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 01P001 (X3) Date Survey Completed 04/18/2014
Name of Provider or Supplier Legacy Of Hope Street Address, City, State 516 20th Street South, Birmingham, AL
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)
Z0189 DONATION AFTER CARDIAC DEATH
CFR(s): 486.344(f)(3)

[If an OPO recovers organs from donors after cardiac death, the OPO must have protocols that address the following:] Use of medications and interventions not related to withdrawal of support;


This STANDARD is not met as evidenced by:
Based on document review and staff interview, the Organ Procurement Organization (OPO) failed to include: 1) Persons who might administer drugs, and 2) Evidence of Collaboration with the hospital staff on the administration of medications who were included in their written protocols for Organ Donor Management. The OPO also failed to follow their own Standard Operating Procedures (SOPs) to ensure all donors received some type of prophylactic coverage, and that a paralytic drug was given at the beginning of the surgical recovery for three (3) of five (5) Donor Records, (#'s 1, 2 & 3) for antibiotics and paralytics. The findings include: Review of the " Standard Operating Procedures (SOPs) " for " Organ Donor Management" with the effective date of 1/30/2014, revealed two components were missing from the protocol: (1) The protocol failed to include the staff who might administer drugs in collaboration with the hospital staff on the administration of medications. In addition, (2)The SOP 7.16 Antibiotic Therapy and 7.17 Paralytics, documented the following, " 17.16.1, "All donors should receive some type of prophylactic coverage ...7.17.4 A paralytic is always given at the beginning of the surgical recovery ... " Donor record review conducted on 4/18/14 with the Certified Procurement Transplant Coordinator (CPTC) revealed antibiotics and paralytics were not administered for 3 of 5 records reviewed for Donor #'s 1, 2 & 3.