Specimen Management

Purpose

This document provides guidance for perioperative surgical specimen management, including handling of specific types of specimens collected during surgical and other invasive procedures that may be sent to the pathology laboratory for examination. The specimen types included are breast cancer specimens, radioactive specimens, explanted devices, potential forensic evidence, placental tissue, highly infectious disease specimens, and prion disease specimens. Guidance is also provided for transferring specimens off the sterile field; handling, containing, labeling, preserving, and transporting specimens; temporary storage; disposal; documentation and records maintenance; policies and procedures; education; and quality.

Specimen management is a complex, interdisciplinary process that is prone to error.¹  Specimen errors are common, with reported rates between 0.43% and 2.9%.^2-4  Preventable errors can occur in all phases of specimen management (ie, preanalytical, analytical, postanalytical),^1,5-7  but most occur in the preanalytical phase. This may be due in part to the number of steps and health care personnel involved in specimen management during this phase.^3,8  The preanalytical phase of specimen management includes ordering, handling, containment, labeling, and transport.⁹  An error in specimen labeling in the preanalytical phase may increase the likelihood that additional errors related to the same specimen will occur in the analytical phase.¹⁰  Perioperative registered nurses (RNs) perform most of the specimen management interventions in the preanalytical phase. Therefore, perioperative RNs may significantly reduce the rate of error and the potential for patient harm by using targeted, evidenced-based nursing interventions.

Specimen errors pose a significant patient safety risk.^1-3,11,12  Steelman et al¹  conducted a nonexperimental study on specimen errors from more than 50 health care facilities during a 3-year period and found that 8% of specimen errors resulted in additional treatment or temporary or permanent patient harm. It is important to understand the type, frequency, and factors that contribute to errors in specimen management to create interventions effective in decreasing errors and reducing the potential for harm.^1,7,13 

Specimen errors in the preanalytical phase include mistakes in collection,^1-3,8,14  container labeling,^{1-4,7,11,14-16}  requisition completion,^1,3,7,11,14  handling (eg, contamination), storage,^1,3,7,11,14  and transport.^1,3,8,14  Factors that can contribute to errors can be categorized as poor team communication,^1,4,7,11  lack of process standardization,^1,4,11  process complexity,^1,4,7,11  and knowledge deficits.^1,7,11  However, specimen errors in the preanalytical phase have been studied less frequently than errors in other phases,³  and study findings are not reported in a standard manner. Some researchers have categorized errors by the process step (eg, labeling or identification, collection, transport).^1,2,9,14  However, in a nonexperimental study, Bixenstine et al³  reported preanalytical specimen errors in two categories where the errors were found: containers and requisition forms.

The following topics are outside the scope of this document:

• surgical technique used for specimen resection,

• clinical laboratory specimens (eg, complete blood count [CBC]),

• microbiology specimens (eg, culture and sensitivity),

• respiratory specimens for disease outbreaks (eg, coronavirus disease 2019 [COVID-19]),

• autologous or allograft tissue,

• traumatically amputated digits and limbs for replantation or autotransplantation;

• specimen ordering processes,

• use of florescence and methylene blue for identification,

• handling of hazardous substances (eg, formaldehyde),

• eyewash stations, and

• general radiation safety.

Refer to

• 42 CFR Part 493¹⁷  for guidance on laboratory requirements,

• the Guideline for a Safe Environment of Care¹⁸  for recommendations on handling of hazardous substances and eye wash stations,

• the Guideline for Autologous Tissue Management¹⁹  for handling of autologous tissue, and

• the Guideline for Radiation Safety²⁰  for general radiation safety principles and safe use of radioactive seeds in brachytherapy procedures.

Evidence Review

A medical librarian with a perioperative background conducted a systematic search of the databases Ovid MEDLINE^®, Ovid Embase^®, EBSCO CINAHL^®, and the Cochrane Database of Systematic Reviews. The search was limited to literature published in English from January 2012 through November 2019. At the time of the initial search, weekly alerts were created on the topics included in that search. Results from these alerts were provided to the lead author until March 2020. The lead author requested additional articles that either did not fit the original search criteria or were discovered during the evidence appraisal process. The lead author and the medical librarian also identified relevant guidelines from government agencies, professional organizations, and standards-setting bodies.

Search terms included accidents (occupational), amputation (traumatic), biopsy, bone nails, bone plates, bone screws, bone wires, breast neoplasms, burial practices, calculi, chain of custody, cholelithiasis, clinical information, clothing, cultural diversity, dermatologic surgical procedures, device removal, diagnostic errors, documentation, ethanol, explant, fixati*, fixation time and amount, fixatives, forensic ballistics, forensic nursing, forensic pathology, formaldehyde, formalin, fresh specimen, fresh tissue, frozen specimen, frozen tissue, funeral rites, gallstones, gross evaluation, gross examination, health care errors, honey, intraoperative care, intraoperative period, label*, lymph nodes, medical errors, mishandling, misidentification, mislabel*, normal saline, nurse’s role, nursing records, occupational diseases, occupational exposure, occupational health, occupational safety, operating room nursing, operating rooms, orthopedic implants, paraffin, paraffin embedding, pathology (surgical), patient identification systems, patient information, patient safety, perioperative care, perioperative nursing practice guidelines as topic, preoperative care, products of conception, prostheses and implants, quality assurance (health care), quality of health care, radiation effects, radiation injuries, radiation monitoring, radiation protection, radiologic health, RPMI 1640, safety, safety precautions, saline solution, specimen contaminat*, specimen defect, specimen handling, specimen storage, specimen type, surgery (operative), surgical pathology process, surgical procedures (operative), surgical site identification, surgical specimen, suture tags, tissue markers, tissue preservation, vacuum, wire localization, wounds (gunshot), and wounds (stab).

Included were research and non-research literature in English, complete publications, and publications with dates within the time restriction when available. Historical studies were also included. Excluded were non-peer-reviewed publications and older evidence within the time restriction when more recent evidence was available. Editorials, news items, and other brief items were excluded. Low-quality evidence was excluded when higher-quality evidence was available, and literature outside the time restriction was excluded when literature within the time restriction was available (Figure 1).

Figure 1

Flow Diagram of Literature Search Results

Adapted from Moher D, Liberati A, Tetzlaff J, Atman DG; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA Statement. PLoS Med. 2009;6(6):e1000097.

Articles identified in the search were provided to the project team for evaluation. The team consisted of the lead author and one evidence appraiser. The lead author and the evidence appraiser reviewed and critically appraised each article using the indicated AORN Research or Non-Research Evidence Appraisal Tools. A second appraiser was consulted in the event of a disagreement between the lead author and the primary evidence appraiser. The literature was independently evaluated and appraised according to the strength and quality of the evidence. Each article was then assigned an appraisal score. The appraisal score is noted in brackets after each reference as applicable.

Each recommendation rating is based on a systematic review and synthesis of the collective evidence, a benefit-harm assessment, and consideration of resource use. The strength of the recommendation was determined using the AORN Evidence Rating Model and the quality and consistency of the evidence supporting a recommendation. The recommendation strength rating is noted in brackets after each recommendation.

Note: The evidence summary table is available at http://www.aorn.org/evidencetables/.

Editor’s note: MEDLINE is a registered trademark of the US National Library of Medicine’s Medical Literature Analysis and Retrieval System, Bethesda, MD. Embase is a registered trademark of Elsevier B.V., Amsterdam, The Netherlands. CINAHL, Cumulative Index to Nursing and Allied Health Literature, is a registered trademark of EBSCO Industries, Birmingham, AL.