A novel approach to managing variation: outpatient therapeutic monitoring of calcineurin inhibitor blood levels in liver transplant recipients.
OBJECTIVE
To apply the principles of statistical process control (SPC) to manage calcineurin inhibitor (CNI) blood levels. We hypothesized that the use of SPC would increase the proportion of CNI blood levels in the target range.


METHODS
The study population consisted of 217 patients more than 3 months after liver transplantation. After demonstration of proof of concept using the rapid cycle improvement process, SPC was applied to the entire population. The change package included definition of target ranges for CNI, implementation of a web-based tool that displayed CNI blood levels on a control chart, and implementation of a protocol and a checklist for management of CNI blood levels. The principal outcome measure was the proportion of CNI blood levels in the target range.


RESULTS
In the pilot study, the proportion of CNI blood levels in the target range increased from 50% to 85%. When the protocol was spread to the entire population, the proportion of drug levels in the target range increased to 77% from 50% (P < .001), whereas the range of CNI levels decreased. The rate of allograft rejection did not change.


CONCLUSIONS
Utilization of SPC increased the proportion of CNI blood levels in target range. These observations may be applicable to the care of other chronic healthcare problems.
Pediatric Liver Care Center, Division of Health policy and Clinical Effectiveness, Cincinnati Children's Hospital, Cincinnati, Ohio, USA.
John C
JC
Bucuvalas
Frederick C
FC
Ryckman
Gajra
G
Arya
Brandy
B
Andrew
Anne
A
Lesko
Conrad R
CR
Cole
Brent
B
James
Uma
U
Kotagal
D000553:Ambulatory Care; D065095:Calcineurin Inhibitors; D002675:Child, Preschool; D002985:Clinical Protocols; D016572:Cyclosporine / Q000097:blood / Q000627:therapeutic use; D004791:Enzyme Inhibitors / Q000097:blood* / Q000627:therapeutic use; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood* / Q000627:therapeutic use; D016031:Liver Transplantation; D008297:Male; D009820:Ohio; D010865:Pilot Projects; D011785:Quality Assurance, Health Care; D013223:Statistics as Topic; D016559:Tacrolimus / Q000097:blood / Q000627:therapeutic use
D065095:Calcineurin Inhibitors; D004791:Enzyme Inhibitors; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus