POCT management

Hi Tyler, thanks for reaching out.  Are you a POCC or do you have other interests for writing an article.  I would like for people to know that there has been and is going to be tremendous growth in POCC and it is a field that laboratory students should be encouraged to learn about and pursue.  POCCs take responsibility for every lab test result generated from their program and work diligently to ensure reliable and accurate results are achieved.  We work hard to maintain compliance with a host of regulations that vary from health care facility to healthcare facility.  Those regulations change frequently and we must be effective communicators as new regulations are created and old ones are discarded.  We wear as many hats as the elementary school teacher:  Information Technology, Biomed, Quality Insurance, Information Management, Procedure writers and owners, Meter Mechanic, Bench Tech, Educator, Compliance Officer; etc. I am sure other group members can add to the list.  We are major medical centers, local hospitals, VA, clinics, and doctors offices.  As a group, we rely heavily on each other through the list serve, emails, phone calls etc.  We are our own educational trainers.  And I might say we are a tight knit group, most whom have never met face to face, but know each other only through electronic communication.  POC programs are like the water from the kitchen faucet. It runs silently and effectively in the background providing life giving information.  You don't miss it until you don't have it and then you are in a panic till it is fixed.  Good luck with your article. 

Well said, Penny!!!!

Thanks for your response Penny, that was very well written!

I am a POCC at ARUP working with the University of Utah currently working on my masters. I decided to write this article because I found that without any general guidelines how to run a POC department most of us all function similarly. Most people I've talked with have similar functions and issues. I really want to gather as many opinions as I can to form something that will truely be helpful.

I have read a lot of articles and books about POC, but I find most (not all) to be unrealistic or way to broad. I have yet to find any surveys or research from an array of individuals that manage POC. I just think there is a lot we could learn and share.

Realistically, the reason we all "function similarly" is because we all have to follow the same regulations. I am not sure what would be more "truly helpful" than following the regulations in a way that you can manage the program, both for the good of the patient and without tearing out your hair.

I told a POCT vendor that I truly felt sorry for their marketing and R/D deptartments. Trying to come up with a product that would be a one size fits all sales win AND that would to be useful to most POCC was almost impossible. You  are catering to clinics, reference labs/drawing sites that do POCT, small rural hosptials with one non-waived device, to medium to large sized systems that have hundreds of non-waived devices...AND the clinic networks and outreach. Just like Penny mentioned.  

In the same manner, I wish you good luck with your article. The similarity is the regulations...the differences are enormous. FTE, regulatory agency, cultural bias for or against POC testing that influences both menu and the support given to POCT...electronic learing systems versus paper comps, pathologists who have no clue and treat POCT waived items like a lab analyser...regulations that are "adapted" from the main lab but make POCC "check a box" to follow them but have no benefit to the patient....and on and on and on....

One thing Penny did forget is that we are all "The Old Woman (Man) Who lives in a Shoe...who has so many kids (operators) we don't know what to do!"

Tyler,  are you familiar with the "Poor Lab's Guide to Regulations" ISBN 1-886958-31-9 from Westgard QC.  This is a generic overview of CLIA, Joint, CAP and COLA with a section on POC.

Deanna,  I am adopting your Old POCC in the shoe adage!!!

What's everyone's take on multiple areas within the hospital and moderately complexed testing? Do they each have their own CLIA certificate or one for the hospital and PT, machines, and cartridges "share" or not? It is within the confines of our hospital and I have worked with both set ups but had directors with different reasons for each. The single CLIA certificate was easier to maintain everyone and everything but am questioning if its kosher with regulatory compliance?!

Our medical director requires every department to get separate CLIA licenses within the hospital. I agree that it is more difficult to maintain but I haven't heard or read anything about regulations that would require it to be either way. I think CLIA will take as many applications as they can get. 

The main reason we do separate licenses is so that if a lab medical director extends his license to share and then someone misuses it then he won't potentially lose his ability to hold a license for 2 years and not be able to practice. Where if a department medical director has his own and then has compliance issues if he loses his ability to hold a CLIA license then he can still practice and it's not a big deal. Someone else in the department can simply apply for a license.

Penny, I actually wasn't familiar with this book, However I will be shortly because I just ordered it! I read quite a few reviews recommending its practical use. Thanks for the recommendation!

Inga,

For an inspection, usually irregardless of agency...more non-waived CLIA will probably mean more time in house for the inspectors and more money spent to maintain the certificate(s) on renewal. One thing to consider....

We place as many items on a non-waived CLIA as possible. Ours are under the lab CLIA in the 6 hospitals I manage, which includes Respiratory Therapy.  This is so we do not have to pay for the multiple CLIA fees and we know exactly how long the inspectors will be in house. 

I have managed it in the "someone else holds them so the lab is not impacted if they fail" model also for 4 hospitals plus Respiratory Therapy.

 You can choose the way you think is best for you....there is not a regulation that says one way or the other.

Penny: Funny story...I was in an ER talking to an operator....how ever I said what I said about her comps she replied" You don't have kids do you?" And I said "Not of my own, but I do have children.....2200 POCT operators." She said...."That is not right...we are not kids." I replied, "Well when I tell you to clean your room because if you don't you won't go to the movies...then I show you how to clean your room by helping you...but you still don't clean it...eventually you do not get to go to the movies as a kid. Insert cleaning your room for doing your comps and QC or you will be removed from access to the POCT analyzer...now you have the picture." She flounced away having no comment. (Now I would probably have to take away an IPAD/IPHONE...)   :-)

I've also worked under both models...having depts. running non-waived CLIA working "independently" (wink-wink), and as our current model, which is to have them under our CLIA.  Having them run independently was mostly a necessity back in the day because my position didn't exist and there was no one from lab administration available to do the oversight.  And there was also the idea, as stated above, to not have their failures to maintain their programs consistently affect the main laboratory.

  The thing was, when those departments were on their own CLIA - the lab STILL got all the questions anyway - either at the last minute, or after they were cited and didn't know how to respond.  So, rather than have emergency prep and emergency cleanup, we decided it would be far better to keep them compliant 365 days a year instead of just around inspection time. 

When we consolidated the separate CLIAs to one, we were supported by the State of PA (who preferred not to have excessive numbers of CLIA certificates in the same location).  There are times when I have non-compliance with my departments that I would LIKE to send them back off on their own :) ....but in the end, as the experts in our field, laboratory should be overseeing POCT.

Tyler,

Going back to your June 30 request for input regarding POC Management, I'm remembering a Special Edition to Point of Care: The Journal of Near-Patient Testing & Technology (think it's June 2013, I could be wrong plus it could have been over more than one issue). It was organized by Jim Nichols, PhD. He invited numerous POCCs and POCT Lab Directors to write on POC Management challenges as I recall.