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From:"Jennings-Siena, Debbie" <> (by way of histonet)
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Hi Ray,
There is a CLIA '88 regulation regarding Histotech's performing gross
examination.  The CLIA'88 reg is:

	The technical supervisor (Pathologist) may delegate to individuals
qualified under Section 493.1489 the responsibility for the physical
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 (pathologist) 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)
of the regulation as appropriate.

Qualifications of Testing Personnel (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 laboratory is
located, if such licensing is required; and meet one of the following

	*Be an MD in the state in which the laboratory is located or have
earned a doctoral, 	master's, or bachelor's degree in a chemical,
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. had 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 or 	accredited by ABHES, CAHER
or other organization approved by HHS or successfully completed a
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 preventive
maintenance, troubleshooting and 			calibration
procedures related to each test performed;

			-a working knowledge of reagent stability and

			-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 grandfathers 	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

I hope that this answers your question.  You can find these regulations at

Debbie J. Siena
NSH Legislative Chairperson
Baylor University Medical Center
Dallas, TX 75246

-----Original Message-----
From: Ray Lopez []
Sent: Thursday, July 06, 2000 6:14 PM
To: HISTONET (E-mail)

I  know theres a new policy about H.T.'S doing gross examination on
surgical spcimens does anyone know what this policy is or were I might find
it written.

                                                Thank you in advance

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