Is ACT proficiency testing required?

14 followers
1 Likes

Our hospital system uses the Hemochron Sig Elite for ACT testing and we are TJC accredited. The PT survey samples are essentially the same as QC (CAP and API samples).  Since the PT samples don't mimic patient samples and mimic QC, PT shows that users can run QC. Therefore, if the users struggle with passing QC (as most do) they're going to struggle with PT. This is the currently the case and "failing" surveys.
I don't see that ACT testing is CLIA required in Subpart I. I'd love to do away with it, if it's an option.
What's everyone else doing??

8 Replies

This is one of my biggest complaints when it comes to proficiency testing. It is only rarely that the sample is even close to a patient sample. I'm not sure about TJC requirements, but for CAP all testing has to have proficiency testing or alternative PT if none is available commercially. 
I have talked with CAP and COLA about this topic. For PT, if the sample needs to be manipulated, or the device needs to be in a different mode than patient testing, our policy states that we (POCT) can assist with advice. They still need to do the actual testing. When I used to do i-STAT PT, I would draw the sample up from the ampule, since the nurses always wanted to push air into the ampule with the syringe. The response from both CAP and COLA has been to accept this, and we've put it into our QA policy. Maybe someday the POCT PT will actually mimic patient testing, but currently I think it needs to be ok that the POCT team help a bit up front. As long as the operators are running the sample as they would a patient (in the case of the Hemochron, a syringe of "blood"), then we need to assist.

You state you are TJC accredited.  While TJC & CAP requirements are based off of CLIA, you are not going to be able to successfully argue against the requirement if TJC states you must do PT testing for the assay.
 
Yes, some PT survey samples for coag are literally relabeled QC bottles, if CAP/API are selling it that way... it meets their requirements for PT.
  • Following the exact steps for hydration of the QC and testing it as soon as its ready is paramount for getting it to work.  We prepare the QC/PT samples and give it to the user to immediately perform the test to ensure it was prepared correctly.  Just handing the unprepared QC/PT vials to the floor and walking away = problems.  

Unless something changed recently (I'm still reading the 2023 update to Subpart I) then all non-waived tests historically have required PT. ACT is a non-waived test, therefore PT has historically been required. Has this changed recently?

It is still required under CLIA which would be the basis for both JC and CAP to my knowledge.  We still do CAP proficiency testing.

Good discussion here - agree with everyone's points, and ultimately I believe that it comes down to the fact it's a non-waived test and both CAP and TJC are going to require PT.
  Not with ACT, but with the AQ CAP Surveys (blood gas/chemistry), I did get a similar response from CAP once, which is if the PT sample is unique and wholly unlike a patient sample, you are permitted to assist.  Quite honestly, I never dreamed they would approve of that.  Formerly, I would always try to make the PT testing as close to the actual patient process as possible, by not proctoring them (I would of course give very specific instructions), in the interest of making it an honest assessment of their abilities, even if it ultimately amounts to more headache for me.  But now I will assist as needed, since CAP approves.

Yes, we have ISTAT ACT and we subscribe to the CT-5 CAP survey.  We also perform ACT on HMS Plus in Perfusion and subscribe to CT-1 for that instrument.  We are CAP so it is required for us to have them done or do alternate performance assessment.  For these assays, it is much easier to just get the surveys rather than do APA.  I rotate through the various areas and operators for them.  Usually don't have too many issues with the ISTAT or HMS Plus.  We did have SIg Elite in the past and CAP survey failures was a big part of moving away from this instrument for ACT testing.

JC response is that ACT is not a regulated analyte and no PT is required. If I'm not going to participate in PT then QSA.01.05.01 would apply. Semiannually evaluate reliability and accuracy. I already get the CAP quality cross check samples for this so that would work out great. 
Thanks for all the responses!! 

A few have mentioned that CAP gave approval to assist with this PT testing or all of the reasons stated.  I absolutely agree! Does anyone have this in writing or know where it is on the CAP website?  I'd love to see it in black and white from CAP.

Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Melisa Wagoner
almost 2 years ago
8
Replies
1
Likes
14
Followers
1074
Views
Liked By:
Suggested Posts
TopicRepliesLikesViewsParticipantsLast Reply
Anybody have experience with the Actalyke?
Edith Synnefakis
about 12 hours ago
0061
Edith Synnefakis
about 12 hours ago
Cal/Ver Istat pCO2
Autilia Sisti
about 12 hours ago
1099
Marcelino Gabriel
about 12 hours ago
Does a PharmD qualify you as a Technical Consultant
McKenna Chandler
5 days ago
10315
JoAnn Crain
about 12 hours ago