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UWHC,UWMF,

Policies,Clinical,UW Health Clinical,General Care and Procedures,Labs/Specimens

Pathology Examination of Patient Materials (2.5.4)

Pathology Examination of Patient Materials (2.5.4) - Policies, Clinical, UW Health Clinical, General Care and Procedures, Labs/Specimens

2.5.4


UW HEALTH CLINICAL POLICY 1
Policy Title: Pathology Examination of Patient Materials
Policy Number: 2.5.4
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: May 26, 2017

I. PURPOSE

A. To describe the requirements for submission, identification, handling, and release of tissue specimens
including exemptions and guidelines for limited examination.
B. To establish standards for the review of relevant pathology slides received from external facilities for patients
prior to initiation of care at UW Health.

II. POLICY ELEMENTS

A. Required Tissue Submission:
i. It is strongly recommended that all specimens not specifically exempted in Section IV. be submitted
for examination to the appropriate Pathology laboratory.
ii. Standard Precautions must be observed when handling patient specimens. Microscopic
examination will be performed whenever there is a request by the attending surgeon or when the
pathologist determines a microscopic examination is indicated by the gross findings or clinical
history.
iii. For surgical specimens that are retained or released to the patient (not inmates), the specimen will
be examined, placed in a sealed container, and labeled with patient identification and the type of
tissue. The medical record must reflect the ultimate disposition/location of the specimen.
Containers with formalin must include warning labels and any hazard precautions. Refer to Section
V. for specimens allowed to be released to patients.
iv. Specimens considered for research purposes are subject to the Institutional Review Board (IRB)
approval and must be cleared by the Department of Pathology prior to submission to another
laboratory.
B. Review of Pathology Materials for Patient Referrals
i. It is the policy of UW Health and its Medical Staff that all relevant pathology slides from external
institutions should be reviewed by UW Health Pathologists on all patients receiving care at a UW
Health facility.
ii. In-house review of outside pathology materials for referred patients seeking medical treatment will
occur prior to initiation of treatment (surgery, chemotherapy, radiation therapy, etc.), absent an
emergency.

III. PROCEDURE

A. The treating physician should request clinically relevant pathology slides from external institutions. The
pathology specimens that are relevant to or establish the patient’s current diagnosis should be submitted to
the appropriate UW Health Pathology laboratory for confirmation of diagnosis prior to any substantive
treatment.
i. If there is a discrepancy between the original diagnosis and the UW Health diagnosis, the
procedure or treatment at UW Health must be postponed, absent an emergency, until a definitive
pathologic interpretation is obtained through means chosen by the appropriate UW Health
attending pathologist.
B. The following surgical specimens must be taken directly to the appropriate Pathology laboratory "fresh," i.e.,
not in formalin or any other type of fixative:
i. Frozen sections.
ii. Lymph nodes or tissue from patients where lymphoma is suspected.
iii. Large specimens such as livers or spleens.
iv. GYN specimens as defined in the related document.(Pathology Reference Card)
v. Breast tissue as defined in the related document (Pathology Reference Card).
C. Specimen Submission Requirements
i. Weekdays 0730 - 1830: Submit specimens for gross and microscopic (permanent) examination
fresh or in formalin. Nights and weekends: Place specimens in formalin (10 times the amount of
tissue). If specimen is very large, place in pathology refrigerator. Place tissue requisition on counter
if the specimen is refrigerated.



UW HEALTH CLINICAL POLICY 5
Policy Title: Pathology Examination of Patient Materials
Policy Number: 2.5.4

ii. Specimens must be transported in leak proof containers. Refer to UW Health Clinical Policy #2.5.1,
Use of Containers for Clinical Specimens.
iii. Specimens which are too large to be transported in standard leak proof containers, (e.g.,
extremities, livers, massive tumors), must be securely bagged in two biohazard (red) bags or
placed in a basin inside of a biohazard (red) bag.
iv. All specimen containers will be labeled immediately after collection and in the presence of the
identified patient in accordance with Clinical Laboratories policy #1502.5.06, Acceptance Policy for
Specimen Identification. Specimens will be labeled with patient’s name and b or c, as stated below.
Additional information (d-h) will be included on the printed requisition and/or label as space allows.
When multiple specimens are being sent together, ensure that the type and sources of tissue and
the requested test are clearly identified on each specimen label.
a. Patient’s name.
b. Birthdate.
c. Medical record number.
d. Physician name.
e. Type and source of tissue.
f. Requested test (e.g., right periaortic lymph node, frozen section).
g. Include your phone number for frozen sections.
h. NOTE: Do not number the specimens unless numbering is necessary for mapping bladder
tumors, staging laparotomies or checking margins.
v. All specimens obtained from a patient for "gross only" or permanent sections will be taken to the
appropriate Pathology laboratory with any frozen sections. Indicate on the printed electronic
requisition form (Pathology Lab Requisition) or the paper forms (Tissue Examination Request Form
UWH# 1280033). The following specimens may require a gross examination only. Exceptions are
at the surgeon or pathologist's discretion.
a. Accessory digits.
b. Bunions and hammertoes.
c. Extraocular muscle from corrective surgical procedures (e.g., strabismus repair).
d. Inguinal hernia sacs in adults.
e. Nasal bone and cartilage from rhinoplasty or septoplasty.
f. Prosthetic breast implants.
g. Prosthetic cardiac valves without attached tissue.
h. Tonsils and adenoids from children under 18 years.
i. Torn meniscus.
j. Varicose veins.
vi. All specimens will be entered into the Operating Room (OR) specimen log books (i.e., Inpatient
OR, Outpatient Surgery Center (OSC), and AFCH OR, or clinic) prior to being sent to the
appropriate Pathology laboratory. If a specimen is taken directly to the appropriate Pathology
laboratory by the surgeon, entry should be noted in the log book by nursing personnel.
vii. Specimens will be taken to specified areas prior to transport to the appropriate Pathology
laboratory: In the main OR specimens will be taken to D6/300 (staff corridor). In OSC specimens
are placed in a designated receptacle outside of F6/289 (front desk).
viii. Counted sponges and instruments will not be taken to Pathology with specimens.
ix. The Pathologist on call will be notified when tissue requires examination on nights or weekends.
The call list is in the OR call schedule book or available in hospital paging system.
x. When organs are removed as part of an organ transplant procedure, the circulator will write on
patient label and Tissue Examination Request Form UWH#1280033 or electronically document in
the Surgical Pathology Lab Requisition the United Network for Organ Sharing (UNOS) number of
the organ the recipient is receiving.
xi. Identify the appropriate container and solution for each specimen. (See Pathology Reference Card)
xii. Documentation will be completed on the Surgical Pathology Lab Request Form and as necessary
additional information included regarding:
a. Specimens removed from OR by someone other than OR staff.
b. Specimens not sent to Pathology per Dr. ___________.
D. The printed electronic requisition form (Surgical Pathology Lab Requisition) or the paper form (Tissue
Examination Request Form UWH# 1280033) will include the following information:
i. Correct identification of the patient preferably printed by a machine or device.
ii. Specimen collection date and time.



UW HEALTH CLINICAL POLICY 5
Policy Title: Pathology Examination of Patient Materials
Policy Number: 2.5.4

iii. Examination Requested: Use "Other" section for electron microscopy or any other specialty test
required.
iv. Staff Physician Performing the Procedure: List attending surgeon's first initial and last name.
v. Staff Physician that needs the Report for Treatment: List as appropriate; typically will be staff
surgeon, but may include others. Ask staff surgeon.
vi. Ordering Location: Identify "OR" or “Clinic Room” and specific room number.
vii. Type and Site of Tissue(s) Sent, Including Procedure(s): Be very specific (e.g., transverse colon
biopsy rather than bowel biopsy).
viii. Clinical Findings and Pertinent Information: Indicate patient's preoperative diagnosis and clinical
history as known.
ix. Include OR suite phone number for frozen sections to facilitate documentation and turnaround time.

IV. SURGICAL SPECIMENS THAT MAY BE EXEMPT FROM PATHOLOGICAL EXAMINATION

A. The following categories of specimens may be exempted from the requirement to be examined by a
pathologist. Any of the specimens listed below may be sent for pathologic examination at the surgeon's
discretion, if there are any unusual clinical or radiological features or if the surgeon has any specific
questions (e.g., with regard to the possibility of infection, tumor, or a metabolic disorder).
i. Specimens that by their nature or condition do not permit productive examination, such as:
a. A cataract removed by phacoemulsification.
b. Orthopedic/surgical hardware and other radio-opaque mechanical devices (documentation
of surgical removal is required).
c. Medical devices such as catheters, gastrostomy tubes, myringotomy tubes, stents,
sutures, or foreign body that have not contributed to patient illness, injury, or death.
d. Portion of rib removed only to enhance operative exposure.
e. Plastic explants from body parts other than the breast.
f. Intrauterine devices without attached soft tissue.
ii. Therapeutic radioactive sources, the removal of which is guided by radiation safety monitoring
requirements.
iii. Foreign bodies (e.g., bullets) that, for legal reasons, are given directly in the chain of custody to law
enforcement representatives.
iv. Foreign bodies removed as a result of aspiration or insertion into an orifice in a patient for the
purpose of providing to the adult patient, parent(s), or guardian for education on potential hazards.
v. Specimens known to rarely, if ever, show pathological change, and removal of which is highly
visible post-operatively, such as:
a. The foreskin from the circumcision of a newborn infant.
b. Normal skin (i.e., skin with no visible lesions, even if lesions are incidental), adipose tissue
(including liposuction fat), mucosa, cartilage and bone removed during plastic/cosmetic
surgical procedures for non-neoplastic disease purposes other than mammoplasty.
c. Burn eschars.
d. Arteries or veins (portions used for bypass grafting).
e. Skin with no incidental lesions or normal tissue removed during a cosmetic or
reconstructive procedure, (e.g., blepharoplasty, cleft palate repair, abdominoplasty,
rhytidectomy, syndactyly repair, provided it is not contiguous with a lesion and the patient
does not have a history of malignancy).
f. Normal toenails and fingernails.
g. Scars excised during re-operation of non-malignant disease.
h. Arthroscopic debridement, menisci, bunionectomies, sesamoid bones, and hammer toes.
i. Intervertebral disc material.
j. Bone donated to the bone bank, bone segments removed as a part of corrective or
reconstructive orthopedic procedures (e.g., rotator cuff repair, synostosis repair, spinal
fusion, falciform ligaments, and tendons).
k. Middle ear ossicles.
l. Tonsils from patients 18 years of age and younger unless there is a history of
transplantation (solid organ or bone marrow) or prior malignancy.
vi. Teeth when there is no soft tissue attached. The anatomic name or anatomic number of each tooth,
or tooth fragment should be recorded.
vii. Traumatically injured appendages or limbs that have been amputated and for which examination



UW HEALTH CLINICAL POLICY 5
Policy Title: Pathology Examination of Patient Materials
Policy Number: 2.5.4

for either medical or legal reasons is not deemed necessary.
viii. Specimens not required for examination by a pathologist and too large for disposal will be placed in
two biohazard (red) bags or placed in a basin inside of a biohazard (red) bag and transported to the
pathology refrigerator. The specimen will be clearly labeled as to the contents and for disposal only.
ix. For research purposes, specimens may be exempted from pathological examination or subjected
to modified pathological examination when approved by the appropriate Pathology laboratory and
the UW Health Sciences IRB or UW Minimal risk IRB

V. RELEASING SPECIMENS TO PATIENTS

A. Specimens that are acceptable for release to patients if requested include (Note: Specimens must be
transported in leak proof containers. Refer to UW Health Clinical Policy #2.5.1, Use of Containers for Clinical
Specimens.):
i. Teeth.
ii. Normal toenails.
iii. Normal fingernails.
iv. Explanted hardware without defect or malfunction. (See Section VI. For devices with defects or
malfunction)
v. Foreign bodies aspirated or inserted by a patient and extracted from the trachea, esophagus, or
other orifice (e.g., nose, ear), may be given to the adult patient, parent or guardian post extraction
for the purpose of educating on potential hazards. Standard Precautions will be used in the
handling and release of foreign bodies described in this paragraph. Release to the adult patient,
parent(s) or guardian must be documented in the patient's medical record. NOTE: Above
specimens (V.A.i-v) are cleaned and for metallic implants sterilized via Immediate Use Steam
Sterilization (IUSS) by OR staff and then sent with patient.
vi. Tonsils.
vii. Calculi/stones.
NOTE: Above specimens (V.A. vi-vii) are sent to Surgical Pathology and processed following
Clinical Laboratories policy #1555.SPPP.5.25, Release of Specimen to Patient. Specimens sent to
pathology and requested for release, other than for burial, are retained by Surgical Pathology for a
minimum of two weeks before release to the patient. The patient must make the appropriate
arrangements to pick-up the specimen by contacting the Department of Pathology.
viii. Foreign bodies that are removed as a part of a medical procedure (e.g., sponge), the result of a
crime, (e.g., bullet), or has known high value, (e.g., a diamond ring) must be reviewed and
approved by the UWHC Legal/Risk Management department before release.
ix. Body appendages, limbs, organs, and other body parts may be released if for purposes of making
whole for burial. Release must be made directly to the funeral home. Release for any other
purpose, must be reviewed and approved by the UWHC Legal/Risk Management department.
B. Patients must sign a receipt for any specimen released from Pathology (see Pathology Policy #5.25 and
#5.25A). The personal representative or spouse or funeral home may sign the receipt for release of the body
parts to the funeral home for burial. UW Health Legal/Risk Management department will determine whether
releases may be made to persons making requests on behalf of a patient in other circumstances and who
must sign the receipt.
C. This policy does not require that the listed specimens be released. If there is a question whether any
specimen should be released, the UW Health Legal/Risk Management department should be consulted.
D. Specimens are not allowed to be released to inmates.

VI. REPORTING AND RELEASING DEFECTIVE DEVICES

A. Devices that are known to have a defect (e.g., orthopedic hardware that requires explantation or removal,
and are requested by the patient or a third party as part of product liability investigation / litigation) are to be
sent to Surgical Pathology upon removal for cleaning and storage, according to standard procedure or if
known in advance, per instruction of requestor via UW Health Risk Management.
B. Request from a third party as part of product liability investigation / litigation should go through UW Health
Risk Management in order to assure that the appropriate releases are signed. If requested prior to
explantation, Risk Management will coordinate communication of any specific third party instructions for
cleaning, storage, and shipping.
C. UW Health Risk Management / Legal Services will make arrangements for possible release to a third party



UW HEALTH CLINICAL POLICY 5
Policy Title: Pathology Examination of Patient Materials
Policy Number: 2.5.4

upon request or request retention by UW Health Surgical Pathology as evidence based on serious injury /
death.
D. UW Health Risk Management should be notified of any explanted defective equipment by completing a
Patient Safety Net (PSN) Event Report in order to comply with required and voluntary reporting to the Food
and Drug Administration (FDA).

VII. FORMS

Tissue Examination Request Form UWH# 1280033

VIII. COORDINATION

Author: Associate Professor, Pathology
Senior Management Sponsor: SVP/Chief Legal Officer
Reviewers: Director, Anatomic Pathology Laboratory Services; Surgical Services; Nursing Education
Coordinator – Adult Intraoperative
Approval committees: Anatomic Pathology Quality Improvement Committee; UW Health Clinical Policy
Committee; Medical Board
UW Health Clinical Policy Committee Approval: February 20, 2017

UW Health is a cohesive, united and integrated academic medical enterprise comprised of several entities.
This policy applies to facilities and programs operated by the University of Wisconsin Hospitals and Clinics
and the University of Wisconsin Medical Foundation, Inc., and to clinical facilities and programs
administered by the University of Wisconsin School of Medicine and Public Health. Each entity is
responsible for enforcement of this policy in relation to the facilities and programs that it operates.

IX. APPROVAL

Peter Newcomer, MD
Chief Clinical Officer

J.Scott McMurray, MD
Chair, UW Health Clinical Policy Committee

X. REFERENCES

College of American Pathologists Policy on Surgical Specimens to be Submitted to Pathology for
Examination (Revised 8/99).
Thomas Jefferson University Hospital Specimen Management Policy.
College of American Pathologists Commission on Laboratory Accreditation/Anatomic Pathology Checklist.
Brigham & Women's Hospital Policy on Specimens Which Need to be Sent to Pathology.
"Surgical Pathology Specimens for Gross Examination Only and Exempt from Submission," A CAP Q-
Probes Study of Current Policies in 413 Institutions 8/98.
MCG Health, Inc (Augusta, GA) Submission of Tissue Policy 2/04.
University of Texas Medical Branch Medical Staff Bylaws - Exempt Specimens.
Clinical Laboratories policy #1502.5.06, Acceptance Policy for Specimen Identification
Clinical Laboratories policy #1555.SPPP.5.25, Release of Patient Specimens

XI. REVIEW DETAILS

Version: Revision
Last Full Review: May 26, 2017
Next Revision Due: May 2020
Formerly Known as: Hospital administrative policy #7.01, Pathology Specimen Care and Handling