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 05/03/2018
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)
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 OPO personnel interview and donor record review on May 1, 2018, the OPO failed to ensure that it had credentialing records to ensure that all physicians and other practitioners who recovered organs in hospitals with which the OPO had agreements were qualified and trained. Findings included:



a.
During an interview on May 1, 2018, OPO personnel stated that the OPO used the ACIN (AOPO Credentials Information Network) to establish the credentials of physicians who originated from outside the OPO's designated service area (DSA) that recovered organs on the OPO's behalf. The ACIN, an online database maintained by the AOPO (Association of Organ Procurement Organizations), enables OPO's to verify the credentials and/or qualifications and training of physicians prior to organ recovery. However, although ACIN information includes which organ(s) any given physician is credentialed to recover and the physician's license number, the ACIN does not include the expiration date of the physician's license to ensure that the license is current at the time of organ recovery.



b.
For five (ADJN349, ADJ4078, AEJP272, AFAU368, and AFDN386) of twelve randomly selected donor records from January 2016 to April 2018, the OPO used the ACIN to establish the credentials of physicians who originated outside the OPO's DSA, and did not verify whether these physicians had valid licenses at the time of organ recovery. For ADJN349, OPO donor records indicated that on October 16, 2016 the OPO recovered kidneys using a physician from outside the OPO's DSA. For ADJ4078, OPO donor records indicated that on November 1, 2016 the OPO recovered kidneys using a physician from outside the OPO's DSA. For AEJP272, OPO donor records indicated that on October 19, 2017 the OPO recovered a liver and pancreas using a physician from outside the OPO's DSA. For AFAU368, OPO donor records indicated that on January 22, 2018 the OPO recovered a heart using a physician from outside the OPO's DSA. For AFDN386, OPO donor records indicated that on April 16, 2018 the OPO recovered a liver using a physician from outside the OPO's DSA.