Subtherapeutic ACT values after standard heparin dosing

I am very happy to see this post, as my plan was to post today for the exact same issue.  We have multiple reports now of excessive doses of heparin where the i-STAT ACTk values are not changing.  I also have opened a case with Abbott but as you stated, their investigations take time.  Lot numbers involved here are at least two --- R25316 (436R253160181) and R25337 (436R253370181) and it is not ALL patients, only a handful.  Our pharmacy is also sending heparin lots back to vendors for investigation but providers are questioning and hesitating.  Can anyone point me to other potential causes we should be looking at?  The issue has been escalated at my organization.  Thank you!

We have had several complaints from our cath lab and surgery departments about this.  A much higher dose of heparin is having to be used to achieve desired Act level.  Pharmacy sent the initial lot of Heparin to be tested; however, heparin ordered from different manufactures have had the same complaints. Swapping out i-STATs and using different ACT lots did not help, and QC and external simulator pass without issue.  

Delia, do you plan on opening a case with Abbott? We have reports of post-procedural bleeding complications now. I am hoping Abbott will expedite their investigation.

Yes...I received a report of unexpected low ACT values after 7000 units dosing. I have also reported this to Abbott.
LOT R25322

We currently have an open case.  Abbott sent an extensive questionnaire to fill out for each patient.  The request included i-STAT serial numbers, Act and heparin lot #'s & manufactures, heparin doses & time stamps etc...

We have been dealing with this issue since mid-December. This issue has spanned several cartridge lots since we discovered it. Our pharmacy and lab have been troubleshooting this for a while now and we still can't determine whether it is the heparin or the cartridges. The main problem is how sporadic it is. Two cases may have a problem then the next one will be fine or one day may be bad across the board and then the next will be ok. Overall, it has been a problem since mid-December.   We have known this has been a widespread issue across the country. My question to the group is anyone having this issue using another ACT device besides the i-STAT and using ACT Kaolin cartridges. Thanks

I have been in POCT a long time. I have seen this issue twice before-once with the ISTAT (early 2000's) and once with the Hemochron (Late 1990's).

With the ISTAT, the heparin lots were tested, lot numbers reported to Abbott. etc....but what the solution came down to was that the heparin was given and the sample for the ACT was taken immediately. (I observed this in the Cath Lab while watching one day. 

We asked them to wait 15 minutes post dose before taking the ACT sample and the problem went away. It did take a while for this information to percolate through all the docs using it for ACT. 

With the Hemochron, the eventual issue was bad lots of foreign manufactured heparin from one source. That was in the 1990's. 

Interesting Deanna, I will look into what our protocol states for heparin dosage and the wait time to test ACT. We are using the ACT-Kaolin cartridges. Anyone using the ACT- Celite cartridges?
Deirdre.

We use ACT K for all areas. I have not had a single complaint.....from 7 hospitals. 

We received a report of a lower-than-expected ACT result just this morning, lot number R25319 (ACT-k). 

From responses received, summarizing lot numbers: R25316, R25337, R25322 and now R25319. Are there any other lot numbers not listed?

Affected lots with us are R25311 , R25326 , R25343 

If it is a case of improper sampling (sample drawn too soon after heparin), why would it have not been observed all along, and not just after the heparin type changed?

Deidre, was the heparin changed by pharmacy only after the problem with subtherapeutic values was observed?

Hi James, yes, removed however issue persists with a new type/vendor of Heparin. 
Deirdre.

OK, so then it's possible it could have been the sampling issue all along, as Deanna suggested?  When I first read your post I thought you were saying the problem was only observed after the pharmacy had a change in heparin vendor.