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 06P001 (X3) Date Survey Completed 04/06/2010
Name of Provider or Supplier Donor Alliance Street Address, City, State 200 Spruce St Suite 200, Denver, CO
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)
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 assure one of one recovery personnel was a qualified physician or other practitioner for one of thirteen donor records reviewed.

The organ procurement operative report with an operation date of October 28, 2006 for sample #9 identified the operating surgeon as staff #6.

The confidential donor form for sample #9 showed the recovery surgeon signature for heart, liver, and kidney signed by staff#6 on October 28, 2006.

The position description for staff #6 dated July 2009 stated " Recovers or assists in the recovery of cadaveric organs for (name of OPO) transplant programs. Serves as an employee of the OPO to surgically remove cadaveric organs for transplantation and research in donor hospitals ... Education and work qualifications: Bachelor ' s degree from a four year college or university required, advanced training or extensive experience in surgical removal of organs for transplant from cadaveric donors required. "

Education was documented as a bachelors in science on the employment application for staff #6.

On April 6, 2010 at 1:20 PM, the director of quality services stated that staff #6 was not a physician, not credentialed, and was a full time staff member.

On April 6, 2010 At 3:05 PM, the chief operating officer stated that staff #6 technical competencies is evaluated by surgical errors ....teaching role is to assist university fellows but no appointment as teaching faculty.

On April 6, 2010 at 3:40 PM, the chief executive officer stated that staff #6 ... came with a background in one thousand recoveries.. was hired to recover organs ... "

On April 6, 2010 during the exit with the chief executive officer, the director of quality systems, and the chief operating officer, no information was provided to identify staff #6 as a qualified practitioner or physician.