Visit summaries, application of Canadian standards to foreign
countries In the June issue of CSCC News I presented a brief
overview of the process of clinical laboratory accreditation. In
this issue I will try to summarize my observations and impressions
after the first round of visits. These are naturally presented from
my point of view. However, since I have participated in twenty of
these visits over the last two years, I believe that my
observations are based on a fairly broad experience as I have
visited laboratories ranging from the very small in local community
hospitals to large regional centres in three provinces and two
countries.
First observation: despite the reservations that I have
expressed in Part 1 concerning the political aspects of the
accreditation dossier, I was delighted to observe that both the
laboratory directors and managers as well as the personnel are
convinced of the importance of quality assurance programmes and are
resolved to apply them as fast as possible to the extent that they
are given the necessary resources. At the end of each of my visits
I asked the personnel the following question: "Do you believe that
the accreditation process is really useful or do you think that it
is a gigantic and useless accumulation of paperwork?" In fact I
never received a negative response concerning its usefulness. This
means that the initial step of sensitization to the process was a
success. It would therefore be a pity to not take advantage of this
and to lose the momentum thus created.
It should also not be forgotten that all the laboratories that
we visited were being evaluated for the first time. We could
therefore not expect that they would all pass with flying colours
the first time around. And, in actual fact, their performances were
not the greatest when compared to the global evaluation of their
institutions except for a few noteworthy exceptions. It has to be
realized that presently we are still in the process of learning, of
sensitizing everyone to the importance of total quality assurance
programmes, of their development and application. With some rare
exceptions, laboratories have to first of all concentrate on
putting in place the framework for accreditation: basic SOPs,
required documentation, plans for continuing education for
personnel, etc. They had neither the time nor the resources to
prepare SOPs describing higher levels of laboratory functionality:
indices of quality assurance, programmes for quality assurance
improvement, a programme for evaluation of personnel competency,
logging of nonconformity incidents and the measure taken to rectify
them, etc. Generally speaking, documents dealing with purely
analytical aspects of the laboratory were well organized (SOPs were
pretty complete, like those for quality control, etc.) Where there
were deficiencies was with SOPs on the quality of service to
laboratory users. The aspect that has to be addressed is user
satisfaction in terms of turn-around-time, accessibility of
services, reliability of analytical reports, etc. I also found that
in some sectors even the notion of quality control (internal and
external) leaves to be desired. The most notable exception is
biochemistry where quality control has been standard practice since
many years.
However, the most disturbing observation made by us, as
Accreditation-Canada visitors, were the numerous deficiencies in
workplace safety and health. The security of everyone entering a
hospital be it patients, visitors or personnel is of the utmost
importance for Accreditation-Canada and so it is essential that
this oversight be rectified. Here are some examples: secure and
restricted laboratory access, the establishment of a workplace
health and safety programme including education of personnel,
verification of protective equipment, the naming of a safety
officer other that the chief technologist where the size of the
laboratory permits and the implantation of a WHIMS programme.
Several laboratories have insufficient space putting the safety of
personnel in jeopardy.
Transfusional services' quality assurance programme was already
fairly well established even before the initiation of
Accreditation-Canada's programme. The tainted blood scandal and the
intense reaction ($$) of the authorities resulted in a "clean-up"
of this sector. Procedures are standardized, documents are complete
and incident reporting is exhaustive. What has been done for blood
banking could set the example for the other laboratories for years
to come. This clearly demonstrates that when there is a will and
the appropriate resources, anything is possible. It is therefore
not surprising that we found little nonconformity in tranfusional
services.
One of the invaluable benefits of these site visits that should
not be underestimated is the opportunity that it gave to many
hospital administrators: hospital CEOs, DPSs, DHSs and directors of
nursing, who make up the teams of visitors, to appreciate the
laboratories and their staff. They now all have a better
understanding of what we do in our "mysterious" laboratories and
are able to appreciate the complexity and difficulty of our
operation. As well, these visits gave an opportunity to laboratory
professionals to interact with their co-workers from other sectors
of the hospital and to better appreciate their role. Too often we
are hunkered down in our labs and forget the "big picture". We tend
to underestimate to difficulties of Administration to meet their
many objectives while at the same time obliged to live up to the
rigid standards fixed by the many agencies responsible for
overseeing the maintenance of quality (like
Accreditation-Canada!).
I also had the opportunity to carry out an accreditation visit
in a private hospital in Saudi Arabia. To say that this institution
was not lacking for money would be a gross understatement. Before
the visit we asked ourselves the following question: given that
their resources are essentially unlimited, what quality assurance
system would they have in place? What priority would they have
given to it? In Canada when we read an SOP on quality assurance
from one of the laboratories that we visit, we inevitably find a
sentence like"…we are committed to give the best service possible
with the resources available to us….". It must be realized that the
key word here is not quality but resources. It
therefore comes as no surprise that we found there an exceptional
quality assurance programme, much superior to what we have found
here. Considering the enormous resources dedicated by this hospital
to the acquisition of the most advanced diagnostic equipment (PET
scan etc.), we expected to find the laboratory equipped with the
latest in robotics and instruments. However, this is not what we
observed: of course the instruments were adequate, but nothing to
write home about. What was particularly impressive was the number
of personnel: many professionals, many technologists and the
innumerable hours and effort that were dedicated to implanting a
quality assurance programme that was practically faultless. The
implication of the professionals, particularly the pathologists, in
the support and development of the quality assurance programme was
remarkable. The priority given to quality was genuine and not just
lip service. This is a radical departure from the attitude of our
Canadian clinical laboratories, where too often the priority is
given to technology, performance, administrative efficiency and
where the quality assurance programme, at best plays a modulating
role by fixing the limit at which overproduction could reduce the
quality of the work performed. This is a complete reversal of
priorities.
What direction should the Accreditation-Canada survey programme
now take and what will be the impact on the organization of
diagnostic services? There are several options. Could it be a
gradual transition to a true laboratory accreditation programme
either independent or ISO 15189? Could it be a programme with teeth
that would penalize laboratories with serious non-conformity issues
that could jeopardize the well being of the population served?
Could it be the granting of a permit of operation dependent on a
satisfactory level of performance? Would there be a system of
oversight and coaching of sub par laboratories by other
organizations? Would these laboratories close with the
centralization and regionalization of services in order to maintain
a better control? Would the accreditation programme be expanded to
include other diagnostic services and in the process diminish the
importance of the evaluation of laboratory services in relation to
other sectors? This remains to be seen. One this is certain, the
time has come to reevaluate the programme, its content, its
methodology and its objectives.