[Histonet] RE: ISO for Pathology

[Stancel, Barbara]

Our laboratory is ISO 17025 certified/accredited. Having said that: Pathology is not under "scope:" our Chemistry and Microbiology sections are under "scope." Our certifying (external auditing)agency is AALA (American Association for Laboratory Accreditation). They have been auditing Chem and Micro for about 10 years. AALA (aka: A2LA) keep saying they will be covering the histology/pathology when they get people trained to perform audits. We have two levels of internal auditing: Laboratory Quality Assurance Division (LQAD) and our Quality Managers (QM). Again, we have a chem QM and a micro QM. Since our section is so small (9 people of the 90 folks) the Micro QM handles Pathology. I am getting ready for our spring internal audit. 

Pathology is expected to jump through ALL of the same hoops as chem and micro. I must say we have work instructions, tracking, and recording forms for everything except bathroom breaks and I am expecting them soon. My e-mail address is below. But if I am not in the lab I cannot access our work e-mail. So be patient with my responses.

Histologically yours,
Barbara Stancel
USDA, FSIS, EL, Pathology 
Athens, Georgia 30605
706-546-3698  or  706-546-3556
barbara.stancel <@t> fsis.usda.gov


Subject: [Histonet] ISO

Is anyone in histoland ISO certified or working on it.  Our rural
hospital for which the lab is CAP accredited has decided to become ISO
certified, all departments. It is a 2 year plan  and we have just
started.   It is quite a process to correlate CAP  and ISO.  We are not
doing the CAP-- ISO process.  Would appreciate any insight or
suggestions. Thanks 

Jane Moose		Jane.Moose <@t> NewberryHospital.net
LIS Coordinator
Newberry County Memorial Hospital
Newberry, SC  29108	P-803-405-7129	F- 803-405-7474

Subject: Re: [Histonet] ISO

Last year CAP began issuing ISO certifications for the med lab (ISO15189-2003) which uses more statistical analysis and is adaptable to the med lab where most of the results are quantitative. CAP offered the certification as an additional one and not to substitute its own certification.
As for the histolab, the only ISO that could be used is ISO9001-2000 that is just a management tool where the results are guaranteed to be obtained according to standards that are not general but particular of each lab, is like saying that the procedures follow what is described in the SOP. Regarding the histolab productivity each one will have to define their own standards and assure that they are met.
The CAP certification for histolabs is more than enough, but in the competitive health care environment any good salesperson working for any given med lab can use an "ISO certification" as a sales enticement for the potential clients, even if they do not know what ISO is.
René J.		Rene J Buesa <rjbuesa <@t> yahoo.com>