality of laboratory results. testing, personnel at each site can test an aliquot of the
Accurate results depend not only on the knowledge same urine specimen and compare results. If commercial
and technical competence of the technologist, but also control materials with sediment constituents are not
on the technologist’s integrity in reporting what actually used to evaluate the microscopic examination, in-house
is obtained. Circumstances can arise in laboratory testing duplicate testing can be instrumental in detecting subtle
that appear to contradict expected test results. When changes in the processing procedure, such as alterations
these circumstances are appropriately investigated, legiti- in centrifugation speed or time. The time and effort
mate explanations that expand the technologist’s scope involved in intralaboratory testing are worthwhile
of experience can be obtained. For example, a patient’s because it ensures that each laboratory and all staff are
test results can differ greatly from those obtained previ- consistently obtaining equivalent results.
ously. Investigation may reveal that a specimen mix-up Results obtained on control materials, as well as from
occurred, or that a drug the patient recently received is duplicate specimen testing, are recorded daily in a tabular
now interfering with testing. This highlights the need for or graphic format. The tolerance limits for these results
good communication among all staff and supervisory must be defined, documented, and readily available in
personnel, as well as the need for staff meetings or the laboratory. When these tolerances are exceeded, cor-
“quality circles” (i.e., a small team of individuals that rective action must be taken and documented.
meet to identify problems and discuss possible solutions) Whether the urinalysis laboratory performs quantita-
to ensure the dissemination of new information. tive urine procedures (e.g., total protein, creatinine)
depends on the facility. In some settings, the urinalysis
laboratory performs only the manual quantitative proce-
Monitoring Analytical Components   dures, whereas the chemistry section performs those pro-
of Quality Assurance cedures that are automated. Regardless, a brief discussion
For internal QA of testing methods, quality control (QC) of the QC materials used for quantitative urine methods
materials are used to assess and monitor analytical error, is necessary. The value assigned to commercial or home-
that is, the accuracy and precision of a method. QC made QC materials is determined in the laboratory by
materials serve to alert the laboratorian of method performing repeated analyses over different days. This
changes that directly affect the quality of results obtained. enables variables such as personnel, reagents, and sup-
These materials can be prepared by laboratory personnel plies to be represented in the data generated. After analy-
or purchased from commercial suppliers. They mimic ses are complete, QC data are tabulated and control limits
patient samples in their physical and chemical character- determined by using the mean and standard deviation
istics, that is, they have the same matrix. For some QC (SD). Initial control (or tolerance) limits can be estab-
materials, the manufacturer determines and assigns lished using a minimum of 20 determinations; as more
expected values. These values should be confirmed and data are accumulated, the limits can be revised. Because
adjusted if necessary to reflect the method and conditions the error distribution is gaussian, control limits are chosen
of each laboratory. such that 95% to 99% of control values will be within
Numerous urinalysis control materials are commer- tolerance. This corresponds to the mean value ± 2 SD or
cially available. Some control materials monitor only ± 3 SD, respectively. Graphs of the QC values obtained
the status of the qualitative chemical examination of over time are plotted and are known as QC or Levey-
urine using reagent strips, whereas other control materi- Jennings control charts. They provide an easy, visual
als include microscopic entities that can monitor the means of identifying changes in accuracy and precision.
microscopic examination and the steps involved in Changes in accuracy are evidenced by a shift in the mean,
processing urine specimens (e.g., centrifugation). The whereas changes in precision (random error) are mani-
microscopic elements present vary with the manufac- fested by an increase in scatter or a widening of the dis-
turer. Quantimetrix Corporation (Redondo Beach, CA) tribution of values about the mean (standard deviation).
(DipandSpin, QuanTscopics) uses stabilized human red External quality assurance measures (e.g., proficiency
blood cells, white blood cells, and crystals. In contrast, surveys) monitor and evaluate a laboratory’s perfor-
Hycor Biomedical Inc. (Garden Grove, CA) (KOVA- mance as compared with other facilities. These QA mea-
Trol) includes stabilized red blood cells, organic parti- sures may take the form of proficiency testing or
cles (mulberry spores) to simulate white blood cells, participation in programs in which each laboratory uses
and crystals. the same lot of QC materials. The latter is used primarily
28 CHAPTER 2  Quality Assurance and Safety

with quantitative urine methods. Monthly, the results terminology. The report should include reference ranges
obtained by each laboratory are reported to the manu- and the ability to add informative statements if war-
facturer of the QC material. Within weeks, reports sum- ranted, for example, “glucose oxidase/reducing sub-
marizing the analytical methods used and the results stances questionable owing to the presence of ascorbic
obtained by each laboratory are distributed. These acid” or “clumps of white blood cells present.” Results
reports are useful in detecting small continuous changes should be quantitative (e.g., 100 mg/dL or 10 to 25
in systematic error in quantitative methods that may not RBCs/HPF [red blood cells per high-power field]) wher-
be evident with internal quality assurance procedures. ever possible. All personnel should use the same (i.e.,
For a laboratory to be accredited, periodic interlabo- standardized) terminology for test parameters (e.g., color
ratory comparison testing in the form of proficiency or clarity terms).
surveys is required by the Clinical Laboratory Improve- Laboratory procedures should describe in detail the
ment Act of 1988 (CLIA 88). This comparison testing appropriate reporting format and should provide criteria
involves the performance of routine tests on survey for the reporting of any critical values. Critical values
samples provided for a fee to participating laboratories. are significantly abnormal results that exceed the upper
Each laboratory independently performs and submits or lower critical limit and are life threatening. These
results to the survey agency (e.g., CAP, Centers for results need to be relayed immediately to the health care
Disease Control and Prevention [CDC]) for assessment provider for appropriate action. The laboratorian is
and tabulation. Before distribution of the survey samples, responsible for recognizing critical values and communi-
the target value of each sample is determined by testing cating them in a timely fashion. Each institution must
at selected or reference laboratories. Using the reference establish its own list of critical values. For example, the
laboratory target values and results submitted by the list might include as critical the presence of pathologic
participant laboratories, the survey agency prepares urine crystals (e.g., cystine, leucine, tyrosine); a strongly
extensive reports and charts for each analyte assessed, positive test for glucose and ketones; and the presence
the method used, and the values obtained. These surveys of a reducing substance, other than glucose or ascorbic
provide valuable information on laboratory performance acid, in an infant.
and testing methods—individually, by specific method, Quality assurance measures, whether internal (QC
and as a whole. materials) or external (proficiency surveys), require doc-
Some urinalysis proficiency surveys include digital umentation and evidence of active review. When accept-
images or photographic slides for the identification of able tolerances are exceeded, they must be recorded
urine sediment components, such as casts, epithelial and corrective action taken. In the clinical laboratory,
cells, blood cells, and artifacts. One approach used to documentation is crucial because an action that was
evaluate these urine sediment images is for each tech- not documented essentially has not been performed.
nologist in the laboratory to independently identify the The goal of an effective QA program is to obtain con-
sediment component. Results are reviewed and shared, sistently accurate and reproducible results. In achieving
and a single answer is ultimately submitted to the survey this goal, test results will reflect the patient’s condition,
agency. Although limited, this approach enables eva­ rather than results modified due to procedural or person-
luation of competence in microscopic identification. In nel variations.
addition, if the process of arriving at an answer by con-
sensus is used, it provides an opportunity to maintain
SAFETY IN THE URINALYSIS
and improve the competence of personnel.
LABORATORY
Although QC materials and proficiency testing
samples help to detect decreased quality in laboratory For years the health care industry has been at the fore-
testing, they do not pinpoint the source of the problem, front in developing policies and procedures to prevent
nor do they solve it. Only with good communication and and control the spread of infection in all areas of the
documentation can analytical problems be pursued and hospital to ensure patient and employee safety. Because
continuing education programs developed. Some prob- clinical laboratory employees are exposed to numerous
lems encountered in the laboratory may be approached workplace hazards in various forms—biological, chemi-
best by the development of a quality circle team. The cal, electrical, radioactive, compressed gases, fires, and
involvement of laboratorians in a problem-solving team so on—safety policies are an integral part of the labora-
reaffirms the technologists’ self-worth and enhances their tory. With passage of the Occupational Health and Safety
commitment to quality goals. Act in 1970, formal regulation of safety and health for
all employees, regardless of employer, officially began.
This law is administered through the U.S. Department
Postanalytical Components   of Labor by the Occupational Safety and Health Admin­
of Quality Assurance istration (OSHA). As a result of the law, written manuals
Urinalysis results can be communicated efficiently and that define specific safety policies and procedures for all
effectively using a standardized reporting format and potential hazards are required in laboratories. Guidelines
 CHAPTER 2  Quality Assurance and Safety 29

for developing these written policies and procedures are address not only the protection of health care personnel,
provided in several Clinical and Laboratory Standards but the prevention of patient-to-patient and healthcare
Institute (CLSI) documents.6,7,8 An additional require- worker-to-patient transmission (i.e., nosocomial trans-
ment of the law is that all employees must document mission) of infectious agents. It combines the major fea-
annual review of the safety manual. The next section tures of UP and BSI into a single guideline with feasible
discusses hazards frequently encountered in the clinical recommendations to prevent disease transmission. Stan-
laboratory when working with urine and other body dard Precautions also dictate that standards or calibra-
fluids (e.g., feces, amniotic fluid, cerebrospinal fluid), as tors, quality control materials, and proficiency testing
well as the policies and procedures necessary to ensure materials be handled like all other laboratory specimens.6
a safe and healthy working environment. The Transmission-Based Precautions of the guideline
apply to specific patients with known or suspected
infections or colonization with infectious agents (e.g.,
Biological Hazards vancomycin-resistant enterococcus [VRE]). Three cate-
Biological hazards abound in the clinical laboratory. gories of transmission-based precautions in the hospital
Today, any patient specimen or body substance (e.g., are described and include contact precautions, droplet
body fluid, fresh tissue, excretions, secretions, sputum, precautions, and airborne precautions. These additional
drainage) is considered infectious, regardless of patient precautions are used when the potential for disease
diagnosis. Table 2-3 provides a brief history and key transmission from these patients or their body fluids is
points of safety guidelines and regulations implemented not completely interrupted by using Standard Precau-
to prevent the transmission of infectious agents in hos- tions alone.
pitals. In the 1980s, the transmission of disease such as It is important to note that Standard Precautions do
human immunodeficiency virus (HIV), hepatitis B virus not affect other necessary types of infection control strat-
(HBV), and hepatitis C virus (HCV) became a major egies, such as identification and handling of infectious
concern for health care workers. To address the issue, in laboratory specimens or waste during shipment; proto-
1987, the Centers for Disease Control and Prevention cols for disinfection, sterilization, or decontamination;
(CDC) issued practice guidelines known as Universal or laundry procedures.6
Precautions (UP). UP was intended to protect health care Traditionally, the three routes of infection or disease
workers, primarily from patients with these bloodborne transmission are (1) inhalation, (2) ingestion, and (3)
diseases. Under UP, body fluids and secretions that did direct inoculation or skin contact. In the laboratory,
not contain visible blood were exempt. At this same aerosols can be created and inhaled when liquids (e.g.,
time, another system of isolation was proposed and body fluids) are poured, pipetted, or spilled. Similarly,
refined; this was called Body Substance Isolation (BSI).9,10 centrifugation of samples and removal of tight-fitting
BSI and UP had similar features to prevent the transmis- caps from specimen containers are potential sources of
sion of bloodborne pathogens but differed with regard airborne transmission. Ingestion occurs when infectious
to handwashing after glove use. UP recommended hand- agents are taken into the mouth and swallowed, as from
washing after the removal of gloves, whereas BSI indi- eating, drinking, or smoking in the laboratory; mouth
cated that handwashing was not required unless the pipetting; or hand-to-mouth contact following failure
hands were visibly soiled. Then in 1991, OSHA enacted to appropriately wash one’s hands. Direct inoculation
the Bloodborne Pathogens Standard (BPS) to address involves parenteral exposure to the infectious agent as a
occupational exposure of health care workers to infec- result of a break in the technologist’s skin barrier or
tious agents, primarily HIV, hepatitis viruses, and retro- contact with the mucous membranes. This includes skin
viruses. BPS requires laboratories to have an exposure punctures with needles, cuts or scratches from contami-
control plan that regulates work practices such as han- nated glassware, and splashes of specimens into the eyes,
dling of needles and sharps and requires hepatitis B vac- nose, and mouth. Although it is impossible to eliminate
cinations, training, and other measures.11,14,15 all sources of infectious transmission in the laboratory,
This became a time of confusion with hospitals the use of protective barriers and adherence to Standard
differing in their isolation protocols, as well as in the Precautions minimize transmission.
handling of body fluids and other substances. It was Under Standard Precautions, all body fluids, secre-
recognized that UP guidelines alone were inadequate tions, and excretions (except sweat) are considered
because infectious body fluids do not always have or potentially infectious and capable of disease trans­
show visible blood. To resolve this conundrum, the mission. Key components of Standard Precautions are
Healthcare Infection Control Practices Advisory Com- good hand hygiene and the use of barriers (physical,
mittee (HICPAC) and the CDC issued in 1996 a new mechanical, or chemical) between potential sources of
two-tier practice guideline known as Standard Precau- an infectious agent and individuals. All personnel must
tions and Transmission-Based Precautions.12,13 Standard adhere to Standard Precautions including ancillary health
Precautions are infection prevention practices that are care staff such as custodial and food service employees,
applied to all patients in all health care settings and that as well as health care volunteers. It is a responsibility of
30 CHAPTER 2  Quality Assurance and Safety

TA B L E 2 - 3 Selected Evolution History of Isolation Precautions in Hospitals7,8

Year Guideline or Regulation Key Points
1985–1988 Universal Precautions (UP) • Established in response to HIV/AIDS epidemic
• Initiated the application of blood and body fluid precautions to all
patients
• Exempted some specimens from precautions, namely, urine, feces,
nasal secretions, sputum, sweat, tears, and vomitus unless visible
blood present
• Included the use of personal protective equipment (PPE) by health
care workers to prevent mucous membrane exposures
• Recommended handwashing after glove removal
• Included recommendations for the handling and disposal of
needles and other sharps
1987 Body Substance Isolation (BSI)9,10 • Emphasized avoiding contact with potentially infectious, moist
body fluids (except sweat), regardless of the presence or absence
of blood
• Similar to UP recommendations for the prevention of bloodborne
pathogen transmission
• Handwashing after glove removal not required unless hands visibly
soiled
• Inadequate provisions to prevent:
• Some droplet transmissions
• Direct or indirect contact transmission from dry skin or
environmental sources
• Airborne droplet nuclei transmission of infection (e.g.,
tuberculosis) over long distances
1991,11 (1999,14 200115) Bloodborne Pathogens Standard11,14,15; • Aimed at reducing health care worker exposure to bloodborne
OSHA pathogens—HIV, hepatitis viruses, and retroviruses—when caring
for patients with known infection
• Requires employer to have an Exposure Control Plan to:
• Educate workers
• Provide necessary supplies and other measures (e.g., PPE,
hepatitis B vaccination, signs and labels, medical surveillance)
1996,12 200713 Standard Precautions and Transmission- • Two-tier approach to prevent disease transmission that emphasizes
Based Precautions; HICPAC/CDC prevention of nosocomial infection and worker safety
• Tier 1: Standard Precautions
• A synthesis of UP, BSI, and 1983 CDC guidelines
• Applies to all body fluids, secretions, excretions (except sweat),
and tissue specimens
• Applies to human-based standards or calibrators, quality control
materials, and proficiency testing materials
• Applies to nonintact skin and mucous membranes of patient
and health care worker
• Tier 2: Transmission-Based Precautions
• Three categories: airborne, droplet, and contact
• Used when Standard Precautions alone are insufficient
• Used for patients with known or suspected infection
• Lists specific syndromes that require temporary isolation
precautions until a definitive diagnosis is made

CDC, Centers for Disease Control and Prevention; HICPAC, Healthcare Infection Control Practices Advisory Committee; OSHA, Occupational Safety and Health
Administration.

each health care department to educate, implement, personal protective equipment (PPE) or barriers must be
document, and monitor compliance with Standard Pre- used. Gloves should be worn when assisting patients in
cautions. In addition, written safety and infection control collecting specimens, when receiving and processing
policies and procedures must be readily available for specimens, when performing any testing procedure, and
reference in the laboratory. when cleaning equipment or work areas. In addition,
Personal Protective Equipment.  When contact with they should be worn at all times in the laboratory, where
body fluids or other liquids is anticipated, appropriate countertops, chairs, and other surfaces are exposed to
 CHAPTER 2  Quality Assurance and Safety 31

these specimens. If the technologist is involved directly

with patients, he or she should change gloves and wash
or sanitize the hands after each patient. In the laboratory,
gloves are changed when they are visibly soiled or physi-
cally damaged. Gloves used in the laboratory should not
be worn outside of the area. Whenever gloves are
removed, or when contact with urine or other body
fluids has occurred, hands should be washed with an
appropriate antiseptic soap.
Protective laboratory coats must be worn in the labo-
ratory and when necessary must be impermeable to
blood and other liquid samples that could be potentially
infectious. Lab coats should be changed daily or more
often if soiled. These coats should not be worn outside
of or be removed from the laboratory area. If splashing
of liquids such as urine, body fluids, or chemicals is FIGURE 2-1  The universal biohazard symbol. (Rodak BF: Hematol-
anticipated, a moisture-resistant (plastic) apron should ogy: clinical principles and applications, ed 2, Philadelphia, 2002,
be worn over the lab coat. Saunders.)
Because processing and performing laboratory proce-
dures on urine and body fluids can often result in sprays,
splatters, or aerosols, laboratory employees should wear bag before removal from the laboratory area by custo-
eyewear, headgear, or masks to protect the eyes, nose, dial staff.
and mouth. Eyeglasses may be sufficient for some situa- All biological specimens, except urine, must be steril-
tions in the laboratory; however, Plexiglas barriers, ized or decontaminated before disposal. Incineration and
safety glasses or goggles, face shields, hood sashes, or autoclaving are acceptable, with the latter usually being
particulate respirators may be necessary for protection, the most cost-effective. Urine, on the other hand, may
depending on the procedure being performed and the be discarded directly down a sink or toilet, with caution
substance being handled. taken to avoid splashing. When discarding urine down
Specimen Processing.  All specimens should be trans- a sink, the technologist should rinse the sink well with
ported to the laboratory in sealed plastic bags, with the water after discarding specimens and at least daily with
request slip placed on the outside of the bag. If the 0.5% bleach (sodium hypochlorite).
outside of the specimen container is obviously contami- Contaminated sharps such as needles, broken glass,
nated because of leakage or improper collection tech- or transfer pipettes must be placed into puncture-
nique, the exterior of the container can be cleaned using resistant containers for disposal. These containers should
an appropriate disinfectant before processing, or it not be overfilled. They should be sealed securely and
should be rejected and a new specimen requested. When enclosed in a clean infectious waste disposal bag to
removing lids or caps from specimens, the technologist protect custodial personnel before removal from the
should work behind a protective shield or should cover laboratory area. Because contaminated sharps are con-
the specimens with gauze or disposable tissues to prevent sidered infectious, they must be incinerated or auto-
sprays and splatters. During centrifugation, specimens claved before disposal.
should be capped or placed in covered trunnions to Noninfectious glass such as empty reagent bottles and
prevent aerosols. Centrifuges should not be operated nonhazardous waste such as emptied urine containers
with their tops open nor stopped by hand. If a specimen are considered normal waste and require no special pre-
needs to be aliquoted, the technologist should use trans- cautions for disposal.
fer pipettes or protective barriers when pouring from the Decontamination.  Several agents are available for the
specimen container. daily decontamination of laboratory surfaces and equip-
Disposal of Waste.  To protect all laboratory personnel, ment. Bleach or a phenolic disinfectant is used most
including custodial staff, adherence to an infectious often in the clinical laboratory. A 0.5% bleach solution,
waste disposal policy is necessary. Because all biological prepared by adding 1 part household bleach to 9 parts
specimens and materials exposed to them (e.g., contami- water (1/10 dilution), is stable for 1 week. Phenolic dis-
nated needles and glassware) are considered infectious, infectants, a combination of phenolic compounds and
they must be disposed of properly. Disposal requires detergents, are purchased commercially; one makes
leakproof, well-constructed receptacles clearly marked appropriate dilutions according to the manufacturers’
with the universal biohazard symbol and available in all recommendations.
laboratory areas (Figure 2-1). These biohazard contain- When spills occur, decontaminants are used to
ers should not be overfilled. In addition, they should be neutralize the biological hazard and to facilitate its
sealed adequately and enclosed within a clean biohazard removal. Because decontaminants are less effective in
32 CHAPTER 2  Quality Assurance and Safety

the presence of large amounts of protein, a body fluid

spill should be absorbed first with a solid absorbent
powder (e.g., Zorbitrol) or disposable towels. If an
absorbent powder is used, the liquid will solidify and
can be scooped up and placed into an infectious waste
receptacle. If disposable towels are used, allow the spill
to be absorbed and pour 0.5% bleach over the towels.
Carefully pick up the bleach-soaked towels and transfer
them into an infectious waste container. Decontaminate
the spill area again using 0.5% bleach and clean it with
a phenolic detergent if desired. All disposable materials
used to clean the spill area must be placed in infectious
waste receptacles.
A
Chemical Hazards
Chemicals are ubiquitous in the clinical laboratory. HAZARDOUS MATERIALS
Many are caustic, toxic, or flammable and must be
specially handled to ensure the safety and well-being of CLASSIFICATION
laboratory employees. The OSHA rule of January 1990 HEALTH HAZARD FIRE HAZARD
requires each facility to have a Chemical Hygiene Plan 4 - Deadly
3 - Extreme
Flash Points
4 - Below 73˚ F
that defines the safety policies and procedures for all danger
2 - Hazardous
3 - Below 100˚ F
2 - Below 200˚ F
hazardous chemicals used in the laboratory. This plan 1 - Slightly
hazardous
1 - Above 200˚ F
0 - Will not burn
includes the identification of a chemical hygiene officer; 0 - Normal
material
policies for handling, storage, and use of chemicals; the
use of protective barriers; criteria for monitoring over-
exposure to chemicals; and provisions for medical con-
sultations or examinations. Educating personnel about
chemical safety policies and procedures is man­datory
REACTIVITY
and requires a documented annual review. By develop- SPECIFIC 4 - May detonate
HAZARD
ing and using a comprehensive Chemical Hygiene Plan, 3 - Shock and heat
may detonate
Oxidizer OX
chemical hazards are minimized and the laboratory Acid ACID 2 - Violent chemical
change
Alkali ALK
becomes a safe environment in which to work. Corrosive
Use NO WATER
COR
W
1 - Unstable if
heated
The labeling of chemicals is fundamental to a labora- Radiation Hazard 0 - Stable

tory safety program. Because hazardous chemicals can

Lab Safety Supply Inc Reorder No. 3650

B
be classified into several categories—including caustic or
FIGURE 2-2  A, Label used by the Department of Transportation
corrosive materials, poisons, carcinogens, flammables, to indicate hazardous chemicals. B, The label identification system
explosives, mutagens, and teratogens—each must be developed by the National Fire Protection Association. (Courtesy Lab
appropriately labeled to ensure proper handling. All Safety Supply Inc., Janesville, WI.)
chemicals are required to have descriptive warning labels
on their shipping containers. These labels are color-coded
and include a pictorial representation of the hazard To limit employee exposure, appropriate usage and
(Figure 2-2). However, when a chemical is removed from handling guidelines for each chemical type must be
its original shipping container, its hazard identity is lost described in the laboratory safety manual. General rules
unless the laboratory appropriately relabels it. Although such as prohibiting pipetting by mouth or sniffing of
OSHA requires the labeling of hazardous chemicals, it chemicals are mandatory. Because the greatest hazard
does not mandate the type of labeling system to be used. encountered in the clinical laboratory is that caused by
By using a consistent identification system, hazards can the splattering of acids, alkalis, and strong oxidizers,
be readily identified and appropriate precautions taken. appropriate use of personal protective equipment is
The National Fire Protection Association developed the required. Use of gloves, gowns, goggles, and a fume hood
704-M Hazard Identification System, using bright, color- or safety cabinet will reduce the potential for injury.
coded labels divided into quadrants. These labels are Chemical safety tips include (1) never grasp a reagent
highly visible and identify the health (blue), flammability bottle by the neck or top, and (2) always add acid to
(red), and reactivity (yellow) hazard for each chemical, water; never add water to concentrated acid. Safety
as well as any special considerations (white). The system equipment such as an eyewash and shower must be
also uses numbers from 0 to 4 to classify hazard severity, readily available and accessible in case of accidental
with 4 representing extremely hazardous. exposure.
 CHAPTER 2  Quality Assurance and Safety 33

The goal of the OSHA hazardous communication substances require special considerations regarding
rule is to ensure that all employees are aware of storage, use, and disposal. Appropriately vented storage
potential chemical hazards in their workplace. This cabinets are necessary to store solvents; the availability
employee “right to know” requires chemical manufac- of these cabinets dictates the volume of flammables
turers and suppliers to provide material safety data allowed to be stored on the premises. Because of poten-
sheets (MSDSs). These sheets, available for each chemi- tially toxic vapors, adequate ventilation during solvent
cal, include identity information, hazardous ingredients, use, such as in a fume hood, is mandatory. Although
physical and chemical characteristics, physical hazards, small quantities of water-miscible solvents may be dis-
reactivity, health hazards, precautions for safe handling posed of in the sewer system with copious amounts of
and use, and regulatory information of the chemical. water, disposal of flammable solvents in this fashion is
Whereas an MSDS for each hazardous chemical used dangerous. All solvent waste should be recovered follow-
in all laboratory areas must be available on site, each ing procedures in glass or other appropriate containers.
laboratory section should retain copies of the MSDS Because not all solvents can be mixed together, a written
for chemicals frequently used in their area for quick laboratory protocol listing acceptable solvent combina-
reference. tions is necessary. After collection, each solvent waste
Handling Chemical Spills.  In the event of a spill, the container must be marked clearly with the solvent type
MSDS for the chemical should be consulted to determine and the relative amount present and must be properly
the appropriate action to take. Each laboratory should stored until disposal.
have available a chemical spill kit that includes absor- Other potential fire hazards in the laboratory include
bent, appropriate protective barriers (e.g., gloves, electrical hazards and hazards from flammable com-
goggles), cleanup pans, absorbent towels or pillows, and pressed gases. Laboratory personnel should report any
disposal bags. Frequently, liquids are contained by discovered deterioration in equipment (e.g., electrical
absorption using a spill compound (absorbent) such as shorts) or its connections (e.g., a frayed cord). If a
ground clay or a sodium bicarbonate and sand mixture. liquid spill occurs on electrical equipment or its con-
The latter is generally appropriate for acid, alkali, or nections, appropriate action must be taken to dry the
solvent spills. Following absorption, the absorbent is equipment thoroughly before placing it back into use.
swept up and placed into a bag or a sealed container for Compressed gases must be secured at all times, regard-
appropriate chemical disposal, and the spill area is thor- less of their contents or the amount of gas in the tank.
oughly washed. Their valve caps should be in place except when in use.
For emergency treatment of personnel affected by A procedure for appropriate transport, handling, and
chemical splashes or injuries, clear instructions should storage of compressed gases is necessary to ensure
be posted in the laboratory. Chemical spills of hazardous proper usage. All laboratory personnel must be aware
substances must be reported to supervisory personnel of the location of all fire extinguishers, alarms, and
and appropriately documented. This permits a review of safety equipment; must be instructed in the use of a
the circumstances and facilitates changes to prevent fire extinguisher; and must be involved in laboratory
recurrence of the incident. Any injury or illness resulting fire drills, at least annually.
from the spill or exposure also requires documentation
and follow-up.
STUDY QUESTIONS
Disposal of Chemical Waste.  All chemicals must be
disposed of properly to ensure safety in the workplace 1. The ultimate goal of a quality assurance program
and in the environment in general. Because chemical is to
disposal differs according to the chemical type, the A. maximize the productivity of the laboratory.
amount to be discarded, and local laws, each laboratory B. ensure that patient test results are precise.
must maintain its own policies for disposal. Following C. ensure appropriate diagnosis and treatment of
performance of laboratory procedures, chemicals often patients.
are diluted adequately or neutralized such that disposal D. ensure the validity of laboratory results
in the sewer system is satisfactory. Flushing sinks and obtained.
drains with copious amounts of water following the 2. Which of the following is a preanalytical component
disposal of aqueous reagents is a good laboratory prac- of a quality assurance program?
tice. Appropriate steps to be followed must be available A. Quality control
in a general laboratory policy or in the laboratory pro- B. Turnaround time
cedure that uses the chemical. C. Technical competence
D. Preventive maintenance
Other Hazards
Organic solvents used in the clinical laboratory represent
health and fire hazards. As a result, these flammable
34 CHAPTER 2  Quality Assurance and Safety

3. Which of the following is a postanalytical compo- 11. Within one facility, what is the purpose of perform-
nent of a quality assurance program? ing duplicate testing of a specimen by two different
A. Critical values laboratories (i.e., in-house duplicates)?
B. Procedure manuals A. It provides little information because the results
C. Preventive maintenance are already known.
D. Test utilization B. It saves money by avoiding the need for internal
4. Analytical components of a quality assurance quality control materials.
program are procedures and policies that affect the C. It provides a means of evaluating the precision
A. technical testing of the specimen. of a method.
B. collection and processing of the specimen. D. It can detect procedural and technical differences
C. reporting and interpretation of results. between laboratories.
D. diagnosis and treatment of the patient. 12. Interlaboratory comparison testing as with profi-
5. The purpose of quality control materials is to ciency surveys provides a means to
A. monitor instrumentation to eliminate down­ A. identify critical values for timely reporting to
time. clinicians.
B. ensure the quality of test results obtained. B. ensure that appropriate documentation is being
C. assess the accuracy and precision of a method. performed.
D. monitor the technical competence of laboratory C. evaluate the technical performance of individual
staff. laboratory practitioners.
6. Why are written procedure manuals necessary? D. evaluate the performance of a laboratory com-
A. To assist in the ordering of reagents and supplies pared with that of other laboratories.
for a procedure 13. The primary purpose of a Standard Precautions
B. To appropriately monitor the accuracy and pre- policy in the laboratory is to
cision of a procedure A. ensure a safe and healthy working environ­ment.
C. To ensure that all individuals perform the same B. identify processes (e.g., autoclaving) to be used
task consistently to neutralize infectious agents.
D. To ensure that the appropriate test has been C. prevent the exposure and transmission of poten-
ordered tially infectious agents to others.
7. Which of the following is not considered to be an D. identify patients with hepatitis B virus, human
analytical component of quality assurance? immunodeficiency virus, and other infectious
A. Reagents (e.g., water) diseases.
B. Glassware (e.g., pipettes) 14. Which agency is responsible for defining, establish-
C. Instrumentation (e.g., microscope) ing, and monitoring safety and health hazards in the
D. Specimen preservation (e.g., refrigeration) workplace?
8. Which of the following sources should include a A. Occupational Safety and Health Administration
protocol for the way to proceed when quality control B. Centers for Disease Control and Prevention
results exceed acceptable tolerance limits? C. Chemical Hygiene Agency
A. A reference book D. National Fire Protection Association
B. A procedure manual 15. Match the mode of transmission with the laboratory
C. A preventive maintenance manual activity.
D. A specimen-processing protocol
9. Technical competence is displayed when a labora- Mode of
Laboratory Activity Transmission
tory practitioner
__  A.  Not wearing gloves when handling 1.  Inhalation
A. documents reports in a legible manner.
specimens 2.  Ingestion
B. recognizes discrepant test results. __  B.  Centrifuging uncovered spe­cimens 3.  Direct contact
C. independently reduces the time needed to __  C.  Smoking in the laboratory
perform a procedure (e.g., by decreasing incuba- __  D.  Being scratched by a broken beaker
tion times). __  E.  Having a specimen splashed into the
D. is punctual and timely. eyes
10. Quality control materials should have __  F.  Pipetting by mouth
A. a short expiration date.
B. a matrix similar to patient samples.
C. their values assigned by an external and unbi-
ased commercial manufacturer.
D. the ability to test preanalytical variables.
 CHAPTER 2  Quality Assurance and Safety 35

C A S E 2 - 1
Both a large hospital and its outpatient clinic have a laboratory area 1. Which of the following conditions present in the hospital labora-
for performance of routine urinalyses. Each laboratory performs daily tory could cause the observed findings in this case?
quality assurance checks on reagents, equipment, and procedures. 1. The urinalysis centrifuge had its brake left on.
Because the control material used does not have sediment compo- 2. The urinalysis centrifuge was set for the wrong speed or time
nents, each laboratory sends a completed urinalysis specimen to the setting.
other laboratory for testing. After the urinalysis has been performed, 3. Microscopic examination was performed on an unmixed or
results are recorded, compared, and evaluated. The criterion for inadequately mixed specimen.
acceptability is that all parameters must agree within one grade. 4. Microscopic examination was performed using nonoptimized
microscope settings for urine sediment viewing (e.g., con-
Results trast was not sufficient to view low-refractile components).
One day, all results were acceptable except those of the microscopic A. 1, 2, and 3 are correct.
examination, which follow: B. 1 and 3 are correct.
C. 2 and 4 are correct.
Hospital Laboratory Clinic Laboratory D. 4 is correct.
RBCs/hpf: 5–10 RBCs/hpf: 25–50 E. All are correct.
WBCs/hpf: 0–2 WBCs/hpf: 0–2 2. Which of the following actions could prevent this from happening
Casts/lpf: 0–2 hyaline Casts/lpf: 5–10 hyaline again?
A. The microscope and centrifuge should be repaired.
On investigation, the results from the clinic were found to be B. The laboratory should participate in a proficiency survey.
correct; the hospital had a problem, which was addressed and rem- C. A control material with sediment components should be used
edied immediately. daily.
D. All results should be reviewed by the urinalysis supervisor
before they are reported.

hpf, High-power field; lpf, low-power field; RBC, red blood cell; WBC, white blood cell.

16. Which of the following is not considered personal 19. Which of the following is not part of a Chemical
protective equipment? Hygiene Plan?
A. Gloves A. To identify and label hazardous chemicals
B. Lab coat B. To educate employees about the chemicals
C. Disinfectants they use (e.g., providing material safety data
D. Eyeglasses sheets)
17. Which of the following actions represents a good C. To provide guidelines for the handling and use
laboratory practice? of each chemical type
A. Washing or sanitizing hands frequently D. To monitor the handling of biological hazards
B. Wearing lab coats outside of the laboratory 20. Which of the following information is not found on
C. Removing lab coats from the laboratory for a material safety data sheet?
laundering at home in 2% bleach A. Exposure limits
D. Wearing the same gloves to perform venipunc- B. Catalog number
ture on two different patients because the patients C. Hazardous ingredients
are in the same room D. Flammability of the chemical
18. Which of the following is not an acceptable disposal
practice?
A. Discarding urine into a sink REFERENCES
B. Disposing of used, empty urine containers with 1. Westgard JO, Klee GG: Quality assurance. In Tietz NW,
nonhazardous waste editor: Fundamentals of clinical chemistry, ed 3, Philadelphia,
C. Discarding a used, broken specimen transfer 1987, WB Saunders.
2. Fraser CG, Petersen PH: The importance of imprecision. Ann
pipette with noninfectious glass waste Clin Biochem 28:207, 1991.
D. Discarding blood specimens into a biohazard 3. Clinical and Laboratory Standards Institute: Preparation and
container testing of reagent water in the clinical laboratory: approved
36 CHAPTER 2  Quality Assurance and Safety

guideline, ed 4, CLSI Document C3-A4, Clinical and Labora- 12. Garner JS: Guideline for isolation precautions in hospitals.
tory Standards Institute, Wayne, PA, 2006, CLSI. Infect Control Hosp Epidemiol 17:53–80, 1996.
4. Clinical and Laboratory Standards Institute: Laboratory docu- 13. Center for Disease Control and Prevention: 2007 guideline for
ments: development and control: approved guideline, ed 5, isolation precautions: preventing transmission of infectious
CLSI Document GP02-A5, Clinical and Laboratory Standards agents in healthcare settings (website): www.cdc.gov/hicpac
Institute, Wayne, PA, 2006, CLSI. /2007IP/2007isolationPrecautions.html. Accessed July 7,
5. Schumann GB, Tebbs RD: Comparison of slides used for 2011.
standardized routine microscopic urinalysis. J Med Technol 14. Occupational Safety and Health Administration: Directives:
3:54–58, 1986. enforcement procedures for the occupational exposure to
6. Clinical and Laboratory Standards Institute: Protection bloodborne pathogens, CPL 2-2.44D, U.S. Department of
of laboratory workers from occupationally acquired infec- Labor, November 5, 1999.
tions: approved guideline, ed 3, CLSI Document M29-A3, 15. Occupational Safety and Health Administration: Directives:
Clinical and Laboratory Standards Institute, Wayne, PA, enforcement procedures for the occupational exposure to
2005, CLSI. bloodborne pathogens, CPL 2-2.69D, U.S. Department of
7. Clinical and Laboratory Standards Institute: Clinical Labora- Labor, November 27, 2001.
tory Safety: approved guideline, ed 2, CLSI Document GP17-
A2, Clinical and Laboratory Standards Institute, Wayne, PA, BIBLIOGRAPHY
2004, CLSI.
8. Clinical and Laboratory Standards Institute: Clinical labora- Clinical and Laboratory Standards Institute: Urinalysis: approved
tory waste management: approved guideline, ed 2, CLSI Docu- guideline, ed 3, CLSI Document GP16-A3, Clinical and Labo-
ment GP05-A2, Clinical and Laboratory Standards Institute, ratory Standards Institute, Wayne, PA, 2009, CLSI.
Wayne, PA, 2002, CLSI. Hazardous materials, storage, and handling pocketbook, Alexan-
9. Lynch P, Jackson M, Cummings M, Stamm W: Rethinking the dria, Va, 1984, Defense Logistics Agency.
role of isolation precautions in the prevention of nosocomial National Fire Protection Association: Hazardous chemical data,
infections. Ann Intern Med 107:243–246, 1987. Boston, 1975, National Fire Protection Association, No. 49.
10. Lynch P, Cummings M, Roberts P, et al: Implementing and Occupational exposure to hazardous chemicals in laboratories,
evaluating a system of generic infection precautions: body final rule. Federal Register 55:3327–3335, 1990.
substance isolation. Am J Infect Control 18:1–12, 1987. Schweitzer SC, Schumann JL, Schumann GB: Quality assurance
11. Occupational Safety and Health Administration: Occupa- guidelines for the urinalysis laboratory. J Med Technol 3:570,
tional exposure to bloodborne pathogens; final rule. Federal 1986.
Register 56:64003–640182 (codified at 29 CFR 1910.1030),
December 6, 1991.