IHC, grossing, Flow, FISH,?etc...are considered high complexity testing.? Embedding, microtomy, special stains.....these are all considered moderate complexity testing.
Roxanne Soto HT(ASCP)QIHC
To: Bonnie Whitaker
Sent: Wed, 9 Jan 2008 8:11 pm
Subject: RE: [Histonet] Who can perform which job functions
I would just ask; is your position substantiated by the language of the
I refers to a Technologist(HTL) not a Technition (HT).
It will help me if I am wrong by the way, thanks for the help.
(a) Possess a current license as a laboratory technologist issued by
the State, if such licensing exists; and
(b)(1) Have earned a bachelor's degree in medical technology from an
accredited university; or
(2) Have successfully completed 3 years of academic study (a minimum
of 90 semester hours or equivalent) in an accredited college or
university, which met the specific requirements for entrance into a
school of medical technology accredited by an accrediting agency
approved by the Secretary, and has successfully completed a course of
training of at least 12 months in such a school; or
(3) Have earned a bachelor's degree in one of the chemical,
physical, or biological sciences and, in addition, has at least 1 year
of pertinent full-time laboratory experience or training, or both, in
the specialty or subspecialty in which the individual performs
(4)(i) Have successfully completed 3 years (90 semester hours or
equivalent) in an accredited college or university with the following
distribution of courses--
(A) For those whose training was completed before September 15,
1963. At least 24 semester hours in chemistry and biology courses of
(1) At least 6 semester hours were in inorganic chemistry and at
least 3 semester hours were in other chemistry courses; and
(2) At least 12 semester hours in biology courses pertinent to the
medical sciences; or
(B) For those whose training was completed after September 14, 1963.
(1) 16 semester hours in chemistry courses that included at least 6
semester hours in inorganic chemistry and that are acceptable toward a
major in chemistry;
(2) 16 semester hours in biology courses that are pertinent to the
medical sciences and are acceptable toward a major in the biological
(3) 3 semester hours of mathematics; and
(ii) Has experience, training, or both, covering several fields of
medical laboratory work of at least 1 year and of such quality as to
provide him or her with education and training in medical technology
equivalent to that described in paragraphs (b)(1) and (2) of this
(5) With respect to individuals first qualifying before July 1,
1971, the technologist--
(i) Was performing the duties of a laboratory technologist at any
time between July 1, 1961, and January 1, 1968, and
(ii) Has had at least 10 years of pertinent laboratory experience
prior to January 1, 1968. (This required experience may be met by
substitution of education for experience); or
(6) Achieves a satisfactory grade in a proficiency examination
approved by HHS.
Anthony Williams BSc. HT (ASCP)
Histotech Exchange LLC
19 Whitmore Street
Lexington, VA 24450
T 1 877 464 8911
F 1 540 301 0071
> Grandfathering in to gross only means that you were grossing before that
> cutoff date. it matters not one bit if you have any certification as far
> CLIA is concerned. That is how it was explained to me by an ex-CLIA
> Bonnie Whitaker
> -----Original Message-----
> From: email@example.com
> [mailto:firstname.lastname@example.org] On Behalf Of
> Sent: Wednesday, January 09, 2008 1:21 PM
> To: Sharon.Davis-Devine
> Cc: email@example.com
> 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: firstname.lastname@example.org
>> Histonet mailing list
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