| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 04P001 | (X3) Date Survey Completed 05/06/2010 |
| Name of Provider or Supplier Arkansas Organ Recovery Agency | Street Address, City, State 1701 Aldersgate Road, Suite 4, Little Rock, AR | |
| 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) |
| 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, the Organ Procurement Organization (OPO) failed to ensure it followed the bylaws requirement for the Advisory Board to meet as a whole and establish a quorum for the transaction of business for the years 2007, 2008, and 2009, as evidenced by: Review revealed the Advisory Board had a membership of 12 members. A review of the bylaws revealed that a quorum was half of the membership. A review of the minutes for 2007 revealed the Advisory Board met 4 times: 1/29/07, 4/30/07, 7/30/07, and 10/29/07. The Advisory Board did not meet as one board and establish a quorum for business transactions in 2007. A review of the Advisory Board minutes for 2008 revealed that the Advisory Board met 2 times: 2/27/08 and 9/9/08. The Advisory Board did not meet as a whole board and establish a quorum for business transactions in 2008. A review of the minutes for the Advisory Board minutes for 2009 revealed the Advisory Board met 2 times: 4/14/09 and 10/6/09. The Advisory Board did not meet as a whole board and establish a quorum for business transacitions in 2009. |
| 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 the OPO (Organ Procurement Organization) did not ensure the credentials were verified for 4 physicians who recovered organs in 4 of 8 donor records reviewed. A review of the OPO policy entitled "Operating Room Procedures For Organ and Recovery" stated: "The Arkansas Regional Organ Recovery Agency will ensure that any visiting recovery personnel is credentialed to perform the recovery of the specific organ. This will be accomplished by referencing the AOPO online AOPO Cedentialls Information Network (ACIN) database." 1. A review of donor record #5 revealed Dr. A recovered the heart. A review of the credential files revealed the OPO did not have credentials for Dr.A. 2. A review of donor record #4 revealed Dr. B. recovered Pancreas/Intestines/Liver. A review of the credential files revealed the OPO did not have confirmation of verification of credentials for the physician. 3. A review of donor record #3 revealed Dr. C. recovered the heart. A review of the credential files revealed the OPO did not have confirmation of verification of credentials for the physician. 4. A review of donor record #7 revealed Dr. D recovered the liver. A review of the credential files revealed the OPO did not have confirmation of verification of credentials for the physician. |
| Z0306 | REQUESTING CONSENT CFR(s): 486.342(a) An OPO must have a written protocol to ensure that, in the absence of a donor document, the individual(s) responsible for making the donation decision are informed of their options to donate organs or tissues (when the OPO is making a request for tissues) or to decline to donate. The OPO must provide to the individual(s) responsible for making the donation decision, at a minimum, the following: (1) A list of the organs and/or tissues that may be recovered. (2) The most likely uses for the donated organs or tissues. (3) A description of the screening and recovery processes. (4) Information about the organizations that will recover, process, and distribute the tissue. (5) Information regarding access to and release of the donor's medical records. (6) An explanation of the impact the donation process will have on burial arrangements and the appearance of the donor's body. (7) Contact information for individual(s) with questions or concerns. (8) A copy of the signed consent form if a donation is made. This STANDARD is not met as evidenced by: Based on record review and interview the Organ Procurement Organization (OPO) did not have a written protocol for and did not provide the individuals responsible for making the donation decision information regarding access to and release of the donor's medical records for donor records #1 - 8. Record review revealed the next of kin consent form did not include information regarding access to and release of the donor's medical records. Interview with the Director of Clinical Services on 5/5/10 at 2:00 PM revealed that there was no written policy nor did the OPO make the next of kin aware of information regarding access to and release of the donor's medical records. |
| Z0313 | POTENTIAL DONOR EVALUATION CFR(s): 486.344(b)(2) [The OPO must do the following:] (2) Determine whether there are conditions that may influence donor acceptance. Based on record review and interview the Organ Procurement Organization (OPO) did not ensure their policies specified elimination criteria for possible donors. The policy entitled: "The Evaluation and Management of Potential Deceased Organ and Tissue Donors" did not include information for how the OPO staff would determine conditions that would influence donor acceptance and did not include information on whether or not there were conditions that might result in preliminary exclusion criteria. During an interview at 2:30 PM on 5/5/10 the Organ Procurement Manager stated the OPO policy does not specify elimination criteria because when United Network for Organ Sharing policy updates occur the OPO would have to change its written criteria also. |
| Z0340 | DEATH RECORD REVIEWS CFR(s): 486.348(b) (b) Standard: Death record reviews. As part of its ongoing QAPI efforts, an OPO must conduct at least monthly death record reviews in every Medicare and Medicaid participating hospital in its service area that has a Level I or Level II trauma center or 150 or more beds, a ventilator, and an intensive care unit (unless the hospital has a waiver to work with another OPO), with the exception of psychiatric and rehabilitation hospitals. When missed opportunities for donation are identified, the OPO must implement actions to improve performance. This STANDARD is not met as evidenced by: Based on interview and record review the Organ Procurement Organization (OPO) failed to ensure its death record review policy specified the components that should be included in the review and the timeframes for summarization of reviews to the hospitals and to the OPO Quality Assessment and Performance Improvement (QAPI) committee. The OPO policy entitled: "Hospital Development Programs Potential Donor Assessment Compliance Policy" did not include information on how recommendations are reported, acted upon and followed up. During interview on 5/5/10 at 2:00 PM the Director of Clinical Services verified the OPO did not have written policies for the timeframes for summarization of the medical record reviews and submission to the QAPI committee. |