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 05/22/2014
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)
Z0000

The following reflect the findings of the Centers for Medicare and Medicaid Services (CMS) during a recertification survey from May 19 - 22, 2014.

This survey included investigation of a complaint (CA00399941) which was unsubstantiated and no deficiency was cited.

Z0057 HOSPITAL AGREEMENTS
CFR(s): 486.322(a)

An OPO must have a written agreement with 95 percent of the Medicare and Medicaid participating hospitals and critical access hospitals in its service area that have both a ventilator and an operating room and have not been granted a waiver by CMS to work with another OPO. The agreement must describe the responsibilities of both the OPO and hospital or critical access hospital in regard to donation after cardiac death (if the OPO has a protocol for donation after cardiac death) and the requirements for hospitals at § 482.45 or §485.643. The agreement must specify the meaning of the terms "timely referral" and "imminent death."


This STANDARD is not met as evidenced by:


Based on record review and interview, the OPO did not ensure that the written hospital agreement described the responsibilities of both the OPO and the hospital regarding DCD (donation after circulatory death).

Finding includes:

In one of 10 hospital agreements reviewed, the OPO did not ensure that the written agreement defined the hospital staff's roles and responsibilities, the OPO's role and responsibilities; as well as the collaboration between the OPO and hospital staff during donation after circulatory death (DCD). Review of policy and procedures revealed that the OPO had a protocol in place for DCD.

During an interview on 5/22/14, an OPO staff member stated that the agreement reviewed was the same for 17 other hospitals in a multi-hospital system.

Z0119 QUALIFICATIONS
CFR(s): 486.326(a)(2)

The OPO must develop and implement a written policy that addresses potential conflicts of interest for the OPO's director, medical director, senior management, and procurement coordinators.


This STANDARD is not met as evidenced by:


Based on record review and interview, the OPO did not develop policy and procedures that addressed potential conflict of interest for the OPO's executive director and medical director.

Finding includes:

Review of the OPO's corporate compliance document revealed that the policy and procedure for conflict of interest did not identify or address potential conflict of interest for employees who were also members of the governing body or medical advisory board. Review of the declaration forms for both employees and members of the board revealed different disclosure forms.

During an interview on 5/21/14, an OPO staff member stated that while the policy and procedure did not specify this, that beginning in 2014, all OPO employees who were also members of the board, such as the executive director (on the governing board), and medical director (on the medical advisory board) will have to complete 2 disclosures yearly. The staff added that for 2014, for example, the executive director had completed both employee and governing body disclosures.