David Williams wrote about 'chain of custody' in laboratory management as discussed in ISO 15189 and 9002.
We have discussed the ISO/DIS 15189 intensively until the deadline for comments September 22 and paid particular attention to any and all clauses and other items which might increase the costs of running a laboratory that has been accredited according to the proposed standard. You may have noticed, however, that the DIS does not mention the position or role of the standard in the ISO system of related standards or its possible use as a normative document in technical accreditation of medical laboratories.
It is our view that the present writing does not exclude any additional local, national or regional rule to meet the needs of a chain of custody. Considering the extremely rare situation when biochemical investigations - by chance - would have any important 'medico-legal consequences', introduction of a clause requiring an established 'chain of custody' that would 'stsnd up agaist cross exemination in the court' does not seem justified.
Anders Kallner MD, Ph.D.
Dept Clin Chem, Karolinska hospital, S-171 76 Stockholm Sweden
E-mail address:
[log in to unmask]
phone: +46 (0)8 5177 49 43
fax:+46 (0)8 5177 28 99
%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
|