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 rst 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 dening 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, 240) in the exempt category and 29 (range, 657) in the category of gross examination only. Signicantly 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;123:133139) agnosis can be made, and that all specimens, except those identied 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 specic 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
Submission of Surgical Pathology SpecimensZarbo & 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, afrmed that original standard of 1926, requiring that specimens removed during a surgical procedure are ordinarily sent to a pathologist for evaluation. They further claried this position by requiring that specimens removed during surgery need to be evaluated for gross and microscopic abnormalities before a nal di-

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. Arch Pathol Lab MedVol 123, February 1999

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. MATERIALS AND METHODS
This Q-Probes quality improvement study was conducted in the rst 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 identied. 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 denitions of terms were provided: Capitated payment arrangement refers to a method of prepayment for health care services by which a provider accepts a xed amount of money per health plan member per month in return for providing a specic list of services to the members over a specied 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 specic 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 specic 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 pathologists 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 denition 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 certication 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.

Table 1. Gross Examination Practices in Participating Institutions

Variable No. (%) of Institutions

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) 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 rst 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 SpecimensZarbo & Nakhleh

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 MedVol 123, February 1999

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

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 ngernails (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 ngernails. 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 Surgeons 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 SpecimensZarbo & Nakhleh 135

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. Mean 10th 25th Median 75th 90th

Surgical pathology 05000 500115 000 15 000

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 .0046), and higher counts were obtained (20 vs 11) in nonteaching institutions (P .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 signicantly 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 MedVol 123, February 1999

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 Submitted for Gross Examination Only

Specimen Name

Exempt from Submission

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 ngernails, not otherwise specied 027 Toenails and ngernails 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 Ophthalmology 037 Chalazion 038 Cornea removed for bullous (aphakic) keratopathy 039 Cornea, not otherwise specied 040 Extraocular muscle and tendon tissue removed during strabismus surgery 041 Iris removed at time of peripheral iridectomy 042 Lens cataracts, not otherwise specied 043 Lens cataracts removed by phacoemulsication 044 Ophthalmic plastic surgical tissues, without underlying malignant or systemic disease 045 Scleral tissue removed at time of trabeculectomy 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 specied 054 Teeth removed for dental caries, periodontal disease 055 Teeth when there is no attached soft tissue 056 Temporomandibular joint 136 Arch Pathol Lab MedVol 123, February 1999

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)

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) 45 (13.0) 101 (28.9) 77 (22.2) 95 7 46 174 79 106 36 106 100 56 48 3 3 83 166 233 (27.1) (2.0) (13.1) (52.3) (22.8) (30.3) (10.2) (29.7) (28.4) (16.0) (13.6) (0.9) (0.8) (23.8) (47.4) (66.2)

98 (32.7) 189 (63.2) 160 (59.3) 56 (19.4) 133 (45.7) 119 (41.2) 63 7 33 94 158 99 61 142 144 79 79 1 1 177 25 32 (21.5) (2.3) (11.5) (39.0) (55.6) (35.4) (20.5) (50.4) (51.4) (27.0) (26.8) (0.3) (0.3) (61.2) (9.5) (13.6)

81 (23.3) 31 (8.8)

183 (62.9) 56 (18.9)

11 14 19 49 24 211 196 86 31 59 155 109 20 179 133 145 187 140 152 12

(3.2) (4.1) (5.5) (14.2) (7.2) (59.9) (57.1) (25.0) (9.1) (17.2) (44.9) (32.2) (5.8) (51.6) (38.7) (42.3) (53.6) (40.3) (43.8) (3.6)

3 27 30 29 17 154 122 66 14 95 136 117 15 181 186 179 205 200 196 31

(1.0) (9.3) (10.5) (10.1) (6.1) (57.7) (50.2) (24.5) (5.0) (32.5) (52.1) (44.8) (5.2) (66.8) (66.7) (64.9) (73.7) (70.9) (70.8) (10.9)

Submission of Surgical Pathology SpecimensZarbo & 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 Submitted for Gross Examination Only

Specimen Name

Exempt from Submission

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 specied 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) 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 specied age Pediatrics 088 089 090 091 092 093 094 Urology 095 096 097 098 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 Foreskin from elective circumcision (adult) Foreskin from phimosis Penile implant Vas deferens from voluntary sterilization

131 (41.7) 50 (14.4) 57 (16.3) 36 46 11 13 15 18 21 20 44 34 224 18 36 20 11 30 63 89 123 36 17 125 7 28 10 24 24 24 230 72 30 33 18 6 27 33 15 85 7 13 45 32 10 15 11 3 110 43 122 55 23 21 20 29 41 41 (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) (18.1) (25.6) (35.7) (10.3) (4.9) (36.1) (2.0) (8.1) (2.9) (7.0) (7.0) (6.9) (65.9) (20.7) (8.6) (9.5) (5.2) (1.8) (7.8) (9.4) (4.3) (25.1) (2.0) (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)

48 (22.4) 64 (22.3) 78 (26.7) 84 132 9 41 50 39 45 53 75 80 188 67 50 23 21 90 155 196 157 67 42 150 9 46 16 124 125 88 102 5 79 92 80 11 70 29 25 167 2 32 148 105 27 26 35 7 159 29 176 32 14 12 19 88 91 37 (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) (53.4) (67.8) (58.3) (23.2) (14.3) (56.4) (3.1) (15.9) (5.6) (43.2) (43.3) (29.7) (41.5) (29.7) (26.4) (30.9) (27.6) (3.9) (23.9) (9.9) (8.4) (59.6) (0.7) (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 Articial heart valves (mechanical) 101 Articial heart valves (xenograft) 102 Calcied 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 stula 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 specied Arch Pathol Lab MedVol 123, February 1999

Submission of Surgical Pathology SpecimensZarbo & 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 nal diagnosis can be made. All specimens, except those identied 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 specic tissue diagnosis, pathologic staging, and other pertinent pathologic observations. Documentation not only chronicles the surgical case but also provides the microscopic identication of tissues and diseases inapparent at gross observation. Simple tissue documentation would include the microscopic verication of vas deferens or vagus nerve. However, during a documentation function, rare but clinically signicant ndings 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 surgeons 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 pathologists 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 specic 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 reects 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 undened. 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.812 The usual basis for suggesting these tissues be subject to gross examination only is that routine microscopic evaluation rarely results in signicant unexpected ndings for some categories of specimens. However, because a disease state is
138 Arch Pathol Lab MedVol 123, February 1999

uncommon in a specied organ, especially one that would signicantly 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 signicant pathologic ndings usually parallel a signicant clinical history.12,13 However, predicating pathologic examination on aberrant or signicant clinical ndings 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 deciency 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 ndings 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 signicant voices.812 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 articial 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 signicant disease at the microscopic level. Further, the gross examinaSubmission of Surgical Pathology SpecimensZarbo & 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 qualications 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 specic protocol has been written. The interpretive guideline, 493.1489(b)(6) Guidelines, reads as follows:
In the case of gross examinations, the technical supervisor may delegate to individuals qualied 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 specic 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 qualied under 493.1489 must be reviewed within 24 hours by the technical supervisor. All microscopic tissue examinations must be performed by individuals qualied under 493.1449(b), (I) or (m), as appropriate.

make specimen exemption decisions, we believe that this multi-institutional aggregate database may serve as a peer practicebased 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 ODonnell of the CAP Quality Practices Committee staff and CAP statistician Molly Walsh, PhD.
References
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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 qualied designee. Given the dearth of outcomes-based data on which to

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