CAP Laboratory Improvement Programs
Surgical Pathology Specimens for Gross Examination
Only and Exempt From Submission
A College of American Pathologists Q-Probes Study of
Current Policies in 413 Institutions
Richard J. Zarbo, MD, DMD, Raouf E. Nakhleh, MD
● Objective.—To survey the scope of current written institutional policies for types of surgical pathology specimens exempt from submission to the laboratory and those
that may be examined by gross inspection only.
Design and Setting.—In the first quarter of 1997, a total
of 413 voluntary participant institutions enrolled in the
College of American Pathologists Q-Probes quality improvement program completed a checklist of 115 proffered
specimens. Also included was a questionnaire defining demographic, practice, and reimbursement variables.
Main Outcome Measures.—The number and types of
specimens exempt from submission and submitted for gross
examination only based on written institutional policy
rather than on unapproved actual practices.
Results.—Most institutions had a written policy for types
of specimens deemed exempt from submission to pathol-
ogy (87.1%) and for types of specimens subject to gross
examination only (76.6%). There was a wide range of numbers of specimen types with a median number of 17 (range,
2–40) in the exempt category and 29 (range, 6–57) in the
category of gross examination only. Significantly higher absolute counts of specimens exempt from submission to pathology were reported by institutions with a greater surgical pathology volume in 1996 and by nonteaching institutions. No aspect of practice was associated with numbers
of specimens for gross examination only.
Conclusions.—This Q-Probes study creates a multi-institutional reference database of current practices to assist
pathologists and clinical staff in the development of written guidelines pertaining to surgical pathology specimen
submission exceptions and gross-only examinations.
(Arch Pathol Lab Med. 1999;123:133–139)
A
Accepted for publication August 21, 1998.
From the Department of Pathology, Henry Ford Hospital, Detroit,
Mich.
Reprints: Richard J. Zarbo, MD, DMD, Department of Pathology,
Henry Ford Hospital, 2799 W Grand Blvd, Detroit, MI 48202.
agnosis can be made, and that all specimens, except those
identified by the clinical staff . . . , are routinely sent to a
pathologist for evaluation.’’ 2 The latter, part of the Leadership and Histopathology Standards, require that ‘‘the
pathologist and the clinical staff jointly determine and
document in writing which categories of surgical specimens usually require only a gross description and diagnosis’’ and that ‘‘the clinical staff, in consultation with a
pathologist, decides the exceptions to submitting specimens removed during a surgical procedure to the laboratory.’’ 2
In our experience, the bases on which these consultative
decisions are made range from anecdote, to peer pressure,
to recommendations published by the Surgical Pathology
Committee of the College of American Pathologists,3 and
to the more recent issue of cost and the potential to trim
health care expenditures. In fact, there is minimal evidence-based data that evaluate actual health outcomes related to exempt status or gross-only examination policies
for specific specimens. Moreover, the clinical contexts in
which the specimens are removed are often unknown.
Therefore, we have undertaken this Q-Probes study to survey the scope of current written policies in participating
laboratories so that this multi-institutional database may
be weighed in future decision making. It is our intent to
Arch Pathol Lab Med—Vol 123, February 1999
Submission of Surgical Pathology Specimens—Zarbo & Nakhleh 133
s incomprehensible as it may seem, there was a time
in the United States when a surgeon practicing within the standard of care could toss an excised pigmented
lesion in the trash, forgoing the now-expected diagnostic
procedure of pathologic assessment. In 1926 the Minimum
Standard for hospitals was published by the American
College of Surgeons to include ‘‘that all tissues removed
at operation shall be examined in the laboratory and reports rendered thereon.’’ 1 Over the ensuing years, pathologic evaluation of excised tissues became the standard
of care, no matter where the surgical procedure is performed. In 1998, the successor health care accrediting
body, the Joint Commission on Accreditation of Healthcare
Organizations, affirmed that original standard of 1926, requiring that ‘‘specimens removed during a surgical procedure are ordinarily sent to a pathologist for evaluation.’’
They further clarified this position by requiring that
‘‘specimens removed during surgery need to be evaluated
for gross and microscopic abnormalities before a final di-
provide pathologists and clinicians with peer comparison
data in order for them to better place in context clinical
requests to change current institutional policies regarding
these specimens.
Table 1. Gross Examination Practices in Participating
Institutions
MATERIALS AND METHODS
In actual practice, which personnel, in addition to a pathologist, perform gross examination and description of specimens
that require gross examination only?
(multiple responses allowed)
This Q-Probes quality improvement study was conducted in
the first quarter of 1997 with a data collection protocol and tools
as previously described.4,5 Each voluntarily participating institution completed a checklist of 115 proffered specimens, categorized by surgical specialty (general and plastic surgery, gynecology, ophthalmology, otorhinolaryngology, oral surgery, orthopedics, pediatric surgery, urology, and vascular surgery) to indicate
whether the specimens were considered exempt from submission
to the pathology laboratory and whether they could be examined
by gross inspection only. Participants were asked to respond only
if these practices were based on written institutional policy rather
than on unapproved actual practices. Institutions that did not
have a written policy of these specimens indicated such and did
not complete the remainder of the checklist.
We derived the list of specimen types in this Q-Probes study
from an informal survey of current practices. It was by no means
a recommendation for policy implementation but rather a research tool to ascertain the frequency of current written practices.
Further analysis of data in this study was performed based on
questionnaire responses related to demographic, practice, and reimbursement variables to identify any associations with the number of specimen types identified. Pathology groups that provide
surgical pathology services for several institutions with different
specimen submission practices replied based on the largest practice setting served.
The following definitions of terms were provided: Capitated payment arrangement refers to a method of prepayment for health care
services by which a provider accepts a fixed amount of money
per health plan member per month in return for providing a
specific list of services to the members over a specified number
of months. Thus, this contractual arrangement is negotiated for
reimbursement based not on actual work performed but on a
preset fee for members of managed care organizations.6 Exempt
from submission refers to specific tissue for which pathology laboratory examination after surgery is not required and/or for
which no laboratory report is generated, according to written institutional policy. Governmental care organization refers to US and
non-US health care organizations in which governmental agencies act as the insurer and provider of health care services (eg,
US Veterans Affairs Medical Centers, federal, state, local, county,
and charitable hospitals, National Health Service of Canada, National Health Service in the United Kingdom). Gross examination
refers to the macroscopic examination of specific tissues, for
which a laboratory report is generated, according to written institutional policy. The examination may include dissection but
not submission of tissue for microscopic examination. However,
at the pathologist’s discretion, tissue may be submitted for microscopic examination. Managed care is a term originally used for
prepaid health care, for example, care provided by a health maintenance organization. The definition has been broadened to include any exclusive network of health care providers who contract to provide quality, cost-effective health care, including that
offered by a preferred provider organization and indemnity insurance coverage that incorporates preadmission certification and
other utilization controls.6 Managed care organization is an organization such as a health maintenance organization, independent
practice association, preferred provider organization, or point-ofservice program that manages health care services to contain
costs.
RESULTS
Institutional Characteristics
A total of 413 institutions participated in this study, 401
(97.1%) from the United States and the remainder from
134 Arch Pathol Lab Med—Vol 123, February 1999
Variable
No. (%) of
Institutions
Pathologist assistant
118 (44.7)
Resident or fellow (pathologist in training)
79 (29.9)
Histotechnologist/technician
52 (19.7)
Medical technologist or technician
5 (1.9)
Clerk or technician
1 (0.4)
Other
3 (1.1)
None of above, only pathologists perform gross
examination
66 (25.0)
Is there a written policy in your laboratory regarding whether
a pathologist is required to personally examine all specimens
for gross examination only, regardless of who may have performed the initial gross examination and description?
(multiple responses allowed)
Yes
91 (22.3)
No
118 (28.9)
Not applicable, only pathologists perform gross
examination
199 (48.8)
Canada (9), Australia (2), and the United Kingdom (1).
Most institutions (94.1%) were accredited by the Joint
Commission on Accreditation of Healthcare Organizations. The majority of participants (86.8%) were College
of American Pathologists (CAP)–accredited laboratories.
The types of the participants’ pathology practices were as
follows: 74.9% pathology group practices; 6.1% state, local,
or federal installations; 5.6% solo practices; 4.6% university medical schools; 3.9% multispecialty groups; 1.0% independent or reference laboratories; and 3.9% other types
of practices.
Managed Care Arrangements
Nearly half (48.2%) of participating laboratories actively
bid on managed care contracts. Most participants approximated that none (3.5%), less than 25% (51.5%), or 26% to
50% (27.4%) of their surgical pathology services (excluding cytology services) were provided to enrollees of managed organizations and that none (50.9%) or less than 25%
(36.8%) of those services were provided under capitated
laboratory payment arrangements.
Gross Examination Practices
Gross examination practices among participating institutions were elucidated in the questionnaire by 2 questions. The first asked, ‘‘In actual practice, which personnel,
in addition to a pathologist, perform gross examination
and description of specimens that require gross examination only?’’ The second question asked, ‘‘Is there a written policy in your laboratory regarding whether a pathologist is required to personally examine all specimens for
gross examination only, regardless of who may have performed the initial gross examination and description?’’
These results are shown in Table 1.
Existence of Written Policy
The majority of institutions had written policies regarding specimens removed during surgical procedures: 87.1%
of participants had a written policy for specimens that
Submission of Surgical Pathology Specimens—Zarbo & Nakhleh
Table 2. Distribution of the Absolute Count of
Different Types of Specimens Deemed Exempt From
Submission to Pathology or for Gross Examination
Only per Participating Institutions’ Written Policies
All Institutions’
Percentiles*
Specimen Type
No. Mean 10th 25th Median 75th 90th
Exempt from submission 359 19.9 2
6 17 29 40
Gross examination only 314 30.4 6 15 29 43 57
* Percentile rankings indicate only greater number of specimens and
not better or worse relative performance.
Table 3. Absolute Counts of Specimens Exempt From
Submission: Association With Surgical Pathology
Volume and Teaching Status
All Institutions’ Percentiles*
Variable
No.
Surgical pathology
0–5000
5001–15 000
.15 000
Mean 10th 25th Median 75th 90th
volume in 1996
81 17.6
1
201 19.7
2
77 22.7
5
8
6
11
13
16
23
27
29
32
37
40
40
Teaching status
Teaching
108 15.4
1
4
11
22
37
Nonteaching
237 22.1
3
9
20
31
43
* Percentile rankings indicate only greater number of specimens and
not better or worse relative performance.
were exempt from submission to pathology, and 76.6%
had a written policy for specimens that were subject to
gross examination only. Only specimen lists from institutions with written policies were used to create the following aggregate databases.
Size of Specimen Lists and Associations
The median number of exempt specimens in 359 institutions was 17. The total range was 0 to 115 specimens,
and the central 10th to 90th percentile range was 2 to 40
specimens (Table 2). Higher absolute counts of different
types of specimens deemed exempt from submission to
pathology (23 vs 13) were directly associated with higher
surgical pathology volumes of more than 15 000 cases accessioned in 1996 (P 5 .0046), and higher counts were
obtained (20 vs 11) in nonteaching institutions (P 5 .0003)
(Table 3).
The median number of specimens submitted for grossonly examination in 314 institutions was 29. The total
range was 0 to 91 specimens, and the central 10th to 90th
percentile range was 6 to 57 specimens (Table 2). The absolute count of specimens submitted for gross examination only was not significantly associated with any aspects
of practice, including participation in managed care contractual agreements.
Types of Specimens Deemed Exempt From Submission
From the aggregate data of 359 institutions, 8 types of
specimens were exempt from submission in more than
50% of laboratories. These common nontissue specimens
included mechanical appliances, hardware, and radioactive sources. The common exempt tissue specimens included placentas from routine and uncomplicated pregnancies and deliveries that appeared normal at the time
of delivery (66.2%), foreskins from circumcision of newArch Pathol Lab Med—Vol 123, February 1999
born children (65.9%), lens cataracts (59.9%), and teeth
(53.6%). Just below this arbitrary 50% threshold were placentas from cesarean deliveries that appeared normal at
time of delivery (47.4%). The remaining exempt specimen
types are listed by surgical specialty in Table 4.
Types of Specimens Deemed for Gross Examination Only
From the aggregate data of 314 institutions, 28 types of
specimens were on gross-only examination lists in more
than 50% of laboratories. These common nontissue specimens included various types of appliances, hardware, implants, and foreign bodies removed at surgery or at endoscopy or were medicolegal evidence and given directly
to law enforcement personnel. The common tissue specimens for gross-only examination included calculi (renal,
ureteral, bladder) (73.8%), teeth (73.7%), lens cataracts
(57.7%), cartilage and bone from septorhinoplasty (53.4%),
and toenails and fingernails (51.4%). The remaining grossonly specimen types are listed by surgical specialty in Table 4.
COMMENT
This Q-Probes study has demonstrated that, as of 1997,
the majority of US health care institutions have developed
written but conservative policies in the exemption of tissue
specimens from submission to the laboratory for pathologic examination. Similarly, the majority of these same
institutions have conservative policies for designation of
tissue specimens that may be assessed by the pathologist
only through gross or macroscopic means. This is evident
in the data showing that, in more than 50% of institutions,
only 8 types of specimens were listed as exempt from examination, and 28 types of specimens were listed as requiring gross examination only from the 115 specimen
types offered for consideration. Of these exempt and
gross-only specimens, most were nontissue, including mechanical appliances, implants and devices, medical and
dental hardware, foreign bodies, calculi, radioactive therapeutic sources, or tissues not readily sectioned, such as
teeth, cartilage and bone from septorhinoplasty, and toenails and fingernails. The only readily sectioned tissue
specimens on lists exempt from submission to the laboratory were normal placentas, newborn foreskins, and lens
cataracts.
In this Q-Probes study, nonteaching institutions and
those with higher annual surgical pathology volumes exempted greater numbers of specimens from submission to
pathologic examination. The reasons for these differences
were not examined in this study but no doubt are attributable to the differing educational missions and practice
styles of these institutions.
The practice of requiring pathologic examination of all
excised tissues can be traced to the American College of
Surgeon’s hospital-based accreditation standard of 1926.1
This was clearly instituted to enhance the quality of patient care at a time when the discipline of surgical pathology was just materializing.7 In 1998 numerous standards addressing this issue are retained by the Joint Commission on Accreditation of Healthcare Organizations in
the Accreditation Manual for Pathology and Clinical Laboratory
Services under the leadership and histopathology quality
control sections.2 These standards read as follows:
LD.3.2.3 The pathologist and the clinical staff jointly determine and document in writing which categories of surgical specimens usually require only a gross description and diagnosis.
Submission of Surgical Pathology Specimens—Zarbo & Nakhleh 135
Table 4. Number and Percentage of Specimens Deemed Exempt From Submission or Suitable For Gross Examination
Only by Surgical Specialty
No. (%) Institutions
Specimen
No. by
Specialty
Exempt from
Submission
Specimen Name
General surgery/plastic surgery
001
Appendices removed incidentally
002
Arthropods (lice, crabs, etc)
003
Bezoars
004
Calculi (renal, ureteral, bladder)
005
Clinically normal tissue removed during cosmetic procedures (eg, blepharoplasty)
006
Colostomy takedown (for diverticular disease)
007
Debridement for recent trauma
008
Debridement from decubitus ulcer
009
Fat contents from liposuction
010
Fecaliths
011
Foreign bodies removed at surgery
012
Foreign bodies that are medicolegal evidence (eg, bullets) given directly to law enforcement
personnel
013
Inguinal hernia sacs in adults
014
Mammary implants
015
Medical devices not contributing to patient illness, injury, or death (eg, gastrostomy tubes,
stents, sutures)
016
Panniculectomy tissue
017
Portions of rib removed only to enhance operative exposure
018
Portions of rib removed only to enhance operative exposure, provided patient does not have a
history of malignancy
019
Scars from recent burns and trauma or old scars from nonneoplasm surgery
020
Skin tags
021
Subcutaneous tissue, excess removed incidental to surgical approach
022
Therapeutic radioactive sources
023
Tissue expander implants
024
Tissue from cosmetic repair from the nose, ear, and face
025
Tissue from extensive soft tissue and bony trauma
026
Toenails and fingernails, not otherwise specified
027
Toenails and fingernails that are grossly unremarkable
028
Traumatically amputated parts of extremities
029
Traumatized digits
Gynecology
030
Fallopian tubes from voluntary sterilization
031
Fallopian tubes removed incidentally to hysterectomy for benign condition
032
Intrauterine contraceptive devices, without attached soft tissue
033
Placentas from cesarean deliveries that appear normal at time of delivery
034
Placentas from routine and uncomplicated pregnancies and deliveries that appear normal at
time of delivery (eg, do not meet criteria for examination)
035
Vaginal foreign bodies
036
Vaginal mucosa and vulvar skin (perineal body) removed during repair of rectocele and
cystocele
2
33
29
40
123
3
35
17
106
46
130
156
(0.6)
(9.6)
(8.5)
(11.8)
(35.2)
(0.9)
(10.0)
(4.8)
(31.0)
(13.3)
(37.8)
(44.6)
Submitted
for Gross
Examination
Only
4
91
105
220
96
10
50
18
61
104
226
189
(1.3)
(32.5)
(37.1)
(73.8)
(34.9)
(3.3)
(16.7)
(6.0)
(23.2)
(37.3)
(77.1)
(69.2)
28 (8.0)
37 (10.7)
152 (43.6)
98 (32.7)
189 (63.2)
160 (59.3)
45 (13.0)
101 (28.9)
77 (22.2)
56 (19.4)
133 (45.7)
119 (41.2)
95
7
46
174
79
106
36
106
100
56
48
(27.1)
(2.0)
(13.1)
(52.3)
(22.8)
(30.3)
(10.2)
(29.7)
(28.4)
(16.0)
(13.6)
63
7
33
94
158
99
61
142
144
79
79
(21.5)
(2.3)
(11.5)
(39.0)
(55.6)
(35.4)
(20.5)
(50.4)
(51.4)
(27.0)
(26.8)
3
3
83
166
233
(0.9)
(0.8)
(23.8)
(47.4)
(66.2)
1
1
177
25
32
(0.3)
(0.3)
(61.2)
(9.5)
(13.6)
81 (23.3)
31 (8.8)
183 (62.9)
56 (18.9)
Ophthalmology
037
Chalazion
038
Cornea removed for bullous (aphakic) keratopathy
039
Cornea, not otherwise specified
040
Extraocular muscle and tendon tissue removed during strabismus surgery
041
Iris removed at time of peripheral iridectomy
042
Lens cataracts, not otherwise specified
043
Lens cataracts removed by phacoemulsification
044
Ophthalmic plastic surgical tissues, without underlying malignant or systemic disease
045
Scleral tissue removed at time of trabeculectomy
11
14
19
49
24
211
196
86
31
(3.2)
(4.1)
(5.5)
(14.2)
(7.2)
(59.9)
(57.1)
(25.0)
(9.1)
3
27
30
29
17
154
122
66
14
(1.0)
(9.3)
(10.5)
(10.1)
(6.1)
(57.7)
(50.2)
(24.5)
(5.0)
Oral surgery
046
Bone associated with extracted tooth
047
Dental appliances
048
Dental restorations
049
Gingiva
050
Hardware (arch bars, wires, bone plates, screws, etc)
051
Impacted teeth
052
Mobile primary teeth
053
Teeth, not otherwise specified
054
Teeth removed for dental caries, periodontal disease
055
Teeth when there is no attached soft tissue
056
Temporomandibular joint
59
155
109
20
179
133
145
187
140
152
12
(17.2)
(44.9)
(32.2)
(5.8)
(51.6)
(38.7)
(42.3)
(53.6)
(40.3)
(43.8)
(3.6)
95
136
117
15
181
186
179
205
200
196
31
(32.5)
(52.1)
(44.8)
(5.2)
(66.8)
(66.7)
(64.9)
(73.7)
(70.9)
(70.8)
(10.9)
136 Arch Pathol Lab Med—Vol 123, February 1999
Submission of Surgical Pathology Specimens—Zarbo & Nakhleh
Table 4. Number and Percentage of Specimens Deemed Exempt From Submission or Suitable For Gross Examination
Only by Surgical Specialty (cont)
No. (%) Institutions
Specimen
No. by
Specialty
Exempt from
Submission
Specimen Name
Submitted
for Gross
Examination
Only
Orthopedics
057
Bone donated to the bone bank
058
Bone from osteotomies
059
Bone segments removed as part of corrective or reconstructive orthopedic procedures (eg,
rotator cuff repair, synostosis repair, spinal fusion)
060
Bone spurs, in addition to the following category of bunions
061
Bunions
062
Carpal tunnel tissue
063
Femoral heads
064
Femoral heads removed for degenerative joint disease (excludes fracture)
065
Intervertebral disks
066
Knee joint
067
Knee joint removed for degenerative joint disease (excludes fracture)
068
Menisci, not otherwise specified
069
Menisci, torn
070
Orthopedic appliances (hardware) and other radiopaque mechanical devices removed at surgery
071
Osteocartilaginous loose bodies
072
Patellar shavings
073
Synovium from reconstruction (eg, anterior cruciate ligament)
074
Tendon
075
Toes removed for functional deformity (eg, hammer toe, mallet and claw toes)
36
46
11
13
15
18
21
20
44
34
224
18
36
20
11
30
(10.3)
(13.2)
(3.2)
(3.7)
(4.3)
(5.1)
(6.1)
(5.7)
(12.6)
(9.8)
(63.6)
(5.1)
(10.3)
(5.7)
(3.1)
(8.7)
84
132
9
41
50
39
45
53
75
80
188
67
50
23
21
90
(28.1)
(43.6)
(3.0)
(13.5)
(16.5)
(13.0)
(15.0)
(17.5)
(25.1)
(26.8)
(70.7)
(22.2)
(16.9)
(7.7)
(7.0)
(30.3)
Otolaryngology
076
Cartilage or bone removed during septoplasty, rhinoplasty, or septorhinoplasty
077
Endoscopically removed foreign bodies
078
Middle ear (myringotomy) tubes
079
Middle ear ossicles
080
Nasal turbinates
081
Otologic reconstructive or other appliances removed at surgery
082
Pharyngoplasty (uvula) specimens removed for sleep apnea
083
Stapes bone removed during surgery for otosclerosis
084
Tonsils and adenoids in patients of any age
085
Tonsils and adenoids in patients ,5 y old
086
Tonsils and adenoids in patients ,10 y old
087
Tonsils and adenoids in patients of some other specified age
63
89
123
36
17
125
7
28
10
24
24
24
(18.1)
(25.6)
(35.7)
(10.3)
(4.9)
(36.1)
(2.0)
(8.1)
(2.9)
(7.0)
(7.0)
(6.9)
155
196
157
67
42
150
9
46
16
124
125
88
(53.4)
(67.8)
(58.3)
(23.2)
(14.3)
(56.4)
(3.1)
(15.9)
(5.6)
(43.2)
(43.3)
(29.7)
Pediatrics
088
089
090
091
092
093
094
Foreskin from circumcision of newborn child
Foreskin from circumcision of any age child
Hernia sac at any site
Inguinal hernia sacs
Supernumerary (accessory) digits
Thymectomy incidental to congenital heart repair
Umbilical hernia sac in a child
230
72
30
33
18
6
27
(65.9)
(20.7)
(8.6)
(9.5)
(5.2)
(1.8)
(7.8)
102
5
79
92
80
11
70
(41.5)
(29.7)
(26.4)
(30.9)
(27.6)
(3.9)
(23.9)
Urology
095
096
097
098
Foreskin from elective circumcision (adult)
Foreskin from phimosis
Penile implant
Vas deferens from voluntary sterilization
33
15
85
7
(9.4)
(4.3)
(25.1)
(2.0)
29
25
167
2
(9.9)
(8.4)
(59.6)
(0.7)
13
45
32
10
15
11
3
110
43
122
55
23
21
20
29
41
41
(3.7)
(14.0)
(10.1)
(3.1)
(4.7)
(3.2)
(0.9)
(32.3)
(13.4)
(35.6)
(17.1)
(6.6)
(6.0)
(5.7)
(8.3)
(11.8)
(12.3)
32
148
105
27
26
35
7
159
29
176
32
14
12
19
88
91
37
(10.7)
(54.8)
(39.0)
(9.8)
(9.7)
(11.9)
(2.3)
(57.6)
(11.2)
(64.9)
(12.5)
(4.8)
(4.1)
(6.5)
(29.5)
(31.6)
(13.9)
Vascular surgery
099
Atheroslerotic plaques
100
Artificial heart valves (mechanical)
101
Artificial heart valves (xenograft)
102
Calcified native heart valves
103
Cardiac bypass grafts, redo
104
Carotid and coronary endarterectomy plaques
105
Extremities amputated for peripheral vascular disease
106
Intravascular catheters
107
Mammary artery/vein, excess from cardiac or peripheral vascular bypass
108
Pacemaker devices
109
Saphenous vein segments harvested for coronary artery bypass
110
Thrombus from arteriovenous fistula
111
Thrombus from vascular graft
112
Thrombus, mural removed during aortic aneurysm repair
113
Varicose veins
114
Vascular graft material
115
Vein segment excess harvested for grafting, not otherwise specified
Arch Pathol Lab Med—Vol 123, February 1999
131 (41.7)
50 (14.4)
57 (16.3)
48 (22.4)
64 (22.3)
78 (26.7)
Submission of Surgical Pathology Specimens—Zarbo & Nakhleh 137
LD.3.2.4 The clinical staff, in consultation with a pathologist,
decides the exceptions to submitting specimens removed during
a surgical procedure to the laboratory.
QC.2 Specimens removed during a surgical procedure are ordinarily sent to a pathologist for evaluation.
Intent of QC.2 Specimens removed during surgery need to
be evaluated for gross and microscopic abnormalities before a
final diagnosis can be made. All specimens, except those identified by the clinical staff as part of LD.3.2.4, are routinely sent to
a pathologist for evaluation.
A number of reasons are generally recognized for the
gross and microscopic pathologic examination of tissues,
including diagnosis, documentation, and surgical review.
During the latter decades of the 20th century, increased
surgical sophistication and endoscopic approaches have
resulted in greater volumes of specimens for diagnostic
pathologic examination. A corresponding growth and development of specialized gross and microscopic expertise
in the practice of surgical pathology have occurred. These
current practices have developed to satisfy the medical
demands and ever-increasing complexity of biopsy interpretation and therapies often predicated on specific tissue
diagnosis, pathologic staging, and other pertinent pathologic observations.
Documentation not only chronicles the surgical case but
also provides the microscopic identification of tissues and
diseases inapparent at gross observation. Simple tissue
documentation would include the microscopic verification
of vas deferens or vagus nerve. However, during a documentation function, rare but clinically significant findings
may be encountered, such as lymphoma, liposarcoma, or
a metastatic cancer in an adult inguinal hernia repair.
Pathologic tissue evaluation forms the objective database
on which surgical (tissue) review committees perform
their assessment of a surgeon’s clinical practice. This hospital-based quality assurance function may be incorporated into performance-based credentialing.
Equally important to the quality of patient care is the
pathologist’s consultative role in the optional selection of
surgical tissues that institutions may choose to exclude
from routine submission to the pathology department,
those that may be subjected to microscopic examination
at the discretion of the pathologist, and those requested
for gross examination only by the clinician. Permitting exclusion of specific tissue for submission for pathologic or
microscopic evaluation requires a written policy that has
been adopted by most participating institutions in this QProbes study. It is not clear whether absence of a written
policy for specimens exempt from submission in 53 laboratories or in 96 laboratories for specimens subject only
to gross inspection reflects an institutional mandate to
submit all operative specimens to pathology or improper
written documentation of the exemption option. Regardless, certain questions must be considered and uncertainties accepted if this course is chosen by the medical staff.
The criteria for selection of specimens for exempt status
or gross-only examination are undefined. Ironically, the
literature touting selective gross examination has focused
on tissues rarely included by the participants in this 1997
Q-Probes study. These tissues include gallbladders, hernia
sacs, appendices, and intervertebral disks.8–12 The usual
basis for suggesting these tissues be subject to gross examination only is that routine microscopic evaluation rarely results in significant unexpected findings for some categories of specimens. However, because a disease state is
138 Arch Pathol Lab Med—Vol 123, February 1999
uncommon in a specified organ, especially one that would
significantly affect patient outcome if undiagnosed, does
not warrant omitting microscopic examination or, taken
one step further, exemption for submission to pathologic
examination. The claim by one group that ‘‘microscopic
examination is of little value when a grossly normal specimen is removed’’ is countered by their own admission
that ‘‘two primary adenocarcinomas [of the appendix]
were not detected by the surgeon at laparotomy’’ and that
‘‘a metastatic gastric carcinoma and a lymphoma were not
evident from gross inspection of the hernia sac alone.’’ 9
Proponents of selective submission or selective microscopic examination have recommended that such decisions be made in the context of an adequate clinical history. This logic is predicated on the belief that significant
pathologic findings usually parallel a significant clinical
history.12,13 However, predicating pathologic examination
on aberrant or significant clinical findings is an optimistic
policy that is unlikely to be consistently applied. Previous
Q-Probes studies have documented lack of pertinent clinical history on surgical pathology requisitions to be a persistent deficiency in current practice.14 Lack of clinical
pathologic correlation has accounted for nearly 30% of all
amended surgical pathology reports, and approximately
9% of errors were detected because additional clinical information became available.15 If tissue is not submitted for
microscopic examination, the quality control feedback
loop between clinician and pathologist will never be established and may compromise patient care.
Further, microscopic examination remains the diagnostic criterion standard despite advances in imaging technology. The value of microscopic examination in diagnosis
is analogous to the value of postmortem examination in
documentation of clinically undetected but major unexpected findings that contributed to patient death in nearly
40% of autopsies.16 Given this track record and variation
in clinician training, clinical experience, communication of
pertinent information, and powers of gross observation, a
conservative stance on these policies regarding surgical
specimens would appear prudent. The fact that the literature repeatedly contains pleas for certain specimens, such
as hernia sacs, intervertebral disks, gallbladders, and appendices, which seldom appear on current specimen lists,
suggests that these pleas are the product of louder but not
clinically significant voices.8–12
More recently, in this managed care era, the notion of
cost-effectiveness has been suggested as a consideration
in the pathologic examination of specimens.8,10,12,13 Discussions of charges and costs have led to the pejorative appellation of ‘‘spreadsheet surgical pathology’’ 17 and proposals that millions of health care dollars could be saved
by eliminating routine microscopic examination of some
specimens.10 Given the reimbursement confusion with
capitation, bundled payments, and inpatient diagnosis related group schedules, the issue of cost becomes nebulous
and dissociated from the artificial charges that are more
readily assessed.
The practice of gross examination and documentation
of specimens and abnormalities is an extremely important
one, not to be taken lightly. It is at this examination that
professional judgment directs the pathologist to initiate
microscopic examination even though the specimen may
qualify on a list for gross examination only. It is well
known that subtle abnormalities may belie significant disease at the microscopic level. Further, the gross examinaSubmission of Surgical Pathology Specimens—Zarbo & Nakhleh
tion and description, if inadequately performed, may have
medicolegal implications (for instance, failing to note and
inform the clinician of a ragged torn tip of a foreshortened
intravascular catheter that may have been left behind to
embolize).
Lastly, there is a potential reimbursement issue for specimens receiving gross examination only not performed but
signed out by the pathologist. United States histopathology laboratories operate under federal Clinical Laboratory
Improvement Amendments of 1988 (CLIA ’88) guidelines
for high-complexity testing that address histopathology
testing personnel qualifications for macroscopic or gross
examination. The CLIA ’88 State Operations Manual18 reads:
‘‘Pathologists assistants are recognized, and pathologists
and technical supervisors can delegate responsibilities to
non pathologist personnel, including some aspects of
gross examinations when a specific protocol has been
written.’’ The interpretive guideline, §493.1489(b)(6)
Guidelines, reads as follows:
make specimen exemption decisions, we believe that this
multi-institutional aggregate database may serve as a peer
practice–based reference for future consideration of lists
of types of specimens exempt from submission and submitted for gross examination only.
The authors gratefully acknowledge the production assistance
of Kim Kruger, Tari Vaughn, and Kim O’Donnell of the CAP
Quality Practices Committee staff and CAP statistician Molly
Walsh, PhD.
References
These requirements raise a potential issue of reimbursement for gross examination only of specimens if someone
other than the pathologist (pathologists assistant, resident,
fellow) performs the gross examination. We believe that
pathologists in US laboratories should familiarize themselves with the CLIA ’88 regulations about gross examination and develop written guidelines pertaining to pathologists’ involvement in gross examination and documentation. We personally have addressed this issue by assuring that the surgical pathologist, who bears the legal
responsibility, performs the gross examination or reviews
the gross tissue after it has been described by a qualified
designee.
Given the dearth of outcomes-based data on which to
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Submission of Surgical Pathology Specimens—Zarbo & Nakhleh 139
In the case of gross examinations, the technical supervisor may
delegate to individuals qualified under §493.1489 the responsibility for the physical examination/description, including color,
weight, measurement and other characteristics of the tissue; or
other mechanical procedures for which a specific written protocol
has been developed. The technical supervisor is ultimately responsible for the diagnosis related to the gross examination and
must sign the examination report. The technical supervisor is not
required to provide direct onsite supervision but is responsible
for the accuracy of all test results reported. All physical examinations/descriptions of tissue including color, weight, measurement and other characteristics of the tissue; or other mechanical
procedures performed in the absence of the technical supervisor
by individuals qualified under §493.1489 must be reviewed within 24 hours by the technical supervisor. All microscopic tissue
examinations must be performed by individuals qualified under
§493.1449(b), (I) or (m), as appropriate.