[Histonet] Special stains

Tue Jan 5 20:11:16 CST 2010

I agree with the majority that you MUST do a validation of the instrument before you run any patient diagnostic samples. Any time you make a change in instrumentation, reagents, procedure or protocol you should run at least a quick validation study to compare results of the new variable(s) to your control method (current) and it must be reviewed and approved by the medical director of your lab. The numbr of samples is always the question and I suggest you investigate whether or not your institution has a an expectation for sample size. The Clinicl lab will be a good place to get information on procedure and process for validation.

That said and for an automated stainer in the Histology lab (Dako or Ventana), I suggest a minimum of three samples on separate runs for each special stain you will perform. If all three are comarable and correlate to the contol method, you can have confidence that you can make the switch and start turnung out patient samples. If you do not create comparable results for the first three, then consult w/ your pathologist as to how many more samples he will feel comfortable reviewing to confirm the performance. You should always stive to produce >95% concordance. I also suggest that you use the "blind study" technique when presenting to the reviewing pathologist. You do not want perception or predjudice to skew your review results. Of course, document all that you do and create a validation folder to house the documents for easy review.

I believe setting up a validation process/protocol for your lab will create more confidence in the instrument, the reagents, the technicians performing the work and you. I have found it is easier to be proactive rather than reactive in producing quality results. Good luck with moving to the automated special stainer. I have used the DAKO for 4+ years and find it will produce a quality stain consistantly.

William DeSalvo, B.S., HTL(ASCP)
Chairperson, NSH QCC

> Date: Tue, 5 Jan 2010 11:33:35 -0800
> From: KGroeger <@t> USLABS.net
> To: Kim.Donadio <@t> bhcpns.org; rjbuesa <@t> yahoo.com
> Subject: RE: [Histonet] Special stains
> CC: histonet <@t> lists.utsouthwestern.edu; Dorothy.L.Webb <@t> HealthPartners.Com; histonet-bounces <@t> lists.utsouthwestern.edu
> 
> I agree, we are validating some new instruments now and have found a lot of variables.
> 
> Karin Groeger
> 
> Histology Supervisor
> 
> US LABS, Irvine,CA
> 
> 949-450-0145 ext. 649
> 
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Kim.Donadio <@t> bhcpns.org
> Sent: Tuesday, January 05, 2010 10:28 AM
> To: Rene J Buesa
> Cc: 'histonet <@t> lists.utsouthwestern.edu'; histonet-bounces <@t> lists.utsouthwestern.edu; Dorothy LWebb
> Subject: Re: [Histonet] Special stains
> 
> In the end it is still a new instrument. It should be validated for all 
> the stains you do on it. This would seem like best practice to me. 
> 
> 
> 
> Kim Donadio 
> Pathology Supervisor
> Baptist Hospital
> 1000 W Moreno St.
> Pensacola FL 32501
> Phone (850) 469-7718
> Fax (850) 434-4996
> 
> 
> 
> Rene J Buesa <rjbuesa <@t> yahoo.com> 
> Sent by: histonet-bounces <@t> lists.utsouthwestern.edu
> 01/05/2010 11:38 AM
> 
> To
> "'histonet <@t> lists.utsouthwestern.edu'" <histonet <@t> lists.utsouthwestern.edu>, 
> Dorothy LWebb <Dorothy.L.Webb <@t> HealthPartners.Com>
> cc
> 
> Subject
> Re: [Histonet] Special stains
> 
> 
> 
> 
> 
> 
> Dorothy:
> I would NOT do it.
> If you do not change the procedure it does not really matter which auto 
> stainer you use. Your "validation" is the reaction of your control that 
> should react as before.
> As a matter of fact, I would be more inclined to made a validation if you 
> change your control rather than if you change the auto stainer.
> If, for example, you are doing IHC and your dilution has been "fine tuned" 
> for a given tissue control and you change the tissue, you will need to 
> "fine tune" the dilution to have the same reaction strength of the epitope 
> in the new control, but you will not have to change your procedure. That 
> is why I always used IHC internal controls, and by using "normal strength 
> epitopes" I don't have to keep validating.
> That is also why I always shied away from using pathological cases to use 
> as epitope controls.
> So, I would not advise you to go through validation because of changing 
> the auto stainer, as long as the procedure is the same.
> René J.
> 
> --- On Tue, 1/5/10, Webb, Dorothy L <Dorothy.L.Webb <@t> HealthPartners.Com> 
> wrote:
> 
> 
> From: Webb, Dorothy L <Dorothy.L.Webb <@t> HealthPartners.Com>
> Subject: [Histonet] Special stains
> To: "'histonet <@t> lists.utsouthwestern.edu'" 
> <histonet <@t> lists.utsouthwestern.edu>
> Date: Tuesday, January 5, 2010, 12:23 PM
> 
> 
> We are switching automated special stain equipment to a different vendor 
> and am wondering if we have to validate all of the special stains we do.  
> I am from the "old school" and the validation process, other than IHC, is 
> not my forte!!  Any advice would be appreciated, so, thanks ahead of 
> time!!
> 
> Dorothy Webb, Ht (ASCP)
> Regions Histology Technical Supervisor
> 651-254-2962
> 
> 
> 
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