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 03/29/2018
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)
Z0168 POTENTIAL DONOR PROTOCOL MANAGEMENT
CFR(s): 486.344(a)(1)

The medical director is responsible for ensuring that potential donor evaluation and management protocols are implemented correctly and appropriately to ensure that potential donors are thoroughly assessed for medical suitability for organ donation and clinically managed to optimize organ viability and function.


This STANDARD is not met as evidenced by:
Based on staff interview, donor record review and review of the "Quality Assurance Review/Audit of Donor Records" policy, the Organ Procurement Organization (OPO) failed to ensure donor records were reviewed by the Medical Director for nine of nine (9 of 9) Donors (Donor #s 2, 3, 4, 5, 6, 7, 8, 9, and 10) The findings include: Review of Donor Records for Donor #s 2, 3, 4, 5, 6, 7, 8, 9 and 10 revealed no evidence that records were reviewed and signed by the Medical Director. Records for Donor #s 2, 3, 4, 5, 6, 7 and 9 revealed they were reviewed and signed by a non-OPO physician. The Donor Records for Donor #s 8 and 10 revealed a typed and unsigned Medical Director Review dated 2/19/18 for Donor #8 and dated 12/27/17 for Donor #10. Review of the OPO's policy entitled, "Quality Assurance Review/Audit of Donor Records," dated 9/13/17, revealed, " ...The Medical Director (or designee) will document the review on FO 1.0 MDRR Medical Director Review of Donor Record and provide details of any actions that were contrary to the effective evaluation and management of potential donors ..." During an interview on 3/29/18 at 10:00 A.M., the Clinical Director (CD) stated to her knowledge the physician who signed the aforementioned Donor records, was not the Medical Director. The CD confirmed the physician that signed the Donor records, had no formal agreement with the OPO.