Suitability of a transport box for blood sample shipment over a long ...

Clinical Biochemistry 44 (2011) 1028–1029
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Clinical Biochemistry
journal homepage: www.elsevier.com/locate/clinbiochem
Case Report
Suitability of a transport box for blood sample shipment over a long period
Giuseppe Lippi a, ⁎, Gabriel Lima-Oliveira b,c,d,e , Sandro Coutino Nazer d , Maria Luiza Lopes Moreira d ,
Rodrigo Fagner Macedo Souza d , Gian Luca Salvagno c , Martina Montagnana c , Marileia Scartezini b ,
Geraldo Picheth b , Gian Cesare Guidi d
a U.O. Diagnostica Ematochimica, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
b Program of Pharmaceutical Sciences, Department of Medical Pathology Federal University of Parana, Curitiba, Parana, Brazil
c Sezione di Chimica Clinica, Dipartimento di Scienze della Vita e della Riproduzione, Università degli Studi di Verona, Verona, Italy
d MERCOSUL: Sector Committee of Clinical Analyses and in Vitro Diagnostics – CSM 20, Rio de Janeiro, Brazil
e Brazilian Society of Clinical Analyses on Sao Paulo State, Brazil
article
info
abstract
Article history:
Received 12 April 2011
Received in revised form 25 May 2011
Accepted 27 May 2011
Available online 13 June 2011
Keywords:
Preanalytical variability
Laboratory errors
Storage
Transportation
Quality
Background: Safety transport boxes are increasingly used to ship laboratory specimens but there is little
information on their capacity to maintain suitable transportation temperatures.
Materials and methods: Inner temperature was assessed using a commercially available transport box
during an 8-h transportation period in the heat.
Results: Temperature stability was unsatisfactory during approximately 64% of the transportation time (i.e.,
from 125 to 450 min).
Conclusions: Transport boxes might be unsuitable for shipping specimens over long periods.
© 2011 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
Introduction
Although laboratory diagnostics strongly contributes to the
screening, diagnosis, follow-up and therapeutic monitoring of most
— if not all — human disorders, diagnostics errors can occur at any step
of the total testing process, i.e., from the appropriateness of the test
request to the interpretation of test results [1]. Within this cycle (i.e.,
the foremost Lundberg's “brain to brain turnaround cycle”), errors
arising from the manually intensive preanalytical activities are
prevailing, representing up to 70% of all laboratory errors. Preanalytical
errors are mostly due to incorrect, inappropriate or mishandled
procedures for collection, handling, preparation and — last but not
least — transportation and storage of the specimens [2–4]. In
particular, due to the widespread networking, centralization of
laboratory diagnostics within large facilities (e.g.., huge, totally
automated and focused factories) and the consequent need to
transport a large number of specimens from peripheral collections
sites to the core laboratories, the problem of appropriate conditions of
sample transportation (i.e., time, temperature and humidity) is
critically emerging [5,6]. Moreover, temperature monitoring is
considered one of the leading issues in transfusion medicine, since
⁎ Corresponding author at: U.O. Diagnostica Ematochimica, Azienda Ospedaliero-
Universitaria di Parma, Via Gramsci, 14, 43126-Parma, Italy. Fax: +0039 0521 703791.
E-mail addresses: ulippi@tin.it, glippi@ao.pr.it (G. Lippi).
routine blood components' transportation should not exceed 10 °C
during transport at a maximum transit time of 24 h, as established by
most guidelines [7]. Safety transport boxes, that are products
designed to maintain the inner environment at a constant temperature
notwithstanding temperature changes outside the container,
are increasingly developed and used to store and ship laboratory
specimens as well as other biological materials. Nevertheless, little
information is available as yet on the effectiveness of these devices to
maintain suitable conditions of temperature, which would not affect
sample quality during long transportation times.
Materials and methods
Suitability of sample transportation was assessed using a commercially
available transport box, purchased from Coleman® (Wichita, Kansas–
United States) with exterior size: 10.63″L×7.87″W×8.27″H, and interior
size: 9.45″L×6.89″W×7.09″H. To warrant the correct temperature range,
four ice reusable dry gel packs with carbopol gel inside (2×200 mL and
2×500 mL) were accurately placed inside the transport box at a private
peripheral blood collection facility. A calibrated temperature recorder
(Trix-8 Temperature Recorder®, LogTag recorders, Adarve®, Brazil) was
also inserted. The temperature monitoring was started immediately
after closure of the box and repeated every 5 min through an 8-hour
study period. According to manufacturer's instruction, the suitable
transportation temperature (i.e., below 10 °C) is reached ~30 min after
0009-9120/$ – see front matter © 2011 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
doi:10.1016/j.clinbiochem.2011.05.028

G. Lippi et al. / Clinical Biochemistry 44 (2011) 1028–1029
1029
Fig. 1. Fluctuation of the inner temperature of a transportation box during the 8-h study period.
closure of the box, so that transportation from the private facility to the
core laboratory by courier as per manufacturer requirements started at
this time point. After 7 h and 30 min of transportation the box arrived
at the destination, in the core laboratory. Temperature data were
further analyzed with LogTag Analyser®. The limit of suitable
temperature fluctuation was established between 2 °C and 8 °C (i.e.,
35.6 °F—46.4°F), in agreement with the current recommendations of the
Clinical and Laboratory Standard Institute (CLSI) [8]. The environmental
temperature during transportation was comprised between 36 °C and
38 °C, whereas that of the private facility and the core laboratory was
~20 °C.
Results
The fluctuation of the temperature within the transport box during
the 8-h study period is shown in Fig. 1. Thirty minutes after the closure
of the box at the private facility the temperature rapidly fell from room
temperature (i.e., ~20 °C) to 6 °C, in agreement with manufacturer's
claim. After beginning of transportation, a nearly linear increase of
temperature was then observed, exceeding the upper suitable limit (i.e.,
8 °C) after 120 min (i.e., 90 min from the beginning of transportation).
Twenty min after arrival at the core laboratory, the internal temperature
of the transport box dropped down at 7 °C. As such, temperature
stability could be considered unsatisfactory during approximately 64%
of the transportation time, i.e., from 125 to 450 min.
Discussion
The increasing centralization of laboratory facilities has raised
important economical, organizational and preanalytical issues such as
the escalation of costs, the longer transportation times and the
potential increase of preanalytical errors due to the often challenging
conditions of transportation and storage of the specimens [5,6].
Establishment and maintenance of appropriate temperatures for
transportation is essential for preserving the quality of whole blood
and even centrifuged specimens, thus preventing irreversible physicochemical
alterations of blood components. According to the current
recommendations of the CLSI, chilled blood specimens should be
maintained at temperatures comprised between 2 °C and 8 °C until
separation [8]. As such, the transportation of samples and blood
components is increasingly accomplished by safety transport boxes,
especially in countries with high or even extreme environmental
temperatures and where shipment might occur over long distances.
Nevertheless, no published data are available to the best of our
knowledge on the performance of transportation boxes as regards
temperature stability throughout long periods of transportation, up to
several hours. Although limited to the evaluation of a single
commercial product the results of this investigation attest that the
recommended temperature for transportation (i.e., between 2 °C and
8 °C) might only be maintained for a limited period of time within a
transport box (e.g., up to 90 min), because the internal temperature
might be dramatically influenced by the environmental conditions. As
such, we hypothesized that some of these products might be
unsuitable to fulfil the requirements of some peripheral facilities
integrated within a network, especially those which ship the
specimens to very distant core laboratories. Rather understandably,
although all the experimental conditions were accurately standardized,
replication of this study at different temperature (e.g., high or
even extreme external temperatures) or humidity, as well as the use
of different types of containers made on different materials, might
provide different outcomes, so that additional studies should be
planned to test this hypothesis.
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