[Histonet] Who can perform which job functions

Wed Jan 9 13:21:17 CST 2008

Dear Sharon:

This is as far as I am concerned very difficult to answer. This is because
you have to bring in High Complexity Testing for the IHC. This is covered
by CLIA 88 and that goes something like this.

NOTE:  The laboratory director may delegate the dissection of specimens to
non-pathologist individuals; these individuals must be qualified as high
complexity testing personnel under CLIA-88 regulations.  The minimum
training/experience required of such personnel is:

1. An earned associate degree in a laboratory science or medical
laboratory technology, obtained from an accredited institution, OR
2. Education/training equivalent to the above that includes at least 60
semester hours or equivalent from an accredited institution.  This
education must include 24 semester hours of medical laboratory technology
courses, OR 24 semester hours of science courses that includes 6 semester
hours of chemistry, 6 semester hours of biology, and 12 semester hours of
chemistry, biology or medical laboratory technology in any combination. 
In addition, the individual must have laboratory training including either
completion of a clinical laboratory training program approved or
accredited by the ABHES, the CAHEA, or other organization approved by HHS
(note that this training may be included in the 60 semester hours listed
above),OR at least 3 months documented laboratory training in each
specialty in which the individual performs high complexity testing.

In addition, the CLIA-88 regulations include exceptions for               
  grandfathered individuals; these regulations (42CFR493.1489 and 1491)
may be found at  
http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1487

It is the responsibility of the laboratory director to determine whether
an individual's education, training and experience satisfies the
requirements of this checklist question.

This checklist question applies only to laboratories subject to CLIA-88.

And if you see at the end if you are not subject to CLIA-88 then you do
not need to worry about it. Question is, are you subject to CLIA-88 under
CAP regulations. What is the mandate for CLIA-88:

Subpart A--General Provisions

    Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.

      Sec. 493.1  Basis and scope.

This part sets forth the conditions that all laboratories must meet to be
certified to perform testing on human specimens under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA). It implements sections
1861 (e) and (j), the sentence following section 1861(s)(13), and
1902(a)(9) of the Social Security Act, and section 353 of the Public
Health Service Act. This part applies to all laboratories as defined under
``laboratory'' in Sec. 493.2 of this part. This part also applies to
laboratories seeking payment under the Medicare and Medicaid
programs. The requirements are the same for Medicare approval as for CLIA
certification.

So as I understand it if you do not have an AA with 24 hours of a
combination of Chemistry and Biology or were grandfathered in with a HTL
(Not a HT), you should not be grossing or doing Immunos even if you are a
certified HT.

I apologize if I am wrong and please set me right.

If someone out there can send me a flow diagram of how all the
certifications is intertwined, what is mandated and what is organization
based (i.e. ASCP)  I would LOVE to get it.

Yours truly,

Anthony Williams BSc. HT (ASCP)
Histotech Exchange LLC
19 Whitmore Street
Lexington, VA 24450
T 1 877 464 8911
F 1 540 301 0071
anthony <@t> histotechexchange.com
www.histotechexchange.com

 Ok, all of you Histonetters I have another question for you.  Who the
> histology laboratory can perform these job functions:  embedding,
> cutting, performing special stains and IHC?  Can a lab assistant perform
> these duties if properly trained or do you have to be classified as a
> Histotech in training?  Can a Cytotech or Med Tech perform such duties,
> again if properly trained?  All opinions and references to such
> requirements would be greatly appreciated.
>
>
>
> Sharon Davis-Devine, CT (ASCP)
>
> Cytology Supervisor
>
> Carle Clinic
>
> 602 West University
>
> Urbana, Illinois 61801
>
> Phone:  217-383-3572
>
> Email:  sharon.davis-devine <@t> carle.com
>
>
>
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