| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 05P004 | (X3) Date Survey Completed 02/16/2022 |
| 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) |
| Z0094 | 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 a review of the Organ Procurement Organization's (OPO)'s standard operating procedures (SOP), the By-Laws of Dialysis Clinics, INC. (DCI) Donor Services INC., document reviews, and interviews, the Conflict of Interest (COI) agreements for five of six of the Governing Board members (GB1 - GB6) were not current. Findings include: A review of the OPO's standard operating procedure (SOP), "Conflict of Interest - Advisory Board and Governing Board," effective date, 11/06/16 revealed, "6.4 ANNUAL STATEMENTS (Article VI) 6.4.1 Each director, principal officer and member of a committee with board delegated powers shall annually sign a statement which affirms that such person: 6.4.1.1 Has received a copy of the conflicts of interest policy 6.4.1.2 Has read and understands the policy 6.4.1.3 Has agreed to comply with the policy and make disclosure when appropriate." A review of the OPO's Governing Boards, "By-Laws of DCI Donor Services Inc." dated June 19, 2017, revealed, "Section 6. Annual Statements and Periodic Review. Each director, officer, employee shall annually sign a statement which affirms that such person has received, read, understood, and agreed to comply with the conflicts of interest policy and to make disclosure when appropriate." A review of the OPO's document, "Board of Directors & Advisory Board Member Conflict of Interest Disclosure Statement," for GB1 showed the following attestation. "I have carefully read the DCI Donor Services (DCIDS) HR. 118 - Conduct and Compliance Program and HR. 113 - Conflict of Interest - Advisory Board and Governing Board and understand the requirements of these as it applies to me. The below responses reflect activities during the following time period, from 01/01/21 to 12/31/21. A review of the OPO's document, "Board of Directors & Advisory Board Member Conflict of Interest Disclosure Statement," for GB2 showed the following attestation. "I have carefully read the DCI Donor Services (DCIDS) HR. 118 - Conduct and Compliance Program and HR. 113 - Conflict of Interest - Advisory Board and Governing Board and understand the requirements of these as it applies to me. The below responses reflect activities during the following time period, from [No Date] to Ongoing." A review of the OPO's document, "Board of Directors & Advisory Board Member Conflict of Interest Disclosure Statement," for GB3 showed the following attestation. "I have carefully read the DCI Donor Services (DCIDS) HR. 118 - Conduct and Compliance Program and HR. 113 - Conflict of Interest - Advisory Board and Governing Board and understand the requirements of these as it applies to me. The below responses reflect activities during the following time period, from [No Date] to [No Date]." A review of the OPO's document, "Board of Directors & Advisory Board Member Conflict of Interest Disclosure Statement," for GB5 showed the following attestation. "I have carefully read the DCI Donor Services (DCIDS) HR. 118 - Conduct and Compliance Program and HR. 113 - Conflict of Interest - Advisory Board and Governing Board and understand the requirements of these as it applies to me. The below responses reflect activities during the following time period, from May 2020 to May 2021." A review of the OPO's document, "Board of Directors & Advisory Board Member Conflict of Interest Disclosure Statement," for GB6 showed the following attestation. "I have carefully read the DCI Donor Services (DCIDS) HR. 118 - Conduct and Compliance Program and HR. 113 - Conflict of Interest - Advisory Board and Governing Board and understand the requirements of these as it applies to me. The below responses reflect activities during the following time period, from 04/30/20 to 04/30/21 and ongoing." In an interview on 02/14/22 at 10:43 AM, the Manager of Quality and Compliance (MOC) confirmed that five of the six governing board member COIs were expired. After reviewing the "By-Laws of DCI Donor Services Inc." dated 06/10/27, and the OPO's SOP, "Conflict of Interest - Advisory Board and Governing Board," effective date, 11/06/16 with the MOC, it was determined that the COIs are to be reviewed, updated, and signed annually. MOC acknowledged the need for an annual review, confirmed that there were no other COIs to provide for review and stated, "I agree, this could be cleaned up a bit." |