Surgical Specimen Management: A Descriptive Study of 648 Adverse Events and Near Misses
Surgical Specimen Management: A Descriptive Study of 648 Adverse Events and Near Misses
Surgical Specimen Management: A Descriptive Study of 648 Adverse Events and Near Misses
Context.Surgical specimen adverse events can lead to management process, with the most common events
delays in treatment or diagnosis, misdiagnosis, reopera- reported during the prelaboratory phase and, specifically,
tion, inappropriate treatment, and anxiety or serious with specimen labeling, collection/preservation, and trans-
patient harm. port. The most common contributing factors were failures
Objectives.To describe the types and frequency of in handoff communication, staff inattention, knowledge
event reports associated with the management of surgical deficit, and environmental issues. Eight percent of the
specimens, the contributing factors, and the level of harm events (52 of 648) resulted in either the need for additional
associated with these events. treatment or temporary or permanent harm to the patient.
Design.A retrospective review was undertaken of Conclusions.All phases of specimen handling and
surgical specimen adverse events and near misses volun- processing are vulnerable to errors. These results provide
tarily reported in the University HealthSystem Consortium a starting point for health care organizations to conduct
Safety Intelligence Patient Safety Organization database by proactive risk analyses of specimen handling procedures
more than 50 health care facilities during a 3-year period and to design safer processes. Particular attention should
(20112013). Event reports that involved surgical speci- be paid to effective communication and handoffs, consis-
men management were reviewed for patients undergoing tent processes across care areas, and staff training. In
surgery during which tissue or fluid was sent to the addition, organizations should consider the use of tech-
pathology department. nology-based identification and tracking systems.
Results.Six hundred forty-eight surgical specimen (Arch Pathol Lab Med. 2016;140:13901396; doi:
events were reported in all stages of the specimen 10.5858/arpa.2016-0021-OA)
solution, or adding solution when it should not have been these 223 reports (30%), information such as date and time
added. About one-third of the collection issues involved of collection, the patients clinical information, or the
specimens that were not immediately placed into the diagnosis was missing or incorrect. In another 69 of the
specimen container, resulting in temporarily misplaced or 223 reports (31%), the label did not have the required
lost specimens. Some specimens were left on the surgical patient identifiers or the patient was incorrectly identified by
field and were, at times, accidentally discarded. Collection name or number. The label or requisition identified the
technique problems involved insufficient biopsy sample size, wrong side or site of specimen collection in 31 reports
margins, or contents or incorrect specimen handling (eg, (14%). Mislabeling, in which the specimen label did not
discarding a portion of specimen). Other collection issues match the requisition, occurred in 25 reports (11%) and
included placing the specimen in the wrong container or often misidentified the patients name. In the remainder, the
type of container. tissue was incorrectly identified (8%; 17 of 223) or not
Specimen Labeling.Almost one-half of the 648 identified on the label or requisition (6%; 14 of 223).
surgical specimen events (n 319) involved a specimen- Specimen Transport.Almost 40% of the 648 reported
labeling issue. In 96 of these events (30%), the specimen events involved issues in specimen transport to the
container was not labeled or the requisition form was not laboratory and/or storage before receipt in the laboratory
sent with the specimen. In the remaining 223 reports (70%), (n 247). Of these 247 transport errors, 99 errors (40%)
the specimen was labeled or had a requisition, but the involved delays in transporting specimens. In 77 events
information was incomplete, inaccurate, or illegible. In 67 of (31%), specimens were misplaced or lost and did not reach
1392 Arch Pathol Lab MedVol 140, December 2016 Surgical Specimen EventsSteelman et al
Table 3. Surgical Specimen Events by Contributing specimen collection practices (27 of 42; 64%); for example,
Factor the tissue had dried because no solution or preservative had
been added, or the specimen was placed in the wrong
Events,a No. (%),
Contributing Factor n 331
solution. In other cases, the quantity was inadequate (n
13; 31%), or the specimen was compromised during
Communication issues, including 172 (52) handling; for example, the container broke and damaged
handoffs
Staff inattention 162 (49) the specimen or the specimen was contaminated.
Knowledge, training, experience 126 (38)
Environmental issues (distractions, 56 (17)
Postlaboratory Phase
interruptions, emergency, lighting) Problems surrounding the timeliness and accuracy of
Patient misidentification 36 (11) surgical specimen results were described in 3% (19 of 648)
Staffing issues (adequacy, staff mix, 26 (8)
float/agency staff) of the event reports. Delays in receiving the results were
Accuracy or availability of test results 23 (7) more common than incorrectly reported results. Some
Order entry or other documentation 20 (6) delays occurred with the patient still in the operating room;
problem for example, the reporting of frozen section results was
Policies/procedures lacking, unclear, or 20 (6) delayed.
staff unaware
Repetitive task 17 (5) Contributing Factors
a
An event may have more than one contributing factor.
Reprinted with permission from Vizient, Inc. Copyright 2015 Vizient. Managers reviewing event reports identified contributing
All rights reserved. Surgical Specimen Events. Chicago, IL: University factors in 51% (331 of 648) of the event reports. Some events
HealthSystem Consortium, Safety Intelligence; 2015:111. involved more than one contributing factor. The most
common contributing factors reported in these 331 reports
were failures in communication or handoffs (52%; n 172);
the laboratory/pathology department. Delays occurred staff inattention (49%; n 162); inadequate knowledge,
when specimens were not immediately transported to the training, and experience (38%; n 126); and environmental
appropriate area. Operating room personnel set specimens issues (17%; n 56), including distractions, interruptions,
aside or stored them temporarily on a counter, in collection emergencies, and poor lighting (Table 3). These factors
boxes, in a refrigerator, or under a stretcher, or the specimen aligned with our review of the event descriptions.
was held until the end of the case (individual or batched Specimen collection errors occurred because surgical staff
specimens) rather than taking or sending them directly to lacked knowledge, training, and experience with the
the laboratory. Other delays occurred when specimens were procedures for handling specimens or communication was
transported to the wrong location or area and had to be unclear about the preservative required. Specimens were
rerouted or were temporarily lost. lost or discarded because of improper handoffs. Factors
In some cases, the specimen was not stored properly in contributing to labeling errors included staff inattention,
the refrigerator (13 of 247; 5%). In others, the preservative/ environmental distractions, failure to follow procedures, and
solution leaked during transport when container lids were changes in staff. In some cases, the surgeon did not clearly
not sealed securely or breakage/compromise of the con- communicate about, or miscommunicated, the specimen
tainer occurred (12 of 247; 5%). type, site or side, or quantity or the nurse misunderstood the
Laboratory Phase directions.
Specimen Processing and Analysis in the Laborato- Factors contributing to delays in transporting specimens
ry.Errors in the laboratory phase were less commonly included heavy workload, interruptions, batching speci-
reported (63 of 648 reports; 10%). The most common issue mens, and staff inattention. Errors during specimen
involved delays in processing and analyzing specimens (31 transport were commonly due to lack of knowledge on
of 63; 49%). Other specimen processing errors included policies and procedures for the delivery of specimens, often
errors logging in specimens (n 6; 10%), lost or during late hours or after hours. Failures in verbal and
compromised specimens in the laboratory (n 6; 10%), physical handoffs contributed to specimens being delivered
tests that were not completed or were incorrectly completed to the wrong location or getting lost when they were
because orders were not entered or unclear orders were not delivered through the pneumatic tube system. In some
clarified (n 5; 8%), specimens in which the incorrect test cases, staff was unaware that surgical specimens were to be
was performed (n 4; 6%), and specimens that were hand-delivered to the laboratory and that delivery via the
incorrectly labeled during the analysis (n 3; 5%). pneumatic tube was in violation of policy. Often, laboratory
Only 8 reported events (13%) involved errors during staff was unaware that a specimen had been delivered
specimen analysis. In 6 of these 8 events (75%), the because it was left on the counter without notice; therefore,
laboratory/pathology staff analyzed the specimen using the the specimen sat unattended and was not processed. Delays
wrong technique; for example, the tissue was oriented in specimen analysis were caused by numerous factors,
incorrectly. In other cases, the procedure setup was incorrect including failures in order entry, indirect handoff to
because important diagnostic information was unavailable. laboratory staff, inadequate specimen quantity or quality,
Two events (25%) were associated with an equipment failures in specimen transport, miscommunication between
malfunction. the surgical staff and laboratory staff, availability of
Specimen Quality.Of the 648 cases, 42 (6%) of the laboratory/pathology staff, and shift changes. In cases in
specimen quality issues were identified through the which the specimens were lost in the laboratory, there was
narrative descriptions and were typically reported by the often more than one specimen and/or different sizes of
laboratory. Most often, these were a result of improper specimens in the same container.
Arch Pathol Lab MedVol 140, December 2016 Surgical Specimen EventsSteelman et al 1393
Harm not available, we were unable to calculate the incidence rate
Most surgical specimen errors were discovered before the of reported events.
patient was significantly harmed. Of the 648 surgical However, the results provide a rich source of information
specimen reports, most were either near miss events on the types of errors that occur and the factors contributing
(43%; n 279) or events that reached the patient and did to those errors. These events can have significant impact on
not result in harm or only caused emotional distress or patient care and outcome, including the need for additional
inconvenience (49%; n 318). About 8% (n 52) of all testing, treatment, and patient monitoring, as well as an
surgical specimen events resulted in either the need for increased length of stay, a higher level of care, admission, or
additional treatment (7%; n 45) or temporary or additional surgery. Although it is beyond the scope of this
permanent harm to the patient (1%; n 7). article to measure the cost of this additional care, it may be
significant and is worthy of additional study.
Some errors resulted in delays, either intraoperatively or
Misidentification and specimen labeling errors are com-
during processing and reporting. In cases in which a delay
mon and represent an important priority for quality-
affected intraoperative interpretation, the error extended the
improvement efforts. Although most labeling errors were
duration of surgery and anesthesia. For example, when
near misses, the potential consequences can be severe when
orders were not identified as rapid for intraoperative
specimens are misidentified or labeled with the incorrect
parathyroid hormone, delays occurred in obtaining results.
patients name or clinical information, which can be critical
When orders were entered into the wrong patients
for correct interpretation of the specimen by the pathologist.
electronic health record, wrong encounter, or an inactive
Other problem-prone processes in the prelaboratory
record, orders were not seen by the laboratory staff and a
phase were specimen collection, preservation, and trans-
delay in processing occurred.
port. Of particular concern are the many specimens that
In many of the events, operating room or laboratory
were compromised when prepared with incorrect transport
personnel identified the error and took corrective action.
medium, fixative, or technique. Policies and procedures
About 54% of the identification/labeling errors (172 of 319)
should be readily accessible for staff at the point of use.
were caught after transport to the laboratory. Errors were
Discussion of planned specimens and their management
also caught when laboratory staff discovered that labeled during the presurgical briefing and verification of specimens
containers were empty or requisitions indicated that not all during the postoperative debriefing adds additional layers of
specimens were in the container, and the specimens were safety.
retrieved. In some of these cases, specimens were found in Commonly, reports indicated that specimens were not
the operating room and/or garbage after staff conducted a received in the laboratory, having been either temporarily or
search. Rarely, lost specimens resulted in additional surgery permanently lost. Lost and compromised specimens can
when it was necessary and possible; however, in some cases, have serious implications for diagnosis and treatment,
the specimen could not be replaced. particularly when they are irreplaceable. Technology-based
Costs Incurred solutions, such as wireless bar code tracking systems and
radiofrequency identification, have been proven to reduce
Overall, managers reviewing reports indicated that the identification errors during all phases of the laboratory
financial cost for surgical specimen-related events was low. process2528 and should be explored for potential benefit.
Of the 648 events reported, the reporter categorized the Less than 10% of reports described issues in processing
costs incurred in 316 cases (49%), and most (212 of 315; and analysis in the laboratory. These results are consistent
67%) reported no or minimal additional cost to the with previous studies reporting errors in the laboratory
organization. Of the 316 reports, 70 (22%) indicated that ranging from 0.1% to 7.44% of the overall total errors.5 It is
the event caused delays in care, and 60 (19%) reported that possible that errors occurring in these phases are reported in
the event caused pain, anxiety, or inconvenience to the other venues, such as internal laboratory quality commit-
patient. Additional laboratory or diagnostic testing or tees, and may be underreported in our data set.
treatment (eg, ambulatory visits or drug therapy) was In our analysis, 43% (279 of 648) of the reports were near
required in 13% (41 of 316) of the events; additional patient misses, suggesting that the processes for managing speci-
monitoring was needed in 5% (n 16); extended length of mens catch many errors before causing clinical consequence
stay, a higher level of care, or an admission was required in to the patient. However, in 18% (117 of 648) of events
3% (n 9); and additional surgery was indicated in 1% (n reviewed by managers, surgical specimen errors resulted in
3) of the cases. the need for additional patient monitoring or treatment,
including ambulatory visits. Four percent (12 of 316) of the
DISCUSSION events involved higher costs associated with hospitalization
This analysis examines a large, generalizable sample of and reoperation. Our analysis did not quantify the cost of
errors reported in the management of surgical specimens litigation, which can be substantial.
and communication of results by more than 50 health care Results of this analysis serve as a starting point for
organizations nationally. Event reporting is voluntary, and identification of systems weaknesses within the context of
the data do not represent all surgical specimen management the individual organization. Key recommendations for
events. In addition, the types of event reports submitted to improving the safety of specimen management are listed
the patient safety organization may vary across organiza- in Table 4.
tions and may not represent all reports. Most reported surgical specimen errors occur in the
Lack of documentation of specimen type did not allow prelaboratory phase. This is consistent with other published
inclusion of some potential events. Reports were reviewed studies.21 In addition to mistakes in labeling and identifi-
by managers within facilities, and inconsistencies in the cation, errors occurred during specimen collection, preser-
completion of reports may exist. Because data on the vation, and transportation. Common contributing factors
number of specimens accessioned at each organization were involved failures in handoff communication, knowledge
1394 Arch Pathol Lab MedVol 140, December 2016 Surgical Specimen EventsSteelman et al
Table 4. Key Recommendations
Recommendation Details
1. Conduct a proactive risk assessment Establish an interdisciplinary team.
Conduct a proactive risk assessment (eg, health care failure mode and effect
analysis),29 and identify processes that are at high risk of failure and in need
of control.
Use results to improve specimen handling processes.
2. Enhance communication and handoffs Discuss anticipated specimens during the preoperative briefing, and verify all
information during the postoperative debriefing.
Include verbal communication and read-back verification of the specimen
type, location, and other relevant information during handoffs of specimens
among the surgeon, scrub nurse, and circulating nurse.2,30
3. Develop effective policies and procedures Establish policies and procedures for the safe handling of surgical specimens.
The AORN, with input from the ACS, provides a framework for these
documents.2
Place specimens in containers as soon as possible after they are obtained.
Label each container with 2 unique patient identifiers, specimen type, and
specimen site.2
Conduct double-checks and cross-checks of the labeling of containers,
requisitions, and logs before transport of specimens.2
Establish safe processes for chain of custody, and ensure the specimens are
physically delivered to laboratory personnel, and critical information is
communicated.2
4. Educate staff Provide training on handling surgical specimens during orientation, annually
and when policies and procedures are updated.
Discuss policies and procedures for specimen labeling, adding solutions/
preservatives, handoffs, transport of specimens (including delivery during off-
hours), and management of rarely collected specimens.
Provide documentation and rapid reference guides at the point of use.
5. Explore technology Consider developing electronic order sets specific to specimens collected in
the operating room.27
Explore technology-based solutions, such as wireless bar codebased tracking
systems and radiofrequency identification to reduce identification errors
during all phases of the process.2528
Abbreviations: ACS, American College of Surgeons; AORN, Association of Perioperative Registered Nurses.
deficits, and the work environment. Multidisciplinary teams 12. Schmidt RL, Messinger BL, Layfield LJ. Internal labeling errors in a surgical
pathology department: a root cause analysis. Lab Med. 2013;44(2):176185.
should evaluate and take action to improve their identified 13. Coffin CM, Spilker K, Zhou H, Lowichik A, Pysher TJ. Frozen section
error-prone processes. diagnosis in pediatric surgical pathology: a decades experience in a childrens
hospital. Arch Pathol Lab Med. 2005;129(12):16191625.
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Accepted submissions will appear on the Archives of Pathology & Laboratory Medicine Web site as a
Web-only supplement to the September 2017 issue. Awards will be presented to the winners of the Top
5 Junior Member Abstract Program.
The CAP17 meeting will be held October 811 in National Harbor, Maryland. Visit the CAP17 Web
site (www.cap.org/cap17) and the Archives Web site (www.archivesofpathology.org) for additional
abstract program information as it becomes available.
1396 Arch Pathol Lab MedVol 140, December 2016 Surgical Specimen EventsSteelman et al