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 Pre-course Assessment of the Participants
Status Report on Quality in BTS
Mechanics of Training
Summary of Subjects Covered
Post-course Assessment of the Participants
Hand outs Provided to the Participants
Evaluation of Course by the Facilitators
Evaluation of Course by the Coordinator
Valedictory
Session
Pre-course
Assessment of the Participants
A questionnaire
with 45 multiple-choice questions was used to assess the pre-course knowledge
of the participants. Twenty-three of the questions related to pure quality
issues and the remaining pertained to quality as applied to BTS. Participants
were given 30 minutes to provide answers to these questions. An analysis of
the result showed that only 7 (35%) of the trainees could give more than 50%
correct answers to all the questions. 
Status
Report on Quality in BTS
The participants
were sent a questionnaire before they left their respective countries. They
were advised to fill up these in consultation with their colleagues and
superiors. A wide variation in quality was seen between the various
countries. Many countries reported some form of quality control within the
laboratories but few had a fully or even partially implemented formal quality
system that covered all major aspects of a BTS. A summary of salient features
of quality in their BTS is given at Annex 3.
Mechanics of Training
The main aim of
the workshop was to provide the participants with the tools of quality
management and demonstrate how to use them in BTS. The training was largely
in the format of short presentations followed by group activities and
extensive interaction with the participants to reinforce the teaching aims
and learning objectives. The group activities involved carrying out an
assigned task in groups and then reporting back for discussion with all the
participants and facilitators. Some activities involved the whole class using
scenarios and role plays (see Annex 2).
The participants
visited the National Blood Centre, Bangkok,
to see the quality management system in operation in BTS. They also visited a
mobile blood donation session organized by the National Blood Centre. Both
these visits were followed by extensive discussions on quality aspects of
visits.
Handouts of all
the presentations were provided to the trainees as part of their work book.
In addition, they were given a list of references on quality. They were also
requested to indicate their requirements of WHO publications on BTS which
will be sent to them in due course of time by WHO.
Summary
of Subjects Covered
 First
week
The participants
briefly presented their expectations from the course which included
improvement in their skills to institute quality systems in their respective
BTS to generate quality products and results. They also opined that after
being trained in this workshop they will be able to impart training to their
colleagues and other personnel in BTS in their respective countries. The
participants also believed that after three weeks’ training they will be in a
better position to advocate the need for quality in BTS, handle
organizational constraints and optimally utilize the resources that are made
available to them.
The major
objective of the activities in the first week was to provide the basics of
quality and create firm foundations for implementing quality systems
following the ISO model. The terminology used internationally in quality was
extensively discussed. Other important topics that were covered included:
quality systems; quality policy; a quality officer's job description;
documentation, with emphasis on standard operating procedures (SOPs);
organizational structure; and process flow charts and validation. All
activities and examples used were based on everyday activities or objects
but, where appropriate, examples pertaining to the blood transfusion service
were used.
Second
week
Participants were
introduced to the concepts of good manufacturing practice (GMP) and started
to apply the quality principles learnt in week one to blood transfusion activities.
Job descriptions and delegation as specifically applied to a blood
transfusion service were emphasised. Flow charts
and SOPs were applied to selected BTS activities. Monitoring and evaluation
activities in the form of error reporting, corrective and preventive action
and quality audits were introduced. Validation of processes and equipment was
also covered. The role and value of training in the quality system were
highlighted. Procurement, maintenance and calibration of equipment;
monitoring of assay performance and the documentation of testing and
processing were also discussed in detail. The costing of activities in a BTS
was discussed using the WHO Module (Costing blood transfusion services
WHO/BLS/98.8) as the basis. The week also concentrated on quality aspects of
blood donors, including donor education, motivation, recruitment and
retention. Donor selection, screening and handling of donated blood and donor
records were discussed. Safety in BTS, including
environmental factors were discussed. A mid-course evaluation of
participants through a 20 open-ended questions was also undertaken.
Third
week
The week
concentrated on applying quality to the main BTS activities. All aspects of
the testing for transfusion transmissible infections (TTIs)
were covered, including quality elements in laboratories and selection of
test kits. An introduction to the concepts of external quality assessment
schemes (EQAS) was given. Applying quality concepts to immuno-haematology
and component preparation, documentation of activities, process flow and
related critical points, and monitoring and evaluation in the immuno-haematology laboratory were discussed. The
clinical interface learning included a general presentation and work on the
role of the BTS in the clinical use of blood. Participants also began a draft
plan for implementing quality into their own particular BTS which was
finalized in consultation with the facilitators. Advice was given with a
template on generating a plan of action. Where quality systems already
existed, some problems were encountered on exactly what the participants
should plan for but the participants were advised to concentrate on critical
areas of their immediate concern and to ensure that they communicated with
the appropriate management personnel to ensure that a collaborative effort
was put into the proposed plan.
Post-course
Assessment of the Participants
A comprehensive
evaluation of the training course was completed on the last day. The results
revealed a significant improvement in the knowledge of the participants. The
pre-course questionnaire was used for post-course assessment as well. The
number of participants who answered more than 50% questions correctly
increased to 95% from 35% as was observed in precourse-assessment.
Hand
outs Provided to the Participants
All the
participants were provided with handouts for the presentation. Additional
notes were also circulated by some of the facilitators. A list of BTS
publications of WHO was circulated to participants who desired that they be
sent all the documents that have been published by WHO
and are available gratis. A few participants requested supply of selected
priced publications of WHO.
Evaluation
of Course by the Facilitators
The facilitators
also reviewed the course. They expressed their satisfaction with the duration
of the course, curriculum, quality of the teaching
material provided by WHO and the response and involvement of participants in
various activities undertaken during the workshop. However, some additional
information was provided by most of the facilitators to fill in the gaps.
They also volunteered their technical services for assisting in the
implementation of QMP.
Evaluation
of Course by the Coordinator
The contents and
duration of the course were adequate. The teaching material was usually
appropriate and the programme of work logical. Field visits to mobile and
static units were educative. A second field visit to the blood centre may be
incorporated so that a functional quality system can be seen by the
participants.
The implementation of the quality system requires
sustained efforts by participants, country programme managers and WHO. A
mechanism with indicators should be developed for monitoring and evaluation
of QMP in Member countries.
Valedictory Session
The valedictory
session was chaired by Dr Sudarshan Kumari, Regional Adviser for Blood safety and Clinical
Technology wherein participants expressed their gratitude to WHO and the
National Blood Centre, Bangkok,
for arranging this workshop. They appreciated the QMP initiative of WHO and enumerated the benefits that had accrued to them
by attending this workshop. Dr Kumari requested
them to commit themselves, and their respective organizations, to the cause
of quality in BTS to ensure safety, adequacy and quality of blood and blood
products. She also assured them of all possible technical support from WHO in achieving their goals.
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