Specimens

Get clinical answers to frequently asked questions about Specimens.

  • How is the disposition of surgical specimens determined? Is there a listing of specimens that do not require examination by a pathologist?

    Answer:

    Policies for the disposition of surgical specimens should be established by a multidisciplinary team including representatives of the pathology laboratory, facility or health care organization physicians, and perioperative registered nurses in accordance with local, state, and federal regulations. The College of American Pathologists (CAP) recommends that each facility or health care organization develop a written policy that lists which specimens are exempt from pathology examination, and which specimens should be submitted for gross examination but are exempt from microscopic examination. The CAP suggests that certain specimens may be exempt from submission to the pathologist for examination, provided there is a procedure for documenting their removal and disposition and that certain specimens be submitted for gross examination only, with exceptions at the pathologist’s discretion.

    Resources:

    •Policy on surgical specimens to be submitted to pathology for examination. Appendix M. 2007. College of American Pathologists. Accessed October 27, 2014.
    •Royal College of Pathologists. Histopathology and Cytopathology of Limited or No Clinical Value. 2nd ed. London, England: Royal College of Pathologists; 2005.
    •Guideline for specimen management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.


    Updated November 6, 2014

  • Does AORN have specific recommendations for managing breast cancer specimens?

    Answer:

    The AORN “Guideline for specimen management” has two recommendations related to managing breast cancer specimens.

    •The first recommendation is that the time of excision, and the time of fixation should be documented.

    •The second recommendation is that the time from excision to fixation should be less than one hour.

    Long delays between excision and fixation of the specimen may result in a decreased ability to detect breast biomarkers in samples. Accurate recording of times can be helpful for verification that the testing was performed during a period of time when the biomarkers were stable.


    Resources:

    •Guideline for specimen management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.
    •Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol. 2010; 28(16):2784-2795.
    •Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131(1):18-43. 
    •Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. Arch Pathol Lab Med. 2014;138(2):241-256. 
    •Yaziji H, Taylor CR, Goldstein NS, et al. Consensus recommendations on estrogen receptor testing in breast cancer by immunohistochemistry. Appl Immunohistochem Mol Morphol. 2008;16(6):513-520. 
    •Hewitt SM, Lewis FA, Cao Y, et al. Tissue handling and specimen preparation in surgical pathology: issues concerning the recovery of nucleic acids from formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med. 2008;132(12):1929-1935.
    •Hicks DG, Boyce BF. The challenge and importance of standardizing pre-analytical variables in surgical pathology specimens for clinical care and translational research. Biotechnic Histochem. 2012;87(1):14-17.


    Updated November 6, 2014

  • Does AORN have specific recommendations for preoperative management of amputated digits and limbs?

    Answer:

    Amputated digits and limbs to be reimplanted should be collected and handled in a manner to protect and preserve the integrity of the specimen and the potential for replantation survival. Amputated digits and limbs should be cooled to help to preserve the tissue and increase the chance of replantation survival. The digit or limb should be handled gently to avoid crushing tissue. It should be wrapped in sponges moistened with saline, placed in a plastic bag, and then placed in another bag or chest filled with ice. This allows for cooling of the digit or limb, prevents direct contact with ice, and helps minimize cell damage that may hinder successful replantation.

    Resources:

    •Guideline for specimen management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. 
    •Li J, Guo Z, Zhu Q, et al. Fingertip replantation: determinants of survival. Plast Reconstr Surg. 2008;122(3):833- 839. 
    •Partlin MM, Chen J, Holdgate A. The preoperative preservation of amputated digits: an assessment of proposed methods. J Trauma. 2008;65(1):127-131. 
    •Allen DM, Levin LS. Digital replantation including postoperative care. Tech Hand Up Extrem Surg. 2002; 6(4):171-177. 
    •Lloyd MS, Teo TC, Pickford MA, Arnstein PM. Preoperative management of the amputated limb. Emerg Med J. 2005;22(7):478-480.


    Updated November 6, 2014 


  • How should explanted medical device specimens be handled?

    Answer:

    Explanted medical devices should be collected and handled according to the health care organization’s policies and procedures; manufacturers’ instructions; and local, state, and federal regulations. Hospitals and other health care facilities that implant medical devices are considered final distributors. Final distributors are subject to medical device tracking requirements and are responsible for providing information to the manufacturer about explanted devices.

    Explanted medical devices that are subject to medical device tracking regulation must be reported to the manufacturer. Serious injury related to an implanted medical device must be reported to the device manufacturer. Deaths related to an implanted medical device must be reported to both the manufacturer and the US Food and Drug Administration (FDA).


    Resources:

    •Guideline for specimen management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.
    •21 CFR 821. Medical Device Tracking Requirements. 2013. US Food and Drug Administration. Accessed October 27, 2014.
    •Medical device tracking; guidance for industry and FDA staff. US Food and Drug Administration. Accessed October 27, 2014. 
    •21 CFR 803 Subpart C. User Facility Reporting Requirements. 2013. US Food and Drug Administration. Accessed October 27, 2014. 
    •Medical device reporting. US Food and Drug Administration. Accessed October 27, 2014.


    Updated November 6, 2014


  • How should explanted orthopedic hardware being returned to the patient be handled?

    Answer:

    Explanted orthopedic hardware to be returned to the patient should be collected, handled, decontaminated, labeled, packaged, and documented according to the facility or health care organization policies and procedures. Before returning the explanted hardware to the patient, facility or health care organization personnel should verify that the explanted hardware has not been recalled and does not need to be returned to the manufacturer. Return of the explanted hardware to the patient should be documented in the patient’s health record, including the patient’s request for return of the explanted hardware and identification of personnel returning the explanted hardware to the patient.

    Explanted orthopedic hardware may be excluded from submission to the pathologist for examination, provided there is an alternative policy in place for documentation of surgical removal. Explanted orthopedic hardware that is not submitted to the pathologist, returned to the manufacturer, or returned to the patient should be disposed of according to the facility or health care organization policies and procedures.

    Resources:

    •Guideline for specimen management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. 
    •Policy on surgical specimens to be submitted to pathology for examination. Appendix M. 2007. College of American Pathologists. Accessed October 27, 2014.


    Updated November 6, 2014


  • Can formalin be stored in the OR or procedure room?

    Answer:

    Formalin should be dispensed and stored in an area other than the OR or procedure room unless ignition sources are not used and the regulatory requirements for locations where formalin is used and stored are met.

    Formalin is a combustible liquid. Storage and use of formalin is regulated by the Occupational Safety and Health Administration and other federal and state health regulatory agencies. Locations where formalin is used must have posted signs warning of formaldehyde use, eyewash stations available within the immediate area, and ventilation systems with adequate capacity to maintain levels below the permissible exposure limits (ie, eight-hour total weighted average of 0.75 ppm or 15-minute short-term exposure limit of 2.0 ppm).

    Resources:

    •Guideline for specimen management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. 
    •NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 2005-149 ed. Cincinnati, OH: National Institute for Occupational Safety and Health; 2007. 
    •CFR 1910.1048: Hazardous substances. Formaldehyde. Occupational Safety and Health Administration. Accessed October 27, 2014.
    •OSHA FactSheet: Formaldehyde. 2011. Occupational Safety and Health Administration. Accessed October 27, 2014.


    Updated November 6, 2014


  • How much formalin should be used for preservation of surgical specimens?

    Answer:

    Specimens should be fully immersed in a ratio of fixative volume to specimen volume determined by the pathologist or receiving pathology laboratory personnel. The volume of formalin required for tissue fixation is not generally agreed upon. The literature is inconclusive regarding the amount of solution that should be used for specimen preservation and the suggested amounts vary.

    Resources:

    •Guideline for specimen management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. 
    •Buesa RJ, Peshkov MV. How much formalin is enough to fix tissues? Ann Diagn Pathol. 2012;16(3):202- 209.
    •Di Novi C, Minniti D, Barbaro S, Zampirolo MG, Cimino A, Bussolati G. Vacuum-based preservation of surgical specimens: an environmentally-safe step towards a formalin-free hospital. Sci Total Environ. 2010;408(16):3092- 3095.
    •Bell WC, Young ES, Billings PE, Grizzle WE. The efficient operation of the surgical pathology gross room. Biotechnic Histochem. 2008;83(2):71-82.
    •Yaziji H, Taylor CR, Goldstein NS, et al. Consensus recommendations on estrogen receptor testing in breast cancer by immunohistochemistry. Appl Immunohistochem Mol Morphol. 2008;16(6):513-520.


    Updated November 6, 2014