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 05P004 (X3) Date Survey Completed 04/02/2010
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)
Z0307 REQUESTING CONSENT
CFR(s): 486.342(b)

If an OPO does not request consent to donation because a potential donor consented to donation before his or her death in a manner that satisfied applicable State law requirements in the potential donor's State of residence, the OPO must provide information about the donation to the family of the potential donor, as requested.


This STANDARD is not met as evidenced by:


Based on record review and interview, the OPO did not ensure that the family member of a potential donor who had consented to donation before his or her death was provided information about donation.

Finding includes:

In one of 4 cases where the donor had first-person consent for donation, review of the donor record revealed the lack of documentation that the family member was provided information on donation.

During an interview on 3/31/10, an OPO staff member stated that the family was given a letter ("For The Family") informing them about the presence of the first-person consent; the actions the OPO will take to honor the potential donor's wishes; the necessary tests and length of evaluation to determine suitability; costs; and other post-donation activities. During another interview on 4/01/10, an OPO staff member stated that in all cases including first-person consent, the family of the potential donor was given the same information on donation. The staff added that an information packet was also given to the family and documentation of the process was made in the narrative notes.

Review of the donor record however revealed the lack of evidence that a copy of letter was given to the family member or that the documentation as referenced above was available in the narrative notes.