Initial Comments:
An unannounced recertification survey was conducted on November 14-16, 2023 at Lehigh Valley Hospital - Transplant Center. It was determined the facility was in substantial compliance with Part 482 - Conditions of Participation for Hospitals - Subpart E - Requirements for Specialty Hospital - 482. 68 Special requirements for transplant centers.
The recertification survey included the following types of organ transplant programs:
AKO - Adult Kidney - only
APO - Adult Pancreas - only
Plan of Correction:
482.98(d)(1) ELEMENT
ADVOCATE NOT INVOLVED IN TRANSPLANT ACTIVITY
Name - Component - 00 - Transplant Types: AKO, APA
482.98(d)(1) The independent living donor advocate or independent living donor advocate team must not be involved in transplantation activities on a routine basis.
Observations:
Based on review of facility documents and interviews with staff, it was determined the facility failed to ensure the Independent Living Donor Advocate position did not create a conflict of interest.
Findings include:
Review on November 15, 2023 of the facility's Organizational Chart revealed, the employee who is the Independent Living Donor Advocate reports up to the hospital's Quality Administrator.
Interview with EMP1 on November 15, 2023 at approximatley 2:15 PM confirmed the hospital's Transplant program reports to the Quality Counsel. Interview also confirmed that the Independent Living Donor Advocate position is supervised by the hospital's Quality department.
Plan of Correction:1. The ILDA (independent living donor advocate) has not and will not participate in transplant activities, and continues to only provide for the living donor as the ILDA.
2. The ILDA reporting structure will change to report to the Service Excellence Department, which will not create a perceived conflict of interest. The ILDA will no longer report to the Quality Administrator. This action will be completed by 1/24/24.
3. On a quarterly basis, the Transplant Program Director will verify that the ILDA is not involved in any transplantation activities.
4. The Chief Quality & Patient Safety Officer is responsible for this plan of correction.
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