Although rare in solid organ transplantation, adverse events caused by donor-derived disease transmission and organ incompatibility have occurred at hospitals across the nation.
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In an effort to ensure living-donor kidney transplant recipients’ safety and to prevent these so-called “never-events” — unexpected donor-recipient tissue incompatibility, infectious disease transmission, and procurement of an anatomically inappropriate allograft — Cleveland Clinic surgeons have developed a first-of-its-kind preoperative checklist that is embedded in the health system’s electronic medical record (EMR).
Prior to the checklist’s implementation, the information it contains was spread across the EMR as well as in paper documents and imaging discs, with individual surgeons documenting the data in their own manner within recipients’ charts.
In the checklist’s first 27 months of utilization in living-donor renal transplants performed at Cleveland Clinic’s Glickman Urological & Kidney Institute, no never-events occurred, compliance was high (during a trial phase), and transplant surgeons found the list easy and quick to use, the researchers report.
“The checklist has allowed us to consolidate essential information from a number of sources into a single place in the patient record that is accessible to the various members of the transplant team and facilitates critical review of the data before surgery” says Bradley Gill, MD, MS, the study’s co-author and a urologic surgery resident in the Glickman Urological & Kidney Institute.
In its most recent analysis of donor-derived adverse transmission events, the Organ Procurement Transplant Network Disease Transmission Advisory Committee (DTAC) reported 32 cases in 2013 of proven or probable transmission of infection, malignancy or other conditions to 42 transplant recipients across the United States. These adverse events resulted in seven deaths: two from malignancies, four from infections and one from other causes.
Although the annual number of potential donor-derived adverse events the DTAC evaluates increased nearly 400 percent between 2006 and 2013, the advisory committee noted that the risk of unexpected disease transmission via transplantation remains exceedingly low. “Even though these events are rare, the checklist was developed to provide a final stop for the surgeon to document critical review of the data to help ensure a never-event will not occur,” Dr. Gill adds.
The checklist created by Cleveland Clinic researchers is a template form that resides in the EMR. It contains five information domains:
The recipient’s demographic and basic laboratory data is automatically populated from the EMR. The recipient’s transplant surgeon then manually enters the remaining information, including in all donor fields, using source documentation (original reports of donor blood/tissue type, viral infection status, etc.).
While manual data entry creates the possibility of human error, it importantly fosters critical review of information at each step, enabling the surgeon to identify abnormalities and order repeat testing or cancel surgery, if necessary. Another failsafe is the requirement that the surgeon finalize the ABO, crossmatch and transmission risk sections by declaring a safety attestation (compatible/incompatible or acceptable/not acceptable).
The checklist centralizes donor and recipient information in a single, secure location accessible by all transplant team members. The checklist is completed days before surgery. The surgical team again preoperatively confirms that the checklist deems the transplant acceptable, before any anesthesia administration or surgical intervention.
Cleveland Clinic researchers conducted a retrospective review of 157 instances of checklist use in living-donor kidney transplants between September 2011 and December 2013. No never-events occurred during that period. One transplant was cancelled the day before surgery when the checklist revealed inadequate infection screening.
The checklist completion rate among the transplant program’s five surgeons was high (87.9 percent) during this initial trial period. However, the researchers deemed this problematic, as anything less than 100 percent checklist completion is a missed opportunity to detect and avoid a potential never-event.
Since the study’s completion, the renal transplant program has developed and implemented a care path that requires use of the living-donor checklist. (Care paths are evidence- and consensus-based manuals detailing the appropriate steps in patient management for specific medical conditions and procedures.) A renal transplant program quality officer also monitors checklist compliance and notifies surgeons of any deficiencies. Overall, the process has been well received and largely successful, Dr. Gill says.
Since the living-donor checklist’s implementation, additional work with the EMR has improved the ability to automatically import more information into the document, as well as upgrading checklist formatting and readability.
Cleveland Clinic is considering a similar preoperative checklist for cadaveric kidney transplantation, although the procedure’s acute time demands present challenges for compliance and completeness, Dr. Gill says. Work in this domain continues.
