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Klinisk Biokemi i Norden · 1 2017
omy conditions are not always present. It is therefore
generally recommended to follow the order of draw
as stated in the CLSI guideline H3-A6, which is also
the procedure at our laboratory.
The third-most frequent error was improper mix-
ing of the samples: 19% did not perform this appro-
priately at the phlebotomy ward, while the number
was 25% at the hospital ward. In comparison, the
error frequency in the EFLM study for this item was
30.4% (9). The significant difference between the
phlebotomy settings could indicate that the working
conditions at the phlebotomy ward are more aligned
with proper laboratory standards, whereas sampling
at the hospital wards often are performed under
more tumultuous conditions. The blood sampling
QC offers a possibility to document a possible critical
impact on the sampling procedure and the following
analysis result. Therefore, the fact that blood sam-
pling conditions are challenging at the hospital wards
can be documented in order to obtain optimal work-
ing conditions for the phlebotomists. Studies have
shown that especially for coagulation testing mix-
ing of the sample is crucial (
16
), and a recent study
showed that 24% of the rejected tests during a year
was due to a clotted specimen (
17
). Results of coag-
ulation testing are often needed fast, and improper
mixing must therefore be avoided, e.g. by using an
automated roller mixer, which can be transported to
the hospital wards (
18
). In the follow-up study, the
error frequency had declined to 3% at the phlebotomy
ward and to 13% at the hospital wards. Again, a clear
focus on a specific procedure needing improvement
appears to have been prosperous, but still there is
room for improvement at the hospital wards.
None of these three most frequent errors were in
the red zone described in the EFLM study as having
the highest combination of impact and probability (9).
An error in the red zone is however the patient identi-
fication process, which according to the CLSI H3-A6
is crucial, and it relies entirely on the phlebotomist
to ensure that the phlebotomy is actually performed
on the individual designated on the request form (7).
Patient identification was performed incorrect in two
instances in the pilot study and once in the follow-up
study. In comparison, the frequency of patient identi-
fication error was as high as 16.1% in the EFLM study
(9), being more frequent among outpatients than
at the hospital wards. No matter what, this type of
error is unacceptable and must be avoided at all cost.
Recently, harmonisation of the patient identification
procedure was suggested by the EFLM WG-PRE in
order to prevent patient identity mix-up (
19
), and
hopefully such harmonized procedures will improve
patient safety in the future.
A new item was introduced in the follow-up study,
namely proper inspection of the venipuncture site to
assure that bleeding indeed had stopped. The study
showed that this was an important issue to include as
it was almost neglected at the phlebotomy ward (only
correctly performed in one out of 30 phlebotomies),
and also very critical at the hospital wards (an error
frequency of 69%). This strongly emphasizes that
the observation scheme must evolve continuously
to exploit new areas, where focus is needed. With
renewed focus on this small item, it will hopefully be
possible to show improvement in the error frequency
for this issue also.
The follow-up study showed that continued focus
on critical key issues do result in significant improve-
ments for the three major issues found in the pilot
study. It is however not enough to identify and deal
with such issues, it is also necessary to maintain focus
on the phlebotomy process and future alterations in
this pivotal procedure. This study was not designed
to demonstrate the possibility of such “maintenance
value” using a QC system, but it is our strong believe
that it is capable of maintaining the focus on the phle-
botomy procedure as it is seen for other QC systems
used by the laboratory every day. More importantly,
the QC system will also be an important asset outside
the laboratory: In the health care system, increasing
fiscal demands and a need of faster turn-around times
are inevitable, which has increased the interest in hav-
ing other professionals than trained phlebotomists to
perform blood sampling. A likely future scenario is
therefore an increased number of decentralised blood
samplings (e.g. by doctors or nurses at the hospital
wards). From a laboratory point-of-view it will be
essential to ascertain the phlebotomy quality, which
will be possible through a blood sampling QC.
In conclusion, continuous QC of the blood sam-
pling procedure using a structured observation
scheme was feasible and useful. It revealed a number
of items that were not conducted compliant with the
phlebotomy guideline. Also, it supported significant
improvements in the adherence to the recommended
phlebotomy procedures and facilitated documenta-
tion of the phlebotomy quality.
