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What Constitutes a Correctly Labeled Specimen?

Article  in  Laboratory Medicine · October 2011

DOI: 10.1309/LM8JJMV5C9XAAHRY

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What Constitutes a Correctly Labeled
Specimen?
DOI: 10.1309/LM8JJMV5C9XAAHRY
A test result can achieve quality patient care only when it
is applied to the health record of the correct patient. Specimen
labeling errors can lead to incorrect diagnoses, unnecessary
treatments, and other adverse patient care effects, as well as
waste staff time spent on sorting and correcting the errors.
To date, the industry has not had a standardized approach
to labeling specimens. This absence of guidance and lack of
industry acceptance of standardization is believed to be related to
the current rate of mislabeled specimens. Charles D. Hawker,
PhD, MBA, FACB, Scientific Director, Automation & Spe-
cial Projects at ARUP Laboratories, Inc., observed this lack
of standardization within the health care community while
working on a project within his own organization using a
camera system to photograph specimen labels. Dr. Hawker
noted the difficulty in accomplishing this task, which was
attributable to the variance in label placement, information
content, and orientation on the specimen.
In an effort to rectify this problem, the Clinical and
Laboratory Standards Institute (CLSI) recently published a
new document, Specimen Labels: Content and Location, Fonts,
and Label Orientation: Approved Standard (AUTO12-A),1 to
identify the required elements that must appear on each label,
including those items that are handwritten, electronically
printed, and bar coded.
The 2011 National Patient Safety Goals (NPSG)2 from
The Joint Commission include a goal for improving the
accuracy of patient identification. This objective has been
a central NPSG since the program was established in 2002,
and is shared by the College of American Pathologists.3 The
goal requires two identifiers on each patient specimen and the
directive that all specimens must be labeled in the presence of
the patient. CLSI document AUTO12 covers specimen label-
ing from the time of collection through all phases of laboratory
processing and testing.
Labeling errors can most often be divided into three
categories: unlabeled, mislabeled, and mismatched specimen
to requisition. CLSI document GP334 provides guidance on
patient and specimen identification (ID) related to the han-
dling of replaceable and nonreplaceable specimens. AUTO12
provides guidance related directly to specimen labels with
the intent of standardization across the health care industry,
including manufacturers and health care facilities. All efforts
should result in a decrease in labeling errors. The impact of
these errors is significant, as noted by these statistics provided
within AUTO12:
• Based on data from a study of 110 laboratories, it was
estimated that one in 18 ID errors caused some type of
adverse patient event.
630 LABMEDICINE ■ Volume 42 Number 10 ■ October 2011 labmedicine.com
Lab Guidelines
& Standards
• More than 160,000 adverse events occur annually in
the United States as a result of laboratories testing
misidentified specimens.
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• In studies examining the frequency of specimen ID errors,
the error rate has ranged from 0.1% to 5%.1,2
In addition to the detriment to patient care, there is a high
amount of manpower involved when a specimen has to be
verified through additional requested information or a newly
collected specimen. The goal is for standardized labels, elec-
tronically printed or handwritten with prelabeled fields, to
be adopted quickly and used within each facility collecting
patient specimens.
As one of the authors of AUTO12, Dr. Hawker identi-
fied the format and location for the five main elements that
need to be included on every specimen. Information was also
included on the optional, customizable elements of a label,
which are often specific to a facility and/or department.
According to Dr. Hawker, “Health care facilities should stan-
dardize with the required fields on the label above the bar
code and use the area below the bar code for the customized
fields that are additionally needed by the facility.” AUTO12
provides for the fixed, required elements and the customizable
options.
It is not uncommon to find a specimen tube in the labo-
ratory that has a number of layered labels and no sight of the
sample volume in order to determine if it is sufficient, hemo-
lyzed, or otherwise suitable. Each time an additional label is
placed on a specimen, it is an opportunity for a mislabeling
event. This standard requires that all labels have the patient’s
name on the first line of the label. Each additional label
placed on a specimen overlaps the labels previously applied,
such that the patient name on the newest label is immediately
below the patient name on the older label. Having the two
patient names positioned immediately next to each other
reduces the possibilities for mislabeling errors. It is guidance
such as this contained within AUTO12 that, while logical,
has not been captured into procedures, and thus not standard-
ized across the health care community.
AUTO12 addresses location and orientation of bar code
identifiers as well as bar code symbology (eg, Code 128, 2D).5
The Centers for Disease Control and Prevention identified
the use of barcoding systems as best practice for reducing
specimen identification errors.6 With technology ever evolving
and laboratories embracing such technology for the efficien-
cies gained, CLSI recognizes that future versions of AUTO12
will continue to address the topic of bar codes. AUTO12
recognizes that not all health care facilities can afford bar code
systems, so it also provides information on handheld labels
and computer-generated labels.
A key goal of this document is to establish consistency
in label content, format, size, and position on the container.

There are several schematics provided within the document
to demonstrate examples of each of the above. These can be
easily applied as training tools for staff development for those
labeling specimens, and included in policies and procedures.
Adoption of this standard by laboratories and all health
care providers who collect and handle clinical laboratory spec-
imens will contribute to a reduction of mislabeled specimens,
ensuring higher quality of reporting and faster delivery of
results. There also needs to be a commitment by the vendors
within the laboratory community, such as those who provide
laboratory information systems, to lead the way with technology
that standardizes to the AUTO12 content.
It is expected that all organizations involved in the licens-
ing and accrediting of laboratories will refer to this standard
in their accreditation checklists used during laboratory inspec-
tions. Dr. Hawker would prefer to see the standardization of
specimen labels on these regulatory checklists within the next
three years and, ideally, within the next two years, but without
penalty during the first year. “I would like to see a focus by the
leadership within the regulatory and accrediting agencies to
provide early announcements of the upcoming standards,”
Dr. Hawker says. ”There is much work involved in coming
into compliance, allowing people to start the work now.”
With raised awareness of the importance of proper specimen
and patient ID in reducing errors, efforts can be defined to
improve patient safety. And it all starts with standardization,
provided only by CLSI document AUTO12-A, Specimen
Labels: Content and Location, Fonts, and Label Orientation:
Approved Standard.
The Expert
Charles D. Hawker, PhD, MBA, FACB
Scientific Director, Automation & Special Projects
ARUP Laboratories, Inc.
hawkercd@aruplab.com
801.584.5261
labmedicine.com October 2011 ■ Volume 42 Number 10 ■ LABMEDICINE 631
View publication stats
Lab Guidelines & Standards
1. CLSI. Specimen Labels: Content and Location, Fonts, and Label Orientation:
Approved Standard. CLSI document AUTO12-A. Wayne, PA: Clinical and
Laboratory Standards Institute; 2011.
2. The Joint Commission. 2011 National Patient Safety Goals. http://www.
jointcommission.org/PatientSafety/NationalPatientSafetyGoals. Accessed
August 29, 2011.
3. College of American Pathologists, Valenstein PN, Raab SS, Walsh MK.
Identification errors involving clinical laboratories: a College of American
Pathologists Q-Probes study of patient and specimen identification errors at
120 institutions. Arch Pathol Lab Med. 2006;130(8):1106-1113.
4. CLSI. Accuracy in Patient and Sample Identification; Approved Guideline. CLSI
document GP33-A. Wayne, PA: Clinical and Laboratory Standards Institute;
2010.
5. Appavu SI; for US Department of Health and Human Services. Analysis of
unique patient identifier options – Final report. http://www.ncvhs.hhs.gov/
Downloaded from https://academic.oup.com/labmed/article-abstract/42/10/630/2657691 by guest on 09 February 2019
app0.htm. Accessed August 29, 2011.
6. CDC. Laboratory medicine best practices: Developing systematic evidence
review and evaluation methods for quality improvement; Phase 3 final
technical report. www.futurelabmedicine.org. Accessed August 29, 2011.
Sheila K. Coffman, BSMT (ASCP), is an implemen-
tation project manager in the point-of-care diagnostics
industry and often works as an independent consultant.
CLSI is a volunteer-driven, membership-supported,
nonprofit organization dedicated to developing standards and
guidelines for the health care and medical testing community
through a consensus process that balances the perspectives of
industry, government, and the health care professions. For
additional information on CLSI, visit the CLSI Web site
at www.clsi.org or call 610.688.0100.