[Histonet] CLIA regulations in Histology

[Elaine allison Hoffman]

Under CLIA regulations, all six elements of competency assessment must be completed for every test a person performs, not just testing in general.Also while CLIA does not specifically require assessment of the competency of personnel performing only pre-analytic and post-analytic activities, it is good practice to do so.
I have several questions in regards to these statements:  What is considered "testing" each person performs specifically in the histology lab?  What examples of pre-analytic and post-analytic activities are performed in the histology lab?  There are so many examples given for the clinical side of the lab but virtually none given for histology.  Yet we are expected to carry out this requirement.  

I got several citations in this area during my last CLIA inspection.  So now I'm required to re-write my Competency Assessment Policy, which I don't really know how to do.  If you ask the CLIA inspectors, they just tell you to go on-line and check out the guidelines which are so vague and confusing and don't give you any information on histology.  

I need specific histology examples of measurable/observable criteria that could be acceptable for each of the six assessment methods.  We are just a tiny GI histology lab doing biopsies from a private physicians' GI scoping facility.  I was told that H&E staining was not considered "testing", neither is embedding, microtomy, coverslipping, etc.  I don't know what is considered pre-analytic or post-analytic activities in histology either.  The guidelines given are so general and wide-ranging.  I need specifics that pertain to histology.
Another citation was also in the area where the pathologists "read" the slides.  I'm required to re-write the competency assessment procedure on our pathologists since they are do provider performed microscopy (PPM) testing.  I need specific examples to do competency assessments on them as well.  I know their "testing" is reading slides under the microscope but I need to observe all 6 assessment methods.  Proficiency testing on pathologists??  

I really need to take a course or class on competency assessments, proficiency testing, pre-analytic and post-analytic activities.  The guideline language is too confusing.  Any suggestions or information would be greatly appreciated.  Thanks....

Elaine Hoffman, HT(ASCP)
The Gastroenterology Clinic & Endoscopy Center, Inc.Warren, Ohio 44483