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 05P001 (X3) Date Survey Completed 05/14/2010
Name of Provider or Supplier Lifesharing Street Address, City, State 7436 Mission Valley Road, San Diego, 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)
Z0327 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:] (2) Withdrawal of support, including the relationship between the time of consent to donation and the withdrawal of support;


Based on record review and interview, the OPO did not ensure that protocols dealing with withdrawal of support in donation after cardiac death were followed. Finding includes: The OPO's policy and procedure for Donation After Cardiac Death (DCD), under Withdrawal of Support, stated that "the procurement coordinator will assure that no member of the transplant team is involved with the end of life care process and only attends the patient after death; " and that when withdrawal of support occurred in the operating room that "the surgical recovery team will leave the room." During an interview on 5/13/10, an OPO staff stated that hospital policy usually determines where withdrawal of support occurs in DCD cases and that OPO staff's responsibility is to ensure that prior to death declaration, no member of the recovery team is in the operating room. In one of two DCD cases where the operating room was used for withdrawal of support, review of the donor record revealed the lack of documentation by OPO staff that no member of the recovery team was in the operating room during withdrawal of support and prior to death declaration.