1

Quality Assessment and Safety

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

CHAPTER OUTLINE
Quality Assessment, 2 Safety in the Urinalysis Laboratory, 7
Quality Assessment: What Is It?, 2 Biological Hazards, 8
Preanalytical Components of Quality Assessment, 2 Chemical Hazards, 11
Analytical Components of Quality Assessment, 4 Other Hazards, 13
Monitoring Analytical Components of Quality References, 14
Assessment, 6 Bibliography, 15
Postanalytical Components of Quality Assessment, 7 Study Questions, 15

K E Y T E R M S1
biological hazard preventive maintenance
Chemical Hygiene Plan (CHP) quality assessment (QA)
critical value quality control materials
decontamination safety data sheet (SDS)
documentation Standard Precautions
external quality assessment technical competence
infectious waste disposal policy test utilization
Occupational Safety and Health Administration (OSHA) turnaround time (TAT);
personal protective equipment (PPE) Universal Precautions (UP)

Definitions are provided in the chapter and glossary

1

1
2 CHAPTER 1 Quality Assessment and Safety

QUALITY ASSESSMENT and development. Not only do continuing education oppor-

tunities provide intellectual stimulation and challenges for
Quality Assessment: What Is It? laboratorians, they also facilitate the development of quality
Quality assessment (QA) is a system designed to ensure the employees and ensure that the urinalysis laboratory is kept
quality of a laboratory’s services (i.e., test results). All labo- abreast of technological advances.
ratory personnel must be aware of the effects that their test A QA program for the urinalysis laboratory consists of three
results and services have on the diagnosis and treatment principal aspects: (1) preanalytical components—processes
of patients. These services must be monitored to ensure that occur before testing; (2) analytical components—aspects
that they are appropriate and effective and that they meet that directly affect testing; and (3) postanalytical components—
established standards for laboratory practice. The Clinical procedures and policies that affect reporting and interpretation
Laboratory Improvement Act enacted by the US Congress in of results. Because an error in any component will directly
1988 (CLIA ’88) was in direct response to growing concern affect the quality of results, each component must be moni-
about the quality of laboratory test results and the need to tored, evaluated, and maintained.
impose external standards to ensure quality results.1 Clinical
laboratories in the United States must be certified by the Preanalytical Components of Quality Assessment
Centers for Medicare and Medicaid Services (CMS; cms.gov) The preanalytical components involve numerous laboratory
or by a private certifying agency (e.g., College of American and ancillary staff and, in many instances, multiple depart-
Pathologists [CAP]) or a CMS-approved state regulatory ments. Because of the importance of cost-effective practices
agency. Certification is an ongoing process to ensure that in test ordering, the laboratory plays a role in monitoring test
laboratories are maintaining compliance with federal regu- utilization—that is, avoiding duplicate testing and ensur-
lations through periodic onsite inspections. QA provides a ing test appropriateness whenever possible. Each laboratory
mechanism for detecting problems and provides an opportu- is unique, and procedures to intercept and eliminate unnec-
nity to improve services. In reality, all components of health essary testing must be designed to fit the workflow of each
care, including physicians, nurses, clinics, hospitals, and their laboratory.
services are involved in QA; the laboratory is only part of this The importance of timely result reporting cannot be over-
larger program to ensure quality health care services. emphasized. A delay in specimen transport and processing
Ensuring the quality of test results was an important part of directly affects specimen turnaround time (TAT). Keep in
the clinical laboratory long before CLIA ’88; the first external mind that the definition of TAT can differ for the laborato-
laboratory surveys were developed in the 1940s. These early rian compared with physicians or nursing personnel. For
surveys revealed that not all laboratories reported the same example, a laboratorian defines TAT as the time from receipt
results on identical blood specimens submitted for hema- of the specimen in the laboratory to reporting of results to a
tologic and chemical analyses. Since the time of those first patient care area or into a data information system. In con-
surveys, all sections of the clinical laboratory have become trast, physicians view TAT as the time from when they write
involved in ensuring the quality, accuracy, and precision of the order for the test until the result is communicated to them
the laboratory results they generate. The urinalysis laboratory for action. To nursing personnel, TAT is the time that elapses
is no exception. from actual specimen collection until the results are commu-
A QA program encompasses all aspects of the urinaly- nicated to them. Therefore to monitor and address potential
sis laboratory. Specimen collection, storage, and handling; delays that directly involve the laboratory, a consensus defini-
instrumentation use and maintenance; reagent quality and tion of TAT and realistic goals for test results must be estab-
preparation; and the laboratorian’s knowledge and techni- lished. This requires a policy for documenting the times of
cal skills must meet specific minimum criteria to ensure the specimen collection, receipt, and result reporting.
quality of the results generated. To achieve the goals set forth Urine specimen collection techniques differ; they are often
in a QA program, a commitment by all laboratory personnel, controlled by medical personnel outside the laboratory and
including those in administration and management, is neces- can have a direct effect on the results obtained (see Tables 2.1
sary. This dedication must be evident in managerial decisions, and 2.2). In addition, numerous physiologic factors can affect
including the allocation of laboratory space, the purchase of the urine specimen obtained (e.g., diet, exercise, hydration,
equipment and supplies, and the budget. Without adequate medications), and depending on the test, appropriate patient
resources, the quality of laboratory services is compromised. preparation may be needed. To ensure an appropriate speci-
Properly educated and experienced laboratory personnel men, collection instructions (including special precautions
with a high level of evaluative skills are essential to ensure and appropriate labeling) must be well written, as well as dis-
the quality of laboratory results. “Many studies have shown tributed to and used by all personnel involved in specimen
that the standards of specimen collection technique and ana- collection.
lytical performance are generally inferior to those obtained Laboratory staff who receive urine specimens must be
by skilled laboratorians.”2 Because of the dynamic environ- trained to identify and handle inappropriate or unaccept-
ment of clinical laboratory science, it is imperative that labo- able specimens. In addition, they must document any prob-
ratorians have access to reference books and opportunities lems encountered so that these problems can be addressed
for continuing education to assist them in skill maintenance and corrected. The procedure the staff should follow involves
 CHAPTER 1 Quality Assessment and Safety 3

(1) ensuring that two unique patient identifiers (e.g., name, the handling of mislabeled specimens, are required to ensure
date of birth, medical record number) are on the request slip consistent treatment by all staff (Table 1.1).
and on the specimen and that they correlate; (2) evaluation of The processing of urine specimens within the labora-
elapsed time between collection and receipt of the specimen tory is another potential source of preanalytical problems.
in the laboratory; (3) the suitability of specimen preservation, Specimens for a routine urinalysis should be tested within
if necessary; and (4) the acceptability of the specimen (e.g., 2 hours of collection (see Chapter 2). If delay in transport to
the volume collected, the container used, its cleanliness— the laboratory or at the reception area is unavoidable, speci-
any evidence of fecal contamination). If the urine specimen mens should be refrigerated. Timed urine collections require
is unacceptable, a procedure must be in place to ensure that a written protocol to ensure adequate mixing, volume mea-
the physician or nursing staff is informed of the problem, surement, recording, aliquoting, and preservation—when
the problem or discrepancy is documented, and appropri- specimen testing is to be delayed or the analyte of interest is
ate action is taken. Written guidelines that list the criteria unstable. With a written procedure for specimen processing
for specimen rejection (Box 1.1), as well as the procedure for in place, all personnel will perform these tasks consistently,
thereby eliminating unnecessary variables.
Because of the multitude of variables and personnel involved
in urine specimen collection and processing, adequate train-
BOX 1.1 Criteria for Urine Specimen ing and supervision are imperative. Communication to per-
Rejection sonnel regarding any procedure changes or introduction of
new procedures must be consistent. Written procedures must
• Insufficient volume of urine for requested test(s)
be available and personnel must perform and follow estab-
• Inappropriate specimen type or collection
lished preventive maintenance schedules. All personnel must
• Visibly contaminated specimen (e.g., with feces, debris)
• Incorrect urine preservative
have appropriate education regarding the biologic and chemi-
• Specimen not properly preserved for transportation delay cal hazards in the laboratory. Preanalytical components are a
• Unlabeled or mislabeled specimen or request form dynamic part of the clinical laboratory and require adherence
• Request form incomplete or lacking to protocol to ensure meaningful test results. In other words,
quality testing cannot make up for a substandard specimen.

TABLE 1.1 Definitions and an Example of Policy for Handling Unlabeled or Mislabeled
Specimens
Definitions
Unlabeled No patient identification is on the specimen container or tube that contains the specimen. Placing 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 request form with the appropriate reason for the
cancellation, e.g., 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 any 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
• sign documentation of the incident
Reporting Results All labeling and signing of documentation must occur before results are released (except in cases of life-
threatening emergencies, such as cardiac arrest, when verbal specimen identification is accepted and
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 Assessment Forward a copy of the incident to the Quality Assessment committee and to the patient care unit involved
Report (e.g., nursing station, clinic, physician’s office).
4 CHAPTER 1 Quality Assessment and Safety

Analytical Components of Quality Assessment The required frequency of maintenance differs depend-
Analytical components are those variables that are directly ing on the equipment used; the protocol should meet the
involved in specimen testing. They include reagents and sup- minimal standards set forth in guidelines provided by The
plies, instrumentation, analytical methods, the monitoring of Joint Commission (TJC) (formerly The Joint Commission
analytical methods, and the laboratory personnel’s technical on Accreditation of Health Care Organizations [JCAHO])
skills. Because each component is capable of affecting test or the CAP. Table 1.2 lists equipment often present in the
results, procedures must be developed and followed to ensure urinalysis laboratory along with the frequency and types of
consistent and acceptable quality. performance checks that should be performed. For example,
temperature-dependent devices are monitored and recorded
Equipment daily; refractometers and osmometers may be checked daily
All equipment—such as glassware, pipettes, analytical bal- or whenever in use. Centrifuges should be cleaned regularly
ances, centrifuges, refrigerators, freezers, microscopes, and (e.g., weekly, as well as after spills), and the accuracy of their
refractometers—requires routine monitoring to ensure timers and speed (revolutions per minute) should be checked
appropriate function, calibration, and adherence to pre- periodically. Automatic pipettes, analytical balances, and
scribed minimal standards. Preventive maintenance sched- fume hoods also require periodic checks, which are deter-
ules to eliminate equipment failure and downtime are also mined by the individual laboratory, and the time interval
important aspects of QA and should be included in perti- depends on usage. Microscopes require daily cleaning and
nent laboratory procedures. The use of instrument mainte- sometimes adjustments (e.g., illumination, phase ring align-
nance sheets for documentation provides a format to remind ment) to ensure optimal viewing. Microscopes and balances
staff of daily, monthly, and periodic maintenance as well as should undergo annual preventive maintenance and cleaning
to record unexpected failures and their resolution. Because by professional service engineers to avoid potential problems
the bench technologist is the first individual to be aware of and costly repairs. A current CAP inspection checklist is an
an instrument failure, troubleshooting and “out-of-control” excellent resource for developing an individualized procedure
protocols need to be included in procedures, and historic ser- for performing periodic checks and routine maintenance on
vice and repair documentation should be readily available for equipment and for providing guidelines on the documenta-
reference. tion necessary in the urinalysis laboratory.

TABLE 1.2 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 Weekly 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 (or when used) Read and record deionized water (SG 1.000) and at least
one standard of knwown 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.
 CHAPTER 1 Quality Assessment and Safety 5

Reagents test principles, reagent preparation, control materials and

Reliable analytical results obtained in the urinalysis labora- acceptance criteria, step-by-step performance, calculations,
tory require the use of quality reagents. The laboratory must reporting of results, and references. Because procedures are
have an adequate supply of distilled water, deionized water, vital to the test results obtained, they must be maintained and
or clinical laboratory reagent water (CLRW), formerly called adhered to when each test is performed. Each procedure must
Type I water. Each urinalysis procedure should specify the include documentation of any procedural changes and must
type of water required for tasks such as reagent preparation or be reviewed regularly—for example, annually. A well-written
reconstitution of lyophilized materials. The quality of CLRW procedure provides a ready and reliable reference for the vet-
requires periodic monitoring for ionic and organic impurities eran technologist, as well as an informational training tool
as well as for microbial contamination.3 In addition, because for the novice. The importance of procedures cannot be over-
CLRW absorbs carbon dioxide, thereby losing its resistivity emphasized, because uniform performance of testing meth-
on storage, it should be obtained fresh daily. CLRW quality ods ensures accurate and reproducible results, regardless of
tolerance limits and the actions to be taken when these limits changes in personnel.
are exceeded must also be available in a written policy. A routine urinalysis procedure incorporates steps to ensure
Today, manufacturers provide many “ready-to-use” consistent quality in each of its components. It details each
reagents as well as the water required to prepare lyophilized examination—physical, chemical, and microscopic—and
materials. When this is not the case, reagent-grade or analyti- includes quality control (QC) checks, acceptable terminology,
cal reagent–grade reagents should be used to prepare reagent and tolerances for each parameter. The procedure also pro-
solutions for qualitative or quantitative procedures. Primary vides steps to follow when tolerances are exceeded or results
standards for quantitative methods must be made from chem- are questionable. Additionally, criteria for the correlation of
icals of the highest grade available. These can be purchased the physical, chemical, and microscopic examinations, as well
from manufacturers or agencies such as the National Institute as follow-up actions are required if discrepancies are discov-
of Standards and Technology (NIST) (formerly the National ered. For instance, if the blood reagent strip test is negative
Bureau of Standards [NBS]) or CAP and can be accurately and the microscopic examination reveals increased red blood
weighed to produce a standard of a known concentration. cells, the specimen should be checked for ascorbic acid or the
From these primary standards, secondary standards or cali- sediment closely reviewed—the “cells” could possibly be an
bration solutions can be made. Any solvents used should RBC “look-alike,” such as monohydrate calcium oxalate crys-
be of sufficient purity to ensure appropriate reactivity and to tals or yeast. Reference materials such as textbooks, atlases,
prevent interfering side reactions. and charts must be available for convenient consultation.
A standard laboratory requirement is to check all newly pre-
pared standards and reagents before using them. This is done Standardization of Technique
by analyzing a control material using new and old standards The manual microscopic examination of urine requires stan-
or reagents. If performance of the new standard or reagent is dardization of technique and adherence to the established
equivalent to performance of the old, it is acceptable and dated procedure by all technologists to enable consistency in results
as approved for use; if it performs inadequately, it should be dis- obtained and in their reporting. Preparing urine for manual
carded and the reagent or standard remade. New lot numbers microscopy requires written step-by-step instructions that
of commercially prepared reagents (e.g., kit tests, reagent strip detail the volume of urine to use, the centrifuge speed, the
tests, tablet tests), as well as different bottles of a current lot num- time of centrifugation, the sediment concentration, and the
ber, must be checked against older, proven reagents before they volume of sediment examined, as well as the reporting format,
are placed into use. Documentation of reagent checks must be terminology, and grading criteria (Box 1.2).5 Several standard-
maintained in the urinalysis laboratory. All standards, reagents, ized microscopic slides (e.g., KOVA [Hycor Biomedical Inc.,
reagent strips, and tablets, whether made in the laboratory or Garden Grove, CA], Urisystem [Fisher Scientific, Waltham,
commercially obtained, must be dated (1) when prepared or MA]) are commercially available for manual microscopy,
received, (2) when their performance is checked and deter- and all are superior to the traditional glass slide and coverslip
mined to be acceptable, and (3) when put into use. Ensuring technique.6 See Chapter 7 for further discussion of manual
the quality of commercial reagent strips and tablet tests used in microscopy and steps that must be taken when commercial
the urinalysis laboratory is discussed further in Chapter 6. standardized slides are not used.7
In contrast, automated microscopy analyzers (see
Procedures Chapter 16) require no specimen preparation (i.e., uncentri-
Procedures for all tests and tasks performed must be avail- fuged urine is used), have good accuracy and precision, and
able in the urinalysis laboratory. An excellent resource for are quick and easy to operate, and their performance is easily
creating and standardizing these documents is provided by monitored and documented using quality control materials.
the Clinical and Laboratory Standards Institute (CLSI)—
for example, document QMS02-A6, Quality Management Qualified Personnel
System: development and management of laboratory docu- The competence of personnel is an important determinant
ments.4 Each procedure should be comprehensive and of the quality of the laboratory result.5,8 Because many of the
include details of proper specimen collection and handling, procedures performed in the urinalysis laboratory are done
6 CHAPTER 1 Quality Assessment and Safety

BOX 1.2 Guidelines for Standardizing Monitoring Analytical Components of

Microscopic Urinalysis6,7 Quality Assessment
Procedural Factors For internal QA of testing methods, QC materials are used to
1. Volume of urine examined (10, 12, 15 mL) assess and monitor analytical error, that is, the accuracy and
2. Speed of centrifugation (400 × g, 600 × g) precision of a method. QC materials serve to alert the labora-
3. Length of centrifugation (3, 5, 10 minutes)
torian of method changes that directly affect the quality of the
4. Concentration of sediment (10:1, 12:1, 15:1)
results obtained. QC materials mimic patient samples in their
5. Volume of sediment dispensed (6–15 µL)
physical and chemical characteristics, that is, they have the
Reporting Factors same matrix. They are usually obtained from commercial sup-
1. Each laboratory should publish its own normal values pliers but can also be prepared by the laboratory, particularly
(based on system used and patient population). for low-volume, esoteric tests. QC materials can be purchased
2. All personnel must use same terminology. with or without assigned expected values for each parameter.
3. All personnel must report results in standard format. Assigned values should be confirmed and adjusted when nec-
4. All abnormal results should be flagged for easy reference. essary to reflect the method and conditions of each laboratory.
Numerous urinalysis control materials are commercially
available. Some control materials monitor only the status of
the qualitative chemical examination of urine using reagent
manually, it is very important to monitor technical com- strips, whereas other control materials include microscopic
petence. Uniformity of technique by all personnel is neces- entities that can monitor the microscopic examination and
sary and can be achieved through (1) proper training, (2) the steps involved in processing urine specimens (e.g., cen-
adherence to established protocols, and (3) performance of trifugation). The microscopic elements present vary with the
QC checks. New technologists should have their technical manufacturer. Quantimetrix Corporation (Redondo Beach,
performance evaluated before they perform routine clinical CA; Dip&Spin, QuanTscopics) uses stabilized human red
tests and periodically thereafter to verify ongoing technical blood cells, white blood cells, and crystals, whereas Hycor
competence. Similarly, new procedures introduced into the Biomedical Inc. (Garden Grove, CA; KOVA-Trol) includes sta-
laboratory must be properly researched, written, and proven bilized red blood cells, organic particles (mulberry spores) to
before placed into use. simulate white blood cells, and crystals. Bio-Rad Laboratories,
Before reporting results, technologists must be able to Inc. (Hercules, CA; Liquichek Urinalysis Control, qUAntify
evaluate the results obtained, recognize discrepancies or Plus Control) includes stabilized human red blood cells,
absurdities, and seek answers or make corrections for those artificial white blood cells, and cystine crystals.
encountered. Performing and recording the results obtained, Another means of monitoring the entire urinalysis proce-
even when they differ from those expected or desired, is par- dure as well as technical competence is to select a well-mixed
amount. Because test results have a direct effect on patient urine specimen and have each technologist or one from each
diagnosis and treatment, the highest level of ethical behav- shift of workers perform the procedure. This provides an
ior is required. Documentation of errors or problems and the intralaboratory or in-house QA. Results should be recorded
actions taken to correct them is necessary to (1) ensure com- and evaluated independently. When multiple laboratory
munication with staff and supervisory personnel, (2) prevent sites within a facility perform urinalysis testing, personnel at
the problem from recurring, and (3) provide a paper trail of each site can test an aliquot of the same urine specimen and
actual circumstances and corrective actions taken as a result. compare results. If commercial control materials with sedi-
These policies should be viewed as a means of guaranteeing ment constituents are not used to evaluate the microscopic
the quality of laboratory results. examination, in-house duplicate testing can be instrumen-
Accurate results depend not only on the knowledge and tal in detecting subtle changes in the processing procedure,
technical competence of the technologist but also on the such as alterations in centrifugation speed or time. The time
technologist’s integrity in reporting what actually is obtained. and effort involved in intralaboratory testing are worthwhile
Circumstances can arise in laboratory testing that appear to because it ensures that each laboratory and all staff are consis-
contradict expected test results. When these circumstances tently obtaining equivalent results.
are appropriately investigated, legitimate explanations that Results obtained on control materials, as well as from
expand the technologist’s scope of experience can be obtained. duplicate specimen testing, are recorded daily in a tabular or
For example, a patient’s test results can differ greatly from graphic format. The tolerance limits for these results must be
those obtained previously. Investigation may reveal that a defined, documented, and readily available in the laboratory.
specimen mix-up occurred or that a drug the patient recently When these tolerances are exceeded, corrective action must
received is now interfering with testing. This highlights the be taken and documented.
need for good communication among all staff and supervi- Whether the urinalysis laboratory performs quantitative
sory personnel, as well as the need for staff meetings to ensure urine procedures (e.g., total protein, creatinine) depends
the dissemination of information. on the facility. In some settings, the urinalysis laboratory
 CHAPTER 1 Quality Assessment and Safety 7

performs only the manual quantitative procedures, whereas component identified by one randomly selected technologist
the chemistry section performs those procedures that are in the laboratory. As with patient samples, the technologist
automated. Regardless, a brief discussion of the QC mate- can seek assistance from a lead tech, supervisor, or patholo-
rials used for quantitative urine methods is provided. The gist, provided that is the laboratory’s standard protocol.9 After
value assigned to commercial or homemade QC materials is submission and receipt of the PT results, group review of the
determined in the laboratory by performing repeated anal- sediment images provides an excellent opportunity to main-
yses over different days. This enables variables such as per- tain and improve the competence of personnel.
sonnel, reagents, and supplies to be represented in the data Although QC materials and PT samples help to detect
generated. After analyses are complete, QC data are tabulated decreased quality in laboratory testing, they do not pin-
and control limits determined by using the mean and stan- point the source of the problem, nor do they solve it. Only
dard deviation (SD). Initial control (or tolerance) limits can with good communication and documentation can analyti-
be established using a minimum of 20 determinations; as cal problems be pursued and continuing education programs
more data are accumulated, the limits can be revised. Because developed. Some problems encountered in the laboratory
the error distribution is Gaussian, control limits are chosen are approached best by the involvement of laboratorians as
such that 95% to 99% of control values will be within toler- a problem-solving team, which can reaffirm their self-worth
ance. This corresponds to the mean value ±2 SD or ±3 SD, and enhance their commitment to quality goals.
respectively. Graphs of the QC values obtained over time are
plotted and are known as QC or Levey-Jennings control charts. Postanalytical Components of Quality Assessment
They provide an easy, visual means of identifying changes in Urinalysis results can be communicated efficiently and effec-
accuracy and precision. Changes in accuracy are evidenced tively using a standardized reporting format and terminology.
by a shift in the mean, whereas changes in precision (random The report should include reference ranges and the ability to
error) are manifested by an increase in scatter or a widening add informative statements if warranted—for example, “glu-
of the distribution of values about the mean (SD). cose oxidase/reducing substances questionable due to presence
External quality assessment measures (e.g., proficiency of ascorbic acid” or “white blood cell clumps present.” Results
surveys) monitor and evaluate a laboratory’s performance should be quantitative (e.g., 100 mg/dL or 10–25 RBCs/HPF
compared with other facilities. These QA measures may take [red blood cells per high-power field]) whenever possible. All
the form of proficiency testing or participation in programs personnel should use the same (i.e., standardized) terminology
in which each laboratory uses the same lot of QC materials. for test parameters (e.g., color and clarity terms).
The latter is used primarily with quantitative urine meth- Laboratory procedures should describe in detail the appro-
ods. Monthly, the results obtained by each laboratory are priate reporting format and should provide criteria for the
reported to the manufacturer of the QC material. Within reporting of any critical values. Critical values are signifi-
weeks, reports summarizing the analytical methods used and cantly abnormal results that exceed the upper or lower critical
the results obtained by each laboratory are distributed. These limit and are life threatening. These results need to be relayed
reports are useful in detecting small, continuous changes in immediately to the health-care provider for appropriate action.
systematic error in quantitative methods that may not be evi- The laboratorian is responsible for recognizing critical values
dent with internal QA procedures. and communicating them in a timely fashion. Each institution
For a laboratory to be accredited, periodic interlaboratory must establish its own list of critical values. For example, the
comparison testing in the form of a proficiency test (PT) is list might include as critical the presence of pathologic urine
required by CLIA ’88.1 A PT program involves the perfor- crystals (e.g., cystine, leucine, tyrosine); a strongly positive
mance of routine tests on survey samples provided for a fee test for glucose and ketones; and in an infant the presence of a
to participating laboratories. Each laboratory independently reducing substance, other than glucose or ascorbic acid.
performs and submits results to the survey agency (e.g., CAP, QA measures, whether internal (QC materials) or external
Centers for Disease Control and Prevention [CDC]) for (PTs), require documentation and evidence of active review.
assessment and tabulation. Before distribution of the PT sam- When acceptable tolerances are exceeded, they must be
ples, the target value of each sample is determined by testing recorded and corrective action taken. In the clinical labora-
at selected or reference laboratories. Using the reference labo- tory, documentation is crucial because an action that is not
ratory target values and results submitted by the participant documented essentially was not performed. The goal of an
laboratories, the survey agency prepares extensive reports and effective QA program is to obtain consistently accurate and
charts for each analyte assessed, the method used, and the val- reproducible results. In achieving this goal, test results will
ues obtained. A PT program provides valuable information reflect the patient’s condition, rather than results modified
on laboratory performance and testing methods—individually, due to procedural or personnel variations.
by specific method, and as a whole.
Some urinalysis PT surveys include digital images or pho-
tomicrographs for the identification of urine sediment com-
SAFETY IN THE URINALYSIS LABORATORY
ponents such as casts, epithelial cells, blood cells, and artifacts. For years, the health-care industry has been at the forefront in
These urine sediment images are reviewed and the sediment developing policies and procedures to prevent and control the
8 CHAPTER 1 Quality Assessment and Safety

spread of infection in all areas of the hospital to ensure patient this conundrum, the Healthcare Infection Control Practices
and employee safety. Because clinical laboratory employees are Advisory Committee (HICPAC) and the CDC issued in
exposed to numerous workplace hazards in various forms— 1996 a new two-tier practice guideline known as Standard
biological, chemical, electrical, radioactive, compressed Precautions and Transmission-Based Precautions.18,19
gases, fires, and so on—safety policies are an integral part of Standard Precautions are infection prevention practices
the laboratory. With passage of the Occupational Health and that are applied to all patients in all health-care settings and
Safety Act in 1970, formal regulation of safety and health for that address not only the protection of health-care personnel
all employees, regardless of employer, officially began. This but also the prevention of patient-to-patient and health-care
law is administered through the US Department of Labor worker-to-patient transmission (i.e., nosocomial transmis-
by the Occupational Safety and Health Administration sion) of infectious agents. It combines the major features of
(OSHA). As a result of the law, written manuals that define UP and BSI into a single guideline with feasible recommenda-
specific safety policies and procedures for all potential haz- tions to prevent disease transmission. Standard Precautions
ards are required in laboratories. Guidelines for developing also dictate that standards or calibrators, QC materials, and
these written policies and procedures are provided in several proficiency testing materials be handled like all other labo-
CLSI documents.10–12 An additional requirement of the law ratory specimens.10 The Transmission-Based Precautions of
is that all employees must document annual review of the the guideline apply to specific patients with known or sus-
safety manual. The next section discusses hazards frequently pected infections or colonization with infectious agents
encountered in the clinical laboratory when working with (e.g., vancomycin-resistant enterococcus [VRE]). Three
urine and other body fluids (e.g., feces, amniotic fluid, cere- categories of Transmission-Based Precautions in the hospi-
brospinal fluid), as well as policies and procedures necessary tal are described: contact precautions, droplet precautions,
to ensure a safe and healthy working environment. and airborne precautions. These additional precautions are
used when the potential for disease transmission from these
Biological Hazards patients or their body fluids is not completely interrupted by
Biological hazards abound in the clinical laboratory. Today, using Standard Precautions alone.
any patient specimen or body substance (e.g., body fluid, It is important to note that Standard Precautions do not
fresh tissue, excretions, secretions, sputum, or drainage) affect other necessary types of infection control strategies,
is considered infectious, regardless of patient diagnosis. such as identification and handling of infectious labora-
Table 1.3 provides a brief history and key points of safety tory specimens or waste during shipment; protocols for
guidelines and regulations implemented to prevent the trans- disinfection, sterilization, or decontamination; or laundry
mission of infectious agents in hospitals. In the 1980s, the procedures.10
transmission of disease such as human immunodeficiency Traditionally, the three routes of infection or disease
virus (HIV), hepatitis B virus (HBV), and hepatitis C virus transmission are (1) inhalation, (2) ingestion, and (3) direct
(HCV) became a major concern for health-care workers. To inoculation or skin contact. In the laboratory, aerosols can
address the issue, in 1987 the CDC issued practice guidelines be created and inhaled when liquids (e.g., body fluids) are
known as Universal Precautions (UP). UP were intended poured, pipetted, or spilled. Similarly, centrifugation of
to protect health-care workers, primarily from patients with samples and removal of tight-fitting caps from specimen
these bloodborne diseases. Under UP, body fluids and secre- containers are potential sources of airborne transmission.
tions that did not contain visible blood were exempt. At this Ingestion occurs when infectious agents are taken into the
same time, another system of isolation was proposed and mouth and swallowed, as from eating, drinking, or smoking
refined; this was called Body Substance Isolation (BSI).13,14 BSI in the laboratory; mouth pipetting; or hand-to-mouth con-
and UP had similar features to prevent the transmission of tact after failure to appropriately wash one’s hands. Direct
bloodborne pathogens but differed with regard to handwash- inoculation involves parenteral exposure to the infectious
ing after glove use. UP recommended handwashing after the agent as a result of a break in the technologist’s skin barrier
removal of gloves, whereas BSI indicated that handwashing or contact with the mucous membranes. This includes skin
was not required unless the hands were visibly soiled. Then punctures with needles, cuts or scratches from contaminated
in 1991, OSHA enacted the Bloodborne Pathogens Standard glassware, and splashes of specimens into the eyes, nose, and
(BPS) to address occupational exposure of health-care work- mouth. Although it is impossible to eliminate all sources of
ers to infectious agents, primarily HIV, hepatitis viruses, and infectious transmission in the laboratory, the use of protective
retroviruses. BPS requires laboratories to have an exposure barriers and the adherence to Standard Precautions minimize
control plan that regulates work practices such as handling transmission.
of needles and sharps, and requires hepatitis B vaccinations, Under Standard Precautions, all body fluids, secretions, and
training, and other measures.15–17 excretions (except sweat) are considered potentially infec-
This became a time of confusion, with hospitals differ- tious and capable of disease transmission. Key components
ing in their isolation protocols, as well as in the handling of of Standard Precautions are good hand hygiene and the use of
body fluids and other substances. It was recognized that UP barriers (physical, mechanical, or chemical) between poten-
guidelines alone were inadequate because infectious body tial sources of an infectious agent and individuals. All per-
fluids do not always have or show visible blood. To resolve sonnel must adhere to Standard Precautions; this includes
 CHAPTER 1 Quality Assessment and Safety 9

TABLE 1.3 Selected Evolution History of Isolation Precautions in Hospitals11,12

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 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)13,14 • Emphasized the avoidance of 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
199115 Bloodborne Pathogens Standard15–17; • Aimed at reducing health-care worker exposure to bloodborne
(1999,16 OSHA pathogens—HIV, hepatitis viruses, and retroviruses—when caring for
200117) 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)
1996,18 Standard Precautions and • Two-tier approach to prevent disease transmission that emphasizes
200719 Transmission-Based Precautions; prevention of nosocomial infection and worker safety
HICPAC/CDC • 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; PPE, personal protective equipment.

ancillary health-care staff such as custodial and food service Personal Protective Equipment
employees, as well as health-care volunteers. It is a respon- When contact with body fluids or other liquids is antici-
sibility of each health-care department to educate, imple- pated, appropriate personal protective equipment (PPE)
ment, document, and monitor compliance with Standard or barriers must be used. Gloves should be worn when
Precautions. In addition, written safety and infection control assisting patients in collecting specimens, when receiving
policies and procedures must be readily available for refer- and processing specimens, when performing any testing
ence in the laboratory. procedure, and when cleaning equipment or work areas.
10 CHAPTER 1 Quality Assessment and Safety

In addition, they should be worn at all times in the labo-

ratory where countertops, chairs, and other surfaces are
exposed to these specimens. If laboratory personnel are
directly involved with patients, gloves should be changed
and hands washed or sanitized after each patient contact.
In the laboratory, gloves are changed when they are visibly
soiled or physically damaged. Gloves used in the laboratory
should not be worn outside 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 laboratory
and when necessary must be impermeable to blood and other
liquid samples that could be potentially infectious. Lab coats
should be changed weekly or more often if soiled. These coats
should not be worn outside of or be removed from the labora- FIG. 1.1 The universal biohazard symbol. (From Rodak
tory area. If splashing of liquids such as urine, body fluids, or BF: Hematology: clinical principles and applications, ed 2,
chemicals is anticipated, a moisture-resistant (plastic) apron Philadelphia, 2002, Saunders).
should be worn over the lab coat.
Because processing and performing laboratory procedures
on urine and body fluids can often result in sprays, splatters,
or aerosols, laboratory employees should wear eyewear, head- adequately and enclosed within a clean biohazard bag before
gear, or masks to protect the eyes, nose, and mouth. Eyeglasses removal from the laboratory area by custodial staff.
may be sufficient for some situations in the laboratory; how- All biological specimens, except urine, must be sterilized or
ever, Plexiglas barriers, safety glasses or goggles, face shields, decontaminated before disposal. Incineration and autoclav-
hood sashes, or particulate respirators may be necessary for ing are acceptable, with the latter usually being the most cost-
protection, depending on the procedure being performed and effective. Urine, on the other hand, can be discarded directly
the substance being handled. down a sink or toilet, with caution taken to avoid splashing.
When discarding urine down a sink, personnel should rinse
Specimen Processing the sink well with water after discarding specimens and at
All specimens should be transported to the laboratory in least daily with a 0.5% bleach (sodium hypochlorite) solution.
sealed plastic bags, with the request slip placed on the outside Contaminated sharps such as needles, broken glass, or
of the bag. If the outside of the specimen container is obvi- transfer pipettes must be placed into puncture-resistant con-
ously contaminated because of leakage or improper collection tainers for disposal. These containers should not be overfilled.
technique, the exterior of the container can be cleaned using They should be sealed securely and enclosed in a clean infec-
an appropriate disinfectant before processing, or it should be tious waste disposal bag to protect custodial personnel before
rejected and a new specimen requested. When removing lids removal from the laboratory area. Because contaminated
or caps from specimens, the technologist should work behind sharps are considered infectious, they must be incinerated or
a protective shield or should cover the specimens with gauze autoclaved before disposal.
or disposable tissues to prevent sprays and splatters. During Noninfectious glass such as empty reagent bottles and
centrifugation, specimens should be capped or placed in cov- nonhazardous waste such as emptied urine containers are
ered trunnions to prevent aerosols. Centrifuges should not considered normal waste and require no special precautions
be operated with their tops open or slowed or stopped by for disposal.
hand. If a specimen needs to be aliquoted, transfer pipettes or
protective barriers should be used when pouring from the Decontamination
specimen container. Several agents are available for the daily decontamination of
laboratory surfaces and equipment. Bleach or a phenolic dis-
Disposal of Waste infectant is used most often in the clinical laboratory. A 0.5%
To protect all laboratory personnel, including custodial staff, to 0.6% active chlorine bleach solution, prepared by adding
adherence to an infectious waste disposal policy is necessary. 1 part household bleach (8.25% sodium hypochlorite) to 14
Because all biological specimens and materials exposed to parts water, is stable for 1 week. It is important to note that in
them (e.g., contaminated needles and glassware) are consid- 2014, manufacturers changed the concentration of household
ered infectious, they must be disposed of properly. Disposal bleach and that it is no longer available as 6% sodium hypo-
requires leakproof, well-constructed receptacles clearly chlorite but as 8.25%. Phenolic disinfectants, a combination
marked with the universal biohazard symbol and available of phenolic compounds and detergents, are purchased com-
in all laboratory areas (Fig. 1.1). These biohazard containers mercially; one makes appropriate dilutions according to the
should not be overfilled. In addition, they should be sealed manufacturers’ recommendations.
 CHAPTER 1 Quality Assessment and Safety 11

When spills occur, decontaminants are used to neutralize BOX 1.3 Safety Data Sheet (SDS) Content
the biological hazard and to facilitate its removal. Because Areas
decontaminants are less effective in the presence of large
amounts of protein, a body fluid spill should be absorbed first Section Content
with a solid absorbent powder (e.g., Zorbitrol) or disposable 1 Identification
towels. If an absorbent powder is used, the liquid will solidify 2 Hazard Identification
and can be scooped up and placed into an infectious waste 3 Composition/Information on Ingredients
receptacle. If disposable towels are used, allow the spill to be 4 First-Aid Measures
absorbed and pour 0.5% bleach over the towels. Carefully 5 Firefighting Measures
pick up the bleach-soaked towels and transfer them into an 6 Accidental Release Measures
infectious waste container. Decontaminate the spill area again 7 Handling and Storage
using 0.5% bleach, and clean it with a phenolic detergent if 8 Exposure Controls/Personal Protection
desired. All disposable materials used to clean the spill area 9 Physical and Chemical Properties
must be placed in infectious waste receptacles. 10 Stability and Reactivity
11 Toxicologic Information
Chemical Hazards 12 Ecologic Information (nonmandatory)
Chemicals are ubiquitous in the clinical laboratory. Many are 13 Disposal Considerations (nonmandatory)
caustic, toxic, or flammable and must be specially handled to 14 Transport Information (nonmandatory)
ensure the safety and well-being of laboratory employees. The 15 Regulatory Information (nonmandatory)
OSHA rule of January 1990 requires each facility to have a
16 Other Information
Chemical Hygiene Plan (CHP) that defines the safety poli-
cies and procedures for all hazardous chemicals used in the
laboratory. This plan includes the identification of a chemi-
cal hygiene officer; policies for handling, storage, and use of
chemicals; the use of protective barriers; criteria for monitor- laboratory appropriately relabels it. Therefore the labels on all
ing overexposure to chemicals; and provisions for medical secondary containers of hazardous chemicals and reagents
consultations or examinations. Educating personnel about must also include the five GHS elements.
chemical safety policies and procedures is mandatory and In the United States under federal Department of
requires a documented annual review. By developing and Transportation (DOT) regulation, all chemicals are also
using a comprehensive CHP, chemical hazards are minimized required to have the National Fire Protection Association
and the laboratory becomes a safe environment in which to (NFPA) 704-M Hazard Identification System descriptive
work. warning on their shipping containers. These bright, color-
The goal of the OSHA hazardous communication rule is coded labels are divided into quadrants that identify the
to ensure that all employees are aware of potential chemical health (blue), flammability (red), and reactivity (yellow) haz-
hazards in their workplace. This employee “right to know” ard for each chemical, as well as any special considerations
requires chemical manufacturers, importers, and distribu- (white) (Fig. 1.4). The NFPA system also uses numbers from 0
tors to provide safety data sheets (SDSs), formerly known to 4 to classify hazard severity, with 4 representing extremely
as material safety data sheets (MSDSs). The OSHA Hazard hazardous. Table 1.4 provides a comparison of OSHA’s HCS
Communication Standard (29 CFR 1910.1200[g]) was label and that of the NFPA.
revised in 2012, and the new SDS format is in alignment To limit employee exposure, appropriate usage and han-
with the United Nations Global Harmonization System of dling guidelines for each chemical type must be described in
Classification and Labeling of Chemicals (GHS). SDS sheets the laboratory safety manual. General rules such as prohibit-
are now provided in a user-friendly, specific 16-section for- ing pipetting by mouth or the sniffing of chemicals are man-
mat, and Box 1.3 lists the content areas. An SDS for each datory. Because the greatest hazard encountered in the clinical
hazardous chemical used in the laboratory must be readily laboratory is that caused by the splattering of acids, alkalis,
available for quick reference. To meet this requirement, each and strong oxidizers, appropriate use of PPE is required. Use
laboratory section may either retain copies of SDSs for chemi- of gloves, gowns, goggles, and a fume hood or safety cabi-
cals frequently used in its area or it may have access to them net will reduce the potential for injury. Chemical safety tips
through a laboratory information system. include (1) never grasp a reagent bottle by the neck or top,
The labeling of chemicals is fundamental to a laboratory and (2) always add acid to water; never add water to concen-
safety program and is an area of major change in the revised trated acid. Safety equipment such as an eyewash and shower
2012 OSHA standard. Chemical labels (Fig. 1.2) must now must be readily available and accessible in case of accidental
include five specific elements: (1) product identifier (name); exposure.
(2) a signal word—danger or warning; (3) a hazard statement;
(4) precautionary statements and pictograms (Fig. 1.3); and Handling Chemical Spills
(5) supplier identification. When a chemical is removed from In the event of a spill, the SDS for the chemical should be
its original container, its hazard identity can be lost unless the consulted to determine the appropriate action to take. Each
12 CHAPTER 1 Quality Assessment and Safety

FIG. 1.2 An OSHA Hazard Communication Standard label sample. (From https://www.osha.gov/
Publications/OSHA3492QuickCardLabel.pdf. Accessed October 9, 2020).

Health Hazard Flame Exclamation Mark

• Carcinogen • Flammables • Irritant (skin and eye)

• Mutagenicity • Pyrophorics • Skin sensitizer
• Reproductive toxicity • Self-heating • Acute toxicity
• Respiratory sensitizer • Emits flammable gas (harmful)
• Target organ toxicity • Self-reactives • Narcotic effects
• Aspiration toxicity • Organic peroxides • Respiratory tract
irritant
• Hazardous to ozone
layer (non-mandatory)

Gas Cylinder Corrosion Exploding Bomb

• Gases under pressure • Skin corrosion/burns • Explosives

• Eye damage • Self-reactives
• Corrosive to metals • Organic pesticides

Flame Over Circle Environment Skull and Crossbones

(Non-mandatory)

• Oxidizers • Aquatic toxicity • Acute toxicity (fatal or

toxic)

FIG. 1.3 The nine OSHA Hazard Communication Standard pictograms for use on chemical labels.
(From https://www.osha.gov/dsg/hazcom/pictograms/index.html. Accessed October 9, 2020).
 CHAPTER 1 Quality Assessment and Safety 13

must be reported to supervisory personnel and appropri-

ately documented. This permits a review of the circumstances
and facilitates changes to prevent recurrence of the incident.
Any injury or illness resulting from the spill or exposure also
requires documentation and follow-up.

Disposal of Chemical Waste

All chemicals must be disposed of properly to ensure safety
in the workplace and in the environment in general. Because
chemical disposal differs according to the chemical type, the
amount to be discarded and local laws, each laboratory must
maintain its own policies for disposal. Following perfor-
mance of laboratory procedures, chemicals often are diluted
A adequately or neutralized such that disposal in the sewer sys-
tem is satisfactory. Flushing sinks and drains with copious
amounts of water following the disposal of aqueous reagents
HAZARDOUS MATERIALS is a good laboratory practice. Appropriate steps to be followed
must be available in a general laboratory policy or in the labo-
CLASSIFICATION ratory procedure that uses the chemical.
HEALTH HAZARD FIRE HAZARD
4 - Deadly Flash Points
4 - Below 73˚ F
Other Hazards
3 - Extreme
danger
2 - Hazardous
3 - Below 100˚ F
2 - Below 200˚ F
Organic solvents used in the clinical laboratory represent
1 - Slightly 1 - Above 200˚ F
0 - Will not burn
health and fire hazards. As a result, these flammable sub-
hazardous
0 - Normal stances require special considerations regarding storage,
material
use, and disposal. Appropriately vented storage cabinets are
necessary to store solvents; the availability of these cabinets
dictates the volume of flammables allowed to be stored on
the premises. Because of potentially toxic vapors, adequate
ventilation during solvent use, such as in a fume hood, is
REACTIVITY
SPECIFIC
4 - May detonate
mandatory. Although small quantities of water-miscible
HAZARD
Oxidizer OX
3 - Shock and heat
may detonate
solvents may be disposed of in the sewer system with copi-
Acid
Alkali
ACID
ALK
2 - Violent chemical ous amounts of water, disposal of flammable solvents in this
change
Corrosive
Use NO WATER
COR
W
1 - Unstable if fashion is dangerous. All solvent waste should be recovered
heated
Radiation Hazard 0 - Stable following procedures in glass or other appropriate con-
tainers. Because not all solvents can be mixed together, a
Lab Safety Supply Inc Reorder No. 3650

B
written laboratory protocol listing acceptable solvent com-
FIG. 1.4 (A) A label used by the Department of Transportation
binations is necessary. After collection, each solvent waste
to indicate hazardous chemicals. (B) The label identification
system developed by the National Fire Protection Association. container must be marked clearly with the solvent type and
(Courtesy Lab Safety Supply Inc., Janesville, WI). the relative amount present and must be properly stored
until disposal.
Other potential fire hazards in the laboratory include elec-
trical hazards and hazards from flammable compressed gases.
Laboratory personnel should report any discovered deterio-
laboratory should have available a chemical spill kit that ration in equipment (e.g., electrical shorts) or its connections
includes absorbent, appropriate protective barriers (e.g., (e.g., a frayed cord). If a liquid spill occurs on electrical equip-
gloves, goggles), cleanup pans, absorbent towels or pil- ment or its connections, appropriate action must be taken to
lows, and disposal bags. Frequently, liquids are contained dry the equipment thoroughly before placing it back into use.
by absorption using a spill compound (absorbent) such as Compressed gases must be secured at all times, regardless of
ground clay or a sodium bicarbonate and sand mixture. The their contents or the amount of gas in the tank. Their valve
latter is generally appropriate for acid, alkali, or solvent spills. caps should be in place except when in use. A procedure for
Following absorption, the absorbent is swept up and placed appropriate transport, handling, and storage of compressed
into a bag or a sealed container for appropriate chemical gases is necessary to ensure proper usage. All laboratory per-
disposal, and the spill area is thoroughly washed. sonnel must be aware of the location of all fire extinguishers,
For emergency treatment of personnel affected by chemi- alarms, and safety equipment; must be instructed in the use
cal splashes or injuries, clear instructions should be posted of a fire extinguisher; and must be involved in laboratory fire
in the laboratory. Chemical spills of hazardous substances drills, at least annually.
14 CHAPTER 1 Quality Assessment and Safety

TABLE 1.4 Comparison of the NFPA and OSHA HCS Labels20

NFPA 704 HCS 2012

Purpose Provides basic information for emergency Informs a worker about the hazards of chemicals in
personnel responding to a fire or spill and those the workplace under normal conditions of use and
planning for emergency response. foreseeable emergencies.
Number system 0–4 1–4
0—least hazardous 1—most severe hazard
4—most hazardous 4—least severe hazard
• Numbers are used to classify hazards and determine
information required on label
• Hazard category numbers are not required on labels
but are required on safety data sheets
Information • Health—Blue • Product identifier
provided on • Flammability—Red • Signal word
label • Instability—Yellow • Hazard statement(s)
• Special Hazards—White • Pictogram(s)
OX—Oxidizers • Precautionary statement(s)
W—Water reactives • Name, address, and phone number of supplier (i.e.,
responsible party)
SA—Simple Asphyxiants
Health hazards Acute (short-term) health hazards only. Acute (short-term) and chronic (long-term) health
on label Chronic (long-term) health effects are not covered. hazards.
• These hazards are relevant for employees working
with chemicals day after day.
• Includes acute hazards such as eye irritants, simple
asphyxiants, and skin corrosives, as well as chronic
hazards such as carcinogens.
Flammability/ Divides flammability (red section) and instability A broad range of physical hazard classes are listed on
physical (yellow section) hazards into two separate the label including explosives, flammables, oxidizers,
hazards on numbers on label. reactives, pyrophorics, combustible dusts, and
label corrosives.
Website www.nfpa.org/704 www.osha.gov/dsg/hazcom/index.html

REFERENCES 4. Clinical and Laboratory Standards Institute (CLSI): Quality

1. US Department of Health and Human Services: Medicare, management system: development and management of
Medicaid, and CLIA programs: regulations implementing laboratory documents: approved guideline, 6th ed., CLSI Docu-
the Clinical Laboratory Improvement Amendments of 1988 ment QMS02-A6, CLSI, Wayne, PA, 2013 CLSI
(CLIA). Final rule, Federal Register 57 FR 7002 (February 18, Document QMS02-A6.
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as 42 CFR part 493. 2000;60:1–96.
2. Fraser CG, Petersen PH. The importance of imprecision. Ann 6. Schumann GB, Tebbs RD. Comparison of slides used for
Clin Biochem. 1991;28:207. standardized routine microscopic urinalysis. J Med Technol.
3. Clinical and Laboratory Standards Institute (CLSI): Prepara- 1986;3:54–58.
tion and testing of reagent water in the clinical laboratory: 7. Clinical and Laboratory Standards Institute (CLSI): Urinaly-
approved guideline, 4th ed., CLSI Document GP40-A4-AMD, sis: approved guideline, 3rd ed., Document GP16-A3, CLSI,
CLSI, Wayne, PA, 2006 CLSI Document GP40-A4-AMD. Wayne, PA, 2009 Document GP16-A3.
 CHAPTER 1 Quality Assessment and Safety 15

8. Clinical and Laboratory Standards Institute (CLSI): Training bloodborne pathogens, CPL 2-2.44D, US Department of Labor,
and competence assessment: approved guideline, 3rd ed., November 5, 1999 CPL 2-2.44D.
CLSI Document QMS03-A3, CLSI, Wayne, PA, 2009 CLSI 17. Occupational Safety and Health Administration: Directives:
Document QMS03-A3. enforcement procedures for the occupational exposure to
9. College of American Pathologists: Clinical Microscopy Survey bloodborne pathogens, CPL 2-2.69D, US Department of Labor,
Kit Instructions, CMP 2016. Northfield, IL: College of November 27, 2001 CPL 2-2.69D.
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approved guideline, 4th ed., CLSI Document M29-A4, CLSI, for isolation precautions: preventing transmission of infectious
Wayne, PA, 2014 CLSI Document M29-A4. agents in healthcare settings (website): www.cdc.gov/hicpac/20
11. Clinical and Laboratory Standards Institute (CLSI): Clinical 07IP/2007isolationPrecautions.html. Accessed July 7, 2011.
laboratory safety: approved guideline, 3rd ed., CLSI Document 20. Occupational Safety and Health Administration: NFPA OSHA
GP17-A3, CLSI, Wayne, PA, 2012 CLSI Document GP17-A3. label comparison quick card (website): https://www.osha.gov/
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laboratory waste management: approved guideline, 3rd ed.,
CLSI Document GP05-A3, CLSI, Wayne, PA, 2011 CLSI
Document GP05-A3. BIBLIOGRAPHY
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enforcement procedures for the occupational exposure to

S T U DY Q U E S T I O N S
1. The ultimate goal of a quality assessment (QA) program 5. The purpose of quality control materials is to
is to A. monitor instrumentation to eliminate downtime.
A. maximize the productivity of the laboratory. B. ensure the quality of test results obtained.
B. ensure that patient test results are precise. C. assess the accuracy and precision of a method.
C. ensure appropriate diagnosis and treatment of D. monitor the technical competence of laboratory staff.
patients. 6. Why are written procedures necessary?
D. ensure the validity of laboratory results obtained. A. To assist in the ordering of reagents and supplies for a
2. Which of the following is a preanalytical component of a procedure
QA program? B. To appropriately monitor the accuracy and precision of
A. Quality control a procedure
B. Turnaround time C. To ensure that all individuals perform the same task
C. Technical competence consistently
D. Preventive maintenance D. To ensure that the appropriate test has been ordered
3. Which of the following is a postanalytical component of a 7. Which of the following is not considered to be an analyti-
QA program? cal component of QA?
A. Critical values A. Reagents (e.g., water)
B. Procedures B. Glassware (e.g., pipettes)
C. Preventive maintenance C. Instrumentation (e.g., microscope)
D. Test utilization D. Specimen preservation (e.g., refrigeration)
4. Analytical components of a QA program are procedures 8. Which of the following sources should include a protocol
and policies that affect the for the way to proceed when quality control results exceed
A. technical testing of the specimen. acceptable tolerance limits?
B. collection and processing of the specimen. A. A reference book
C. reporting and interpretation of results. B. A procedure
D. diagnosis and treatment of the patient. C. A preventive maintenance manual
D. A specimen-processing protocol
16 CHAPTER 1 Quality Assessment and Safety

9. Technical competence is displayed when a laboratory 15. Match the mode of transmission with the laboratory
practitioner activity.
A. documents reports in a legible manner. Mode of
B. recognizes discrepant test results. Laboratory Activity Transmission
C. independently reduces the time needed to perform a
__ A. Not wearing gloves when 1. Inhalation
procedure (e.g., by decreasing incubation times). handling specimens 2. Ingestion
D. is punctual and timely.
__ B. Centrifuging uncovered 3. Direct contact
10. Quality control materials should have specimens
A. a short expiration date. __ C. Smoking in the laboratory
B. a matrix similar to patient samples. __ D. Being scratched by a
C. their values assigned by an external and unbiased broken beaker
commercial manufacturer. __ E. Having a specimen
D. the ability to test preanalytical variables. splashed into the eyes
11. Within one facility, what is the purpose of performing __ F. Pipetting by mouth
duplicate testing of a specimen by two different
laboratories (i.e., in-house duplicates)? 16. Which of the following is not considered personal
A. It provides little information because the results are protective equipment?
already known. Gloves
B. It saves money by avoiding the need for internal A. Lab coat
quality control materials. B. Disinfectants
C. It provides a means of evaluating the precision of a C. Goggles
method. 17. Which of the following actions represents a good
D. It can detect procedural and technical differences laboratory practice?
among laboratories. A. Washing or sanitizing hands frequently
12. Interlaboratory comparison testing as with proficiency B. Wearing lab coats outside the laboratory
surveys provides a means to C. Removing lab coats from the laboratory for launder-
A. identify critical values for timely reporting to clini- ing at home in 2% bleach
cians. D. Wearing the same gloves to perform venipuncture on
B. ensure that appropriate documentation is being two different patients because the patients are in the
performed. same room
C. evaluate the technical performance of individual 18. Which of the following is not an acceptable disposal practice?
laboratory practitioners. A. Discarding urine into a sink
D. evaluate the performance of a laboratory compared B. Disposing of used, empty urine containers with non-
with that of other laboratories. hazardous waste
13. The primary purpose of a Standard Precautions policy C. Discarding a used, broken specimen transfer pipette
in the laboratory is to with noninfectious glass waste
A. ensure a safe and healthy working environment. D. Discarding blood specimens into a biohazard container
B. identify processes (e.g., autoclaving) to be used to 19. Which of the following is not part of a Chemical
neutralize infectious agents. Hygiene Plan?
C. prevent the exposure and transmission of potentially A. To identify and label hazardous chemicals
infectious agents to others. B. To educate employees about the chemicals they use
D. identify patients with hepatitis B virus, human (e.g., providing material safety data sheets)
immunodeficiency virus, and other infectious C. To provide guidelines for the handling and use of
diseases. each chemical type
14. Which agency is responsible for defining, establishing, D. To monitor the handling of biological hazards
and monitoring safety and health hazards in the 20. Which of the following information is not found on a
workplace? safety data sheet (SDS)?
A. Occupational Safety and Health Administration A. Exposure limits
B. Centers for Disease Control and Prevention B. Catalog number
C. Chemical Hygiene Agency C. Hazardous ingredients
D. National Fire Protection Association D. Flammability of the chemical
 CHAPTER 1 Quality Assessment and Safety 17

CASE 1.1
Both a large hospital and its outpatient clinic have a laboratory 1. Which of the following conditions present in the hospital
area for the performance of routine urinalyses. Each labora- laboratory could cause the observed findings in this case?
tory performs daily QA checks on reagents, equipment, and 1. The urinalysis centrifuge had its brake left on.
procedures. Because the control material used does not have 2. The urinalysis centrifuge was set for the wrong speed or
sediment components, each laboratory sends a completed uri- time setting.
nalysis specimen to the other laboratory for testing. After the 3. Microscopic examination was performed on an unmixed
urinalysis has been performed, results are recorded, compared, or inadequately mixed specimen.
and evaluated. The criterion for acceptability is that all param- 4. Microscopic examination was performed using nonop-
eters must agree within one grade. timized microscope settings for urine sediment viewing
(e.g., contrast was not sufficient to view low-refractile
Results components).
One day, all results were acceptable except those of the micro- A. 1, 2, and 3 are correct.
scopic 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 hap-
Casts/lpf: 0–2 hyaline Casts/lpf: 5–10 hyaline pening 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 C. A control material with sediment components should be
remedied immediately. used 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.