| 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) |
| 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 and interview, the OPO did not have bylaws for each board that addressed potential conflict of interest. Finding includes: During an interview on 3/31/10, an administrative staff member stated that the OPO had developed and approved policies and procedures that addressed potential conflict of interest for members of the medical advisory and governing boards, as well as for employees. Review of the governing board as well as the medical advisory board bylaws however, revealed that the bylaws did not include a provision that identified and addressed potential conflict of interest. In the same interview on 3/31/10, the staff member stated that the advisory board bylaw required advisory board members to "refrain from engaging in personal activities which would injure or take advantage of the organization or are in any way contrary to the interests of the corporation." While the staff member added that this statement in the bylaw addressed potential conflict of interest, it did not identify situations that constituted conflict of interest and steps the OPO would take to address any potential conflict of interest. |
| Z0261 | QUALIFICATIONS CFR(s): 486.36(a)(3) The OPO must have credentialing records for physicians and other practitioners who routinely recover organs in hospitals under contract or arrangement with the OPO and ensure that all physicians and other practitioners who recover organs in hospitals with which the OPO has agreements are qualified and trained. This STANDARD is not met as evidenced by: Based on record review and interview, the OPO did not have credentialing records to ensure that physicians and other practitioners who recover organs were qualified and trained. Finding includes: In three donation cases where organ recovery was performed by a surgeon outside of the OPO's designated service area, review of donor records revealed the lack of documentation that the surgeon's credential was verified prior to organ recovery to ensure that he or she was trained and qualified. Furthermore, during an interview on 4/01/10, a staff member stated that the OPO relied on a database made available by the AOPO (Association of Organ Procurement Organizations) in October, 2009 where OPOs can verify the credential of each surgeon prior to organ recovery. The staff member added that the database (AOPO Credentialing Information Network-ACIN ) contained credentialing information on surgeons supplied by their transplant centers on a voluntary basis. Review of an ACIN printout revealed that while the surgeon's license number and organs for which the surgeon has, accordingly, been privileged to recover were listed, the expiration date of the license and privileges was not available to ensure that credentialing information was current. |
| 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. |
| 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 was certified. Finding includes: In two of 2 donation cases after cardiac death (DCD), 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 4/01/10, an OPO staff stated that the ABO result printout from the hospital's electronic health information database did not include the name of the hospital. |
| Z0335 | ORGAN PREPARATION AND TRANSPORT CFR(s): 486.346(a) (b) The OPO must send complete documentation of donor information to the transplant center with the organ, including donor evaluation, the complete record of the donor ' s management, documentation of consent, documentation of the pronouncement of death, and documentation for determining organ quality. Two individuals, one of whom must be an OPO employee, must verify that the documentation that accompanies an organ to a transplant center is correct. This STANDARD is not met as evidenced by: Based on record review and interview, the OPO did not always send complete documentation of donor information to the transplant center; and did not ensure that two individuals verified that documentation that accompanied an organ to a transplant center was correct. Finding includes: OPO policy and procedure required that copies of donor information including ABO results, serology test results, medical and social history, donor evaluation and records of donor management, consent forms, copy of death pronouncement, as well as documentation of organ quality were sent with the organ to the transplant center. The policy and procedure also required that two individuals one of whom was an OPO employee verified that the documentation was correct. In one of 8 donation cases where 4 organs (heart, liver, and both kidneys) were recovered, review of the donor record revealed that while labels ("toe tags") were completed for the heart and right kidney (and copies of which were attached to the label verification form in the donor record), evidence that labels were completed for the left kidney and liver was not available. Review of documentation by an OPO staff on the label verification form revealed that while "both organs were released (to the transplant surgeon/transplant center) on ice cooler;" and that the "toe tag was placed on organs and donor chart attached to the ice cooler," further review did not identify the documents sent with the organ or that two individuals verified that the documentation was correct. During an interview on 3/31/10, another OPO staff stated that labels were completed for each organ recovered and that all required documentation outlined in the policy and procedure were sent with the organ even if the organ was transported from one operating room to another. |