RE: HT Grossing

That is all fine and good if your lab is not CLIA certified. If it is, the inspector will want to see the documentation and educational records for your high complexity testing personnel. I have been through several CLIA inspections and the inspector always considered grossing high complexity testing. He never asked what was being grossed.

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

Ok all! I'm going open a can of worms here.CLIA is an interpretation and a guideline...Not Law...This issue came up recently and I told them what CLIA said.The powers that be, called CAP.CAP said." Its up to each institution,and the Pathologists .To determine what they consider high complexity testing.Some say it starts at the gross of small biopsies..Others say not.So we don't have a fine a line as to what is or isn't.Its up to your Paths.As long as gross is being trained by the steps in listed in CAP.You are fine

----- Original Message -----

From: Charles.Embrey

Sent: Wednesday, January 15, 2003 11:36 AM

Subject: RE: HT Grossing

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