Five years of experience with staff training in an ISO15189-accredited ART laboratory.

Bart Desmet, Ronny Janssens, Johan Sterckx, Hilde Van De Velde, Greta Verheyen

Research output: Contribution to journalConference paper


Introduction: Of crucial importance for a successful ART programme is the assurance
of a well-trained and skilled staff. A requirement of the ISO 15189:2007
standard is to "ensure that there is sufficient qualified personnel with adequate
documented training and experience to meet the needs of the laboratory" and
that "the competency of each person to perform assigned tasks is assessed
training, and periodically thereafter. Retraining and reassessment is
performed when necessary". Hereafter, the organisation and five years of experience
with staff training in an accredited ART laboratory is presented.
Material and Methods: Before a new staff member is qualified to perform the
assigned tasks, he/she needs to fulfil objective, self-defined criteria. The trainee
needs to understand the scientific and technical background of the process by
reading the standard operating procedures (SOPs) which are used as a knowledge
database. Thereafter, practical training is started, first by observation of
an experienced staff member, followed by working under supervision. If the
predefined criteria are met, the trainee is qualified to perform independently.
of the training programme and the qualification criteria are formalised
in 24 different lab training schedules. Throughout the training, the trainee
documents the training details in a logbook. Individual results are registered
in preformatted documents and are used for evaluation of the trainee's performance
by the training supervisor. Finally, the training schedule is signed by
the laboratory director. The training schedules and the predefined criteria are
regularly evaluated and updated if necessary. After qualification, evaluations
are performed regularly.
Results: Over this five-year period, 61 staff members were trained to perform
new tasks and in total 244 training schedules were initiated. The 24
training schedules cover generic training (quality management, safety,
equipment management, maintenance..) and specific tasks (semen analysis,
semen preparation, oocyte collection, IVF, ICSI, cryopreservation, embryobiopsy...)
and are started in a logical sequence to build up competences.
The average duration to finalise an individual schedule is variable, depending
on complexity and qualification criteria. On average, three months are needed
for egg retrieval and two months for semen analysis. Initially, ICSI training
took nine months. The predefined critera seemed too strict and could
not be met within a reasonable period. Therefore, criteria were adapted as
follows. Firstly, 10 in-vitro-matured oocytes are injected. Thereafter, the
trainee can inject one oocyte in 10 clinical cycles with more than 8 mature
oocytes. In a next phase, the trainee needs to achieve 60% fertilisation rate in
50 mature oocytes which represent maximum 25% of the collected oocytes
per cycle. Fulfilling these criteria, the trainee is allowed to inject 50% of the
mature oocytes within a cycle (200 oocytes in total). Finally, all the oocytes
of minimum 20 patients are injected under supervision, aiming to achieve
minimum 65 % fertilisation rate and maximum 10% degeneration rate. Average
duration of training for ICSI is now six months. After qualification, each
staff member is re-evaluated. Retraining was initiated for two staff members.
Follow up is performed by calculating individual ICSI performance at regular
intervals during the first year, and later on a yearly basis. In 2010, the
average for 19 qualified staff members was 78.2% fertilisation rate and 5.6%
degeneration rate.
Conclusions: In a quality-certified ART laboratory, training of personnel
according to well-defined criteria is mandatory but time consuming. After
completion of the training schedule, continuous follow-up is needed. The time
required to fulfil the training schedule for a specific task depends on the skills
of the performer, on the number of training schedules running for a specific
task and on the chances for training which is related to the size of the clinical
Original languageEnglish
Pages (from-to)256, 351
Number of pages2
JournalHuman Reproduction
Publication statusPublished - Jul 2011
EventUnknown -
Duration: 1 Jul 2011 → …


  • ART laboratory


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