| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 05P002 | (X3) Date Survey Completed 03/29/2018 |
| Name of Provider or Supplier Onelegacy | Street Address, City, State 221 S Figueroa St, Suite 500, Los Angeles, 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 conducted from March 26 - 29, 2018: |
| Z0120 | QUALIFICATIONS CFR(s): 486.326(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 interview and on one of 15 donor records reviewed, the OPO did not ensure that it had credentialing records to ensure that all physicians and other practitioners who recover organs in hospitals with which the OPO had agreements were qualified and trained. Finding includes: During an interview on 3/29/18, an organ allocation staff member (OPO Staff 1) stated that the OPO uses the ACIN (AOPO Credentials Information Network) to ascertain the credentials of physicians that recover organs on behalf of the OPO. The ACIN, which is maintained by the AOPO (Association of Organ Procurement Organizations) is an online database that enables the OPO to quickly verify the credentials and/or qualifications and training of physicians prior to organ recovery. Review of the clinical record revealed that Donor A was an organ donor on 10/12/16 and that his heart was recovered. The ACIN database noted that Physician A, the recovering physician, was credentialed to recover heart and lungs and that his status was "Active" with an approval date of 7/16/12. Further review however, revealed that while Physician A's license number was posted, the database did not include the license expiration date to ensure that it was current at the time of recovery. Further review of the clinical record revealed that Donor 2 was also a liver donor. Review of the ACIN profile which was created by another OPO indicated that Physician B, who performed the recovery, was credentialed to recover liver, kidneys, and pancreas. The profile further noted that the physician's status was "Active" and had an approval date of 7/17/17. While the physician's medical license number was posted, the expiration date however was not provided to ensure that it was current. During the same interview, OPO Staff 1 explained that the OPOs who provided the physicians' credentials on the ACIN database should have included and/or updated the information. In the same interview, another administrative staff member (OPO Staff 2) added that OPO practice was to visually inspect the physician's actual license prior to organ recovery. However, documentation of this process was not available in the donor record. |
| Z0188 | DONATION AFTER CARDIAC DEATH CFR(s): 486.344(f)(2) [If an OPO recovers organs from donors after cardiac death, the OPO must have protocols that address the following:] Withdrawal of support, including the relationship between the time of consent to donation and the withdrawal of support; This STANDARD is not met as evidenced by: Based on record review and interview, the OPO did not have DCD (donation after cardiac death) protocols that addressed withdrawal of support including the relationship between the time of consent to donation and the withdrawal of support. Finding includes: Review of the OPO's policy and procedure (111.3) on organ donation after cardiac death (DCD) revealed that during the organ donation, the "procurement team will wait in a nearby room until they are called in" to the operating room (OR) after death declaration had been made. Another policy and procedure on donation after circulatory death (13.56v9) further noted that "Members of the transplant teams are not allowed in the OR until death has been pronounced." During an interview on 3/28/18, a procurement coordinator (OPO Staff 3) stated that members of the organ recovery team are not allowed in the OR until after death declaration had been made. OPO Staff 3 added that a procurement coordinator is in the OR only to document the withdrawal of care and to complete the flow sheet (DCD Intraoperative Flow Sheet) which includes several data fields such as the extubation date/time, date/time of pronouncement of death, the name of the pronouncing physician, and the time the transplant team enters the OR after death had been declared. The OPO's DCD policy also noted that the organ procurement coordinator "will facilitate the donation process throughout the organ recovery in the hospital O.R." In a separate interview on 3/29/18, a tissue recovery staff member (OPO Staff 4) explained that one of the responsibilities of the tissue recovery coordinator (TRC) is to be in the OR during the withdrawal of care process. When asked what the TRC's role or responsibility is during the process, OPO Staff 4 stated that the TRC would just stand by, support the procurement coordinator when needed, and call in the transplant team into the OR after death had been declared. Review of both the OPO's policy and procedure mentioned above however did not outline the roles and responsibility of the tissue recovery coordinators in the OR during the withdrawal of care process and prior to death declaration. |