Necessity of Clinical Information in Surgical Pathology
A College of American Pathologists Q-Probes Study of 771 475 Surgical
Pathology Cases From 341 Institutions
Raouf E. Nakhleh, MD; Gordon Gephardt, MD; Richard J. Zarbo, MD, DMD
● Objectives.—To examine the frequency and nature of
problems caused by inadequate clinical data provided on
surgical pathology requisition forms.
Design.—Participants in the 1996 Q-Probes voluntary
quality improvement program of the College of American
Pathologists were asked to document prospectively all surgical pathology cases with inadequate information. Inadequate clinical information was defined as the pathologist’s
need for additional clinical information before a diagnosis
could be rendered, regardless of the amount of information
already present on the requisition slip. Cases that had no
clinical information on a requisition slip were not counted
if the lack of history did not hinder diagnosis. The study
concluded when 3 months had elapsed or 40 surgical pathology cases were documented. The following data were
recorded for each case: anatomic site, type of procedure,
nature of disease, method of obtaining additional information, importance of obtained information, and the
length of delay in the final diagnosis.
Participants.—Three hundred forty-one laboratories, 322
of which were from the United States.
Results.—A total of 5594 cases (0.73%) required additional clinical information for diagnosis (10th through 90th
percentile range, 3.01% to 0.08%). Institutions with greater average occupied bedsize, a greater number of cases
accessioned per year, and a greater number of pathologists
had a lower percentage of cases with inadequate clinical
data (P , .05). Sixty-eight percent of these cases had no
delay in completion of a case, 16.2% had a delay of 1 day
or less, and 15.1% of cases were delayed more than 1 day.
In 59.4% of cases, the additional clinical information obtained confirmed the initial diagnostic impression. In
25.1%, the information was not relevant to the pathologic
diagnosis. In 6.1% there was a substantial change in the
diagnosis or a revised report was issued, and in 2.2% no
additional information could be obtained. Specific anatomic sites that correlated with a higher rate of changed diagnoses or revised reports in cases with inadequate information included the small bowel, the bronchus/lung, and
the ovary. Resection specimens were also significantly associated with a higher rate of changed diagnoses or revised
reports when additional information was obtained, as were
malignant neoplasms and therapy-induced changes.
Conclusions.—This study establishes an aggregate rate of
cases with inadequate clinical information for diagnosis
(0.73%) and documents the extent of problems caused by
inadequate clinical information. The criticality of appropriate clinical information provided to the pathologist is
identified for specific anatomic sites and disease processes
and is reflected in changed diagnoses or revised reports.
(Arch Pathol Lab Med. 1999;123:615–619)
T
College of American Pathologists (question 08.1105 of the
1998 Laboratory Checklist) and the Joint Commission on
Accreditation of Healthcare Organizations 1998 Standard
QC.2.1.1.2,3 Both standards require that each surgically removed specimen is accompanied by pertinent clinical information and, to the degree known, by the preoperative
and postoperative diagnosis.
In a previous Q-Probes study concerning surgical pathology specimen identification and accessioning,4 we noted that no clinical history or clinical diagnosis was present
on requisition slips in 2.4% of cases. In the current study,
we examine the effects of inadequate clinical information.
Our focus, however, is on cases in which the pathologist
felt that more clinical information was necessary to render
an appropriate diagnosis, regardless of the information
that was present on the requisition slip. Therefore, the deficiency rate differs from the previous Q-Probes study.4
Our aims are to (1) define the magnitude of the problem,
(2) determine problematic organ systems or types of specimens where clinical information is essential for accurate
diagnosis, (3) assess delay in diagnosis attributed to this
lack of communication, (4) evaluate the methods of obtaining additional information, and (5) correlate these data
o our knowledge, there have been no studies examining the nature and extent of diagnostic and reporting
problems occurring secondary to lack of information in
surgical pathology. As Juan Rosai, MD, eloquently stated:
By its very nature, surgical pathology depends heavily on the
input of clinicians and surgeons who are fully aware of the potentials and limitations of the specialty. They should know that
a microscopic diagnosis is a subjective evaluation that acquires
full meaning only when the pathologist is fully cognizant of the
essential clinical data, surgical findings and type of surgery. The
requisition slip for pathological study should ideally be completed by a physician familiar with the case. . . .1
These principles are understood in surgical pathology
and are satisfied by the majority of clinical physicians.
They are codified in the laboratory accreditation standards
outlined by the Laboratory Accreditation Program of the
Accepted for publication February 15, 1999.
From the Departments of Pathology, Henry Ford Hospital, Detroit,
Mich (Drs Nakhleh and Zarbo) and Promina Kennestone Hospital, Marietta, Ga (Dr Gephardt).
Reprints: Raouf E. Nakhleh, MD, Department of Pathology, Henry
Ford Hospital, 2799 W Grand Blvd, Detroit, MI 48202.
Arch Pathol Lab Med—Vol 123, July 1999
Clinical Information in Surgical Pathology—Nakhleh et al 615
Table 1. Association of 3 Practice Characteristics With the Rate of Requisitions Lacking Adequate Clinical Information
Percentage of Cases Lacking Adequate Clinical Data, All Institutions Percentiles
No. of
Institutions
10th
25th
50th
(Median)
75th
90th
All laboratories
341
3.01
1.57
0.62
0.22
0.08
Occupied bedsize
1–150
151–300
.300
106
120
78
4.38
2.29
2.30
2.30
1.31
1.12
0.97
0.60
0.38
0.40
0.17
0.21
0.07
0.07
0.08
No. of surgical pathology cases accessioned in 1995
0–5000
92
5.80
5001–9000
97
2.52
9001–13 000
70
2.86
.13 000
82
2.00
2.41
1.38
1.21
0.73
1.27
0.70
0.55
0.35
0.43
0.16
0.21
0.17
0.14
0.06
0.07
0.10
No. of full-time equivalent pathologists
0.0–1.9
62
2.0–2.9
87
3.0–3.9
66
4.0–4.9
53
$5.0
73
2.56
1.96
1.24
1.02
0.80
1.13
0.87
0.47
0.65
0.38
0.38
0.27
0.12
0.15
0.22
0.10
0.07
0.00
0.10
0.10
4.45
3.12
2.71
1.94
2.46
with practice parameters for peer group comparison and
benchmarking.
changes in diagnosis or a revised report. Statistical significance
was assumed for P , .05 for all of these analyses.
METHODS
RESULTS
In 1996, 341 participants in the College of American Pathologists voluntary subscription quality improvement program, QProbes, prospectively documented all surgical pathology cases in
which the requisition slip failed to provide adequate clinical data.
The Q-Probes format for data collection and handling has been
described in detail previously. Cases were considered to have
inadequate clinical data on the requisition slip if the pathologist
required additional clinical information before a diagnosis could
be made, regardless of the amount of information already present. Cases that had no clinical information on a requisition slip
were not counted if the lack of history did not prevent the rendering of a diagnosis and the sign-out of the case. The data collection period lasted for 3 months or until data were collected on
40 surgical pathology cases that required additional clinical information, whichever occurred first. The following data were recorded for each case: (1) anatomic site of specimen, (2) type of
procedure used to obtain the specimen, (3) the nature of the disease, (4) method of obtaining additional information, (5) the importance of the clinical information obtained, and (6) the length
of delay in the final diagnosis due to the need for additional
clinical information. Participants selected answers to these various parameters from a predetermined menu of items. Participants also completed a questionnaire regarding their surgical pathology practices, including the surgical pathology volume accessioned by the laboratory in 1995, the number of cases accessioned during the study period, the number of full-time
equivalent surgical pathologists, whether space was available on
the requisition slip for clinical history, whether special requisitions were used for specific organs, whether specific policies existed requiring that clinical information be included on requisition forms, and how this policy was enforced.
Univariate nonparametric Wilcoxon and Kruskal-Wallis analyses were used to test for a difference in the distribution of the
rate of inadequate clinical information with respect to multiple
variables. A semiparametric multiple regression analysis was
performed to determine which combinations of variables were
significantly associated with the ranked values of the rate of inadequate clinical information. Fisher exact tests were performed
to test whether proportions were significantly different for 2
groups, namely, the overall number of surgical pathology cases
and the cases in which additional information led to substantial
Of the 341 institutions that submitted data for this
study, 322 were from the United States, 7 from Canada, 5
from the United Kingdom, 2 from Australia, and 1 each
from Hong Kong, Belgium, and New Zealand. Eighty-four
percent reported that their laboratories were accredited by
the College of American Pathologists, and 69% were accredited by the Joint Commission on Accreditation of
Healthcare Organizations. The average occupied bedsizes
of participating institutions were categorized as follows:
1–150 beds (34.8%), 151–300 beds (39.3%), 301–450 beds
(14.8%), 451–600 beds (5.6%), and more than 600 beds
(5.6%). Private nonprofit organizations accounted for
65.8% of the institutions; 7.5% were private, for profit;
4.0% were independent laboratories; 3.1% were university
hospitals; 18.9% were governmental (county, 5.6%; city,
3.4%; state, 1.9%; veterans, 4.0%; armed forces, 1.2%); and
1.9% were from other nongovernmental organizations.
City hospitals accounted for 61.5%, 21.7% were suburban,
15.2% rural, 1.2% federal, and 0.3% were other. A total of
34.1% considered themselves to be teaching hospitals,
65.9% did not, and 16.8% had a pathology residency program.
During the study period, participants accessioned and
signed out a total of 771 475 surgical pathology cases. Of
these, 5594 (0.73%) required additional clinical information before the case could be completed. The median institutional rate of cases with inadequate clinical information for diagnosis was 0.62%, the rate at the 10th percentile
was 3.01%, and at the 90th percentile, 0.08%. The highest
rate of cases with inadequate clinical information was
20%.
Three factors showed a significant inverse relationship
with the rate of requisitions lacking adequate clinical information. Institutions with greater average occupied bedsize, a greater number of cases accessioned per year, and
a greater number of pathologists in the practice all had
lower percentages of cases lacking adequate clinical data
616 Arch Pathol Lab Med—Vol 123, July 1999
Clinical Information in Surgical Pathology—Nakhleh et al
(Table 1). Multiple practice characteristics were not associated with the rate of surgical pathology requisitions lacking adequate clinical information, including using special
requisition slips for certain anatomic sites or organs, allowing sufficient space on requisition slips for clinical history, and having a policy requiring clinical information
before sign-out.
A written departmental policy requiring documentation
of clinical history on the requisition slip before sign-out
of the case was in place in 60.7% of the institutions. Enforcement of this policy was accomplished by various
mechanisms, including telephoning the appropriate nurse
or physician for the missing information (16 institutions),
specimens rejected and returned to the submitting physician for completion (23 institutions), documentation or
report to a quality assurance committee or surgical case
review committee (26 institutions), and other multiple responses in 42 institutions. The remaining 100 institutions
did not respond to this question.
In the assessment of reporting delay associated with obtaining additional clinical information required for diagnosis, 32% of cases were judged to have been delayed;
15.1% of cases experienced a delay of more than 1 day.
The vast majority (68%) had no delay, and 16.2% experienced a delay that was 1 day or less.
The most common method of obtaining additional clinical information was through direct communication with
the physician (49.6%), followed by obtaining information
through a computerized medical information system
(11.9%), communication with nursing (10.5%), previous
surgical pathology reports (8.0%), communication with
other health care personnel (5.8%), chart review (5.3%),
and other (8.9%).
In 59.4% of cases the additional clinical information confirmed the initial diagnostic impression, and in 25.1% of
the cases it was not relevant to the pathologic diagnosis.
In 4.2% of the cases the diagnosis was substantially
changed because of the additional clinical information,
and a revised report was issued in 1.9% of cases. Thus,
6.1% of cases that required additional clinical information
for diagnosis were substantially changed or a revised report was issued once the adequate information was obtained. In 2.2% of cases no additional information could
be obtained. In 7.2% of cases the response was ‘‘other’’.
Two practice characteristics were found to be statistically associated with the impact of the additional clinical
information on the diagnosis. Institutions with a greater
number of surgical pathology cases accessioned in 1995
had a significant association with an increased percentage
of cases in which the additional clinical information
helped to confirm the initial diagnosis (P 5 .0104). A
greater number of surgical pathology cases accessioned in
1995 (P 5 .0015) and a greater number of full-time equivalent pathologists (P 5 .0031) were significantly associated
with a greater percentage of cases in which the obtained
information led to a substantial change in diagnosis.
Anatomic sites significantly associated with a changed
diagnosis or a revised report included the small bowel,
the bronchus/lung, and the ovary (Table 2). Resections
and segmental resections were also significantly associated with a higher rate of changed diagnoses or revised
reports (Table 3), as were 2 disease conditions, malignant
neoplasms and therapy-induced changes (Table 4). For
cases in which the specimen was obtained through biopsies and curettings, significantly more cases with inadeArch Pathol Lab Med—Vol 123, July 1999
Table 2. Frequency of Cases in Which Requested
Clinical Information Led to a Change in Diagnosis or
Preparation of a Revised Report, According to
Anatomic Site (n 5 5473 cases)
Anatomic Site
Urethra
Breast (male)
Mediastinum
Ovary*
Small bowel*
Pleura
Fallopian tube
Bronchus/lung*
Penis
Anus
Muscle
Esophagus
Ear/nose/throat (larynx)
Thyroid
Other urinary
Testis
Other female genital
Oral cavity
Bladder
Liver
Soft tissue
Appendix
Uterus
Skin
Large bowel
Breast (female)
Bone/joint
Kidney
Stomach
Not on list provided
Central nervous system
Gallbladder
Prostate
Blood vessel
Lymph node
Endometrium
Other gastrointestinal tract
Bone marrow
Omentum/peritoneum
Placenta
Cervix
Thymus
Myometrium
Ureter
Adrenal gland
Parathyroid
Biliary tree
Peripheral nerve
Pancreas
Spleen
Other male genital
Total
* Significant at P , .05.
No. of
Cases
6
13
20
47
146
45
28
237
10
30
31
116
119
37
25
25
103
65
65
263
194
43
123
725
407
263
243
57
171
287
64
69
141
25
158
268
85
199
34
130
271
8
3
5
7
7
1
4
9
18
23
5473
No. of Cases
With Changed
Diagnosis or
Revised Report
(%)
1
2
3
7
17
5
3
24
1
3
3
11
10
3
2
2
8
5
5
19
14
3
8
42
23
15
13
3
9
14
3
3
6
1
6
10
3
6
1
2
3
0
0
0
0
0
0
0
0
0
0
322
(16.7)
(15.4)
(15.0)
(14.9)
(11.6)
(11.1)
(10.7)
(10.1)
(10.0)
(10.0)
(9.7)
(9.5)
(8.4)
(8.1)
(8.0)
(8.0)
(7.8)
(7.7)
(7.7)
(7.2)
(7.2)
(7.0)
(6.5)
(5.8)
(5.7)
(5.7)
(5.3)
(5.3)
(5.3)
(4.9)
(4.7)
(4.3)
(4.3)
(4.0)
(3.8)
(3.7)
(3.5)
(3.0)
(2.9)
(1.5)
(1.1)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(5.9)
quate clinical information were found to result in a
changed diagnosis or a revised report if a malignant neoplasm or therapy-induced change was present (Table 5).
Cases in which the specimen was obtained through resection procedures were also significantly more likely to result in a changed diagnosis or revised report if a malignant neoplasm was involved (Table 6).
Clinical Information in Surgical Pathology—Nakhleh et al 617
Table 3. Frequency of Cases in Which Requested
Clinical Information Led to a Change in Diagnosis or
Preparation of a Revised Report, According to Type of
Procedure
No. of
Cases
Endoscopic biopsy
Incisional biopsy
Needle biopsy
Excisional biopsy
Not specified
Curettings
Forceps
Total biopsies and
curettings
Segmental resection*
Resection*
Total resections*
Other
Unknown
All procedures
726
295
615
1005
744
347
67
3799
176
811
987
448
117
5351
No. of Cases
With Changed
Diagnosis or
Revised Report
(%)
54
21
33
54
35
12
2
(7.4)
(7.1)
(5.4)
(5.4)
(4.7)
(3.5)
(3.0)
211 (5.6)
21 (11.9)
69 (8.5)
90 (9.1)
20 (4.5)
1 (0.9)
322 (6.0)
* Significant at P , .05.
Table 4. Frequency of Cases in Which Requested
Clinical Information Led to a Change in Diagnosis or
Preparation of a Revised Report, According to Nature
of Disease Process
Nature of Disease Process
Therapy-induced change*
Malignant neoplasm*
Inflammation, immunologic disease, or infection
Benign neoplasm
Other
Benign prolifeation/
hyperplasia
Hereditary/congenital disease
Unknown
Premalignant neoplasia
Metabolic disease
Total
* Significant at P # .05.
No. of
Cases
No. of Cases
With Changed
Diagnosis or
Revised Report
(%)
164
1092
18 (11.0)
105 (9.6)
1270
375
884
84 (6.6)
21 (5.6)
41 (4.6)
752
28
462
282
34
5343
30
1
13
8
0
321
(4.0)
(3.6)
(2.8)
(2.8)
(0.0)
(6.0)
COMMENT
In his article ‘‘Limitations of Histologic Diagnosis,’’
Rambo6 states:
Because of certain nineteenth century dogmas and because the
teaching of pathology used to be relegated primarily to the longforgotten preclinical phase, pathologists traditionally have been
regarded to be more scientific than many of their colleagues. A
mystic perversion of this assumption prevails among those clinicians who believe that the pathologists, given only a piece of a
patient’s tissue, have all the other ingredients necessary to produce
a statement of absolute truth at the end of his report. More dangerous to mankind is a pathologist with the same concept. . . .
Incomplete communication between the clinician and the pathologist may make diagnosis difficult or impossible. To perform
intelligently, a consultant must know all the facts that have any
bearings on the case. To render a diagnosis of an inherently puz618 Arch Pathol Lab Med—Vol 123, July 1999
Table 5. Frequency of Cases With Biopsy Procedures
in Which Requested Clinical Information Led to a
Change in Diagnosis or Preparation of a Revised
Report, Divided by Nature of Disease Process
Nature of Disease Procedure
Therapy-induced change*
Malignant neoplasm*
Inflammation, immunologic disease, or infection
Benign neoplasm
Other
Benign proliferation/
hyperplasia
Premalignant neoplasia
Unknown
Hereditary/congenital disease
Metabolic disease
Total
* Significant at P # .05.
No. of
Cases
No. of Cases
With Changed
Diagnosis or
Revised Report
(%)
127
784
15 (11.8)
61 (7.8)
923
283
482
59 (6.4)
16 (5.7)
22 (4.6)
608
241
270
13
26
3757
22
7
6
0
0
208
(3.6)
(2.9)
(2.2)
(0.0)
(0.0)
(. . .)
Table 6. Frequency of Cases With Resection
Procedures in Which Requested Clinical Information
Led to a Change in Diagnosis or Preparation of a
Revised Report, Divided by Nature of Disease Process
Nature of Disease Procedure
Malignant neoplasm*
Inflammation, immunologic disease, or infection
Hereditary/congenital disease
Unknown
Other
Therapy-induced change
Benign proliferation/
hyperplasia
Premalignant neoplasia
Benign neoplasm
Metabolic disease
Total
* Significant at P , .05.
No. of
Cases
No. of Cases With
Changed Diagnosis
or Revised Report
(%)
254
37 (14.6)
248
12
67
166
28
21
1
5
12
2
(8.5)
(8.3)
(7.5)
(7.2)
(7.1)
99
15
82
5
976
7
1
4
0
90
(7.1)
(6.7)
(4.9)
(0.0)
(. . .)
zling bit of tissue with only vague knowledge of its source and
no concept of the clinical problem is as foolhardy as to undertake
an appendectomy on the basis of hearsay evidence that the patient had a pain in his belly.
Published in 1962, these words faithfully echo the essence of this study.6
In this Q-Probes study we examined the extent and severity of problems arising from inadequate clinical information, and to our knowledge, this is the first multi-institutional study of its kind. Using this multi-institutional
design, we have established the magnitude of the problem
(0.73% of cases), which may serve as a benchmark applicable for future comparisons in quality improvement programs. We have also demonstrated that smaller hospitals
and smaller laboratories tend to have higher rates of cases
with inadequate clinical information than larger hospitals
and laboratories. This is important for peer group comparisons. The difference may be due to the more general
nature of practice in a smaller hospital and to a lack of
Clinical Information in Surgical Pathology—Nakhleh et al
specific clinical specialists and pathologist ‘‘experts’’ in
various organ systems who form close working relationships with small groups of clinicians. It may also be postulated that additional clinical information may be less of
an issue in larger hospitals and in multipathologist groups
staffed by subspecialized pathologists, who have enhanced diagnostic abilities and a more in-depth understanding of disease processes and clinical situations in
specific clinical areas.7 This is best exemplified in settings
in which the pathologist is an integral part of a clinical
treatment team, where knowledge is shared on a continual
basis. A multipathologist group is also more likely to have
routine intradepartmental consultation between members.8
Larger laboratories were also associated with a higher
percentage of cases in which obtained clinical information
helped confirm the initial diagnosis and led to a changed
diagnosis. In other words, the additional information was
more often useful. While the reasons for these findings
are not clear, some of the characteristics of larger groups
may also contribute to the pathologist’s ability to find useful clinical information more often.
Another aim of the study was to identify anatomic sites
for which additional clinical information was more likely
to lead to a change in diagnosis. We identified 3 organ
systems (small bowel, lung, and ovary) that were more
often associated with a change in diagnosis or a revised
report when additional clinical information was obtained.
In addition, resection specimens were more likely to lead
to a changed diagnosis or a revised report if additional
information was obtained. Furthermore, cases involving
malignant neoplasms and therapy-induced changes had
significantly higher rates of changed diagnoses or revised
reports when additional information was obtained. The
reasons that these characteristics were associated with a
revised report or changed diagnosis were not specifically
evaluated in this study and are likely to be multifactorial.
From our own experience, therapy-induced changes in biopsy tissue best exemplifies the pathologist’s need for clinical information. In numerous conditions (eg, inflammatory bowel disease, prostate cancer, and allograft rejection), therapy has been shown to change the histologic
appearance of the lesion and may lead to an improper
diagnosis.9–11
Recently, several articles have highlighted the role of
inadequate clinical information contributing to diagnostic
errors and amended reports in surgical pathology. In a
College of American Pathologists Q-Probes study addressing specimen identification and accessioning, 2.4% of
cases submitted to surgical pathology had no clinical history provided on the requisition slip at all.4 In a subsequent Q-Probes study, which quantitated amended surgical pathology reports, it was noted that 10% of the
amended reports resulted directly from additional clinical
information unknown to the pathologist at the time of
Arch Pathol Lab Med—Vol 123, July 1999
original sign-out. An additional 20% of cases came to the
pathologist’s attention because of a clinicopathologic discrepancy recognized by the clinician.12 In our practice,
when clinicians ask for a review of a case, they usually
bring additional clinical information to the pathologist.
Inadequate clinical information has also been the underlying cause of malpractice claims brought against pathologists. In a review of 53 pathology malpractice claims,
Troxel and Sabella13 documented that failure to obtain all
relevant information (which often is not provided on the
pathology request slip) contributed to one fifth of the diagnostic errors (11 cases). Similarly, McBroom and Ramsay14 noted that clinical information affected 7.5% of surgical pathology reports that were amended during review
of cases for clinicopathologic conferences. They also pointed out that a significant proportion of cases that were
amended were the result of the special expertise of the
pathologists reviewing these cases. This expertise very
likely reflects the expert’s enhanced visual diagnostic ability and also reflects his or her knowledge of the clinical
disease process occurring in the particular area of interest.7,8 In other words, a full understanding of the clinical
picture optimizes the pathologist’s ability to see his or her
way to the most accurate diagnosis. As Goethe said, ‘‘you
only see what you know.’’
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