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 01P001 (X3) Date Survey Completed 03/29/2018
Name of Provider or Supplier Legacy Of Hope Street Address, City, State 516 20th Street South, Birmingham, AL
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)
Z0200 COMPONENTS OF A QAPI PROGRAM
CFR(s): 486.348(a)

The OPO's QAPI program must include objective measures to evaluate and demonstrate improved performance with regard to OPO activities, such as hospital development, designated requestor training, donor management, timeliness of on-site response to hospital referrals, consent practices, organ recovery and placement, and organ packaging and transport. The OPO must take actions that result in performance improvements and track performance to ensure that improvements are sustained.


This STANDARD is not met as evidenced by:
Based on document review and staff interview, the Organ Procurement Organization (OPO) failed to include measures to evaluate and improve 1) the timeliness of on-site response to hospital referrals and 2) delays in completing chart audits required prior to tissue donation processing. The findings include: Cross Refer: Z121 1) The OPO's "Responding to a Potential Donor" policy, dated 12/5/14, did not address or specify a timeframe for staff arrival at the hospital. Review of Appendix A of the QAPI Plan revealed that "Timely Response" was one of the indicators being monitored. The percent of time the response was timely for 2017 was listed as 99.55% of the time. During an interview on 3/29/18 at 10:00 A.M., the Clinical Director stated after a Donor referral was made, OPO staff onsite arrival time was not tracked or monitored because there was no policy in place. During an interview on 3/29/18 at 12:00 P.M., the Director of Quality Management (DQM) stated that the 99.55% figure noted in the QAPI Plan Appendix A, regarding timely response, was in reference to how often the Family Support Coordinator (FSC) met the requirement to call the hospital within an hour of the referral. She said that the QAPI Plan did not include any measures to determine how timely the onsite response was. 2) The OPO's Complaint Log revealed that they received a complaint in March 2018 from their Tissue Processing partner regarding delays in receiving Tissue Donor charts, which resulted in tissue processing delays. The Complaint Log revealed that 60+ (over 60) charts were late in being audited and that this resulted in tissue processing delays of 90+ (over 90) days. The Complaint Log also revealed that the auditing delays were due to a lack of staff. During an interview on 3/29/18 at 12:00 P.M., the Director of Quality Management (DQM) revealed that the OPO had staffing issues at the time of the above complaint and the lack of sufficient staff caused the delay. She acknowledged that while the OPO did take actions to improve the timeframe; these improvements were not implemented proactively. When the complaint was received the turnaround time was at least 90 days. The DQM stated the implemented improvements had reduced this time to 45 days but said staffing continued to be an issue and was being addressed. She added that at full staffing, prior to the complaint, turnaround time for these chart audits had been 23 days. Review of the document entitled, "Quality Assessment and Performance Plan for the (name of OPO)," dated 1/22/18, revealed the following, "The (name of OPO) will establish annually through it's strategic planning process, key performance measures and targets that will be incorporated in Appendix A Quality Assessment and Performance Improvement (QAPI) Goals of the QAPI Plan". Further review of the QAPI Plan Appendix A revealed that the number of complaints from Tissue Processing partner was one of the indicators monitored. The number of complaints from Tissue Processing partner for 2017 was five (5). However, there were no indicators regarding timeliness of Tissue Donor record quality audits or delays in sending Tissue Donor records and tissues for processing.