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 03P001 (X3) Date Survey Completed 04/29/2010
Name of Provider or Supplier Donor Network Of Arizona Street Address, City, State 201 West Coolidge, Phoenix, AZ
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 were always followed. Finding includes: The OPO's policy and procedure for Organ Donation after Cardiac Death (DCD) stated that "at no time between the withdrawal of support and declaration of death may the surgical team be in the same room as the patient." The policy further noted that "withdrawal of support may occur (in) a pre-operative holding area ("induction room"), post-anesthesia care unit (PACU), or the OR (operating room) itself." During an interview on 4/28/10, an OPO staff stated that the family's wishes as well as hospital policy dictated where withdrawal of support was to be conducted. The staff added that regardless of the venue, the OPO did not allow any member of the recovery team inside the operating room or in the same room as the potential donor prior to death declaration. In three of 3 cases of donation after cardiac death, including one where withdrawal of support occurred in the operating room, review of the donor records revealed the lack of documentation by OPO staff that no member of the recovery team was in the same room as the potential donor during withdrawal of care and prior to death declaration. (Reference Donors 8, 9 and 10.)