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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.

Monitoring
interpretive
   also in·ter·pre·ta·tive
adj.
Relating to or marked by interpretation; explanatory.



in·terpre·tive·ly adv.
 rate categories for Papanicolaou tests (Pap
tests), concordance of
cytotechnologist

n.
A technician trained in medical examination and identification of cellular abnormalities.



cytotechnologist

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
gynecologic
 /gy·ne·co·log·ic/ () () pertaining to the female reproductive tract or to gynecology.
 
cytology
 , in biology, the study of the structure of all normal and abnormal components of cells and the changes, movements, and transformations of such components.
. These
quality assurance measures were evaluated as part of a larger project by
the
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
Amendments

 of 1988 (
CLIA
 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
in tandem

 to identify
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
abnormality
 /ab·nor·mal·i·ty/ ()
1. the state of being abnormal.

2. a malformation.


n.
 identified on
the
Pap test
  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
concordance/
discordance
 /dis·cor·dance/ () the occurrence of a given trait in only one member of a twin pair.discor´dant


n.
 of cytotechnologist and pathologist
interpretations should be used as a metric. Other questions are how and
when to
adjudicate
,
v
 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 (
TAT

abbr.
Thematic Apperception Test



TAT

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
debatable
  
adj.
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.

METHODS

The CAP, with support from the
Centers for Disease Control and
Prevention

 (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.
 (
CDC

), 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
Cytotechnology
  
n.
A technician trained in medical examination and identification of cellular abnormalities.



cy
, and
the American Society of
Clinical Pathology

n.
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
United States
 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
Rosemont, Illinois
 (41.990730, -87.873816)GR1.
, on June 4, 2011.
Participants in the conference included working group members,
representatives from national cytopathology and cytotechnology
organizations,
Centers for Medicare and Medicaid Services

 (
CMS

), the
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
questionable. The
stratified
 /strat·i·fied/ () formed or arranged in layers.


adj.
Arranged in the form of layers or strata.
 consensus responses were
categorized
  
tr.v. cat·e·go·rized, cat·e·go·riz·ing, cat·e·go·riz·es
To put into a category or categories; classify.



cat
 as
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
evidenced-based practices.

RESULTS

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,
interpretative
  
adj.
Variant of interpretive.



in·terpre·ta
 rates would be
expected to vary among laboratories. For example, CAP benchmarking data
from 2006 showed that the rate of low-grade
squamous intraepithelial
lesion


A term used to categorize the severity of abnormal changes arising in the squamous, or outermost, layer of the cervix.
 (
LSIL
 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 (
HSIL
 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

atypical
 /atyp·i·cal/ () irregular; not conformable to the type; in microbiology, applied specifically to strains of unusual type.


adj.
 
squamous cells

Thin, flat cells on the surfaces of the skin and cervix and linings of various organs.

Mentioned in: Cervical Cancer
 of undetermined significance (
ASCUS

n. pl. as·ci
A membranous, often club-shaped structure in which typically eight spores are formed through sexual reproduction of ascomycetes.



ascus

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 (ASCUS:
SIL

 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
surrogate marker
 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
 for inadequate
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

n.
Dysplastic changes beginning at the squamocolumnar junction in the uterine cervix that may be precursor to squamous cell carcinoma.
 grade 2+.
(6) Therefore, benchmarking data without data correlating it to quality
outcomes can be
deceptively
  
adv.
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.
 reassuring.

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
more study.

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
implementation of
human papillomavirus
 (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.
 (
HPV
 human papillomavirus.


abbr.
human papilloma virus


 
) testing or review of HPV
results.

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
glandular
 /glan·du·lar/ ()
1. pertaining to or of the nature of a gland.

2. glanular.


adj.
1.
 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
endometrial
 /en·do·me·tri·al/ () pertaining to the endometrium.



n relating to the end-ometrium or cavity of the uterus.
 cells in
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
postmenopausal

adj.
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
 or having
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
cytologic

 criteria; 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 (
CYP

.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
discrepant
  
adj.
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.
Adjudication

 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
malignancy
 see cancer.
 (
NILM

) 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
second person.

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
downgrading

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
 a cytotechnologist
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
herpes

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
Actinomyces
 /Ac·ti·no·my·ces/ () a genus of bacteria (family Actinomycetaceae).



Actinomyces israe´lii
, 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

downgrade

 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
written survey
relating to
 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
clinician
 /cli·ni·cian/ () an expert clinical physician and teacher.


n.
 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
receiving
colposcopy
 Definition

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
litigation

. The voting at the
consensus conference reflects the awareness of difficulties in detecting
glandular lesions. Only 27.7% thought it unnecessary to show a

premalignant
 /pre·ma·lig·nant/ () precancerous.


adj.
Precancerous.



premalignant

precancerous.
 or malignant glandular lesion to a third person, whereas
39.4% thought this was not needed for similarly severe
squamous
 /squa·mous/ () scaly or platelike.



 or squa·mose
adj.
1. Covered with or formed of scales; scaly.

2.
 lesions
(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
hysterectomy
 , 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
herpes
simplex virus


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
early repeat
according to

prep.
1. As stated or indicated by; on the authority of:

2. In keeping with:

3.
 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
having
menstrual
 /men·stru·al/ () pertaining to the menses or to menstruation.



 or men·stru·ous
adj.
Of or relating to menstruation.
 cycles and are
asymptomatic

adj.
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
additional review.

Turnaround Time

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

biannually
  
adj.
1. Happening twice each year; semiannual.

2. Occurring every two years; biennial.



bi·an
. 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

finalized

. 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
starting point

 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
misinformation
  
tr.v. mis·in·formed, mis·in·form·ing, mis·in·forms
To provide with incorrect information.



mis
 for the
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.

COMMENT

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
proscriptive
  
n.
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
to
proscribe
  
tr.v. pro·scribed, pro·scrib·ing, pro·scribes
1. To denounce or condemn.

2. To prohibit; forbid. See Synonyms at forbid.

3.
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
proscribed

 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/
Agency for
Toxic Substances and Disease Registry

. The authors would like to
acknowledge Barbara Blond, MBA, MT(
ASCP
 American Society of Clinical Pathologists.
) for her many contributions to
this project.

References

(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.
2013;137(2): 158-163.

(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.
2010;134(3):331-335.

(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.
1994;38(3):291-298.

(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,
Auger
 : see drill.


auger

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
carcinogenic

 human papillomavirus (HPV)
testing and HPV16 or HPV18
genotyping

 for
cervical cancer
 Definition

Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors.
 screening of
women aged 25 years and older: a subanalysis of the ATHENA study. Lancet
Oncol. 2011;12(9):880-890.

(7.) Kapali M, Agaram NP, Dabbs DJ, Kanbour A, White S, Austin RM.
Routine endometrial sampling of asymptomatic
premenopausal

adj.
Of or relating to the years or the stage of life immediately before the onset of menopause.


 adjective
 women
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,
De Saussure

 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.
2009;53(6):653-658.

(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
DNA chip

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
gene chip
 test for the
detection of high-grade cervical lesions. Int J Gynecol Cancer.
2009;19(5):924-928.

(13.) Davey DD, Cox JT, Austin RM, et al. Cervical cytology
specimen adequacy: patient management guidelines and optimizing specimen
collection. J Lower
Genital Tract

n.
The genital passages of the urogenital system.



The organs involved in reproduction.
 Dis. 2008;12(2):71-81.

(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.
1998:19(5):321-322.

Karen M.
Clary
 see sage.
, 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,
SCT

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,

Rochester, New York

 (Dr Clary);the Department of Clinical Sciences,

University of Central Florida

, and Orlando Veterans Administration
Medical Center,
Orlando, Florida

 (Dr Davey); the Department of
Pathology,
Mercy Health System

,
Janesville, Wisconsin

 (Dr Naryshkin);
the Department of Pathology, Magee-Womens Hospital,
University of
Pittsburgh Medical Center

,
Pittsburgh, Pennsylvania
) 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,
Northfield, Illinois
 (42.
; the Division of
Cytopathology, Hofstra Northshore Long Island Jewish School of Medicine,

New Hyde Park, New York

 (Ms Sugrue); and the Department of Pathology, St
Joseph
Mercy Hospital

,
Ann Arbor, Michigan

 (Dr Tworek).

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
Disease
Registry

 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
regulations.

Reprints: Karen M. Clary, MD, Department of Pathology, Rochester
General Hospital, 1425 Portland Ave, Rochester, NY 14621 (e-mail:
karen.clary@rochestergeneral.org).

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%

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