| 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) |
| Z0227 | ADMINISTRATION AND GOVERNING BODY CFR(s): 486.324(a)(1) While an OPO may have more than one board, the OPO must have an advisory board that has both the authority described in paragraph (b) of this section and the following membership: (1) Members who represent hospital administrators, either intensive care or emergency room personnel, tissue banks, and voluntary health associations in the OPO's service area. Based on record review and interview, the organ procurement organization (OPO) failed to have one of four required members on the advisory board (tissue bank representative). The OPO advisory board membership list for 2010 identified the tissue medical director as ex-officio member. Another representative from a tissue bank was not identified on the list of members. The OPO Advisory board of directors meeting summary dated November 3, 2009 identified the tissue medical director under the category of " others present " and not as a member. The Advisory Board by laws adopted as of April 27, 2009 stated " The Advisory Board shall be comprised of Members who fulfill the regulatory requirements ..... Members who represent hospital administrators, either intensive care or emergency room personnel, tissue banks, and voluntary health associations in the OPO ' s service area. " On April 6, 2010 at 1:20 PM the director of quality systems stated that the tissue medical director is the only tissue representative (on the advisory board). During the survey exit on April 6, 2010 at 5:25 PM, the surveyor requested additional information to show that the advisory board included a member from a tissue bank. The chief executive officer, the director of quality systems, and the chief operating officer were present. A voting member representing the tissue banks was not identified. |
| Z0235 | ADMINISTRATION AND GOVERNING BODY CFR(s): 486.324(d) The OPO must have bylaws for each of its board(s) that address potential conflicts of interest, length of terms, and criteria for selecting and removing members. This STANDARD is not met as evidenced by: Based on record review and interview, the governing board by laws from April 27, 2009 to April 6, 2010 did not address criteria for removal of members. The second amended and restated bylaws dated April 27, 2009 of the governing body did not identify criteria for removal of members. On April 6, 2010 at 3:40 PM, the chief executive officer stated that the (governing) board meets five times a year, the bylaws require an annual meeting, and the expectation is that they (members) come (to the meeting). |
| Z0259 | QUALIFICATIONS CFR(s): 486.326(a)(1) The OPO must ensure that all individuals who provide services and/or supervise services, including services furnished under contract or arrangement, are qualified to provide or supervise the services. This STANDARD is not met as evidenced by: Based on record review and interview, two of ten donor staff (donor staff #6 and #9) did not meet the qualifications of their position. The position description for organ clinical supervisor (staff #9) dated March 2010 required CPTC (certified procurement coordinator) within one year of employment. A memo dated April 5, 2010 and signed by the director of organ procurement stated Staff #9 will register for her CPTC exam in June, 2010 and will take the exam immediately after returning from leave in early July, 2010. On April 6, 2010 at 3:30 PM, the director of quality services stated that Staff #9 has been in the supervisory role since August 2008. The position description for staff #6 dated July 2009 required ACLS (advanced cardiac life support) certification. Review of staff #6 employee record on March 31, 2:20 PM with the director of talent management showed that the ACLS for staff #6 expired on May 31, 2006. During an interview on April 6, 2010 at 3:05 PM, the chief operating officer confirmed that staff #6 did not have a current ACLS. |
| 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. |