Keywords
quality control - cytodiagnosis - uterine cervical neoplasms - mass screening
Palavras-chave
controle de qualidade - citodiagnóstico - neoplasias do colo do útero - triagem em
massa
Introduction
With ∼ 530,000 new cases per year worldwide, cervical cancer is the fourth most common
form of cancer among women, accounting for the deaths of 266,000 women per year.[1] In Brazil, it is the third most frequent type of cancer, with an adjusted mortality
rate for the world population of 4.98 per 100 thousand women in 2015.[2] A total of 16,370 new cases are estimated for the 2018/2019 period, 490 in the Rio
de Janeiro city.[3]
It is possible to reduce the incidence and mortality due to cervical cancer with early
detection through screening, diagnostic confirmation and treatment of precursor lesions
in a timely manner. The strategy used in Brazil for its screening is cytopathologic
examination of the uterine cervix in women aged 25 to 64 years, with intervals of
3 years, after 2 negative annual tests.
The specific clinical course to be adopted based on the results of these tests is
based on the Brazilian Nomenclature for Cervical Cytopathological Reports[4] and must follow the recommendations of the Brazilian Guidelines for the Screening
of Cervical Cancer, reviewed in 2016.[5]
With the development of the Cervical Cancer Control Information System (SISCOLO, in
the Portuguese acronym) in 1999, in a partnership between the National Cancer Institute
José Alencar Gomes da Silva (INCA, in the Portuguese acronym) and the Information
Technology Department of the Unified National Health System (DATASUS, in the Portuguese
acronym), it became possible to manage and monitor cervical cancer control actions
throughout the country. The SISCOLO allows the preparation of reports, among them
the External Quality Monitoring (MEQ, in the Portuguese acronym).[6]
Through the analysis of the MEQ, it was observed that most of the Brazilian laboratories
present quality indicators of the cervical cytopathological exam outside the recommended
standards.[7]
[8] This test presents a variable sensitivity, mainly due to the subjectivity of the
analysis, which can cause intra- and interobserver errors. As a strategy to ensure
the continuous improvement of the quality of cervical cytopathology, the Ministry
of Health proposed the implementation of MEQ, which consists of a review of the cytopathological
exams by a laboratory other than the one that performed the first reading.[9]
[10]
In Brazil, the concern with the quality of these examinations was made official with
ministerial order no. 79, of July 6, 1998,[11] joint ministerial order No. 92, of 2001,[12] the National Program for the Control of Cervical and Breast Cancer, launched on
March 22, 2011[13] and the Federal decree no. 3,388 of December 30, 2013.[14]
The MEQ in Municipality of Rio de Janeiro (MRJ, in the Portuguese acronym) was implemented
in 2013 following the recommendations made by INCA. The flow was agreed between representatives
of the Primary Care Superintendency, the Cancer Technical Area Management (GCA, in
the Portuguese acronym).) and the External Quality Monitoring Unit (UMEQ, in the Portuguese
acronym), with adaptations over the years for the needs identified posteriorly.
At each cycle, between the fifth and tenth working days of the current month, the
municipal coordination sends the “External Quality Monitoring File” and the “list
of exams to be reviewed” to the UMEQ, and the “list of exams to be reviewed” to the
monitored laboratory.
The monitored laboratory delivers the slides listed to the UMEQ within 10 days (from
the receipt of the list), and the slides are packed in appropriate and labeled transport
boxes, organized in ascending numerical order and in correspondence with the copies
of the reports. The carton must be completely filled, void spaces are filled with
bubble wrap or similar so there is no loss of sequence during transport.
The UMEQ reviews the exams within 30 calendar days (preanalytical, analytical and
postanalytical phases), which can be extended to 45 days if there are more than 2,500
exams to be reviewed, considering the technical limit of 2,500/month established by
it. At the end of the review, the UMEQ returns all the slides with identification
of the discordant ones (clinically relevant) accompanied by the reports of the MEQ.
If there is interest of the monitored laboratory, because it does not comply with
the UMEQ report, a consensus meeting must be held for joint analysis of the discordant
cases, to be scheduled by the monitored laboratory, sending to the UMEQ an Excel listing
and the slides to be analyzed within 5 working days prior to the meeting.
Once the definitive reports have been released, the UMEQ prepares the final report
and generates the files “Exports and Outpatient Production Report (BPA, in the Portuguese
acronym) of the MEQ,” closing the corresponding competence, and sends them to the
Municipal Health Secretariat of Rio de Janeiro (SMS-RJ, in the Portuguese acronym).
The municipal coordination evaluates the new reports and sends them to the General
Coordinators of Primary Care of the Planning Areas (CAPs, in the Portuguese acronym),
assigning to the Primary Health Care Units (APS, in the Portuguese acronym), for active
search, a list of women with an indication to repeat cytopathological exam or colposcopy,
according to the MEQ result. This list is accompanied by a personalized invitation
letter, prepared by the Technical Area of Cancer Management, in agreement with the
UMEQ and the monitored laboratories, clarifying to the women about the quality control
process and requesting their attendance at the APS to perform a new exam of control
or be scheduled to the secondary reference unit. In cases of repetition of the exam,
the GCA send to the units the definitive results to be registered, informed and delivered
after counseling with an attending professional.
Three units of secondary referral in cervical pathology in the city of Rio de Janeiro
participated in the process welcoming women with a change of diagnosis after MEQ for
diagnostic investigation, with a schedule made by the management of the cancer technical
area. Until 2016, this schedule was made by e-mail, being included in the Regulation
Center System (SISREG, in the Portuguese acronym) in 2017. Parallel to the scheduling,
the GCA sends to the secondary unit the nominal listing, results (original and MEQ)
and guidelines regarding the reception of these women.
From September 2013 to March 2017, it was possible to improve the External Quality
Monitoring, increase the number of cycles, strengthen the partnerships involved in
the process, evaluate the performance in the cervical cytopathology diagnosis of the
two main laboratories contracted that provide this service to the public primary health
care units in the city of Rio de Janeiro, discuss the difficulties in the process
and their contributions to the quality line of cervical cancer care.
The objective of this study was to present the experience of the city of Rio de Janeiro
in the performance of the MEQ from September 2013 to March 2017, and the performance
of the participating laboratories, analyzing the interobserver agreement, proportions
of unsatisfactory exams, rejected samples, false-negative and false-positive tests
over time.
Methods
A descriptive, observational, cross-sectional, retrospective study was performed using
information from the SISCOLO, municipal coordination module of Rio de Janeiro, MEQ
report of the cervical samples evaluated by the two main laboratories that provide
this service to the public primary health care network in the city of Rio de Janeiro
and the exams reviewed by the UMEQ.
The sample consisted of 16,649 records of cervical cytopathological examinations performed
by the participating laboratories, reviewed in the MEQ, from September 2013 to March
2017, including all the exams entered in SISCOLO in this period. Those inserted in
the period after March 2017 and those that were not included in this database were
excluded.
The data was collected from the synthetic reports of each MEQ using aggregate records
of the results of the monitored laboratory and review.
The cytopathological examinations of the cervix were considered as rejected when they
were outside the minimum criteria necessary for the UMEQ review; unsatisfactory when
reading was impaired by the presence of acellular or hypocellular material (< 10%
of the smear); when there was presence of blood, pyocytes, drying artifacts, external
contaminants or intense cellular superposition, not allowing a diagnostic conclusion
normal;[9]
[10]
[11]
[12]
[13]
[14]
[15] when results were within the limit of normality; when there was inflammation, benign
cellular alterations and when they were positive according to the Brazilian Nomenclature
for Cytopathological Reports.[9]
Discordant exams, with a change of diagnostic category implying a change in clinical
behavior after the execution of the MEQ, were classified as: false negatives, those
whose monitored laboratory classified as normal or benign alteration, and after the
review, the result was atypical squamous cells of unknown significance (ASC-US), low-grade
squamous intraepithelial lesion (LSIL), atypical squamous cells, cannot rule out high-grade
squamous intra-epithelial lesion (ASC-H), more severe or unsatisfactory results and
false-positive results when the monitored laboratory defined the outcome as ASC-US,
LSIL, ASC-H or more severe outcomes and, after review, the report was unsatisfactory,
normal, or benign. Cases with change in diagnosis without causing change in clinical
behavior were also considered discordant.
For the analysis of agreement among the observers, based on each MEQ performed, the
Kappa (K) index was used. The statistical method Kappa is divided into six categories,
according to [Table 1].
Table 1
Kappa (K) interpretation
|
Kappa interpretation
|
|
K = 1
|
Perfect agreement
|
|
0.80 < K < 1
|
Excellent agreement
|
|
0.60 < K < 0.80
|
Good agreement
|
|
0,40 < K < 0.60
|
Moderate agreement
|
|
0 < K < 0.40
|
Poor agreement
|
|
K = 0
|
No agreement
|
Source: Landis and Koch (1977).[16]
The proportions of false positives, false negatives, unsatisfactory samples and rejected
samples were estimated, as well as the reduction of disagreements for each laboratory.
After the collection and analysis of the records of the SISCOLO Synthetic Quality
External Monitoring Reports, the information was tabulated in a Microsoft Excel (Microsoft
Corp., Redmond, WA, USA) spreadsheet.
All information extracted from the system was analyzed and considered in secrecy,
maintaining their anonymity, in order not to entail risks and damages to the participants.
The project was approved by the Research Ethics Committee of the Municipal Health
Secretariat of Rio de Janeiro on 08/29/2017-CAAE 70812117.6.0000.5279.
Results
Between September 2013 and March 2017, 12 cycles of MEQ of cervical cytopathology
were performed in the city of Rio de Janeiro, with the participation of the two main
laboratories contracted, here called “Alpha laboratory” and “Beta laboratory,” with
six cycles each.
A total of 19,158 exams were selected by SISCOLO, of which 19,130 (99.85%) were monitored,
16,649 (87.03%) were reviewed by the UMEQ, 2,481 (12.97%) were rejected and 441 (2.65%)
were considered unsatisfactory ([Table 2]).
Table 2
Records of the external reports of Quality External Monitoring (SISCOLO) with selected
results, monitored results, revised results, unsatisfactory results, rejected samples
and their percentages, by laboratory and monitoring cycle
|
Laboratory Monitoring cycle
|
SRs
n
|
MRs
n (%)
|
RRs
n (%)
|
URs
n (%)
|
RSs n (%)
|
|
BETA laboratory 092013
|
1,933
|
1,930 (99.84)
|
1,632 (84.56)
|
44 (2.70)
|
298 (15.44)
|
|
BETA laboratory 042014
|
771
|
768 (99.61)
|
738 (96.09)
|
42 (5.69)
|
30 (3.91)
|
|
BETA laboratory 122014
|
3,339
|
3,333 (99.82)
|
1,421 (42.63)
|
34 (2.39)
|
1,912 (57.37)
|
|
BETA laboratory 102015
|
2,041
|
2,041 (100.00)
|
1,996 (97.80)
|
20 (1.00)
|
45 (2.20)
|
|
BETA laboratory 012016
|
4,007
|
4,005 (99.95)
|
3,886 (97.03)
|
75(1.93)
|
119 (2.97)
|
|
BETA laboratory 032017
|
1,796
|
1,795 (99.94)
|
1,773 (98.77)
|
23 (1.30)
|
22 (1.23)
|
|
ALPHA laboratory 012015
|
433
|
433 (100.00)
|
427 (98.61)
|
9 (2.11)
|
6 (1.39)
|
|
ALPHA laboratory 042015
|
1,201
|
1,200 (99.92)
|
1,170 (97.50)
|
29 (2.48)
|
30 (2.50)
|
|
ALPHA laboratory 092015
|
1,168
|
1,168 (100.00)
|
1,154 (98.72)
|
24 (2.08)
|
15 (1.28)
|
|
ALPHA laboratory 012016
|
546
|
546 (100.00)
|
544 (99.63)
|
7 (1.29)
|
2 (0.37)
|
|
ALPHA laboratory 052016
|
1,208
|
1,197 (99.09)
|
1,195 (99.83)
|
17 (1.42)
|
2 (0.17)
|
|
ALPHA laboratory 012017
|
715
|
714 (99.86)
|
714 (100.00)
|
20 (2.80)
|
0 (0.00)
|
|
Total
|
19,158
|
19,130 (99.85)
|
16,650 (87.03)
|
344 (2.07)
|
2,481 (12.97)
|
Abbreviations: MRs, monitored results; RSs, rejected samples; RRs, revised results;
SISCOLO, Cervical Cancer Control Information System (in the Portuguese acronym); SRs,
selected results; URs, unsatisfactory results.
The concordance between observers (monitored laboratory and reviewer) was evaluated
using the statistical method Kappa (K), with a mean of 0.85 and median of 0.86 showing
excellent agreement. The “Beta laboratory” presented excellent agreement in all MEQs,
with Kappa ranging from 0.85 to 0.89. The “Alpha laboratory” presented good agreement
(Kappa from 0.76–0.78) in 2 cycles of the 2015 MEQ, becoming excellent in the last
cycle of the 2015 MEQ, 2016 and 2017, with Kappa varying from 0.81 to 0.92 ([Table 3]). Of the 16,650 examinations reviewed, there was concordance in 15,546 (93.40%),
and disagreement in 1,104 (6.63%), of which 895 (5.38%) indicated a change of conduct
([Table 3]).
Table 3
Concordance in the results of cervical cytopathological examinations and disagreement
with change of conduct by laboratory and monitoring cycle
|
Laboratory monitoring cycle
|
Concordant n (%)
|
Discordant n (%)
|
Discordant with change of conduct
n (%)
|
Total
|
Kappa
|
|
BETA laboratory 092013
|
1,551 (95.04)
|
81 (4.96)
|
74 (4.53)
|
1,632
|
0.88
|
|
BETA laboratory 042014
|
682 (92.41)
|
56 (7.59)
|
39 (5.28)
|
738
|
0.85
|
|
BETA laboratory 122014
|
1,327 (93.38)
|
94 (6.62)
|
73 (5.14)
|
1,421
|
0.84
|
|
BETA laboratory 102015
|
1,863 (93.34)
|
133 (6.66)
|
106 (5.41)
|
1,996
|
0.87
|
|
BETA laboratory 012016
|
3,666 (94.34)
|
220 (5.66)
|
180 (4.63)
|
3,886
|
0.87
|
|
BETA laboratory 032017
|
1,681 (94.81)
|
92 (5.19)
|
83 (4.68)
|
1,773
|
0.88
|
|
ALPHA laboratory 012015
|
367 (85.95)
|
60 (14.05)
|
46 (10.77)
|
427
|
0.76
|
|
ALPHA laboratory 042015
|
1,050 (89.74)
|
120 (10.26)
|
93 (7.95)
|
1,170
|
0.79
|
|
ALPHA laboratory 092015
|
1,086 (94.11)
|
68 (5.89)
|
56 (4.85)
|
1,154
|
0.88
|
|
ALPHA laboratory 012016
|
503 (92.46)
|
41 (7.54)
|
31 (5.70)
|
544
|
0.82
|
|
ALPHA laboratory 052016
|
1,083 (90.63)
|
112 (9.3)
|
89 (7.45)
|
1,195
|
0.81
|
|
ALPHA laboratory 012017
|
687 (96.22)
|
27 (3.78)
|
23 (3.22)
|
714
|
0.92
|
|
Total
|
15,546 (93.40)
|
1,104 (6.63)
|
895(5.38)
|
16,650
|
0.85
|
Of the 441 (2.65%) unsatisfactory results, the UMEQ diagnosed 11 (0.06%) atypical
epithelial changes (2.5%), 5 (0.00%) in the “Beta laboratory” and 6 (0.00%) in the
“Alpha laboratory” ([Figs. 1] and [2]).
Fig. 1 Synthetic external monitoring report produced by the cervical cancer information
system (SISCOLO). Distribution of cytopathological results diagnosed by the review
laboratory and the monitored laboratory (Beta), from September 2013 to March 2017.Abbreviations:
ASC-US, atypical squamos cells of undetermined significance not possible High grade
lesion, ASC-H: atypical squamos cells of undetermined significance cannot exclude
High grade lesion, LSIL: low grade squamous intrapithelial lesions, HSIL: High grade
squamous intrapithelial lesions, HSIL/HSIL-microinvasor: High grade squamous intrapithelial
lesions with suspeccious of microinvasion, AGC-US, atypical glandular cells of undetermined
significance; AGC-H, atypical glandular cells cannot exclude high-grade glandular
lesion; AIS, endocervical adenocarcinoma in situ; AI, adenocarcinoma invasor. *atypical
undifined cells of undeterminated significance not possible high grade lesion; **atypical
undifined cells of undeterminated significance cannot exclude high grade.
Fig. 2 Synthetic external monitoring report produced by the cervical cancer information
system (SISCOLO). Distribution of cytopathological results diagnosed by the review
laboratory and the monitored laboratory (Alpha), January 2015 to January 2017.Abbreviations:
ASC-US, atypical squamos cells of undetermined significance not possible High grade
lesion, ASC-H: atypical squamos cells of undetermined significance cannot exclude
High grade lesion, LSIL: low grade squamous intrapithelial lesions, HSIL: High grade
squamous intrapithelial lesions, HSIL/HSIL-microinvasor: High grade squamous intrapithelial
lesions with suspeccious of microinvasion, AGC-US, atypical glandular cells of undetermined
significance; AGC-H, atypical glandular cells cannot exclude high-grade glandular
lesion; AIS, endocervical adenocarcinoma in situ; AI, adenocarcinoma invasor. *atypical
undifined cells of undeterminated significance not possible high grade lesion; **atypical
undifined cells of undeterminated significance cannot exclude high grade.
The highest percentage of agreement between observers in the 2 monitored laboratories
was observed between the normal results and benign alterations—7,438 (92.54%) in the
“Beta laboratory, 3,146 (86.64%) in the” Alpha laboratory—and the highest diagnostic
disagreement occurred in the results of atypical glandular cells (AGC), 164 (61.88%)
and 21 (43.75%), respectively ([Figs. 1] and [2]).
In 4 out of 8 (50%) invasive carcinoma results, the “Beta laboratory” was in disagreement
with the UMEQ regarding the results of 2 high-grade squamous intraepithelial lesion
(HSIL) and 2 HSIL/HSIL microinvasion without change of care conduct. In the “Alpha
Laboratory” there was 100% agreement ([Figs. 1] and [2]).
From the 1,683 (14.7%) ASC-US results from the “Beta laboratory,” the UMEQ diagnosed
17 (0.14%) as HSIL, 17 (0.14%) as AGC and 4 (0.03%) as atypical undetermined cells;
in 1,196 (22.9%) ASC-US results of the “Alpha laboratory,” the UMEQ diagnosed 14 (0.02%)
as HSIL and 13 (0.02%) as AGC. In 675 (5.8%) LSIL results from the “Beta laboratory,”
the UMEQ diagnosed 52 (0.45%) as HSIL, 10 (0.08%) as ASC-H and 1 (0.00%) as HSIL/HSIL
microinvasion; and in 259 (4.97%) results of the “Alpha laboratory,” the UMEQ diagnosed
16 (0.30) as HSIL, 7 (0.01%) as ASC-H and 1 (0.00%) as AGC. In these cases, there
was delay in the care delivery according to the established recommendations ([Figs. 1] and [2]).
The 209 (1.83%) false-negative results from the Beta laboratory were distributed in
133 (1.16%) ASC-US, 45 (0.39%) LSIL, 11 (0.10%) ASC-H, 7 (0.06) HSIL, 10 (0.08%) AGC
and 3 (0.03%) invasive adenocarcinoma, and in the “Alpha laboratory, there were 78
(1.50%) false-negative results, with 36 (0.69%) cases of ASC-US, 22 (0.42%) LSIL,
12 (0.23%) ASC-H, 6 (0.12%) HSIL, 2 (0.04) AGC ([Figs. 1] and [2]).
The 162 (1.42%) false-positive results from the Beta laboratory were distributed in
123 (1.07%) ASC-US, 3 (0.03%) ASC H, 7 (0.06) LSIL, HSC and 26 (0.23%) AGC, and in
the “Alpha laboratory” were 178 (3.42%) being 159 (3.06%) ASC-US, 7 (0.13%) ASC-H,
1 (0.02%) LSIL, 6 (0.12%) HSIL and 2 (0.04%) AGC ([Figs. 1] and [2]).
There was a change in clinical behavior in 895 (5.38%) of the 1,104 (6.63%) results
with a discordant diagnosis from 2013 to 2017. In the “Beta laboratory” 555 (5.91%)
clinical conduct changes occurred in 676 (5.91%) discordant results. Of these, 178
(1.56%) were false-negative results that should have repeated cytology in 6 to 12
months; 31 (0.27) were false-negative results that should have performed colposcopy;
162 (1.42%) were false-positive results that required only the recommended screening
and 11 (0.10%) were negative reports given on unsatisfactory slides that should have
been collected again in 6 to 12 weeks. In the “Alpha laboratory,” there were 338 (6.50%)
changes in clinical behavior in the 428 (8.22%) discordant results. Of these, 58 (1.11%)
were false-negative results that should have repeated the cytology in 6 to 12 months,
20 (0.38%) were false-negative results that should have performed the colposcopy,
178 (1.42%) were false positives that only needed the recommended screening and 2
(0.10%) were negative reports given on unsatisfactory slides that should have been
collected again in 6 to 12 weeks ([Figs. 1] and [2]).
Discussion
The implementation of the MEQ of the cervical cytopathological exams in the city of
Rio de Janeiro followed the recommendations from INCA, started in 2013. The participation
of the laboratories was progressive, and the joint work was decisive to overcome the
difficulties encountered. Since then, the MEQ has been performed systematically.
The diversity of methods used for the MEQ in other countries, the peculiarity of the
model adopted in Brazil and the little literature on the subject make it difficult
to compare with the results obtained by other authors.
The UMEQ evaluation process had three phases: preanalytical, analytical and postanalytical,
which defined the examinations reviewed or rejected for nonconformities, unsatisfactory,
false negatives and false positives.[9]
A total of 19,130 cervical cytopathological exams were monitored at the 2 participating
laboratories, with rejection of 2,481exams (12.97%), which were not reviewed by the
External Quality Monitoring Unit (UMEQ) for presenting unconformities. Considering
the whole sample, this indicator was well above the acceptable level (0.1%),[9] and was strongly influenced by the performance of the “Beta laboratory,” which showed
rejection of 2,426 out of 13,872 monitored tests (17.49%), and mainly in the third
cycle, in which 1,912 out of 3,333 examinations were rejected (57.37%). Educational
interventions were performed, which resulted in a drop in the rejection percentage
of this laboratory to 1.23% in the last cycle studied. This fact reinforces the importance
of the actions of permanent education, quality assurance of the cervix cytopathological
exam. The “Alpha laboratory” presented rejection of 55 out of 5,258 tests (1.05%),
not impacting the result of this indicator.
Of the 16,650 cervix cytopathological exams reviewed by the UMEQ in the period, 441
(2.65%) were considered unsatisfactory, of which 239/ out of 11,446 (2,08%) came from
the “Beta laboratory,” and 179 out of 5,203 (3.43%) came from the “Alpha laboratory.”
This indicator remained within the acceptable limit (5%), with the exception of only
the third cycle of the “Beta laboratory” (5.69%). In this regard, the results found
in the present study were better than the results described in studies performed in
Mato Grosso do Sul (11.4%), Goiânia (21.0%), and São Paulo (3.8%) and were surpassed
only by studies performed in Paraná (1.8%).[17]
[18]
[19]
[20] This data may reflect the good technical quality of the team performing the cervix
cytopathological exams in the Municipal Units of Primary Health Care, the continuing
education and effectiveness of the External, Internal Quality Monitoring program in
improving the quality of these exams.
The performance of each participating laboratory was assessed based on the agreement
between observers (Kappa index) and the discordant test percentage estimated in the
MEQ cycles. It was observed that the concordance between observers (monitored laboratory/UMEQ)
of the “Beta laboratory” remained excellent in all cycles of the studied period. In
the “Alpha laboratory” the agreement was good in the first two cycles of MEQ, becoming
excellent in the following cycles. A progressive and significant improvement in agreement
between the “Alpha laboratory” and UMEQ was observed over time.
In this study, the reviewers were aware of the initial report, which may have influenced
the analyses.[8]
[21] The report was made from the records of the External Synthetic Monitoring Report
presenting the results of 16 categories of cytopathological diagnosis of the cervix.[9]
The median K index of the MEQ cycles in the city of Rio de Janeiro in this study was
0.86, coming close to the K indexes of the states of Paraná (0,88)[20] São Paulo (0.80),[19] corroborating the quality warranty of the reliability of cervix cytopathological
exams performed by the laboratories evaluated.[19]
[20]
The percentage of diagnostic disagreement in the reviewed examinations was 6.63, of
which 5.38% required a change of conduct. Despite the low percentages,[20] educational interventions are necessary because of their clinical impact. They were
found predominantly in the results of squamous and glandular atypia of undetermined
significance, in which the interobserver variability is greater, there is greater
difficulty in defining the diagnosis, increasing the chance of false-negative and
false-positive results. In the case of glandular atypia, the clinical implications
are very relevant, as it requires a specific clinical management and it is related
to more serious diseases.[21]
The delay in the care delivery according to the defined recommendations was observed
in a small percentage in both laboratories 0.15%.
The false-negative results of both laboratories predominated in the ASC-US category
with low percentages,[18]
[19] especially in cases of greater clinical relevance (postconsensus diagnosis of HSIL
or more severe lesion), tending to decrease with cycles. These results have a great
impact on screening programs, which may result in loss of follow-up, delaying the
early diagnosis of precursor lesions of cervical cancer.[10]
The false-positive results presented their highest percentages in the ASC-US category,
and although they were low,[20] the “Beta laboratory” showed a tendency towards an increase in the incidence of
false positives, while the “Alpha laboratory” showed a significant reduction. This
reduction is important and necessary to avoid unnecessary diagnostic investigation,
causing physical and emotional harm to women, undue occupation of places in specialized
procedures, overloading and honoring health services.[22]
Diagnostic discordance leads to changes in clinical behavior that directly impact
on quality of care and screening programs.
The results of false diagnoses are due to inadequate collection, technical failures
in fixation, staining of the samples and errors in reading and interpretation of cytomorphological
criteria, being more frequent in the border diagnosis, which involves greater subjectivity
(ASC-US, ASC- H, AGC).[10]
[22] To minimize these issues, the professionals who work in the primary care units carry
out training and retraining; the monitored laboratories adopted measures to improve
their infrastructure, internal quality control in all stages of the process (sampling,
analysis and delivery of the final result), participation in the MEQ and meetings
to discuss the discordant cases, contributing to the standardization of cytomorphological
criteria, reducing interobserver variability. The UMEQ provided the monitored laboratories
with a report with detailed pre and postanalytical evaluation data, CD images of discordant
diagnoses, recommendations for improvements that should be implemented, and participated
in the continuing education of professionals involved in the process.
Our results showed a good performance of the participating laboratories. However,
there is a need to reduce the percentage of rejected samples, discordant results with
change of conduct and false-positive results through the systematization of MEQ and
continuing education.
One difficulty encountered in the management of MEQ was the lack of reports of experience
regarding the way the second outcome was communicated to women with change of behavior,
the strategy of calling and selecting the secondary referral units, ensuring reception
and counseling. The understanding of the process by these women was fundamental, and
not one case of non-acceptance or ethical questioning was registered.
Conclusion
The implementation of the MEQ has increased the efficiency of the process involved
in cytopathological examinations of the cervix and consequently in the screening and
early detection of cervical cancer. Our results revealed that this process was an
important diagnostic improvement exercise, and its performance in a systematic way
had a direct impact on the quality of the cytopathological exams performed by the
participating laboratories. The continuing education of professionals, and the continuity
of process monitoring were the main strategies that ensured the progressive improvement
of the quality and reliability of these exams in the scope of the Unified National
Health System (SUS, in the Portuguese acronym), contributing to the qualification
of care in the line of care of cervical cancer in the city of Rio de Janeiro. Ethical
and responsible behavior throughout the process, especially in the active pursuit
of women to change behavior, was critical in the quality of care.
