Posted by Sten Westgard, MS
Now that the age of the IQCP is here, laboratories are grappling with the time and effort it takes to build their Individualized Quality Control Plans. How long should it take to build an appropriate IQCP?
- 40+ hours
- 21-40 hours
- 11-20 hours
- 5-10 hours
- Less than 5 hours?
How much time has it taken for you? How much time do you think it should take?
The answer, of course, depends on how you do the IQCP. Are you doing it by hand? Or are you using a program that's designed to design IQCPs?
Karen Clark, the POC manager at the Baptist Memorial Hospital, with the help of CarePoint Solutions, conducted a time-study of building an IQCP "from scratch" vs. the amount of time it took to build an IQCP when there was support from computer software.
The abstract was presented at the CPOCT International Symposium in 2014, later published in the Point of Care Testing Journal in June 2015 (see the link below).
The manual development of the IQCP took 76 hours. But building the IQCP with the help of computer software took only 26 hours.
Now, the study didn't determine whether or not either risk assessment was sufficient and thorough, nor whether or not the resulting quality control plan was appropriate and controlled all risks (the study was completed before IQCPs were being inspected), but it is a sign that informatics could potentially speed the development of IQCPs for laboratories.
Anecdotally, I have talked with laboratories that, doing a thorough job, are spending 40-80 hours of staff time on their IQCPs for different systems. While the staff that has to perform these duties are already paid for - no new staff is being hired just to perform IQCP development - that is a time and opportunity cost. All the hours that a lab spends developing IQCPs are hours that can't be devoted to some activity that adds value to the laboratory operations.
A Study of the time and resources required in the development of an Individualized Quality Control Plan for a moderate complexity test system (subscription required), Clark K, Donohue WR, Lebo R, Durish L, Scoggins S, Point of Care: The Journal of Near-Patient Testing & Technology: June 2015 - Volume 14 - Issue 2 - p 45–52