Please explain about AP and if CLIA 88 regards IHC as high complexity
testing is there a conflict with AP or are you saying that IHC was never
considered high complexity testing?
I only ask because when I went to the nationals in Toronto there was a
workshop on IHC and there was some discussion about it being High
Complexity Testing. In the best tradition of Gunther I may be wrong.
Anthony Williams BSc. HT (ASCP)
Histotech Exchange LLC
19 Whitmore Street
Lexington, VA 24450
T 1 877 464 8911
F 1 540 301 0071
Grossing yes-- IHC no, unless they slipped something in very recently, it
> still covered under the 'pathologists as the testing personnel' clause in
> Bonnie Whitaker
> -----Original Message-----
> From: firstname.lastname@example.org
> [mailto:email@example.com] On Behalf Of
> Sent: Wednesday, January 09, 2008 1:21 PM
> To: Sharon.Davis-Devine
> Cc: firstname.lastname@example.org
> Subject: Re: [Histonet] Who can perform which job functions
> 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
> 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
> 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
> must include 24 semester hours of medical laboratory technology courses,
> 24 semester hours of science courses that includes 6 semester hours of
> chemistry, 6 semester hours of biology, and 12 semester hours of
> 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
> 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
> individual performs high complexity testing.
> In addition, the CLIA-88 regulations include exceptions for
> grandfathered individuals; these regulations (42CFR493.1489 and 1491)
> be found at
> It is the responsibility of the laboratory director to determine whether
> 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
> 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
> 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
> 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: email@example.com
>> Histonet mailing list
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