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 05P001 (X3) Date Survey Completed 03/17/2022
Name of Provider or Supplier Lifesharing Street Address, City, State 7436 Mission Valley Road, San Diego, 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)
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 medical record review, policy review and interview, the Organ Procurement Organization (OPO) staff failed to show documentation that all Recovery Surgeon's (RS) credentials were valid prior to organ recovery. Of the 12 Donor records reviewed, there were 26 RSs that had to be verified as having valid credentials prior to organ recovery. The documentation for one of the 26 RSs in two records was deficient. Finding includes: Review of the OPO's, "Pre-Recovery Verification Form," effective date 03/13/19, located in the EMR scanned documents for DCD4 revealed RS5 was listed on the OPO's "Pre-Recovery Verification Form," as the RS for the heart and lungs. RS5 was also listed as the lung RS for DCD4 in the EMR under the team tab. There were no ACIN credentials listing for RS5 in the EMR. A paper chart was provided and reviewed with the Organ Quality Supervisor (OQS) and the Lead Surgical Coordinator (LSC). It was confirmed that there was no ACIN search listed in the medical record prior to recovery of DCD4's organs. A review of the OPO's policy, Surgical Coordinators' Responsibilities in the Operating Room," Document Number: ORCL-029, effective date 10/07/19 states, "Print the documents needed to review case with donor hospital OR staff and transplant Recovery Surgeons. This will include at least: ...Surgeon credentialing document: Access the ACIN database to print verification of Recovery Surgeon credentials prior to organ recovery." The OPO's policy, "Recovery Surgeon Credentialing and Responsibilities," Document Number: ORCL-001, effective date 04/20/21 revealed that the OPO's policies did not address verifying credentialing for RSs who come in to recover organs from outside the OPO's Designated Service Area (DSA). In an interview on 03/17/22 at 2:15 PM, it was verified that RS4, RS5, and RS6 were listed as the primary RSs for lungs, heart and lungs, and kidney, liver, and pancreas respectively and confirmed in the Digital Donor electronic record system. RS5 had no ACIN credential listing in the medical record at all including a paper chart. This deficiency was identified in the OPO's reapproval survey completed 04/11/18. The OQS explained that he/she remembers getting a letter from AOPO stating that they acknowledge the opportunity for process improvement and would enhance a feature in their system to document the expiration date of recovery personal and practitioners. The corrections implemented for this deficiency in the 04/11/18 Reapproval survey have not been sustained.