Transplant Adverse Events and Thorough Analysis UNOS Region 5 Collaborative Anne Gabriel, RN, BSN, CCTC, CPHQ, CMQ/OE March 15, 2017 I want to thank John and Marlene for once again organizing this collaborative session that brings the OPO world and the transplant world together. This meeting over the years has given all of us some understanding and insight into how the other half lives, and supported the collaboration between us. So thank you. I’m going to talk about one of the aspects that CMS has asked all transplant centers to incorporate into their QAPI process and the one that may be most challenging to understand and comply with. As far back as 2011, CMS expanded on the condition of participation for transplant centers which said centers are required to have QAPI programs. At first, they didn’t outline what that program would look like, but they started a pilot survey to look at centers and see what they had in place. Within a couple of years, CMS offered a much more detailed outline of what they consider to be a comprehensive QAPI program and expanded their pilot program. About this time, after the SRTR hadn’t released program outcomes for several cycles, they released several all at once.

Transplant Adverse Event Policy A transplant center policy must address: Establishment and implementation of policies about how to review AEs Identification, reporting, analysis, and prevention of AEs Thorough analysis process of any adverse event How the analysis will be used to effect change Some of us, although in general we had a good idea of how are program’s were doing, we’re suprised to see what our outcomes actually were. About this time, CMS stepped in with the QAPI surveys and made it clear to the transplant community that the purpose of the QAPI surveys would be to review programs with less than expected outcomes to ensure that these programs had a plan in place to measure their processes and performance, and to take action if the measures indicated a need. CMS became very prescriptive about what they wanted in a solid QAPI progam, and what they were looking for. Most of the what they are looking for is pretty straightforward and geared toward programs identifying problems or issues, putting action into place to fix or improve those issues, and measuring and sustaining those improvements. The part of the plan that many centers struggle with is how to identify a certain segment of their issues, those CMS calls transplant adverse events. 1

What is a Transplant Adverse Event? Unanticipated death or serious injury Serious complications or death caused by living donation Transplantation of organs by mismatched blood types Unintended transmission of infectious disease to a recipient An event with potential to cause harm Source: 42 CFR 482.70 CMS has a minimum definition of an adverse event as you can see here on this slide; what you have outlined in your QAPI plan can be more comprehensive or more detailed. What your center calls transplant adverse events is part of your transplant QAPI plan and transplant adverse events should be integrated into the hospital’s quality plan Its important to remember that CMS considers transplant adverse events to be events occurring in any phase of transplant This slide lists Unanticipated death. Key is unanticipated. SO you wouldn’t necessarily consider the death of a patient on the waitlist to be unanticipated, and therefore not an adverse event requiring further analysis. Any living donor event, because this is a healthy individual, such as need for a blood transfusion or a hospital stay extended a day or two beyond your center’s average, could be considered an adverse event Unintentional transplant of mismatched blood types, transmission of infectious disease, and then the broad catch all of everything else, basically, the potential to cause harm. Such as, 1

What is a Transplant Adverse Event? An Event with Potential to Cause Harm Operative complications Event requiring higher level of care Readmissions Graft failure Patient death Medication Errors Falls Lab errors or delays Infections Returns to the OR Rejections Returns to the OR falls Infections Operative complications Etc Our catch all includes anything we report to the Patient Safety Portal requires thorough review Source: 42 CFR 482.70 3

Transplant Adverse Event/Patient Safety Process Identification Staff reporting Triggers (data) Events reporting systems QAPI meetings Investigation/Analysis Thorough Analysis by Transplant Quality Case Review by Transplant Quality RCA by Transplant Quality & Hospital Patient Safety Preventative Actions New or revised policies or procedures New or revised protocols or processes Staff training/education So what CMS is looking for, first of all, is that you have it spelled out as to what is an adverse event. Once an adverse event is identified, there must be a process in place for how it will be handled. Staff reporting. Mr. Jones came to clinic this week with a fever and infection. He was transplanted the same day as Mr. Jones and he has the same would infection. Triggers – Anything in your center’s definition could be a trigger – for instance, something you need to report to the Patient Safety portal. Mislabelled kidney for insytance. Event reporting system – we have Midas, and have any patient flagged so that when we get the monthly report, any occurrence to a transplant patient will come to out attention. QAPI meetings – this is where we might pick up readmissions about our target, and need to look into readmissions further Investigation and Analysis may take several different forms as well – the transplant quality team case review, thorough analysis led by the quality team but expanded to include members of the team, escalated or addressed by hospital patient safety Following the analysis, a determination will be made of what action needs to be taken or none. An action plan would be put into place, measures to ensure the plan is working, and tracking to make sure the improvement takes place and sustained. 4

Thorough Analysis Find the cause Understand the cause Find all potential issues Review previous incidents to look for trends To prevent future recurrences investigation To identify areas for improvement Not all transplant adverse events rise to the level of thouough analysis, but a review of all identified adverse events should take place to determine whether a thorough analysis is needed. At our center, the Quality Team does the intial review of all reported events to determine if they rise to the level of needing a thorough analysis. The purpose of the thorough analysis is to take a deep dive into the occurrence to find the cause, understand it, identify ways to prevent or improve. Once we identify that an occurrence needs a thorough analysis, we present it to the transplant team or appropriate area for that to take place. At our center, this happens in several different venues. The quality team reviews all of the Midas reports monthly. These include such things as patients extubating themselves, and could be one time occurences, the unit reviewed it and no further action was taken. We do track and trend these occurences though, so we could follow up if it’s a continuing problem. In another example, an ad hoc meeting may be called for an unexpected patient death at or very soon after transplant. This would involve a thorough analysis and require involvement of any team member who was involved. But a death in the first year might not be reviewed until the next M and M meeting. Something like the potentially contaminated flush solution requires a timely review of the situation, but may not rise to the level of a thorough investigation. 1

Thorough Analysis What happened? When? Where? Who was involved? What equipment or technology was involved What policies, procedures or processes were involved? Was it preventable? Is there a risk of harm to others? Any multi-disciplinary team member can and should be involved: coordinators, social workers, surgeons, etc. Representatives from other areas are necessary to include. If its an infection issue, The ID physician and the unit nurse, mambe the infection control nurse. We systematically review the issue, asking the above questions. Sometimes, after the first what happened, and you begin to ask the 5 whys, the other information falls into place. It is very important to document this exercise, using a template of some type helps. It guides you through the process of conducting the thorough analysis, and you can attach your action plan. CMS will not look at or “grade” the issues you have identified, but they will look to see that there is evidence of thorough analysis and follow through. 9

Thorough Analysis - Contributing Factors Comments Human Factors Environment Equipment Policies Procedures Organizational Its important to look at contributing factors, to get to the bottom of what happened without assigning blame. 5

Preventative Actions – Make a Plan Human factors – is more training needed? Environment – are safety measures in place? Equipment – is it old or malfunctioning Policies and procedures – are they followed or do they need updated? Organizational – does reporting between departments need to be reexamined? Your action plan following the thorough analysis should be evident. Will you change a policy? How will you educate the staff to the policy change? How will you document that the team has been educated? 1

Follow Up Activities •Follow up and monitor actions – most often overlooked aspect of the process •Define the timeframes for when an action will be followed up to determine improvement •Sustain improvement to lead to improved patient outcomes And finally, there must be evidence that you have measures in place to evaluate improvements – If you said you are going to change the discharge teaching with a goal of decreasing readmissions, be able to show evidence of how and when the teaching was changed, and measure the change in readmissions following the new teaching process. Continue to measure and review, make adjustments if necessary to achieve improvements, and continue to measure to encsure the improvements are sustained. 8

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