The role of monitoring interpretive rates, concordance between cytotechnologist and pathologist interpretations before sign-out, and turnaround time in gynecologic cytology quality assurance: findings from the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference Working Group 1.
Relating to or marked by interpretation; explanatory.
rate categories for Papanicolaou tests (Pap
tests), concordance of
A technician trained in medical examination and identification of cellular abnormalities.
a medical laboratory technologist specializing in cytology.
and pathologist interpretations
before sign-out, and turnaround time are 3 categories of monitors that
may be useful for quality assurance in
/gy·ne·co·log·ic/ () () pertaining to the female reproductive tract or to gynecology.
, in biology, the study of the structure of all normal and abnormal components of cells and the changes, movements, and transformations of such components.
quality assurance measures were evaluated as part of a larger project by
College of American Pathologists
(CAP) that surveyed a wide range of
quality assurance monitors in gynecologic cytology. The monitoring of
interpretive rates is mandated by the
Clinical Laboratory Improvement
of 1988 (
Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a
’88) and by accrediting agencies,
including the CAP. Most frequently, such rates are monitored for the
entire laboratory and for cytotechnologists, and less frequently for
pathologists. Determining what rates should be monitored, who should be
monitored, how frequently, and how such monitoring should occur within
the laboratory were issues addressed in this study.
Cytotechnologists and pathologists work
potentially precancerous and cancerous cells on Pap tests. Disagreements
may arise between the cytotechnologist and pathologist as to the
presence of abnormal cells, or the degree of
1. the state of being abnormal.
2. a malformation.
or , medical procedure used to detect cancer of the uterine cervix.
. The manner in which these disagreements are handled will
potentially impact patient care. Tracking such disagreements between
cytotechnologists and pathologists may be used as a quality metric.
Objectives for quality assurance guidelines are to determine if and how
/dis·cor·dance/ () the occurrence of a given trait in only one member of a twin pair.discor´dant
of cytotechnologist and pathologist
interpretations should be used as a metric. Other questions are how and
discrepancies between cytotechnologists and
pathologists, and what types of cases should be shown to a third party
before sign-out of the Pap test by the pathologist.
Turnaround time (
Thematic Apperception Test
1. tube agglutination test.
2. tetanus antitoxin.
) for Pap tests is a readily quantified measure
in the cytology laboratory. However, the effectiveness of TAT as a
quality metric is
1. Being such that formal argument or discussion is possible.
2. Open to dispute; questionable.
3. In dispute, as land or territory claimed by more than one country.
. Turnaround time may relate more to customer
satisfaction or to laboratory staffing than to laboratory quality.
Monitoring TAT may have a negative impact if its use causes undue
pressure on cytotechnologists, resulting in rushing Pap test screening.
If and how monitoring TAT should be part of a quality assurance plan in
the cytology laboratory is at issue.
The CAP, with support from the
Centers for Disease Control and
(CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.
), conducted a national survey of quality assurance
practices in gynecologic cytology. This Web-based survey was developed
by the 3 senior authors of the CAP project with input from national
organizations (CAP Cytopathology Resource Committee, the American
Society of Cytopathology, the American Society for
A technician trained in medical examination and identification of cellular abnormalities.
the American Society of
1. The practice of pathology as it pertains to the care of patients.
2. The subspecialty in pathology concerned with the theoretical and technical aspects of laboratory technology that pertain to the
), and CDC colleagues. The
survey was distributed to all laboratories that participate in
gynecologic cytology proficiency testing in the
officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world’s third largest country in population and the fourth largest country in area.
, and more
than 540 survey responses were received. For details of the complete
process of this study, including the development of the survey, enhanced
Web-based input, and culmination in a consensus conference, see the
introductory article. (1) In short, expert cytopathologists and
cytotechnologists were recruited to become part of 5 working groups that
studied the survey data on different aspects of quality assurance. These
working groups added follow-up questions to the survey, which were
available online and elicited additional opinions. Evaluating the data
and follow-up questions, together with a review of the literature, the
working groups developed a series of preliminary statements on good
laboratory practices in cytology quality assurance and presented these
at a consensus conference in
, on June 4, 2011.
Participants in the conference included working group members,
representatives from national cytopathology and cytotechnology
Centers for Medicare and Medicaid Services
CDC, and individuals who accepted invitations after completing the
written survey. Representatives from the working groups presented their
draft statements to the audience participants who voted electronically
on the issues. Some statements received a clear consensus from the
audience, some had clearly no consensus, and for others, consensus was
/strat·i·fied/ () formed or arranged in layers.
Arranged in the form of layers or strata.
consensus responses were
tr.v. cat·e·go·rized, cat·e·go·riz·ing, cat·e·go·riz·es
To put into a category or categories; classify.
agreement”: 70% to 79%; moderately strong agreement”: 80% to
89%; strong agreement”: 90% to 98%; and nearly complete
agreement”: 99% to 100%. The voting resulted in a number of
consensus good laboratory practice statements. Limitations of the
process include the small number of participants in the consensus
conference, and the basis largely on expert opinion, rather than on
Monitoring Interpretive Rates
The monitoring of interpretive rates is common practice among the
laboratories surveyed, although which rates are monitored and the
frequency of monitoring varies (Tables 1 and 2). Some interpretive rates
are either mandated by CLIA regulations and/or required as a component
of laboratory certification by deemed organizations, especially the CAP.
Theoretically, some interpretive rates, such as the percentage of
cancer, are population-specific indices that are not expected to vary
over time unless there is a shift in the demographics of the patient
population served. And, as different laboratories serve populations of
women with different demographics,
Variant of interpretive.
rates would be
expected to vary among laboratories. For example, CAP benchmarking data
from 2006 showed that the rate of low-grade
A term used to categorize the severity of abnormal changes arising in the squamous, or outermost, layer of the cervix.
Low-grade squamous intraepithelial lesion, see there
) on liquid-based Pap tests varied among laboratories from a
low of 1.1% at the fifth percentile to more than 7% at the 95th
percentile. Rates for high-grade squamous intraepithelial lesion (
High-grade squamous intraepithelial lesion, see there
varied more than 20-fold from 0.1% to 2%. (2)
That being said, cervicovaginal cytology does have a subjective
component to interpretations, and thus interpretive rates could vary as
a reflection of thresholds for specific interpretations, such as between
/atyp·i·cal/ () irregular; not conformable to the type; in microbiology, applied specifically to strains of unusual type.
Thin, flat cells on the surfaces of the skin and cervix and linings of various organs.
Mentioned in: Cervical Cancer
of undetermined significance (
n. pl. as·ci
A membranous, often club-shaped structure in which typically eight spores are formed through sexual reproduction of ascomycetes.
pl. asci; the spore case of Ascomycetes.
) and LSIL,
for example. In this regard, the monitoring of interpretive rates might
be useful for intralaboratory monitoring of consistency, which
cytotechnologists and pathologists use in applying interpretative
criteria. Published scientific data concerning the usefulness of the
application of the monitoring of specific diagnostic rates to an
effective quality assurance program, however, is quite scant, and thus
this area is wide open for future research exploration. That which might
seem logical or intuitive on the surface may not always bear out after
subjection to scientific scrutiny. For example, the limited published
data concerning the correlation of overall abnormal pickup rates and
false-negative fraction (3) showed no correlation. Findings such as this
are important to consider when making choices as to which metrics to use
and for which purposes.
Survey Results.–Another example would be that of regular
monitoring of categories of abnormalities subject to poor interobserver
and intraobserver variability, such as ASCUS. Such monitoring makes
sense in regard to an individual laboratory’s reproducibility of
results, and the subsequent trust that clinicians may put in such
reports. Indeed, the monitoring of ASCUS was reported by 83.9% of 528
laboratories (Table 1), the highest rate for any of the diagnostic
categories, indicating a great degree of consensus that ASCUS is an
important diagnostic rate to monitor.
ASCUS is also one of the categories that is most subject to
diagnostic drift” and variability among both pathologists and
cytotechnologists. Because the ASCUS to squamous intraepithelial lesion
ratio) has much less variability than the ASCUS rate,
this monitor is more useful for interlaboratory comparisons, such as in
benchmarking. (4) Indeed, in our written survey, the ASCUS:SIL ratio was
the only interpretive rate opined to be very useful by more than half of
respondents (53.5 %) (Table 3). A study correlating
cytotechnologists’ ASCUS:SIL ratios with sensitivity (5) showed
that the mean screening sensitivity for cytotechnologists with ASCUS:SIL
ratios less than 1.5 was significantly less than that for
cytotechnologists whose ASCUS:SIL ratio was more than 3.0. The authors
also suggested that an ASCUS:SIL ratio less than 1.5 for a
cytotechnologist might be useful as a
Lab medicine A parameter or measured to detect a pathologic condition when a more specific test doesn’t exist, is impractical or not cost-effective; surrogate testing has been used for non-A, non-B hepatitis, measuring ALT and antibodies to HBV
screening sensitivity. Note that this study compared ASCUS:SIL ratios of
individual cytotechnologists before final interpretation of cases by
pathologists, and thus higher ratios are expected. Indeed, the 2006 CAP
benchmarking data (2) showed that the average laboratory ASCUS: SIL
ratio was about 1.5. However, too much emphasis on a low ASCUS:SIL ratio
in a laboratory could potentially have a negative impact on laboratory
sensitivity. A recent clinical trial showed that several laboratories
with ASCUS:SIL ratios of 1.5 or less had less than 50% adjusted
screening sensitivity for
cervical intraepithelial neoplasia
Dysplastic changes beginning at the squamocolumnar junction in the uterine cervix that may be precursor to squamous cell carcinoma.
(6) Therefore, benchmarking data without data correlating it to quality
outcomes can be
In a deceptive or deceiving manner; so as to deceive.
Usage Note: When deceptively is used to modify an adjective, the meaning is often unclear.
Interestingly, 41.9% of written survey respondents reported that
other undesignated diagnostic rates, not listed on the survey, were
useful to them in monitoring quality (Table 3). This obviously requires
The most common interval for monitoring of diagnostic rates was
monthly (Table 2). As diagnostic rates for entities other than ASCUS
tend to be rather stable over time unless there is a shift in
demographics, the monthly frequency of monitoring probably reflects a
logistic convenience, as many laboratories collect the raw data for
calculating error rates on a monthly basis. For rates with expected
fluctuations, such as ASCUS or ASCUS:SIL, monthly monitoring might make
more sense. However, such frequent monitoring may pose a problem for
small laboratories with extremely small volumes, such as 500 or less
cases per year, as their rates may fluctuate widely just by statistical
chance. Also, comparing their rates to published benchmarks may also be
misleading for the same reason. Some laboratories use a rolling 12
months of data collection, which can be analyzed monthly, quarterly, or
at some other interval, based upon the suitability to individual
laboratories. This is an area that needs more research.
Follow-up Questions Posted on Internet Site.–The detailed comments
from the follow-up online questions were interesting. Only 56% of 87
respondents reported ever seeing a shift in an actively monitored
diagnostic rate laboratory-wide. A similar percentage reported ever
seeing a shift in an actively monitored individual diagnostic rate, but
the reasons attributed to the changes were different. The most common
factors (mentioned in 25% of the comments each) attributed to the shift
were a change in technique/ methodology, such as adding imaging or
switching to a different liquid-based method and personnel receiving
feedback about recently missed cases, review of diagnostic criteria, and
others. For shifts in individual diagnostic rates, the common factor
attributed was the individual receiving feedback or participating in
open discussion, supporting the intuitive importance of providing
feedback to individuals. Common but less frequently cited reasons were a
change in personnel (pathologists or cytotechnologists) and
(HPV), any of a family of more than 60 viruses that cause various growths, including plantar warts and genital warts, a sexually transmitted disease. Detectable warts can be or removed, usually by chemicals, freezing, or laser, but often recur.
human papilloma virus
) testing or review of HPV
When asked why participants found that monitoring ASCUS was
helpful, most alluded to the fact that ASCUS is the clinical decision
point, and an indicator of the threshold of abnormality. Participants
felt that monitoring ASCUS rates prevents overcalling and undercalling
and helps to keep interpretations within the laboratory uniform.
However, the follow-up online questions revealed that of 87 respondents,
71% and 68% reported that ASCUS rates varied greatly both among
cytotechnologists and pathologists, respectively. This seems to
challenge the impression that merely monitoring the ASCUS rates would
necessarily produce uniformity. One respondent mentioned that
cytotechnologists who miss ASCUS also tend to miss HSIL, an observation
that is supported by the literature. (3)
When asked which interpretive rates were felt to not be useful,
most comments included relatively rare but significant interpretations
such as atypical
1. pertaining to or of the nature of a gland.
cells, atypical squamous cells, cannot
exclude high-grade squamous intraepithelial lesion (ASC-H), and cancer.
This issue was discussed in detail at the conference, and the suggestion
was made to combine these categories into a monitor that could be
followed even in low-volume laboratories. However, 43.5% of attendees at
the consensus conference felt that this was not useful. Only future
research will clarify this newly identified controversy.
Another category felt to be problematic, and one documented now to
lead to many unnecessary procedures, was normal
/en·do·me·tri·al/ () pertaining to the endometrium.
n relating to the end-ometrium or cavity of the uterus.
women older than 40 years. This was also a topic of discussion at the
conference. Scientific data show that the only women with
normal-appearing endometrial cells who may require endometrial sampling
or ultrasound assessment are those who are
Of or occurring in the time following menopause.
Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr
clinically abnormal bleeding. (7)
From the follow-up online questions, most reporting laboratories
(95%) monitor the total abnormal rate. Eighty-two percent monitor both
laboratory and individual rates. More than half of the respondents (58%)
felt that cytotechnologists and pathologists should have access to their
diagnostic rates. Such feedback was felt to be helpful because it
provided “peer pressure” to outliers, making counseling easier
when needed; helped people know how they were doing in relation to
others in the laboratory and to CAP benchmarks; improved education and
sharing of cases; helped to refine skills and
helped with accuracy and managing of diagnostic thresholds.
Fifty-nine percent of online respondents felt that each
person’s individual interpretive rates should be shared
confidentially with him or her. Several commented that it was helpful to
openly publish/display interpretive rates within the laboratory, but
that people should not be individually identifiable. A few commented
that the sharing of interpretive rates could actually be a negative,
depending upon how they were used, for example, as a basis for merit
raises. While there are correlations between some rates and performance,
such as the correlation between ASCUS:SIL ratios and sensitivity cited
above, such correlations are not absolute; therefore, it is important to
use more than 1 metric. This once again brings up the importance of
tying benchmarks to clinically significant metrics such as error rates
or sensitivities for significant lesions.
Consensus Good Laboratory Practice Statements and Comments.–Table
4 lists the good laboratory practice statements generated from the
survey, the Internet follow-up questions, and opinions of the authors
for monitoring interpretive rates in gynecologic cytology. These
statements were voted on at the consensus conference, and in cases where
there was no clear initial consensus, the statements were revised and
voted on again.
Concordance of Cytotechnologist and Pathologist Interpretations
Tracking discrepancies between cytotechnologists and pathologists
is incorporated into the evaluation of individual performance as
mandated by CLIA. However, the methods for monitoring and analyzing
discrepancies are not specified. The CAP checklist requires
documentation of each individual’s diagnostic discrepancies and
corrective actions taken (
.07660). The CAP checklist also requires
comparison of individual cytotechnologist interpretation to the final
diagnosis in gynecologic specimens signed out as abnormal, as part of
the 6-month workload assessment (CYP 0.08575). Most laboratories
incorporate some evaluation of discrepancy analysis as part of the
every-6-month workload review, and this has been advocated as a possible
quality metric. (8-10) Establishing a baseline level of discrepancies is
important so that trends can be analyzed. Individual discrepancy rates
can be compared to the laboratory rate, and individual rates can be
tracked over time. Laboratories also need to determine what level of
discrepancy is important to track and whether upgraded or downgraded
interpretations, or both, need to be monitored. Laboratories should also
consider formalizing procedures and policies to adjudicate
Marked by discrepancy; disagreeing.
[Middle English discrepaunt, from Latin discrep
interpretations of Pap tests between cytotechnologists and pathologists
before sign-out of the Pap test.
of discrepancies may be
challenging in laboratories with 1 pathologist and cytotechnologist or
in laboratories with only a pathologist.
Survey Results.–From the survey, greater than 73% of laboratories
activelymonitor the rates at which a pathologist upgrades a
cytotechnologist’s diagnosis at the time of initial sign-out, and
greater than 62% of laboratories actively monitor the rates at which a
pathologist downgrades a cytotechnologist’s diagnosis at the time
of initial sign-out (Table 5). The most critical upgrades monitored are
from negative for intraepithelial lesion or
) to either
LSIL or to HSIL or greater, monitored respectively by 97.9% and 96.6% of
the 381 laboratories that responded to this survey question (Table 6).
Upgrades from NILM to ASCUS and to ASC-H are also frequently monitored
by 74.8% and 81.9% of laboratories, respectively, as are upgrades from
ASCUS to HSIL, monitored by 83.2% of laboratories. Monitoring upgrades
from LSIL to HSIL and ASC-H to HSIL was not as frequent, with only 65.9%
and 57.0% of laboratories, respectively, following these rates.
The most frequent and most important downgrades monitored by
laboratories are from HSIL to NILM and LSIL to NILM, each monitored by
more than 94% of the 320 laboratories that responded to this question in
the survey (Table 7). Monitoring of downgrades from either ASC-H or
ASCUS to NILM is followed respectively by 80.6% and 72.5% of
laboratories, and monitoring downgrades of HSIL to either LSIL or to
ASC-H is followed respectively by 64.4% and 60.6% of laboratories.
In adjudicating discrepancies between cytotechnologists’ and
pathologists’ diagnoses, only 49.5% of laboratories have a written
policy specifying the process to resolve 2-grade discrepancies, and only
25.2% have such a written policy in cases of 1-grade discrepancies
(Table 8). For 2-grade discrepancies, the Pap test in question is
frequently shown by the pathologist to a second person before sign-out:
32.2% to the original cytotechnologist, 24.7% to another pathologist,
and 4.5% to another cytotechnologist. In only 33.7% of laboratories that
responded did the pathologist diagnosis stand without further action. By
contrast, in the case of 1-grade discrepancies, such as from LSIL to
ASCUS, most laboratories (68.5%) responded that the pathologist’s
diagnosis stands and only 27.6% responded that the case was shown to a
Follow-up Questions Posted on Internet Site.–Seven additional
questions were posted on a Web site in an attempt to supplement the
written survey questions. The number of responses, ranging from 62 to
87, was low when compared to the number of responders to the written
survey. From the responses, most pathologists (60%) seek additional
review of particular cases before
A reduction in the quality rating of a security issue, generally a bond. A downgrading may occur for various reasons including a period of losses, or increased debt service required by restructuring a firm’s capital to include more debt and less
diagnosis (Table 9). The most frequent cases that elicit second review
are HSIL (78%), atypical glandular cells (54%), and ASC-H (41%).
Similarly, 37 of 61 cytotechnologists indicated that they seek
additional review before forwarding a case to a pathologist (Table 10).
The most frequent case shown by a cytotechnologist is a Pap test
interpreted as atypical glandular cells.
Forty-nine percent of pathologists indicated that they did not
routinely confirm an abnormal Pap test result by showing it to another
individual before sign-out (Table 11). Of those pathologists that did
confirm a diagnosis, this was most frequently done at the discretion of
the pathologist and not for any specific interpretive category.
Frequently, Pap tests not interpreted as abnormal or reactive are
routinely reviewed by pathologists before sign-out (Table 12). The most
frequent Pap test in this category is one containing
Any virus of the herpesvirus group, which comprises a family of 70 species, 5 of which are pathogenic to humans; the term also refers to any infection caused by these viruses.
, shown by
81% of responders. Unsatisfactory Pap tests and those with benign
endometrial cells follow those with herpes at 59% and 44%, respectively.
Written responses were solicited in the “other” category,
chosen by 29%. Many of these comments indicated that endometrial cells
identified in women either older than 40 years or older than 50 years,
or the presence of
/Ac·ti·no·my·ces/ () a genus of bacteria (family Actinomycetaceae).
, were Pap tests that were frequently
shown: (45% and 35%, respectively).
Consensus Good Laboratory Practice Statements and Comments.–Table
13 lists the good laboratory practices generated by data from the
written survey, the Internet discussion site, and opinion of the authors
for monitoring concordance of cytotechnologist and pathologist
interpretations. These were voted on at the consensus conference and in
cases where there was no clear consensus, the statements were reworded
and resubmitted for voting.
As shown in Table 13, statement 1a, while there was strong support
to actively monitor upgrades of cytotechnologist interpretations,
particularly of NILM to SIL+, by pathologists, there was not clear
consensus on which other cytotechnologist interpretations should also be
monitored. The statement was revised and resubmitted.
Cytotechnologists are responsible for screening slides for
potential abnormalities. The rate at which interpretations are upgraded
was deemed to be an important quality monitor by 79.7% of conference
participants (Table 13, statement 1b). However, there was no consensus
as to the definition of a significant discrepancy. Some laboratories may
choose to monitor any case upgraded from negative to abnormal (ASCUS+)
plus upgrades from ASCUS or LSIL to HSIL. Other laboratories may prefer
to define upgraded discrepancies more narrowly with normal to SIL+
counted. At the very least, upgrades of NILM to SIL+ should be
considered as a monitor.
As shown in Table 13, statement 2, there was less consensus as to
whether downgraded interpretations should be monitored. Some
laboratories only monitored significant downgrades, while other
laboratories had broader definitions. Pathologists are responsible for
making the final determination on abnormal cases, based not only on
cellular features but also clinical history and management implications.
There is an expectation that many specimens interpreted as potentially
atypical by cytotechnologists will be downgraded to negative by
pathologists, and similarly, there will be some cases in which a minor
is made because there is uncertainty as to the nature of an
abnormality. An example is a case downgraded from HSIL to ASC-H when
there is uncertainty, in order to prevent potential overtreatment. In
the written survey sent to laboratories, many participants agreed that
only significant downgrades should be monitored. For example, 96.3% of
laboratories monitor downgrades of HSIL to negative, whereas only 60.6%
monitor downgrades from HSIL to ASC-H.
Laboratories may address significant discrepancies in
interpretations between cytotechnologists and pathologists in a variety
of ways. Often the pathologist uses individual discretion in determining
which types of cases should be adjudicated by a third person. In the
relate prep →
relate prep → ,
2-step discrepancies, 33.7% of respondents
stated that the pathologist’s diagnosis stands without further
action, while most either reviewed the case with the cytotechnologist
(32.2%) or consulted a second pathologist (24.7%). At the conference,
62.5% strongly agreed that discrepancies of 2 degrees or more should be
showed to a third person when possible, and 29.2% agreed with
reservations. Since clear consensus was not obtained on which diagnostic
categories may benefit from review by a third person (Table 13,
statement 3a), the question was restated and resubmitted for a vote
(statement 3b). Examples of cases meeting these criteria would be
upgrades from NILM to HSIL or downgrades of cases from HSIL+ to
negative. Small laboratories with only a single cytotechnologist and
pathologist have challenges in adjudicating discrepancies. Some
mechanisms for addressing discrepancies in small laboratories include
reviewing the case at a multiheaded microscope, correlating the
interpretation with later biopsies, and sending select cases out of the
laboratory for outside consultation. Obtaining HPV testing in certain
situations may be a possibility, but this has to be tempered by the fact
that there is a small false-negative rate of HPV testing in HSIL and
cancer cases. (11,12) Furthermore, HPV testing should be requested in
consultation with the
/cli·ni·cian/ () an expert clinical physician and teacher.
after discussion of possible pitfalls.
Regardless of how individual laboratories may handle discrepancies,
73.7% of consensus conference participants agreed that laboratories
should have policies about which categories of discrepancies should be
reviewed by a third individual before sign-out. These policies will
clarify expectations for both cytotechnologists and pathologists and
provide more uniform handling of specimens, which may impact
significantly on patient care. Policies dealing with 1-grade
discrepancies, such as from HSIL to ASC-H, are not as critical as
policies handling a 2-grade discrepancy such as from HSIL to NILM. In
the former case, there is no or minimal change in patient management,
while in the latter, patient management will be different.
Certain types of high-risk specimens may especially benefit from
review by a third person; examples are atypical glandular cells and
those results, such as HSIL, that will impact on the patient’s
Colposcopy is a procedure that allows a physician to take a closer look at a woman’s cervix and vagina using a special instrument called a colposcope. It is used to check for precancerous or abnormal areas.
and biopsy. Glandular lesions are problematic and
are not infrequently the cause of
. The voting at the
consensus conference reflects the awareness of difficulties in detecting
glandular lesions. Only 27.7% thought it unnecessary to show a
/pre·ma·lig·nant/ () precancerous.
or malignant glandular lesion to a third person, whereas
39.4% thought this was not needed for similarly severe
/squa·mous/ () scaly or platelike.
1. Covered with or formed of scales; scaly.
(Table 13, statements 4 and 5).
Laboratories should have policies as to which cases benefit from
review by a second person (cytotechnologist or pathologist), even if not
required by CLIA. These may include unsatisfactory, endometrial cells in
women older than 40 years, glandular cells in women post
, surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries
and herpes. CLIA requires that all reactive and potentially abnormal
cases be reviewed and confirmed by a pathologist. However there is no
requirement that certain Bethesda categories be confirmed by a second
individual. Some of these types of specimens have important clinical
management implications. Examples include unsatisfactory specimens,
endometrial cells, and certain types of organisms including
A virus that can cause fever and blistering on the skin, mucous membranes, or genitalia.
Mentioned in: Conjunctivitis
herpes simplex virus
(Table 13, statement 6a). Greater than 90% of consensus
conference participants agreed that laboratories should have policies as
to which cases benefit from such review (Table 13, statement 6b).
Specimens designated as “unsatisfactory” generally require
1. As stated or indicated by; on the authority of:
2. In keeping with:
American Society for Colposcopy and Cervical
Pathology management guidelines. (13) Additional review helps to promote
intralaboratory reproducibility in application of adequacy criteria.
Furthermore, patients who have received chemotherapy or radiation
therapy may have lower-cellularity specimens, and there are no data to
suggest a minimum numeric threshold; thus, the pathologist may evaluate
clinical history and exercise clinical judgment in certain cases
designated by the cytotechnologist as unsatisfactory. (13) Endometrial
sampling is recommended for postmenopausal women with benign-appearing
endometrial cells, while women age 40 years or older who are still
/men·stru·al/ () pertaining to the menses or to menstruation.
Of or relating to menstruation.
cycles and are
Exhibiting or producing no symptoms.
Persons who carry a disease and are usually capable of transmitting the disease but, who do not exhibit symptoms of the disease are said to be
can return to routine
screening. (14) In addition, differentiating atypical glandular cells
from shed endometrial cells is challenging, and such cases benefit from
Turnaround time has been historically associated with causing
pressure on cytotechnologists to increase productivity at the expense of
quality. (15) With the implementation of CLIA ’88, however, strict
regulations have limited the number of slides cytotechnologists are
allowed to screen per day and individual workload limits are assessed
1. Happening twice each year; semiannual.
2. Occurring every two years; biennial.
. Given these quality measures, during the last decade the
concept of TAT has evolved to become a readily quantifiable measure in
the cytology laboratory and to have an impact on quality. (16) A timely
reporting of results translates into timeliness of patient care.
However, it may be argued that gynecologic cytology is a screening test,
which decreases the sense of urgency for the results.
Turnaround time is generally defined as the time a specimen is
accessioned in the laboratory to the time the report is signed out or
. However, there is variability among laboratories in defining
when the TAT cycle starts and when it ends.
Turnaround time can be considered a reliable indicator for
evaluation of laboratory staffing by identifying bottleneck areas in any
part of the test cycle. Turnaround time is monitored to examine the
functionality of the overall service, including slide preparation,
cytotechnologist screening, and pathologist sign-out. Turnaround time
also relates to customer satisfaction and may influence decisions about
where to refer gynecologic cytology work, especially considering the
competitive environment in the current health care arena. (17) In
addition, as patients become more knowledgeable about laboratory testing
through targeted marketing and other means, the demand for prompt
reporting increases, thus influencing the necessity to monitor TAT.
Survey Results.–From the survey, a laboratory’s expectations
on Pap test TAT varied widely, from 1 to 7 or more days, with a median
Pap test TAT of 3 business days (Table 14). Laboratories reported that
actual TAT was less than the expected TAT, as shown in the percentile
distributions in Table 14. How laboratories define and measure TAT
varied; 57.2% of respondents defined the
as the date/
time of accessioning the Pap test, while 24.1% used date/ time of
specimen receipt, and 14.6% used date/time of specimen collection. There
was more universal agreement on the definition of the ending point for
TAT measurement, as date/time report finalized (89.1%). Other
definitions of ending points included date/time results delivered to
physician (4.2%) and date/time case reviewed by technologist or
pathologist (4.0%). The most common frequency of TAT monitoring was
monthly (46.6%), followed by daily (20.4%) and quarterly (11.6%). The
most common metric used to measure TAT variance was percentile
distribution within a certain TAT (54.2%), followed by mean TAT (32.4%)
and percent of cases deviating from TAT expectation (15.5%) (Table 15).
Follow-up Questions Posted on Internet Site.–Five additional
questions were posted on the Web site to attempt to supplement the
written survey questions. The number of responses on the Web site (76)
was much lower than the responses to the written survey. From the
responses, 59% of laboratories agreed that monitoring TAT is an
effective quality metric. Monitoring TAT was reported to be useful for
monitoring staffing needs in the laboratory, and as a metric for
customer service. Thirty-three percent of laboratories felt that
monitoring TAT is not an effective quality metric, with several opinions
stating that a faster TAT does not equate to quality work. Eight percent
of respondents were “unsure” if monitoring TAT is an effective
quality metric. There was evidence of some
tr.v. mis·in·formed, mis·in·form·ing, mis·in·forms
To provide with incorrect information.
requirement of TAT monitoring, with 61% of respondents believing that
TAT monitoring was mandated, primarily by clinical guidelines.
Thirty-two percent of respondents report that monitoring TAT negatively
affects quality, including causing undue pressure on cytotechnologists
to meet screening quotas. Of the 21% who report that monitoring TAT
positively affects quality, timely patient care and use as a staffing
monitor were given as examples. Forty-seven percent of respondents were
“unsure” if TAT constraints negatively or positively affect
quality, with many stating TAT did not affect quality, or that TAT could
have both positive and negative effects.
Table 16 lists the good laboratory practice statements generated
from the written survey, Internet questions and comments, and opinions
of the authors, on monitoring Pap test TAT. These statements were voted
on at the consensus conference. Most consensus conference participants
agreed that TAT should be monitored in gynecologic cytology (Table 16,
statement 1). Awareness of TAT should be a consideration in the overall
laboratory quality performance, including addressing individual
capabilities and limits. However, the use of TAT monitoring should never
compromise the quality of the Pap test evaluation in any phase of the
cycle. Laboratory directors and managers should be aware of the
potential negative implications of monitoring TAT. Thirty-two percent of
respondents report that monitoring TAT negatively affects quality,
including causing undue pressure on cytotechnologists to meet screening
quotas, possibly leading to increase in false-negative rates and
screening errors, and possibly leading to increased ASCUS rates.
There was strong agreement among consensus conference participants
that we should not attempt to establish a universally acceptable TAT in
gynecologic cytology (Table 16, statement 2). A specific TAT for Pap
tests is not required as certification criteria for laboratory
inspections (18) (CAP, American Society of Cytopathology, CMS). There is
no evidence in the literature to support the establishment of a TAT
limit for Pap tests. The survey results showed a wide range of
laboratory TAT for Pap tests, ranging from 1 to 7 or more days, with a
median TAT of 3 business days. Turnaround time is best used as an
internal measure to assess the workflow in gynecologic cytology rather
than as a benchmark for interlaboratory comparison.
Most consensus conference participants agreed that individual
laboratories should determine how to measure or define TAT (Table 16,
statement 3). The most common measurement of TAT starts with date/time
of accessioning and ends with report sign-out. A minority of
laboratories use different definitions of TAT, and this should not pose
a problem, since the measurement is largely used for internal
assessments. There was strong agreement that individual laboratories
should determine the frequency of TAT monitoring and the metric to
determine TAT variance (Table 16, statements 4 and 5). The needs for TAT
monitoring may vary by differences in individual laboratories,
especially given differences in laboratory information systems.
The good laboratory practice statements presented herein have a
range of consensus agreement or even disagreement, reflecting
differences in opinion and practice patterns of consensus conference
attendees. While there are many strengths of this process, there are
also shortcomings to the methodology of this process. This process was
not a prospective study, but a survey of practice patterns and of
opinions from working group members and consensus conference attendees.
However, it would be difficult to construct a prospective study of the
numerous good practice statements set forth in this survey, and many of
the quality monitors in this survey are mandated by regulations from
CLIA or accreditation criteria by CAP and other agencies. While
literature was reviewed and cited when possible, the literature was not
formally evaluated for strength of evidence. Not infrequently, however,
there was a dearth of literature on certain quality topics, such as
monitoring of concordance between cytotechnologist and pathologist
interpretations of Pap tests before sign-out.
The working group authors and consensus conference attendees were
sensitive to the weaknesses and strengths of this process. The good
laboratory practice statements were often crafted to not be
1. The act of proscribing; prohibition.
2. The condition of having been proscribed; outlawry.
[Middle English proscripcion, from Latin
given the limitations of this survey process and the vast differences
among many cytopathology laboratories. Indeed, the revisions to some of
the good laboratory practice statements noted above reflect this
struggle. The objective of these laboratory practice statements are not
tr.v. pro·scribed, pro·scrib·ing, pro·scribes
1. To denounce or condemn.
2. To prohibit; forbid. See Synonyms at forbid.
a. To banish or outlaw (a person).
a regulated quality assurance program, but rather to frame
both areas of agreement and disagreement so that cytopathology
laboratories may choose quality metrics, in addition to those mandated
by regulations, that may be suited to their particular practice. In
cases of metrics
by CLIA regulations, the survey process can
highlight methods that may make the use of these metrics more meaningful
to the daily operation of the laboratory.
This report was supported in part from a contract (GS-10F-0261K)
funded by the Centers for Disease Control and Prevention/
Toxic Substances and Disease Registry
. The authors would like to
acknowledge Barbara Blond, MBA, MT(
American Society of Clinical Pathologists.
) for her many contributions to
(1.) Tworek JA, Henry MR, Jones BA. College of American Pathologist
Consensus Conference on Good Laboratory Practices in Gynecologic
Cytology: background, rationale, and organization. Arch Pathol Lab Med.
(2.) Eversole GM, Moriarty AT, Schwartz MR, et al. Practices of
participants in the College of American Pathologists Interlaboratory
Comparison Program in Cervicovaginal Cytology 2006. Arch Pathol Lab Med.
(3.) Krieger PK, Naryshkin S. Random rescreening of cytologic
smears: a practical and effective component of quality assurance
programs in both large and small cytology laboratories. Acta Cytologica.
(4.) Davey DD, Naryshkin S, Nielsen ML, Kline TS. Atypical squamous
cells of undetermined significance: interlaboratory comparison and
quality assurance monitors. Diag Cytopathol. 1994;11(4):390-396.
(5.) Renshaw AA, Deschenes M,
: see drill.
Tool (or bit) used with a carpenter’s brace for drilling holes, usually in wood. It looks like a corkscrew and produces extremely clean holes, almost regardless of how large the bit is.
M. ASC/SIL ratio for
cytotechnologists: a surrogate marker of screening sensitivity. Am J
Clin Pathol. 2009;131(6):776-781.
(6.) Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL,
Behrens CM. Performance of
human papillomavirus (HPV)
testing and HPV16 or HPV18
Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors.
women aged 25 years and older: a subanalysis of the ATHENA study. Lancet
(7.) Kapali M, Agaram NP, Dabbs DJ, Kanbour A, White S, Austin RM.
Routine endometrial sampling of asymptomatic
Of or relating to the years or the stage of life immediately before the onset of menopause.
shedding normal endometrial cells in Pap tests is not cost effective.
Cancer Cytopathol. 2007; 111(1):26-33.
(8.) Cibas ES, Dean B, Maffeo N, Allred EN. Quality assurance in
gynecologic cytology: the value of cytotechnologist-cytopathologist
discrepancy logs. Am J Clin Pathol. 2001;115(4):512-516.
(9.) Voytek TM, Mody DR, Davey DD. Quality assessment and
improvement in cytopathology. In: Nakhleh RE, Fitzgibbons PL, eds.
Quality Improvement Manual in Anatomic Pathology. Northfield, IL:
College of American Pathologists; 2002:115-116.
(10.) Bongiovanni M,
B, Kumar N, Pache JC, Cibas ES. A
quality control study on cytotechnologist-cytopathologist concordance
and its relationship to the number of dots on the slide. Acta Cytol.
(11.) Katki HA, Kinney WK, Fetterman B, et al. Cervical cancer risk
for women undergoing concurrent testing for human papillomavirus and
cervical cytology: a population-based study in routine clinical
practice. Lancet Oncol. 2011;12(7): 663-672.
(12.) Kang WD, Kim CH, Cho MK, et al. Comparison of the hybrid
capture II assay with the human papillomavirus
See DNA microarray.
Noun 1. DNA chip – a microchip that holds DNA probes that form half of the DNA double helix and can recognize DNA from samples being tested
test for the
detection of high-grade cervical lesions. Int J Gynecol Cancer.
(13.) Davey DD, Cox JT, Austin RM, et al. Cervical cytology
specimen adequacy: patient management guidelines and optimizing specimen
collection. J Lower
The genital passages of the urogenital system.
The organs involved in reproduction.
(14.) Wright TC, Massad LS, Dunton CJ, et al. 2006 consensus
guidelines for the management of women with abnormal cervical cancer
screening tests. Am J Obstet Gynecol. 2007;197(4):346-355.
(15.) Bogdanich W. The Pap test misses much cervical cancer through
lab’s efforts. Wall Street Journal. November 2, 1987:1.
(16.) Jones BA, Valenstein PN, Steindel SJ. Gynecologic cytology
turnaround time: a College of American Pathologists Q-Probes Study of
371 laboratories. Arch Pathol Lab Med. 1999;123(8):682-686.
(17.) Bewtra C. Cytology turnaround time: are we being too fast?
Diag Cytopathol. 2003:29(5):241-242.
(18.) Yu GH, Gupta PK. The pathologic obsession with turnaround
time in gynecologic cytology: is it warranted? Diag Cytopathol.
, MD; Diane D. Davey, MD; Sonya Naryshkin, MD; R.
Marshall Austin, MD, PhD; Nicole Thomas, CT(ASCP); Beth Anne Chmara,
CT(ASCP); Chiara Sugrue, MBA, MS,
A tumor occurring at the base of the fetus’s tailbone.
Mentioned in: Prenatal Surgery
(ASCP); Joseph Tworek, MD
Accepted for publication May 15, 2012.
From the Department of Pathology, Rochester General Hospital,
(Dr Clary);the Department of Clinical Sciences,
, and Orlando Veterans Administration
(Dr Davey); the Department of
Mercy Health System
the Department of Pathology, Magee-Womens Hospital,
Pittsburgh Medical Center
) is the second largest city in the Commonwealth of Pennsylvania.
(Dr Austin); CAP Pap
Program (Ms Thomas) and the Department of Cytologic Surveys (Ms Chmara),
College of American Pathologists,
; the Division of
Cytopathology, Hofstra Northshore Long Island Jewish School of Medicine,
(Ms Sugrue); and the Department of Pathology, St
The authors have no relevant financial interest in the products or
companies described in this article.
The findings and conclusions in this report are those of the
authors and do not necessarily represent the views of the Centers for
Disease Control and Prevention/Agency for Toxic Substances and
Public health A surveillance system that collects and maintains structured records on the new cases of a specific disease or condition for a specified time period and population; a DR analyzes, and interprets data those with a common illness or
and are not intended
to take the place of
applicable laws or
Reprints: Karen M. Clary, MD, Department of Pathology, Rochester
General Hospital, 1425 Portland Ave, Rochester, NY 14621 (e-mail:
Table 1. Actively Monitored Diagnostic Rates (N = 528) Diagnostic Rate Laboratory Cytotechnologist Frequency Percentage Frequency Percentage None 9 1.7 17 3.2 NILM 407 77.1 374 70.8 Unsat 443 83.9 380 72.0 LSIL 437 82.8 398 75.4 HSIL 435 82.4 399 75.6 SCC 383 72.5 337 63.8 Other malignancies 355 67.2 311 58.9 ASCUS 443 83.9 404 76.5 ASC-H 398 75.4 359 68.0 AGC 399 75.6 361 68.4 ASCUS:SIL ratio 424 80.3 324 61.4 NILM:SIL ratio 96 18.2 82 15.5 Other 90 17.0 75 14.2 Diagnostic Rate Pathologist Frequency Percentage None 56 10.6 NILM 169 32.0 Unsat 182 34.5 LSIL 208 39.4 HSIL 207 39.2 SCC 180 34.1 Other malignancies 161 30.5 ASCUS 215 40.7 ASC-H 194 36.7 AGC 192 36.4 ASCUS:SIL ratio 198 37.5 NILM:SIL ratio 46 8.7 Other 46 8.7 Abbreviations: AGC, atypical glandular cells; ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; ASCUS:SIL ratio, the ratio of cases with an interpretation of atypical squamous cells of undetermined significance to cases with squamous intraepithelial lesions; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesion or malignancy; NILM:SIL ratio, the ratio of cases with an interpretation of negative for intraepithelial lesion or malignancy to cases with squamous intraepithelial lesions; SCC, squamous cell carcinoma; Unsat, unsatisfactory. Table 2. Monitoring Frequency How Frequently Are the Diagnostic Rates Monitored? Frequency Percentage Daily 9 1.8 Weekly 3 0.6 Monthly 333 64.8 Bimonthly 4 0.8 Quarterly 62 12.1 Semiannually 65 12.6 Annually 32 6.2 Other 6 1.2 Table 3. Usefulness of Diagnostic Rates in Monitoring Quality Diagnostic N Average Very 4, % 3, % 2, % Not Rate Rank Useful Useful 5, % 1, % NILM 439 3.6 33.3 21.6 24.1 11.8 9.1 Unsat 492 4.0 44.3 23.8 20.3 7.1 4.5 LSIL 490 4.0 41.8 26.9 22.9 5.7 2.7 HSIL 490 4.1 46.5 24.1 22.2 4.5 2.7 SCC 432 3.7 36.6 21.8 23.4 10.9 7.4 Other 409 3.6 35.7 20.3 24.9 10.3 8.8 malignancy ASCUS 492 4.2 51.0 23.8 18.1 5.3 1.8 ASC-H 459 4.0 44.2 24.4 21.4 6.5 3.5 AGC 451 3.8 33.3 28.8 23.9 8.9 5.1 ASCUS:SIL 465 4.2 53.5 23.0 16.1 5.2 2.2 ratio NILM-SIL 132 3.5 33.3 18.9 23.5 11.4 12.9 ratio Other 86 3.5 41.9 11.6 17.4 12.8 16.3 Abbreviations: AGC, atypical glandular cells; ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; ASCUS:SIL ratio, the ratio of cases with an interpretation of atypical squamous cells of undetermined significance to cases with squamous intraepithelial lesions; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesion or malignancy; NILM:SIL ratio, the ratio of cases with an interpretation of negative for intraepithelial lesion or malignancy to cases with squamous intraepithelial lesions; SCC, squamous cell carcinoma; Unsat, unsatisfactory. Rankings based on a scale of 1 to 5: not useful to very useful. Table 4. Consensus Good Laboratory Practice Statements: Monitoring Interpretive Rates 1. Monitoring of interpretive rates for all Bethesda System categories is potentially useful, as each Bethesda System category is clinically relevant. Do you agree with the consensus statement? Yes: 94.3% No: 5.7% Should standard categories of interpretive rates be monitored in all laboratories? Yes: 85.1% No: 6.3% Should each individual laboratory choose which interpretive rates to monitor? Yes: 20.7% No: 79.3% 2. It is most useful to monitor interpretive rates for cytotechnologists individually and in comparison for the entire laboratory. Do you agree with the consensus statement? Yes: 100% 3. It is currently unclear whether or not monitoring interpretive rates for individual pathologists beyond laboratory rates as a whole is useful. Is monitoring interpretive rates of individual pathologists useful to you? Yes: 85.7% No: 12.9% Other: 1.4% Is this an area that should be explored? Yes: 90.5% No: 3.2% Other: 6.4% 4. Consider monitoring combined interpretive rates of "dangerous abnormals," defined as cancer, suggestive of cancer, HSIL, AGC, and ASC-H. Do you think that using the combined category "dangerous abnormals" could be useful? Yes, in low-volume/low-prevalence laboratories only: 15.9% Yes, in any laboratory: 34.8% No: 43.5% Don't know: 5.8% 5. Monthly monitoring of interpretive rates may be useful, if possible. Is monthly monitoring: Too frequent: 43.1% Not frequent enough: 1.7% Just right: 55.2% 5a. Revised statement: Regular monitoring of interpretive rates may be useful and the individual laboratory should determine the frequency of monitoring. Do you agree? Yes: 98.2% No: 1.9% 6. Providing feedback of interpretive rates is important. Should individual interpretive statistics be provided to cytotechnologists and pathologists as feedback? Yes, regularly: 88% No, not at all: 1% Only as part of scheduled employee reviews: 11% Abbreviations: ACG, atypical glandular cells; ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; HSIL, high-grade squamous intraepithelial lesion. Table 5. Monitoring Change in Diagnosis Frequency Percentage The rates at which a pathologist upgrades a cytotechnologist's diagnosis at the time of initial sign-out are actively monitored per cytotechnologist: Yes 376 73.3 No 137 26.7 The rates at which a pathologist downgrades a cytotechnologist's diagnosis at the time of initial sign-out are actively monitored per cytotechnologist: Yes 312 62.5 No 187 37.5 Table 6. Upgrade Rates Monitored for Cytotechnologists (N = 381) Cytotechnologist Pathologist Diagnosis Diagnosis ASCUS ASC-H LSIL Frequency Percentage Freq Percentage Freq NILM 285 74.8 312 81.9 373 ASCUS ... ... 179 47.0 216 LSIL ... ... 169 44.4 ... ASC-H ... ... ... ... ... Cytotechnologist Pathologist Diagnosis Diagnosis LSIL HSIL or Greater Percentage Freq Percentage NILM 97.9 368 96.6 ASCUS 56.7 317 83.2 LSIL ... 251 65.9 ASC-H ... 217 57.0 Abbreviations: ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; Freq, frequency; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesion or malignancy. Table 7. Downgrade Rates Monitored for Cytotechnologists (N = 320) Cytotechnologist Pathologist Diagnosis Diagnosis NILM ASCUS Freq Percentage Freq Percentage ASCUS 232 72.5 ... ... ASC-H 258 80.6 158 49.4 LSIL 302 94.4 189 59.1 HSIL or greater 308 96.3 274 85.6 Cytotechnologist Pathologist Diagnosis Diagnosis ASC-H LSIL Freq Percentage Freq Percentage ASCUS ... ... ... ... ASC-H ... ... ... ... LSIL ... ... ... ... HSIL or greater 194 60.6 206 64.4 Abbreviations: ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; Freq, frequency; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesion or malignancy. Table 8. Additional Monitoring Characteristics Frequency Percentage In cases of a 2-grade or greater discrepant diagnosis between a pathologist and a cytotechnologist, how is the discrepancy most commonly resolved? The pathologist's diagnosis stands without 172 33.7 further action By reviewing the Papanicolaou test with 164 32.2 original cytotechnologist Discrepancies are shown to a second 126 24.7 pathologist Other 24 4.7 Discrepancies are shown to a second 23 4.5 cytotechnologist By HPV testing 1 0.2 There is a written laboratory policy specifying the process for resolution of a 2-grade discrepancy: Yes 252 49.5 No 257 50.5 In cases of a 1-grade or greater discrepant diagnosis between a pathologist and a cytotechnologist, how is the discrepancy most commonly resolved? The pathologist's diagnosis stands 350 68.5 without further action By reviewing the Papanicolaou test with 94 18.4 original cytotechnologist Discrepancies are shown to a second 37 7.2 pathologist Other 18 3.5 Discrepancies are shown to a second 10 2.0 cytotechnologist By HPV testing 2 0.4 There is a written laboratory policy specifying the process for resolution of a 1-grade discrepancy: Yes 129 25.2 No 383 74.8 Abbreviation: HPV, human papillomavirus. Table 9. For Pathologists, Are There Particular Cases for Which You Seek Additional Review Before Downgrading a Cytotechnologist Diagnosis? Frequency Percentage Yes 37 60 No 18 29 Unsure 7 11 Total 62 100 If Yes, for Which of the Following Diagnoses? (Check All That Apply) ASCUS 10 27 ASC-H 15 41 LSIL 7 19 HSIL 29 78 AGC 20 54 Abbreviations: AGC, atypical glandular cells of undetermined significance; ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion. Table 10. For Cytotechnologists, Are There Particular Cases for Which You Seek Additional Review Before Forwarding a Case on to a Pathologist? Frequency Percentage Yes 37 61 No 22 36 Unsure 2 3 Total 61 100 If Yes, for Which of the Following Cases? (Check All That Apply) ASCUS 16 46 ASC-H 15 43 LSIL 2 6 HSIL 9 26 AGC 20 57 Abbreviations: AGC, atypical glandular cells of undetermined significance; ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion. Table 11. Are Abnormal Interpretations Confirmed by Showing the Papanicolaou Test Slide to Another Individual Before Final Sign-Out? Frequency Percentage Yes 33 49 No 33 49 Unsure 1 1 Total 67 100 If Yes, for Which of the Following Diagnoses? (Check All That Apply) ASCUS 9 22 ASC-H 11 28 LSIL 4 10 HSIL 12 30 AGC 12 30 Individual cases at the 25 62 discretion of the pathologist only Abbreviations: AGC, atypical glandular cells of undetermined significance; ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion. Table 12. For Which Papanicolaou Test Findings (Other Than Abnormal and Reactive) Do You Require Pathologist Review? Frequency Percentage Benign endometrial cells 31 44 Unsatisfactory 41 59 Obscuring factors 10 14 Herpes 57 81 Individual cases at the 16 23 discretion of the pathologist only Other glandular 25 36 processes Other 20 29 Table 13. Consensus Good Laboratory Practice Statements: Monitoring Concordance of Cytotechnologist and Pathologist Interpretations Percentage 1a. Actively monitor rates at which a pathologist upgrades cytotechnologist interpretations before sign-out. A. Agree, NILM to SIL+ (negative to SIL or higher) 25.8 B. Agree, NILM to SIL+, also ASCUS to HSIL 25.8 C. Agree, A and B plus NILM to ASCUS 17.7 D. Agree, any upgrades to abnormal plus LSIL or 29.0 ASC-H to HSIL E. Do not monitor upgrades 1.6 1b. Revised statement: Actively monitor rates at which a pathologist upgrades cytotechnologist interpretations before sign-out. Definition of upgrades should be determined by the laboratory. Do you agree? A. Yes 79.7 B. No 15.3 C. Other 3.4 D. Other 1.7 2. Actively monitor rates at which a pathologist downgrades cytotechnologist interpretations before sign- out. Do you: A. Agree, HSIL+ or LSIL to NILM only 65.2 B. Agree, ASCUS+ (all abnormal) to NILM 10.1 C. Agree: all abnormal to NILM, and HSIL to ASC-H 14.5 or LSIL D. Do not monitor downgrades 10.1 3a. Show discrepancies of 2 degrees or more to a third person when possible. Do you: A. Strongly agree 62.5 B. Agree with reservations 29.2 C. Disagree 8.3 3b. Revised statement: Laboratories should have policies about which categories of discrepancies should be reviewed by a third individual before sign-out. Do you agree? A. Yes 73.7 B. No 22.8 C. Other 3.5 4. Some cases benefit from review by a third person even if not upgraded/downgraded (squamous). Which cases benefit from third-person review (squamous)? A. ASC-H and greater 19.7 B. HSIL and greater 18.3 C. Squamous cell carcinoma only 22.5 D. Not necessary 39.4 5. Some cases benefit from review by a third person even if not upgraded/downgraded (glandular). Which cases benefit from third-person review (glandular)? A. Both atypical glandular cells and adenocarcinoma 55.4 B. Adenocarcinoma only 15.4 C. Not necessary 27.7 D. Other 1.5 6a. Some cases benefit from routine review by a second person even if CLIA does not require confirmation by a pathologist. Which cases benefit from routine review by second person (cytotechnologist or pathologist) even if not required by CLIA? A. Herpes 4.0 B. Endometrial cells in women >40 y 0 C. Glandular cells in women post hysterectomy 2.7 D. B and C only (glandular processes) 16.2 E. All examples (A, B, C) 59.5 F. Not necessary routinely (only at the discretion 17.6 of the screener) 6b. Revised statement: Laboratories should have policies as to which cases benefit from review by a second person (cytotechnologist or pathologist), even if not required by CLIA. These may include: --Unsatisfactory --Endometrial cells in women >40 y --Glandular cells in women post hysterectomy --Herpes Do you agree? 90.7 A. Yes 9.3 B. No Abbreviations: ASC-H, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; ASCUS, atypical squamous cells of undetermined significance; CLIA, Clinical Laboratory Improvement Amendments of 1988; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesion or malignancy; SIL, squamous intraepithelial lesion. Table 14. Turnaround Time (TAT) Expectations Frequency Percentage Laboratory's expected Papanicolaou test TAT in business days 1 33 7.7 2 90 21.0 3-4 122 28.4 5-6 123 28.7 >7 61 14.2 Laboratory's median Papanicolaou test TAT in business days 1 60 15.2 2 109 27.5 3-4 163 41.2 5-6 40 10.1 >7 24 6.1 Table 15. Turnaround Time (TAT) Monitoring Frequency Percentage Which metric is used to measure TAT variance? (N = 491) (a) Percentile distribution within a 266 54.2 certain TAT Mean TAT 159 32.4 Percentage of cases deviating from 76 15.5 TAT expectation/standard Median TAT 61 12.4 Average length of deviation from 39 7.9 TAT expectation/standard Other 36 7.3 How frequently does the laboratory monitor Papanicolaou test TAT? Daily 104 20.4 Weekly 40 7.9 Monthly 237 46.6 Bimonthly 4 .8 Quarterly 59 11.6 Semiannually 13 2.6 Annually 23 4.5 Other 29 5.7 When does the clock start ticking for the TAT measurement? Date/time accessioned 297 57.2 Date/time received for processing 125 24.1 Date/time collected 76 14.6 Other 8 1.5 Date/time ordered by provider 7 1.3 Date/time received for screening 5 1.0 Date/time results submitted for 1 .2 reporting (a) Multiple responses were allowed. Table 16. Consensus Good Laboratory Practice Statements: Turnaround Time (TAT) in Gynecologic Cytology 1. Turnaround time should be monitored in gynecologic cytology. Do you agree? A. Yes: 80.3% B. No: 19.7% 2. We should not attempt to establish a universally acceptable TAT in gynecologic cytology. Do you agree? A. Yes: 90.1% B. No: 9.9% 3. Individual laboratories should determine how to measure/ define TAT. Do you agree? A. Yes: 74.3% B. No: 25.7% 4. Individual laboratories should determine the frequency of TAT monitoring. Do you agree? A. Yes: 98.6% B. No: 1.4% 5. Individual laboratories should determine the metric used to measure TAT variance. Do you agree? A. Yes: 91.3% B. No: 8.7%