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 04P001 (X3) Date Survey Completed 05/06/2010
Name of Provider or Supplier Arkansas Organ Recovery Agency Street Address, City, State 1701 Aldersgate Road, Suite 4, Little Rock, AR
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)
Z0306 REQUESTING CONSENT
CFR(s): 486.342(a)

An OPO must have a written protocol to ensure that, in the absence of a donor document, the individual(s) responsible for making the donation decision are informed of their options to donate organs or tissues (when the OPO is making a request for tissues) or to decline to donate. The OPO must provide to the individual(s) responsible for making the donation decision, at a minimum, the following: (1) A list of the organs and/or tissues that may be recovered. (2) The most likely uses for the donated organs or tissues. (3) A description of the screening and recovery processes. (4) Information about the organizations that will recover, process, and distribute the tissue. (5) Information regarding access to and release of the donor's medical records. (6) An explanation of the impact the donation process will have on burial arrangements and the appearance of the donor's body. (7) Contact information for individual(s) with questions or concerns. (8) A copy of the signed consent form if a donation is made.


This STANDARD is not met as evidenced by:
Based on record review and interview the Organ Procurement Organization (OPO) did not have a written protocol for and did not provide the individuals responsible for making the donation decision information regarding access to and release of the donor's medical records for donor records #1 - 8. Record review revealed the next of kin consent form did not include information regarding access to and release of the donor's medical records. Interview with the Director of Clinical Services on 5/5/10 at 2:00 PM revealed that there was no written policy nor did the OPO make the next of kin aware of information regarding access to and release of the donor's medical records.