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 05P005 (X3) Date Survey Completed 04/16/2010
Name of Provider or Supplier Donor Network West Street Address, City, State 12667 Alcosta Blvd, Suite 500, San Ramon, 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)
Z0318 TESTING
CFR(s): 486.344(c)(2)

[The OPO must do the following:] (2) Ensure that screening and testing of the potential donor (including point-of-care testing and blood typing) are conducted by a laboratory that is certified in the appropriate specialty or subspecialty of service in accordance with part 493 of this chapter.


This STANDARD is not met as evidenced by:


Based on record review and interview, the OPO did not ensure that testing of the potential donor including blood-typing, was conducted in a laboratory that is certified.

Finding includes:

In three of 11 donation cases, review of the donor records revealed that one of two ABO results did not identify the name of the hospital or laboratory where the test was performed. Without the identifier, determining whether the hospital or laboratory was certified could not readily be made.

During an interview on 4/14/10, OPO staff stated that the ABO results were printed out of the hospital's electronic health information system which did not include the hospital's name.