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 05P002 (X3) Date Survey Completed 03/19/2010
Name of Provider or Supplier Onelegacy Street Address, City, State 221 S Figueroa St, Suite 500, Los Angeles, 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)
Z0319 TESTING
CFR(s): 486.344(c)(3)

[The OPO must do the following:] (3) Ensure that the potential donor's blood is typed using two separate blood samples.


This STANDARD is not met as evidenced by:


Based on record review, and interview, the OPO could not demonstrate that two separate blood samples were typed for 3 of 18 donor cases sampled (Donors 5, 9, and 14).

Findings include:

1. Donor 5's donor form documented recovery of heart, liver, kidneys, and pancreas on 3/08/08. A computer screen print out with Donor 5's blood type did not identify the testing laboratory, the date and time the blood sample was drawn, and the source of the computer screen print out.

2. Donor 14's operative summary documented recovery of kidney, adrenal, liver and spleen on 10/14/08. A computer screen print out with Donor 14's blood type did not identify the testing laboratory, the date and time the blood sample was drawn, and the source of the computer screen print out.

3. Review of Donor 9's record revealed an ABO report from the National Institute of Transplantation dated 8/3/06 of an "O Positive" result. While another report dated 7/30/06 indicated an ABO result of "O Positive" and identified the patient's name, date of birth, sex, medical record, case number and location code, it did not however identify the name of the hospital or of the testing laboratory. In an interview on 3/18/10, the administrative staff stated that they were aware of the hospital's identity where the lab result came from but that the print out from the hospital does not include the hospital's name.

The OPO policy titled "UNOS ABO Confirmation Policy" dated 11/3/2009 stated that "(name of OPO) is responsible for the verification of two separate ABO/Rh blood type determinations from two separate laboratories on deceased donors prior to running a match -run for organ allocation and surgical incision. .... PTC will enter the donor's ABO from the hospital's source document into UNet (first verification)."