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Introduction

The Guideline for Specimen Management has been approved by the AORN Guidelines Advisory Board. It was presented as a proposed guideline for comments by members and others. The guideline is effective May 15, 2014. The recommendations in the guideline are intended to be achievable and represent what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the guideline can be implemented. AORN recognizes the many diverse settings in which perioperative nurses practice; therefore, this guideline is adaptable to all areas where operative and other invasive procedures may be performed.

Purpose

This document provides guidance for management of surgical specimens in the perioperative practice setting, including guidance for the handling of body parts being reattached to the patient, forensic and radioactive specimens, and explanted medical devices and orthopedic hardware. Surgical techniques for resection of specimens is outside the scope of this guideline. This document does not address clinical laboratory specimens obtained for diagnostic or other screening procedures performed on blood, body fluids, or other potentially infectious materials. The reader should refer to 42 CFR 493, Laboratory Requirements, for guidance in this area.1 

Specimen management is a multifaceted, multidisciplinary process that includes

  • needs assessment,

  • site identification,

  • collection and handling,

  • transfer from the sterile field,

  • containment,

  • specimen identification and labeling,

  • preservation,

  • transport,

  • disposition of the specimen, and

  • documentation.

Accurate specimen management requires effective multidisciplinary communication, minimized distractions, and awareness of the potential opportunities for error. An error is an unintended act of omission (ie, failing to perform an action) or commission (ie, performing an action that results in harm).2  Errors in specimen management leading to inaccurate or incomplete diagnosis, the need for additional procedures, and physical and psychological injury have been reported.3-5 

In a survey commissioned by the Association of Directors of Anatomic and Surgical Pathology to assess perceptions and definitions of errors in surgical pathology and to examine and measure the frequency of errors among its members, researchers randomly surveyed pathologists in 40 academic pathology laboratories in the United States and one in Canada (N = 41). When asked to indicate where most errors in surgical pathology occurred, 53% of respondents indicated the preanalytical phase (ie, before the specimen reaches the pathology laboratory for analysis and processing), 38% indicated the analytical phase (ie, within the pathology laboratory while the specimen is being analyzed and processed), and 6% indicated the postanalytical phase (ie, after the specimen has been analyzed and processed in the pathology laboratory).6 

Examples of errors that may occur during the preanalytical phase include incorrect

  • pathology request,

  • order entry,

  • patient identification,

  • specimen identification,

  • specimen (or no specimen) in the container,

  • collection or handling methods,

  • container or preservative, and

  • transport methods or destination.

Examples of errors that may occur during the analytical phase include

  • equipment malfunction,

  • specimen mix-ups, and

  • undetected failure in quality control.

Examples of errors that may occur during the postanalytical phase include

  • confirmation of erroneous data,

  • failure or delay in pathology reporting or addressing the pathology report,

  • excessive turnaround time, and

  • improper data entry and manual transcription.

Errors that may have occurred during the preanalytical phase are often detected during the analytical phase because the histology visualized under the microscope does not correspond to the biopsy site specified in the accompanying documentation or clinical history.7  There are many points in the analytical phase during which an error can occur. Errors occurring during the analytical phase have the potential to cause great patient harm because the results of the examination by the pathologist may be critical for effective patient care.7 

Errors in specimen management may be classified as

  • near misses (ie, the error has the potential to harm the patient, but does not, either by chance or because the error was detected before harm resulted),7,8 

  • adverse events (ie, the error causes the patient either inconvenience or harm),7  or

  • sentinel events (ie, the error results in significant harm to the patient).8 

Specimen management errors may be attributed to human factors (eg, poor communication, fatigue, inadequate education or competency verification), the environment, equipment failure, or inadequate policies and procedures.7  The causes of specimen management errors may be determined through a process of root cause analysis in which knowledgeable individuals and other persons involved in the event make a critical analysis and a determination as to the factor(s) that contributed to the error.7 

Most errors in specimen management are a result of human errors caused by slips, lapses, and mistakes.7 

  • Slips are unintended actions9  (eg, placing an incorrect label on a specimen container).

  • Lapses are omissions of intended actions9  (eg, omitting the last letter of a patient’s name and writing “Smith” rather than “Smithe”).

  • Mistakes are errors of conscious thought9  (eg, choosing to disregard known policies and procedures).

Most errors in specimen management are classified as slips and lapses. Errors caused by slips and lapses are the result of automatic actions and are therefore difficult to prevent.7  These type of errors are often not noticed at the time they occur.7  The result of the error may not become apparent until hours or days after it has occurred.7 

The true frequency of errors in specimen management is difficult to quantify. Most estimates are based on studies conducted in single institutions. Estimates based on multi-institutional studies suggest that the number of errors in specimen management varies widely among institutions and is likely associated with specimen identification practices unique to the institution.7 

Reducing errors in specimen management requires a careful examination of the preanalytical, analytical, and postanalytical phases for system flaws that may contribute to errors and be responsive to analysis and correction. The simple application of redundancy to various portions of the specimen management cycle (ie, double-checking steps of the process that may be subject to slips and lapses) has the potential to significantly reduce errors.7,10 

Evidence Review

A medical librarian conducted a systematic search of the databases MEDLINE, CINAHL, and the Cochrane Database of Systematic Reviews for meta-analyses, systematic reviews, randomized controlled and non-randomized trials and studies, case reports, reviews, and guidelines. Scopus was also consulted, although not searched systematically. Search terms included specimen handling, surgical specimen, specimen type, fresh specimen, fresh tissue, anticoagulants, explant, bone screws, bone plates, bone nails, calculi, gallstones, urinary calculi, kidney stones, renal calculi, surgical pathology, clinical pathology, cell biology, cytology, stone analysis, gross examination, gross evaluation, fixatives, additives, tissue preservatives, preservative, saline solution, paraffin, formaldehyde, formalin, cryoultramicrotomy, freezing, time factors, transportation, chain of custody, container, transfer, handling, mishandling, delivery, storage, organizational policy, documentation, clinical information, name, patient information, patient identification systems, labels, labeling, mislabeling, suture tags, tissue markers, medical errors, diagnostic errors, equipment contamination, specimen contamination, safety precautions, occupational health, occupational accidents, radioactive, radioactivity, forensic, wounds, gunshot, forensic pathology, law enforcement, religion, cross-cultural comparison, cultural diversity, funeral rites, radiologic health, occupational accidents, occupational health, perioperative nursing, nurse’s role, intraoperative care, intraoperative period, perioperative care, surgical procedures, and operating rooms.

The search was originally limited to literature published in English between January 2007 and October 2012. The medical librarian conducted the first database search on October 11, 2012. Older articles were included when there were no articles within this time period. Additional articles not identified in the original search were obtained after a review of the reference lists of the articles obtained originally. In addition, between October 2012 and January 2014, the results of alerts established at the time of the initial searches were considered. During the development of the document, the lead author requested supplementary searches and requested additional articles that either did not fit the original search criteria or were discovered during the evidence appraisal process. Finally, the lead author and the medical librarian identified relevant guidelines from government agencies and standards-setting bodies.

More than 374 articles or documents were reviewed in preparation for writing this guideline. Approximately 120 were ultimately selected for inclusion as suitable references. Articles were rejected primarily because they addressed surgical techniques for specimen resection or procedures for processing of specimens in the pathology laboratory.

As relevant research and other evidence was located, it was independently evaluated and critically appraised according to the strength and quality of the evidence using the AORN Evidence Appraisal Tools (Research and Non-Research) by the lead author and an independent reviewer. The reviewers participated in conference calls to discuss their individual appraisal scores and to establish consensus. Each article or study was assigned an appraisal score as agreed upon by the reviewers. The appraisal scores are noted in brackets at the end of each citation in the references list at the end of the document.

After the evidence was reviewed and appraised, the collective evidence supporting each intervention within a specific recommendation was rated using the AORN Evidence Rating Model. Ratings include Strong Evidence, Regulatory Requirement, Moderate Evidence, Limited Evidence, Benefits Balanced With Harms, and No Evidence. Factors considered when applying the AORN Evidence Rating Model to the collective body of evidence included the quality of research, quantity of similar studies on a given topic, consistency of results supporting a recommendation, and whether the potential benefits of following the recommendation outweigh the harms. The evidence rating is noted in brackets following each intervention.

 

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

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