[Histonet] CLIA Compliance Regulations for histology staff coverage

2013-07-18 Thread Akemi Allison
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: aalli...@montereygi.com
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Re: [Histonet] CLIA Compliance Regulations for histology staff coverage

2013-07-18 Thread Jennifer MacDonald
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 akemiat3...@yahoo.com
To: Histonet Histonet@lists.utsouthwestern.edu
Date:   07/18/2013 08:34 AM
Subject:[Histonet] CLIA Compliance Regulations for histology staff 
coverage
Sent by:histonet-boun...@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: aalli...@montereygi.com
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Re: [Histonet] CLIA Compliance Regulations for histology staff coverage

2013-07-18 Thread Kim Donadio
CLIA only regulated labs can have uncertified or licensed personel doing task 
such as embedding, microtomy and standard HE 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 jmacdon...@mtsac.edu
To: Akemi Allison akemiat3...@yahoo.com 
Cc: Histonet Histonet@lists.utsouthwestern.edu; 
histonet-boun...@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 akemiat3...@yahoo.com
To:    Histonet Histonet@lists.utsouthwestern.edu
Date:  07/18/2013 08:34 AM
Subject:        [Histonet] CLIA Compliance Regulations for histology staff 
coverage
Sent by:        histonet-boun...@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: aalli...@montereygi.com
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