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Klinisk Biokemi i Norden · 1 2017
Continuous quality control of the blood sampling
procedure using a structured observation scheme
Tine Lindberg Seemann, Mads Nybo
Department of Clinical Biochemistry and Pharmacology, Odense University Hospital,
Denmark
First published in Biochemia Medica 2016;26(3):337-45.
Introduction
The ongoing vast automation of the laboratories helps
reducing the number of errors related to the labo-
ratory, but preanalytical errors remains a challenge,
and studies has reported that up to 75% of laboratory
errors occur in the preanalytical phase (
1
,
2
,
3
), where
the blood sampling procedure is a pivotal area: It is
well-known that phlebotomy errors can influence the
diagnosis and also affect patient care in a harmful way
(
4
,
5
), and recent reports on the un-harmonised train-
ing in European countries of the personnel performing
phlebotomy (
6
) and the lack of adherence to guidelines
by e.g. the Clinical and Laboratory Standards Institute
(CLSI) (
7
) and the International Organization for
Standardization (ISO) (
8
) is therefore alarming (
9
).
The European Federation of Clinical Chemistry and
Laboratory Medicine (EFLM) Working Group for the
Preanalytical Phase (WG-PRE) has therefore recom-
mended monitoring phlebotomy quality regularly
in order to ensure the quality of the blood collection
procedure (9). Quality control (QC) of phlebotomy is
however challenging because errors associated with
phlebotomy covers a variety of aspects such as patient/
sample misidentification, prolonged use of tourniquet,
inadequate patient preparation, low blood collection
volume, and impeded healthcare worker safety (3). A
structured QC assessment of the blood sampling pro-
cedure is therefore needed: This will not only assure the
blood sampling quality, but also enable documentation
of the sampling quality, and last but not least assess-
ment of untrained personnel will make it possible for
the laboratory organization to ensure the blood sample
quality for
all
samples arriving at the laboratory as
requested in the ISO 15189:2012.
A continuous QC of the blood sampling procedure
was introduced at our university hospital using a
structured observation scheme as suggested by the
EFLM WG-PRE (9). The hypotheses were that i) an
observational QC would enable identification of some
critical issues in the blood sampling procedure, and
ii) implementation of corrective actions (education of
the staff) would result in better adherence to the gui-
delines. The aim of our study was to assess the level
of compliance with the local phlebotomy guideline, to
investigate if the tool could help identifying necessary
focus items, and finally to study whether continuous
QC of the phlebotomy procedure over time would
improve adherence to the phlebotomy guideline.
Materials and methods
The investigation was conducted at Odense Univer-
sity Hospital, Denmark, as an observational study in
two phases: a pilot study and a follow-up study.
Pilot study
All staff members performing phlebotomy at Depart-
ment of Clinical Biochemistry and Pharmacology,
Odense University Hospital, Denmark, were obser-
ved. At Odense University Hospital the vast majority
of blood samples are drawn by professionally trained
laboratory technicians, an education that includes
