Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 05P002 (X3) Date Survey Completed 03/29/2018
Name of Provider or Supplier Onelegacy Street Address, City, State 221 S Figueroa St, Suite 500, Los Angeles, CA
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
Z0188 DONATION AFTER CARDIAC DEATH
CFR(s): 486.344(f)(2)

[If an OPO recovers organs from donors after cardiac death, the OPO must have protocols that address the following:] Withdrawal of support, including the relationship between the time of consent to donation and the withdrawal of support;


This STANDARD is not met as evidenced by:
Based on record review and interview, the OPO did not have DCD (donation after cardiac death) protocols that addressed withdrawal of support including the relationship between the time of consent to donation and the withdrawal of support.



Finding includes:



Review of the OPO's policy and procedure (111.3) on organ donation after cardiac death (DCD) revealed that during the organ donation, the "procurement team will wait in a nearby room until they are called in" to the operating room (OR) after death declaration had been made. Another policy and procedure on donation after circulatory death (13.56v9) further noted that "Members of the transplant teams are not allowed in the OR until death has been pronounced."



During an interview on 3/28/18, a procurement coordinator (OPO Staff 3) stated that members of the organ recovery team are not allowed in the OR until after death declaration had been made. OPO Staff 3 added that a procurement coordinator is in the OR only to document the withdrawal of care and to complete the flow sheet (DCD Intraoperative Flow Sheet) which includes several data fields such as the extubation date/time, date/time of pronouncement of death, the name of the pronouncing physician, and the time the transplant team enters the OR after death had been declared. The OPO's DCD policy also noted that the organ procurement coordinator "will facilitate the donation process throughout the organ recovery in the hospital O.R."



In a separate interview on 3/29/18, a tissue recovery staff member (OPO Staff 4) explained that one of the responsibilities of the tissue recovery coordinator (TRC) is to be in the OR during the withdrawal of care process. When asked what the TRC's role or responsibility is during the process, OPO Staff 4 stated that the TRC would just stand by, support the procurement coordinator when needed, and call in the transplant team into the OR after death had been declared.



Review of both the OPO's policy and procedure mentioned above however did not outline the roles and responsibility of the tissue recovery coordinators in the OR during the withdrawal of care process and prior to death declaration.