News from the Canadian Society for Clinical Chemists
Clinical Laboratory Accreditation by Accreditation Canada
The First Two Years of the Programme From a Personal Perspective
Part One: Background and the Present Situation

Contributed by Dr. Maurice Dupras. Translated by Dr. Mary-Ann Kallai-Sanfaçon Editor-in-Chief, CSCC News, First published in the CSCC Newsletter

In 2005 the Quebec Ministry of Health and Social Services sent a directive to all public institutions stating that before the end of 2008, all clinical laboratories would have to become accredited by an internationally recognized body. The accreditation in question would have to conform to standards based on the international standards ISO 15189 as well as the standard CSA Z-902 developed for blood bank services and approved by the Ministry. After a tendering process, the Ministry approved the accreditation programme jointly developed by Accreditation Canada formerly known as CCACC (Canadian Council of Accreditation of Health Services) and CSA (Canadian Standards Association). Accreditation Canada already had the necessary infrastructure and experience concerning the logistics of accreditation visits, that is: the training of visitors, a communication network with the establishments it serves, the deployment of teams in the field, results evaluation templates etc, while the CSA provides expertise in the development and adaptation of standards.

In order to comply with the Ministry, visitors were to be recruited from clinical laboratory professionals (scientists, laboratory physicians, technologists). The Ministry was also adamant that clinical laboratory visits be carried out in parallel (simultaneously, if possible) to accreditation visits of the entire establishment. This was, at least, the initial plan and it would have required major changes because the present programme is not a programme for the accreditation of clinical laboratories, contrary to current belief. Rather, it is a programme to evaluate health care facilities in which clinical laboratories are also visited and the clinical laboratory only contributes 10 to 15% to the overall grade of the hospital or perhaps a bit more due to the weighting of certain criteria.

The importance of the clinical laboratory should be emphasized because until now, a visit of this department only represented a tiny part of the visitors’ activities. It is thus inaccurate to speak of “laboratory accreditation” and this has consequences that cannot be ignored. In the first place, laboratory professionals who have been misled in believing that this accreditation would lead to an ISO 15189 accreditation have been disappointed. Secondly, and more importantly, the impact of an unsatisfactory laboratory visit is attenuated by the fact that it is buried in the overall evaluation of the institute visited whether multi-site or not. The tragedy is that administrators of these centres thus have little incentive to allocate funds to improve quality assurance in the laboratory.

This being Quebec, there has to be an intra-provincial/provincial/national conflict in the mix. The Conseil québécois d’agrément (CQA) a uniquely Quebec body and a competitor of Accreditation Canada (despite the fact that they have essentially the same goals) has also been given the authorization by the Ministry to accredit public health care facilities. Furthermore, because the CQA does not have the expertise to evaluate clinical laboratories, it has signed an agreement with the Bureau des normes du Québec (BNQ), which is accredited for the evaluation of numerous standards including those of quality assurance, for example ISO 9000 and its derivatives (ie. ISO15189). This is not the end of it. The CQA subsequently entered into a partnership agreement with Accreditation Canada for the accreditation of all the CSSSs (Centres de santé et services sociaux) of Quebec. These establishments (CSSS) are local entities that unify under the 2 same administration all the public health care and social services facilities of a particular district: acute health care (hospital centres), community health services (CLSCs and/or clinics) long term care facilities etc. In theory, this agreement should have put an end to national/provincial competition. However, the contract with BNQ for the clinical laboratories has not been cancelled; laboratories in an institution that has asked for a “Quebec” accreditation visit by the CQA are visited by the BNQ. What this means is that at the present time there are two different criteria and two different groups of visitors. This should end shortly at the conclusion of ongoing negotiations between Accreditation Canada and the BNQ.

In principle both Accreditation Canada and the BNQ use the same Ministry-approved evaluation criteria. It is therefore curious that they do not approach a laboratory visit in the same way. Accreditation Canada is more interested in verifying that the necessary policies, processes and procedures are in place and that the practice corresponds with the written SOPs without necessarily looking at the content of those procedures. The BNQ, on the other hand, is more interested in judging the content of procedures in order to ensure that that the directives of the professional orders are respected. How the evaluation of a laboratory by the BNQ (never done at the same time as a general visit by Accreditation Canada) will fit in with the global evaluation of a CSSS and what will be the consequences of an unsatisfactory evaluation of a clinical laboratory is far from clear.

If this is not confusing enough, it seems that the BNQ will continue to be in the picture. They can grant an official ISO 15189 accreditation to a hospital laboratory or a part of a laboratory and they have no intention of giving up this activity. In contrast, at least for the time being, Accreditation Canada cannot. There is a single hospital laboratory in the public sector that is trying to be accredited ISO but who knows how this project will evolve. I certainly don’t have a clue.

Accreditation Canada also offers to inspect laboratories in provinces other than Quebec who wish to be accredited and who don’t have their own provincial programme. Up until now the Atlantic Provinces have been evaluated often on a voluntary basis. Similarly to Quebec, the visit and evaluation of the clinical laboratories is only part of the overall evaluation of the particular regional establishment visited. Accreditation Canada also has foreign health care institutions as its clients, in particular in the Middle East, the Carribean, Italy and South America. Therefore an accreditation visit of the clinical laboratory is within the realm of possibility and in fact I had the opportunity to participate in such a visit in Saudi Arabia. I gained some valuable lessons from this visit and I will share my experiences in part two of my article in the next issue of CSCC News.