3
Cytologic Screening Programs
be an additional tool in the strategies for reducing morbidity
and mortality from cervical cancer but will not replace screen-
ing and early treatment, and will be a component of a compre-
hensive strategy with the long-term goal of eliminating cervical
cancer.44
Screening Programs and HPV DNA Test
Cervical-vaginal cytology continues to be the method of choice
for mass prevention of cervical cancer. However, there are
discussions regarding its limitations with regard to sensitivity,
specificity, and ability to reproduce.49
One of the first applications of the HPV test in clinical practice
has been in women referred for a colposcopy after an abnormal
pap smear.50 The combination of methods has been proposed
in an attempt to improve the sensibility of the Pap test. Among
these the association of cytology with the molecular test for
HPV using hybrid capture (HC) has been highlighted. This tech-
nology presents high sensitivity for high-degree intraepithelial
lesions and age-dependent specificity. In young women the
specificity of HC-2 is lower than cytology and in women over
35 the specificity is equal to cytology. Studies show that the
woman with negative HC-2 for HPV with normal cytology is at
low risk for developing cervical cancer in the next 10 years.50
Other studies have shown an improvement in sensitivity in
cervical intraepithelial neoplasia (CIN) 3 cases.
The FDA approved HC-2 for HPV DNA as an assistant
method for cytology in women over the age of 30.24 Apart from
the improvement in sensitivity in the detection of lesions the
use of HC will bring about a larger spacing of time between
screenings and virtual reduction in the number of consultations
in a screening program.
However, some studies have shown evidence that the HPV
test could be potentially superior in screening when compared
with cytology.51,52
The Role of Laboratory in Screening Programs
The laboratory can make an important contribution to the struc-
turing and organization of cervical screening programs based on
the Papanicolaou test. It should be included in the global plan-
ning, with a logical structure of hierarchy, regionalization, and
above all integration with the healthcare system.
Data collected through the laboratory, apart from produc-
ing epidemiological and administrative information on the
results of the tests, permit the creation of indicators to help in
monitoring and evaluating, not just the quality of the laboratory
activities, but also the quality of programming, thus helping to
generate pertinent and useful investigations which contribute
toward the improvement of effectiveness and efficiency of the
program.53 Using laboratory data it is possible to achieve some
of the required guarantees in cervical screening programs, such
as to confirm that women in the target population are being
screened and are receiving appropriate management, and to
confirm the target geographic group coverage (Table 3.1).29
Monitoring of the different steps in the program can pro-
vide valuable information for the identification of problems
and planning of respective measures for improvement. Care
in the setting of parameters and indicators is fundamental in
the monitoring of each stage of the program, in order to take
into account local differences. The indicators can provide useful
data both for the laboratory and for the local and/or regional
manager in programming suitable action.
The lab, when integrated into a screening program, should
have among its objectives top quality production, training, and
updating of personnel and the guarantee of a secure place of
work, where risk factors are under control and the environment
is protected.53
In the area of laboratory governance, it is possible to contrib-
ute toward an atmosphere of monitoring and evaluation, which
helps in decision-making and guarantees attention to quality.
Table 3.1
Confirming that women in target demographic groups are screened
Datum
source of datum
Purpose of datum collection
Quality target
Correlate datum with
Patient age
Cytology requisition
Confirm target age-group coverage
100% of target age group
Denominator data
(usually estimated)
Patient permanent
address
Cytology requisition
Confirm target geographic group
coverage
100% of target
geographic district
Denominator data
(usually estimated)
Patient current address
and/or phone number
Cytology requisition
Recontact and recall women with
atypical Pap smear results
100% recontact and recall
of women with HGSIL
Denominator data
(usually estimated)
Date of smear collection
Cytology requisition
Measure turnaround time of
screening test
Locality-specific
benchmarks
Date of cytology report
ID of smear collector
Cytology requisition
Improved sensitivity of screening
test
0% unsatisfactory rate
Pap smear adequacy
ID of cytotech
Cytology report
Estimate sensitivity of screening test
Locality-specific
benchmarks
Pap smear rates of call
ID of pathologist
Cytology report
Estimate sensitivity of screening test
Locality-specific
benchmarks
Pap smear rates of call
Specimen adequacy
Cytology report
Improve sensitivity of screening test
0% unsatisfactory rate
ID of smear collector
Pap smear result
Cytology report
Multiple
Multiple
Multiple
D a ta c o lle c t e d b y c y t o lo g y la b o r a t o r ie s f r o m e a c h s c r e e n in g e v e n t.
R e p r o d u c e d w it h p e r m is s io n o f E ric J. S u b a . C r o s s in g t h e q u a lit y c h a s m : a r e q u ir e m e n t f o r s u c c e s s fu l c e r v ic a l c a n c e r p r e v e n t io n in d e v e lo p in g c o u n tr ie s .
Clin Lab Med
2 0 0 4 ;2 4 :9 4 8 .29
53
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