See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/291672320

What Constitutes a Correctly Labeled Specimen?

Article  in  Laboratory Medicine · October 2011

DOI: 10.1309/LM8JJMV5C9XAAHRY

CITATIONS READS

0 22

1 author:

Charles D Hawker

67 PUBLICATIONS   991 CITATIONS   

SEE PROFILE

Some of the authors of this publication are also working on these related projects:

Clinical Laboratory Automation View project

Parathyroid Hormone Radioimmunoassay View project

All content following this page was uploaded by Charles D Hawker on 09 February 2019.

The user has requested enhancement of the downloaded file.

 Lab Guidelines
& Standards
What Constitutes a Correctly Labeled • More than 160,000 adverse events occur annually in
Specimen? the United States as a result of laboratories testing
misidentified specimens.

Downloaded from https://academic.oup.com/labmed/article-abstract/42/10/630/2657691 by guest on 09 February 2019

DOI: 10.1309/LM8JJMV5C9XAAHRY
• In studies examining the frequency of specimen ID errors,
A test result can achieve quality patient care only when it the error rate has ranged from 0.1% to 5%.1,2
is applied to the health record of the correct patient. Specimen
labeling errors can lead to incorrect diagnoses, unnecessary In addition to the detriment to patient care, there is a high
treatments, and other adverse patient care effects, as well as amount of manpower involved when a specimen has to be
waste staff time spent on sorting and correcting the errors. verified through additional requested information or a newly
To date, the industry has not had a standardized approach collected specimen. The goal is for standardized labels, elec-
to labeling specimens. This absence of guidance and lack of tronically printed or handwritten with prelabeled fields, to
industry acceptance of standardization is believed to be related to be adopted quickly and used within each facility collecting
the current rate of mislabeled specimens. Charles D. Hawker, patient specimens.
PhD, MBA, FACB, Scientific Director, Automation & Spe- As one of the authors of AUTO12, Dr. Hawker identi-
cial Projects at ARUP Laboratories, Inc., observed this lack fied the format and location for the five main elements that
of standardization within the health care community while need to be included on every specimen. Information was also
working on a project within his own organization using a included on the optional, customizable elements of a label,
camera system to photograph specimen labels. Dr. Hawker which are often specific to a facility and/or department.
noted the difficulty in accomplishing this task, which was According to Dr. Hawker, “Health care facilities should stan-
attributable to the variance in label placement, information dardize with the required fields on the label above the bar
content, and orientation on the specimen. code and use the area below the bar code for the customized
In an effort to rectify this problem, the Clinical and fields that are additionally needed by the facility.” AUTO12
Laboratory Standards Institute (CLSI) recently published a provides for the fixed, required elements and the customizable
new document, Specimen Labels: Content and Location, Fonts, options.
and Label Orientation: Approved Standard (AUTO12-A),1 to It is not uncommon to find a specimen tube in the labo-
identify the required elements that must appear on each label, ratory that has a number of layered labels and no sight of the
including those items that are handwritten, electronically sample volume in order to determine if it is sufficient, hemo-
printed, and bar coded. lyzed, or otherwise suitable. Each time an additional label is
The 2011 National Patient Safety Goals (NPSG)2 from placed on a specimen, it is an opportunity for a mislabeling
The Joint Commission include a goal for improving the event. This standard requires that all labels have the patient’s
accuracy of patient identification. This objective has been name on the first line of the label. Each additional label
a central NPSG since the program was established in 2002, placed on a specimen overlaps the labels previously applied,
and is shared by the College of American Pathologists.3 The such that the patient name on the newest label is immediately
goal requires two identifiers on each patient specimen and the below the patient name on the older label. Having the two
directive that all specimens must be labeled in the presence of patient names positioned immediately next to each other
the patient. CLSI document AUTO12 covers specimen label- reduces the possibilities for mislabeling errors. It is guidance
ing from the time of collection through all phases of laboratory such as this contained within AUTO12 that, while logical,
processing and testing. has not been captured into procedures, and thus not standard-
Labeling errors can most often be divided into three ized across the health care community.
categories: unlabeled, mislabeled, and mismatched specimen AUTO12 addresses location and orientation of bar code
to requisition. CLSI document GP334 provides guidance on identifiers as well as bar code symbology (eg, Code 128, 2D).5
patient and specimen identification (ID) related to the han- The Centers for Disease Control and Prevention identified
dling of replaceable and nonreplaceable specimens. AUTO12 the use of barcoding systems as best practice for reducing
provides guidance related directly to specimen labels with specimen identification errors.6 With technology ever evolving
the intent of standardization across the health care industry, and laboratories embracing such technology for the efficien-
including manufacturers and health care facilities. All efforts cies gained, CLSI recognizes that future versions of AUTO12
should result in a decrease in labeling errors. The impact of will continue to address the topic of bar codes. AUTO12
these errors is significant, as noted by these statistics provided recognizes that not all health care facilities can afford bar code
within AUTO12: systems, so it also provides information on handheld labels
• Based on data from a study of 110 laboratories, it was and computer-generated labels.
estimated that one in 18 ID errors caused some type of A key goal of this document is to establish consistency
adverse patient event. in label content, format, size, and position on the container.

630 LABMEDICINE ■ Volume 42 Number 10 ■ October 2011 labmedicine.com

 Lab Guidelines & Standards

There are several schematics provided within the document 1. CLSI. Specimen Labels: Content and Location, Fonts, and Label Orientation:
to demonstrate examples of each of the above. These can be Approved Standard. CLSI document AUTO12-A. Wayne, PA: Clinical and
Laboratory Standards Institute; 2011.
easily applied as training tools for staff development for those
2. The Joint Commission. 2011 National Patient Safety Goals. http://www.
labeling specimens, and included in policies and procedures. jointcommission.org/PatientSafety/NationalPatientSafetyGoals. Accessed
Adoption of this standard by laboratories and all health August 29, 2011.
care providers who collect and handle clinical laboratory spec- 3. College of American Pathologists, Valenstein PN, Raab SS, Walsh MK.
imens will contribute to a reduction of mislabeled specimens, Identification errors involving clinical laboratories: a College of American
ensuring higher quality of reporting and faster delivery of Pathologists Q-Probes study of patient and specimen identification errors at
results. There also needs to be a commitment by the vendors 120 institutions. Arch Pathol Lab Med. 2006;130(8):1106-1113.
within the laboratory community, such as those who provide 4. CLSI. Accuracy in Patient and Sample Identification; Approved Guideline. CLSI
document GP33-A. Wayne, PA: Clinical and Laboratory Standards Institute;
laboratory information systems, to lead the way with technology 2010.
that standardizes to the AUTO12 content. 5. Appavu SI; for US Department of Health and Human Services. Analysis of
It is expected that all organizations involved in the licens- 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

ing and accrediting of laboratories will refer to this standard app0.htm. Accessed August 29, 2011.
in their accreditation checklists used during laboratory inspec- 6. CDC. Laboratory medicine best practices: Developing systematic evidence
tions. Dr. Hawker would prefer to see the standardization of review and evaluation methods for quality improvement; Phase 3 final
specimen labels on these regulatory checklists within the next technical report. www.futurelabmedicine.org. Accessed August 29, 2011.
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 Sheila K. Coffman, BSMT (ASCP), is an implemen-
improve patient safety. And it all starts with standardization, tation project manager in the point-of-care diagnostics
provided only by CLSI document AUTO12-A, Specimen industry and often works as an independent consultant.
Labels: Content and Location, Fonts, and Label Orientation: CLSI is a volunteer-driven, membership-supported,
Approved Standard. nonprofit organization dedicated to developing standards and
The Expert guidelines for the health care and medical testing community
Charles D. Hawker, PhD, MBA, FACB through a consensus process that balances the perspectives of
Scientific Director, Automation & Special Projects industry, government, and the health care professions. For
ARUP Laboratories, Inc. additional information on CLSI, visit the CLSI Web site
hawkercd@aruplab.com at www.clsi.org or call 610.688.0100.
801.584.5261

labmedicine.com October 2011 ■ Volume 42 Number 10 ■ LABMEDICINE 631

View publication stats