RE: {Spam?} RE: {Spam?} RE: HT Grossing

Sorry, the water seems to be a little muddy around this issue. I am attaching a letter from Debbie Siena the NSH Legislative Chair on the NSH take on the law. I think that at the end of 493.1489 (7) throws in an extra requirement (7) For histopathology, meet the qualifications of Sec. 493.1449 (b)or (l) to perform tissue examinations. I think this is where the Associate degree minimun come in.

Gross Examination of Tissue (section 493.1461 (e) and Section 493.1489 (b)
(c) Guidelines-
The Technical supervisor (Pathologist) may delegate to individuals qualified
under section 493.1489 the responsibility for the physician
examination/description, including color, weight, measurement and other
characteristics of the tissue; or other mechanical procedures for which a
specific written protocol has been developed.

The Technical supervisor is ultimately responsible for the diagnosis related
to the gross examination and must sign the examination report. The
technical supervisor is not required to provide direct onsite supervision
but is responsible for the accuracy of all test results reported. All
physical examinations/descriptions of tissue including color, weight,
measurement and other characteristics of the tissue; or other mechanical
procedures performed in the absence of the technical supervisor by
individuals qualified under section 493.1489 must be reviewed within 24
hours by the technical supervisor. All microscopic tissue examinations must
be performed by individuals qualified under section 493.1489 (b), (l) or
(m).

Qualifications of Testing personnel (Citation 493.1489):
The laboratory must have a sufficient number of people qualified as Testing
Personnel to perform high complexity testing. Each individual performing
high complexity testing must possess a current license issued by the state
in which the lab is located, IF SUCH licensing is required; AND meet one of
the following requirements:

* Be an MD in the state in which the laboratory is located or have
earned a doctoral, master's, bachelor's degree in chemistry, physical,
biological or clinical laboratory science, or medical technology from
an accredited institution; or

*have earned an associate degree in a chemical, physical or
biological science or medical laboratory technology from an accredited
institution; or

*have previously qualified or could have qualified as a technologist
under the March 14, 1990 Final rule (CLIA '67) on or before February
28, 1992 (i.e. passed the HHS proficiency exam); or

*on or before April 24, 1995 be a high school graduate or equivalent
and have either graduated from a medical laboratory or clinical
laboratory training program approved by ABHES, CAHEA, or other
organization approved by HHS or successfully completed an official US
military medical laboratory training course of at least 50 weeks
duration and have held the military enlisted occupational specialty of
Medical Laboratory Specialist; or

*Until September 1, 1997-have earned an academic high school diploma
or equivalent; and have documentation of training appropriate for the
testing performed prior to analyzing patient specimens. Such training
must ensure that the individual has:

-the skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation
or fixation, processing or preparation, transportation and
storage of specimens;
-the skills required for implementing all standard laboratory
procedures;
-the skills required for performing each test method and for proper
instrument use;
-the skills required for performing preventative maintenance,
troubleshooting and calibration procedures related to each test
performed.
-a working knowledge of reagent stability and storage;
-the skills required to implement the quality control policies and
procedures of the laboratory.
- an awareness of the factors that influence test results; and
-the skills required to assess and verify the validity of patient
test results through the evaluation of quality control sample values
prior to reporting patient test results.

As of September 1, 1997, testing personnel must have an associate's degree,
as specified previously, to continue testing. However, the April 24, 1995
final rule grandfather's personnel performing high complexity testing on or
before April 24, 1995---these individuals did not need to meet additional
training or education requirements to continue performing testing.

Debbie J. Siena
NSH Legislative Chair
Baylor University Medical Center
214-820-2465

Have you read the part of the Federal Register section 493.1489. re: High Complexity Testing? It outlines the specific college credits in specific areas (biology and chemistry etc.) needed for high complexity testing. We have an HT (ASCP) who does not have an AA but has fulfilled these requirements and does the gross dissection...

-----Original Message-----
From: Charles.Embrey [mailto:Charles.Embrey@carle.com]
Sent: Wednesday, January 15, 2003 10:02
To: Cheasty, Sandra
Cc: 'histonet@pathology.swmed.edu'
Subject: RE: {Spam?} RE: HT Grossing

No. You can become a histotech after January 2005 with 60 semester hours of college and no associate degree but you would still not qualify as high complexity testing personnel without an associate degree in a biological or chemical science or medical laboratory technology. Not just any Associate Degree will do.

I believe you can also qualify without an AA or BS degree, the regulations list how many credit hours of certain kinds of classes are required...

CLIA '88 lists the requirements for non-pathologists grossing. Grossing is considered high-complexity testing even if it's a punch biopsy or a shave. CLIA '88 states "On or before April 24 1995 (I) be a high school graduate or equivalent; and (b) have documentation of training appropriate for the test performed before analyzing patient specimens"................After that date it requires an associate degree in a biological or chemical science or medical laboratory technology -or- qualify as a medical technologist with a bachelor's degree from an accredited institution -or- earned a bachelor's degree in a chemical, physical, biologic or clinical laboratory science.

ref. CLIA '88 493.1489

Also CAP requires a written instruction detailing what specimens may be grossed with direct vs indirect pathologists' observation. Direct means that the pathologist literally watches over your shoulder while you gross the specimen. Indirect means that he is readily available to consult.

I hope this helps,

Charles R. Embrey Jr. PA(AAPA), HT(ASCP)
Histology Manager
Carle Clinic, Urbana Illinois

(217) 383-6621

Whether a simple small skin tag or dissection of an entire colon, I was told by the local CLIA rep that the requirements are the same.

It falls under the CLIA High Complexity Testing Personnel Qualifications, Federal Register VOl. 60, No. 78, April 1995, section 493.1489.

If anyone out there can summarize the standard and post it on the Histonet, it would be greatly appreciated. Don't most HT's that have gone through a formal 2 or 4 year bonifide histology college program satisfy these requirements?

Sandra Cheasty
Lab Operations Manager
Loma Linda University Pathology

-----Original Message-----
From: SMello8438@aol.com [mailto:SMello8438@aol.com]
Sent: Tuesday, January 14, 2003 15:08
To: histonet@pathology.swmed.edu
Subject: HT Grossing