| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 05P002 | (X3) Date Survey Completed 03/19/2010 |
| Name of Provider or Supplier Onelegacy | Street Address, City, State 221 S Figueroa St, Suite 500, Los Angeles, 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) |
| 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 organ procurement organization advisory board bylaws did not address potential conflicts of interest for the bylaws amended 2/09/2010. Finding includes: Review on 3/17/10 of the written bylaws of the OPO's advisory board amended on 2/09/10 did not include a provision for identifying and addressing potential conflicts of interest for advisory board members. During an interview on 3/18/10, an OPO staff member stated that while the OPO had a policy on conflict of interest, the advisory board bylaws however did not include a provision for identifying potential conflicts of interest and how these could be addressed for members of the advisory board. |
| Z0262 | STAFFING CFR(s): 486.326(b)(1) The OPO must provide sufficient coverage, either by its own staff or under contract or arrangement, to assure both that hospital referral calls are screened for donor potential and that potential donors are evaluated for medical suitability for organ and/or tissue donation in a timely manner. This STANDARD is not met as evidenced by: Based on record review and interview, the OPO did not ensure that onsite evaluation of a potential donor was conducted within 1 - 2 hours as required by policies and procedures. Findings include: 1. On 3/17/10 at 3:40 p.m. a record review of Donor 6 Referral Information revealed that a referral was made on 1/08/08 at 12:00 p.m. and the OPO arrived on 1/08/08 at 2:45 p.m. for a response time of 2 hours and 45 minutes. 2. On 3/17/2010 at 4:05 p.m., a record review of Donor 2 Referral Information notes that a referral was made on 1/14/2007 at 4:24 p.m. and the OPO arrived at 6:45 p.m. for a response time of 2 hours and 25 minutes. Review of the OPO's policy and procedure on "Response to Referrals" required that "on site response to a referral is expected within 1 to 2 hours. If a delayed response is expected, the AOC (administrator on-call) and hospital will be notified." During an interview on 3/17/10, an OPO staff stated that any delay response was also documented in the donor record including case notes by the staff assigned to conduct the onsite evaluation. Review of the donor records however did not reveal any such documentation; or that the AOC and the hospital were informed. |
| Z0307 | REQUESTING CONSENT CFR(s): 486.342(b) If an OPO does not request consent to donation because a potential donor consented to donation before his or her death in a manner that satisfied applicable State law requirements in the potential donor's State of residence, the OPO must provide information about the donation to the family of the potential donor, as requested. This STANDARD is not met as evidenced by: Based on record review and interview, the OPO did not ensure that information about donation was given to the family of a potential donor who had, prior to his or her death, given consent to donation. Finding includes: Review of two of 2 records of donors who had first-person consent revealed the lack of evidence that their family was given information regarding donation. During an interview on 3/17/10, an OPO staff member stated that the same information was given to family members of potential donors whether or not a first-person consent was executed. The staff member added that the "Document of Gift" form as well as a "supplemental" form should also indicate that information was given, and that by signing both forms, the family member acknowledges receipt of the information. The staff also stated that case notes should also document that donation information was given to the family member. Review of the "Document of Life" form revealed that in addition to verification of donor registry, the form also documented family notification of the presence of first-person consent. And while the "supplemental" form contains a provision that when checked "yes" authorizes the OPO to contact the family member and "my family by mail, phone, or voice message in order to provide support, education and outreach," there was no documentation about what information regarding donation was provided. (Reference Donors 7 and 16.) |
| Z0319 | TESTING CFR(s): 486.344(c)(3) [The OPO must do the following:] (3) Ensure that the potential donor's blood is typed using two separate blood samples. This STANDARD is not met as evidenced by: Based on record review, and interview, the OPO could not demonstrate that two separate blood samples were typed for 3 of 18 donor cases sampled (Donors 5, 9, and 14). Findings include: 1. Donor 5's donor form documented recovery of heart, liver, kidneys, and pancreas on 3/08/08. A computer screen print out with Donor 5's blood type did not identify the testing laboratory, the date and time the blood sample was drawn, and the source of the computer screen print out. 2. Donor 14's operative summary documented recovery of kidney, adrenal, liver and spleen on 10/14/08. A computer screen print out with Donor 14's blood type did not identify the testing laboratory, the date and time the blood sample was drawn, and the source of the computer screen print out. 3. Review of Donor 9's record revealed an ABO report from the National Institute of Transplantation dated 8/3/06 of an "O Positive" result. While another report dated 7/30/06 indicated an ABO result of "O Positive" and identified the patient's name, date of birth, sex, medical record, case number and location code, it did not however identify the name of the hospital or of the testing laboratory. In an interview on 3/18/10, the administrative staff stated that they were aware of the hospital's identity where the lab result came from but that the print out from the hospital does not include the hospital's name. The OPO policy titled "UNOS ABO Confirmation Policy" dated 11/3/2009 stated that "(name of OPO) is responsible for the verification of two separate ABO/Rh blood type determinations from two separate laboratories on deceased donors prior to running a match -run for organ allocation and surgical incision. .... PTC will enter the donor's ABO from the hospital's source document into UNet (first verification)." |
| Z0342 | ADVERSE EVENTS CFR(s): 486.348(c)(2) (2) The OPO must conduct a thorough analysis of any adverse event and must use the analysis to affect changes in the OPO ' s policies and practices to prevent repeat incidents. This STANDARD is not met as evidenced by: Based on record reviews and staff interviews, the OPO failed to conduct a thorough analysis of an adverse event. This failed practice has the potential of repeat incidents and does not allow the opportunity to affect corrective change to policy and practices. This occurrence was found in one of eighteen sampled donor records reviewed. Finding includes: On 3/17/10 at 9:15 a.m., a record review of Donor 2's progress notes dated 1/18/07 at 8:00 a.m., 10:00 a.m., and 10:00 p.m., stated that the surgeon from a local transplant hospital called to inform the OPO that they had received the right kidney instead of the left kidney that was requested. No adverse event documentation of the incident was found in the donor record as per the OPO policies QS07.08v2, QS07.10v2 and QS07.13v2. On 3/18/10 at 2:52 p.m., in an interview with a quality improvement staff, when questioned about the adverse event, she stated that an investigation of the event was in progress and no adverse event documentation was found regarding the kidney mix-up. The investigation had determined that the person who wrote the note about the kidney mix-up was no longer working at the OPO as of a month ago. On 3/18/10 at 3:05 p.m., in an interview with another quality improvement staff, she stated that a review of the OPO records and Donor Net records showed that the correct organs went to the transplant centers that the organs were initially intended to be delivered and that the organs were transplanted. She stated that no documentation was available to explain how the mix-up occurred. The staff added that she would write a summary that would explain the event from available documentation. On 3/18/10 at 4:45 p.m. in an interview with the quality improvement staff, she stated that the courier service confirmed that the right and left kidneys went to the correct transplant centers. She stated that there was a problem with the packaging. She said that the local transplant center transplanted the correct kidney and that another transplant center was supposed to get the left kidney. |