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 07/19/2018
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)
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 July 18, 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 July 18, 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 eight (ADAT340, ADB1495, ADEJ027, AEBR051, AEG4220, AFBI199, AFDB202, and AFF0249) of twelve randomly selected donor records from January 2016 to June 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 ADAT340, OPO donor records indicated that on January 23, 2016 the OPO recovered a liver using a physician from outside the OPO's DSA. For ADB1495, OPO donor records indicated that on February 28, 2016 the OPO recovered a heart using a physician from outside the OPO's DSA. For ADEJ027, OPO donor records indicated that on May 11, 2016 the OPO recovered a liver using a physician from outside the OPO's DSA. For AEBR051, OPO donor records indicated that on February 19, 2017 the OPO recovered a liver using a physician from outside the OPO's DSA. For AEG4220, OPO donor records indicated that on August 2, 2017 the OPO recovered kidneys and a heart using a physician from outside the OPO's DSA. For AFBI199, OPO donor records indicated that on February 12, 2018 the OPO recovered a heart, kidneys, and a liver using physicians from outside the OPO's DSA. For AFDB202, OPO donor records indicated that on April 4, 2018 the OPO recovered a liver using a physician from outside the OPO's DSA. For AFF0249, OPO donor records indicated that on June 15, 2018 the OPO recovered kidneys using a physician from outside the OPO's DSA.