[Histonet] CLIA regulations in Histology

[Kim Donadio]

I always added competency for my staff in their annual evaluations. It did include:Accessions specimens accurately ( pre-analytical)-ie: specimen handlingKnows how to start and maintain tissue processor with competency ( pre-analytical)Grosses specimens accurately ( analytical) and high complexity Embeds tissue samples with accuracy ( analytical)Performs microtomy with few errors and acceptable quality ( analytical)Maintains H&E stain line with competency ( analytical)- also should have PT 2 times a year for H&E quality. purchasePerforms special stains with quality results and few errors ( analytical)Performs IHC with quality results and few errors ( analytical and high complexity)- also need PT 2 times a year. purchaseCoverslips and labels slides with few errors ( post analytical) -case assemblyPerforms transcription with few errors ( post-analytical) Performs frozen sections with high degree of quality ( analytical)Performs frozen sections 90% of time under 20 mins ( analytical) Above is many, not all that I've always included with my annual evaluation. In which you (the supervisor) and the Medical director sign and verify that you have observed your staff and monitored them during these procedures. This was part of the Quality assurance program and monitored daily under the Quality Management program. ie; keeping track of any errors, repeats, problems and computing that data into measurable stats. < Reviewing data.  Problem solving skills: Data for this can be extracted from your QM logs at "How was the error fixed?", which should be recorded in your QM data.  So while CLIA may not regulate( as far as extra educational requirements) microtomy, embedding, routine staining are certainly things you need to show competency on for your staff.  As far as PPM's go,the providers had a test for competency that they had to have another provider check off on and sign that they observed the other provider performing the test and were competent in that test. They also have to have for each PPM type test they did 2 PT ( proficiency test) a year, 6 months apart. Either by second reviews, purchase from outside source or in house quiz.  For pathologist reading slides, have another qualified pathologist do second reviews for so many cases a year. 2-3% usually was the amount they chose.  ie: < Blind reviews.  Sorry this is so long. It should be longer but that's a bunch your asking and I tried to summarize best I could. I'm sure many others can add to this as its a big subject and honestly requires a lot.  I recommend purchasing a CLIA manual. And I'm not sure but Anderson used to offer a 24 CE course on CLIA. I took it but that was back when rocks was money. :)  Hope this helps.  Kim D    
      From: Elaine allison Hoffman via Histonet <histonet at lists.utsouthwestern.edu>
 To: Histonet List <histonet at lists.utsouthwestern.edu> 
 Sent: Friday, August 28, 2015 10:12 AM
 Subject: [Histonet] CLIA regulations in Histology
   
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
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