| 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) |
| Z0235 | ADMINISTRATION AND GOVERNING BODY CFR(s): 486.324(d) The OPO must have bylaws for each of its board(s) that address potential conflicts of interest, length of terms, and criteria for selecting and removing members. This STANDARD is not met as evidenced by: Based on record review, the OPO did not have bylaws for each board that addressed potential conflict of interest. Findings include: 1. Review of the OPO's "Amended and Restated Bylaws" revealed the lack of provision that identified and addressed potential conflict of interest for members of the medical advisory board. 2. Article XI of the same bylaw noted that "The Board of Directors shall adopt and periodically review and, as necessary, revise, a policy governing conflict of interest." The bylaw however did not include provisions for the identification of potential conflict of interest; did not specify the frequency of any review or conditions for revisions; and did not include procedures for how potential conflict of interest would be addressed. |
| Z0237 | ADMINISTRATION AND GOVERNING BODY CFR(s): 486.324(f) The OPO must have procedures to address potential conflicts of interest for the governing body described in paragraph (d) of this section. This STANDARD is not met as evidenced by: Based on record review and interview, the OPO did not have procedures for ensuring that members of the governing body complied with potential conflict of interest policy. Finding includes: During an interview on 4/14/10, an OPO staff stated that policies and procedures on conflicts of interest were contained in several documents including the "Corporate Compliance" and "Conflicts of Interest Policy." Review of the "Corporate Compliance" document revealed that "Any person serving on the (OPO) Board of Directors shall, as condition of such membership, comply with Conflict of Interest Provisions of the (OPO) By-Laws." The document further noted that "Members of the Board of Directors shall be expected and required to execute the Conflict of Interest Policy and Confidentiality Agreement in effect at the time of such membership, and will abide by the requirements of such agreement as long as the individual serves on the Board thereafter." (Principle D: Conflict of Interest.) Review of the "Conflicts of Interest Policy" document revealed that "Each director, officer, and key employee shall annually sign a statement, on a form approved by the board, which affirms that such person has received a copy of the conflicts of interest policy, has read and understand the policy, has agreed to comply with the policy, and understands that the Corporation is a charitable organization and that in order to maintain its federal tax exemption it must engage primarily in activities which accomplish one or more of its tax exempt purposes." (Article VII: Annual Statements.) Review of governing board documents revealed that of 15 members of the board of directors, eight had evidence of current signed conflict of interest disclosure statements on file. Of the seven remaining, three had their statements signed during the survey after OPO staff had been notified that their statements could not be located; and four were to have theirs completed in May, 2010. Further review revealed the lack of evidence of prior signed disclosure statements on file to indicate that annual statements were being completed annually as required by the policy. |
| 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. |