[Histonet] CLIA Compliance Regulations for histology staff coverage

[Kim Donadio]

CLIA only regulated labs can have uncertified or licensed personel doing task such as embedding, microtomy and standard H&E staining as CLIA does not regulate those task as Jennifer mentioned. That said, who is going to gross in the biopsies( High complexity task) in the other persons absence? Because that is a CLIA regulated task and needs to be done by someone who meets CLIA 1489, which is the education, AS degree that includes the required biology and chemistry, or 60 hrs of education that includes the required biology and chemistry. 
 
http://www.mass.gov/eohhs/docs/dph/clinical-lab/clia-lab-qualifications.pdf
 
 
Kim D 


________________________________
From: Jennifer MacDonald <JMacDonald <@t> mtsac.edu>
To: Akemi Allison <akemiat3377 <@t> yahoo.com> 
Cc: Histonet <Histonet <@t> lists.utsouthwestern.edu>; histonet-bounces <@t> lists.utsouthwestern.edu 
Sent: Thursday, July 18, 2013 1:27 PM
Subject: Re: [Histonet] CLIA Compliance Regulations for histology staff coverage


California does not have licensure for histotechs.  To my knowledge 
California does not have any regulations concerning who can cut biopsies. 
There are many labs that have uncertified people working without the 
supervision of certified people.  That being said, is this the only reason 
the Pathologist wants the cases sent our during her absence?  He is the 
one that has to sign his name to the cases.



From:  Akemi Allison <akemiat3377 <@t> yahoo.com>
To:    Histonet <Histonet <@t> lists.utsouthwestern.edu>
Date:  07/18/2013 08:34 AM
Subject:        [Histonet] CLIA Compliance Regulations for histology staff 
coverage
Sent by:        histonet-bounces <@t> lists.utsouthwestern.edu



Good morning to all in Histoland!

Hopefully, one of you can help me with a question which was proposed to me 
by a fellow histologist working in a very small GI histology lab. 

Here is what information she gave me:  She is training a histology 
assistant in house to do all the histology technical responsibilities at 
the request of the GI doctors.  She said her OJT assistant is doing a 
great job technically, but she has not yet registered in school to finish 
her  AA Degree so she can sit for the HT exam.  She has been working under 
her instruction for 1 year.  Her lab is California State and CLIA 
licensed.

The GI doctors want the assistant to cover for her while she is on 
vacation.  The pathologist who is the medical director does  not think 
that CLIA Regulations allows this and wants the specimens sent out during 
her absence.  She needs the CLIA Regulations stating what the guidelines 
are so her lab is complying to regulations.  She didn’t want to call CLIA 
because it would send a RED FLAG up.  I also didn’t want to call them 
because they may ask me what the name of the lab was that was proposing 
this question.  

I told her that this was most likely illegal, but she needs it in black 
and white.  Do any of you have that information or a web link to go to at 
your finger tips? She needs the regulations by next week.

Thank you in advance for your help,
Akemi

Akemi Allison-Tacha, BS, HT/HTL (ASCP) 
Pathology Manager
Monterey Bay GI Consultants
23 Upper Ragsdale Drive, Suite 200
Monterey, CA 93940
(381) 375-3577  X117
Email: aallison <@t> montereygi.com
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