PART ONE
General Cytology
practice. Issues and problems identified through the quality
management process need to be addressed and resolved. Gath-
ering of laboratory statistics is best accomplished by collection
of monthly reports during quality assurance meetings presided
over by the director.
Cytotechnologists
Cytotechnologists should meet one of the following require-
ments:
(1) Be certified as a cytotechnologist by either the
American Society of Clinical Pathologists or the
US Department of Health, Education and Welfare;
or
(2) Previously have been admitted to the practice of
cytotechnology by existing regulations under a
grandfather clause.
Physical Laboratory Facilities
The laboratory should be clean, well lighted, adequately ven-
tilated, and functionally arranged so as to minimize problems
in specimen handling, evaluation, and reporting. The area for
specimen preparation and handling should be separate from
the area where specimens are evaluated and reported. Formal-
dehyde and xylene (if in use) should be carefully monitored due
to the possible presence of hazardous vapor concentrations.
Safety Precautions
Laboratory personnel must be protected against hazards (chem-
ical, electric, fire, infections, or others) by using well-ventilated
hoods and biologic safety hoods for handling potentially infec-
tious material. Fire precautions should be posted and tested.
Each employee should participate in fire drills and should know
the location of the fire extinguisher, blankets, emergency fire
alarm, and exits. Safety shower, eye wash stations, and proce-
dures to follow in case of chemical spills or splash to the body
should be posted and readily visible in the laboratory.
Equipment
An adequate number of binocular microscopes of good quality
and proper working order must be available. Laboratory instru-
ments and equipment should be under periodic maintenance to
monitor and ensure malfunctions do not adversely affect ana-
lytical results. A sample of slides from slide preparation instru-
ments including liquid-based technology and cytocentrifuge or
filtration methods should be routinely reviewed microscopically
for technical acceptability.
Specimen Collection
Cytologic specimens should be accepted and examined only if
requested by a licensed medical practitioner and collected in
accordance with instructions regarding recommended collec-
tion techniques. The cytopathology laboratory should inform
the originator of the sample if the specimens are "unsatisfac-
tory" and detail adequacy qualifiers such as presence or absence
of a transformation zone component or obscuring factors in
"satisfactory samples."29,53-56
Preparation, Fixation, and Staining Procedures
The specimens must be identified with the patient's name and/
or a unique identifier and must be accompanied by a requisi-
tion form with the requesting physician's name, address, date
of specimen collection, specimen source, and appropriate clini-
cal information about the patient. When the specimen arrives
in the laboratory the laboratory staff affix an accession number
or bar code label on each slide for further identification. The
laboratory should have written criteria for rejecting specimens.
Fixation while the specimen is still wet is recommended for
conventional cell samples and rinsing of spatula and brush
in preservative solution (kit provided by manufacturers) for
liquid-based specimens. The Papanicolaou staining procedure
is strongly suggested for most cytologic samples, unless addi-
tional staining procedures are warranted. Staining solutions
and chemicals used in the cytopathology laboratory should be
labeled with the time of preparation, purchase, or both. Stain-
ing solutions should be filtered regularly to avoid contamina-
tion and should be covered when not in use. Effective measures
to prevent cross-contamination between gynecologic and non-
gynecologic specimens during the staining process must be used.
Separate runs followed by filtration or changing of solutions or
a separate staining setup is recommended.
Slide Evaluation Workload
Regulations as to the number of specimens a cytotechnologist
may evaluate in a 24-hour period are currently set at 100 slides
per an 8-hour day. This regulation may not do justice to the vari-
ous conditions that influence the quality of the slide evaluation
performance. The percentage of atypical cases evaluated versus
the percentage of negative cases in varying populations as well
as screening of nongynecologic specimens should be consid-
ered when workloads are established. This regulation ensures
that the number and type of cytologic samples evaluated do
not, through fatigue, adversely affect the cytotechnologist's per-
formance. Some slides are easier and less fatiguing to evaluate
and some cytotechnologists are more experienced than others.
Other activities in which the cytotechnologist participates, such
as participation on the fine needle aspiration service and quality
control activities, should appropriately reduce their workload in
the evaluation of cell samples. The interpretation of the cyto-
technologist should become a permanent record and available
for future review.
Cytologic Terminology
The vaginal/ectocervical/endocervical cytology sample should
be interpreted preferably by using the Bethesda System.56 The
nongynecologic material should be interpreted in medical
terms, i.e., conform and correspond to diagnostic reporting
systems in histopathology.
Laboratory Records, Logs, and Files
Each specimen should be recorded and a sequential accession
number assigned together with the name of the patient and
the originator of the sample. Test records must be retained for
at least 2 years. The negative gynecologic cell samples should
be retained on file for a minimum of 5 years and negative fine
needle aspirates for 10 years or indefinitely if they exhibit
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