The draft ISO standard 15189 "Medical Laboratories – Particular Requirements for Quality and Competence", which
is expected to be ratified as an international and European standard before the end of this year, has the
following to say on the subject:
"4.5.1 The laboratory shall have an effective, documented procedure for evaluating and selecting referral
laboratories as well as consultants who are to provide second opinions for histopathology, cytology, and
related disciplines. The laboratory management, with the advice of users of laboratory services, where
appropriate, shall be responsible for selecting and monitoring the quality of referral laboratories and
consultants. The laboratory shall ensure that the referral laboratory or referral consultant is competent to
perform the requested examinations."
and:
"4.5.4 The referring laboratory and not the referral laboratory shall be responsible for ensuring that referral
laboratory examination results and findings are provided to the person making the request. If the referring
laboratory provides the report, it shall include all essential elements of the results reported by the referral
laboratory, without alterations that could affect clinical interpretation.
This does not mandate that the referring laboratory report every word and the exact format of the referral
laboratory report, unless this is required by national/local laws or regulations. The referring laboratory
director may elect to provide additional interpretative remarks to those, if any, of the referral laboratory,
in the context of the patient and the local medical environment. The author of such added remarks should be
clearly identified."
It does not actually say that the referral laboratory should be identified on the report - I think the Working
Group felt that this was obvious and did not need to be stated!
Regards to all,
Des Kenny, Dublin (member of ISO TC212/WG1 - the working group with responsibilty for 15189)
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