| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 05P004 | (X3) Date Survey Completed 04/02/2010 |
| Name of Provider or Supplier Sierra Donor Services | Street Address, City, State 1760 Creekside Oaks Drive, Suite 160, Sacramento, 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) |
| Z0335 | ORGAN PREPARATION AND TRANSPORT CFR(s): 486.346(a) (b) The OPO must send complete documentation of donor information to the transplant center with the organ, including donor evaluation, the complete record of the donor ' s management, documentation of consent, documentation of the pronouncement of death, and documentation for determining organ quality. Two individuals, one of whom must be an OPO employee, must verify that the documentation that accompanies an organ to a transplant center is correct. This STANDARD is not met as evidenced by: Based on record review and interview, the OPO did not always send complete documentation of donor information to the transplant center; and did not ensure that two individuals verified that documentation that accompanied an organ to a transplant center was correct. Finding includes: OPO policy and procedure required that copies of donor information including ABO results, serology test results, medical and social history, donor evaluation and records of donor management, consent forms, copy of death pronouncement, as well as documentation of organ quality were sent with the organ to the transplant center. The policy and procedure also required that two individuals one of whom was an OPO employee verified that the documentation was correct. In one of 8 donation cases where 4 organs (heart, liver, and both kidneys) were recovered, review of the donor record revealed that while labels ("toe tags") were completed for the heart and right kidney (and copies of which were attached to the label verification form in the donor record), evidence that labels were completed for the left kidney and liver was not available. Review of documentation by an OPO staff on the label verification form revealed that while "both organs were released (to the transplant surgeon/transplant center) on ice cooler;" and that the "toe tag was placed on organs and donor chart attached to the ice cooler," further review did not identify the documents sent with the organ or that two individuals verified that the documentation was correct. During an interview on 3/31/10, another OPO staff stated that labels were completed for each organ recovered and that all required documentation outlined in the policy and procedure were sent with the organ even if the organ was transported from one operating room to another. |