NOTE: The Institute for Healthcare Improvement and the National Patient Safety Foundation have designated the week of March 11-17, 2018, as Patient Safety Awareness Week. It’s an opportunity to reflect on the importance of developing a safety culture and sharing insights on specific ways to improve patient safety. Look for additional articles over the next few months discussing how UNOS’ Department of Member Quality and the OPTN/UNOS Membership and Professional Standards Committee work with members to promote a culture of safety.
OPOs that have not had a regularly scheduled site survey in a year or more may not know about a number of enhancements made to the process by UNOS’ Department of Member Quality. The changes are designed to make the survey process more time-efficient and allow surveyors to have a more thorough understanding of the OPO’s processes and potential areas of improvement.
“We’re casting a wide net and also providing more feedback” in the updated process, said Tina Rhoades, RN, B.S.N., Manager of Site Survey at UNOS. “Instead of just saying ‘here is what we found wrong,’ we’re heading in the direction of providing them more resources and more educational opportunities – not just to catch errors but to prevent errors.”
PJ Geraghty, M.B.A., CPTC, Vice President of Clinical Services at Donor Network of Arizona, noticed the shift in emphasis during his OPO’s recent review. “Of all the site visits I’ve been through, this was probably the most collegial of all of them. The surveyors were overall friendly and positive and not trying to play a ‘gotcha’ game.”
What is different now?
One major change to recent surveys is that UNOS collects and reviews case records prior to going onsite and shares with the OPO the records to be reviewed. This saves time for both surveyors and OPO staff during the onsite visit.
The advance review also allows surveyors and OPOs to identify and potentially resolve some questions or discrepancies before the on-site visit. “We will take anything we can’t verify before we come onsite and review that with the actual donor medical record, said Rebecca Smith, RN, Site Surveyor at UNOS. “That allows us to spend more time onsite talking about improvement of the issue.”
OPOs who have had recent surveys agree they are much more time-efficient. “These used to be three or four day surveys – they were done with us by about noon the second day,” said Geraghty. “They were able to review the DDRs (deceased donor registration forms) up front and come to us and say, ‘Here’s what we’re trying to find.’ “
Walt Nickels, RN, B.S.N., CCRN, CPTC, Director of Clinical Services at Arkansas Regional Organ Recovery Agency, agreed. “You get the initial letter ahead of the visit, and it helps you prepare. You can take the cases and review them in advance. Being prepared is very important. In our case there was more legwork prior to having them come on site, but the audit itself didn’t take as long as it did in the past.”
In addition, surveyors now place greater emphasis on understanding the OPO’s processes and quality management/improvement processes. This includes interviews with front-line staff and asking them to demonstrate how they walk through their protocols. “It’s been revealing,” said Smith. “Sometimes the written policies are not in line with what the front-line staff is doing. Sometimes the staff is doing great according to policy, but the policy itself needs clarification. We’ve seen some opportunities for improvement where the front-line staff are a little confused about the written policies.”
“The nice thing about the staff interviews is that they’re allowed to bring resources such as SOPs and guidelines, just like they would be able to do in real time,” said Nickels. “That way, the auditors know what they’re doing or, if not, what information they’re working from.”
“If they let us learn about their process, it helps us identify opportunities to support them,” said Rhoades. “Generally the more open the OPO is to providing information, that allows any errors to be seen in a fuller context. The goal is for them to fix the problem.”
Prompt attention to any issues identified is often a key to whether and how the Membership and Professional Standards Committee (MPSC) further evaluates the OPO. “What we present to the MPSC is a bigger package – we’re not just summarizing individual findings but information about what led to those mistakes and what you’ve done to correct them,” said Rhoades. If we know what your process issues are through honest and open interviews, then your response is going to be better. And overall, that helps give a true picture of what you’ve done to improve.”
“It’s also been an opportunity for the coordinators to realize who UNOS is,” added Smith. “Many of them hear UNOS being mentioned, but unless they’re very involved with UNOS, they may not always see the importance in knowing why we ask what we ask of their staff.”
In October 2017, UNOS implemented a new CAP (corrective action plan) checklist for OPO site surveys. The checklist is a template form outlining key elements for the OPO to use in responding to any issues identified. Member Quality staff use this checklist in reporting to the MPSC. “We’re asking them to go through and speak to everything on the checklist, even if they may not take specific actions on some issues,” said Rhoades. “It shows the thoroughness of their response.”
UNOS has also created a senior position to help ensure that site monitoring is current and consistent and aligns with OPTN obligations and the OPTN Evaluation Plan. Liz Friddell, RN, B.S.N., has been named to the position of Senior Site Surveyor for Monitoring.
Preparing for a site visit
Everyone interviewed stressed the importance of preparation for the site visit. Much of that preparation is on an ongoing basis independent of the survey itself. “Make sure your own internal standard operating procedures directly reflect OPTN policy, and make sure what your staff are doing in practice matches the policy,” said Nickels. Geraghty noted a staff member at his OPO is specifically tasked with reviewing OPTN policy and system notices and ensuring that procedures are updated accordingly.
Dan Meyer, CQA, CQT, Director of Quality and Regulatory Affairs at Donor Network of Arizona, said that in specifically preparing for a visit, he starts with reviewing OPTN policy requirements and the Evaluation Plan. “I compare our procedures against the requirements to see where there are gaps. Then I go to the staff meetings of the affected departments, and we go over what’s going to happen and what kind of questions they may get. And we review our records as well. The big things are going through what the inspectors are going to look at and verifying our procedures are up-to-date and the records are in good shape.“
Rhoades noted that once OPOs receive notification of the upcoming visit, they may seek clarification of any of the issues the review may cover. “If they need to clarify things such as, ‘Will we need computers?’ or how many coordinators we need to speak with, don’t assume anything. Today’s survey is definitely not like the one you had three years ago.”
At any time, if OPOs have questions about OPTN requirements, they can contact their regional administrator. They can also access the most recent update of the OPTN Evaluation Plan. It allows them to research how critical data such as authorization, serologies, and declaration of death will be reviewed.
Keep in mind, however, the Evaluation Plan may not address all requirements, especially if the survey is not routine and if there are potential patient safety concerns identified. For example, certifying declaration of death also involves applicable state law. In that instance, said Rhoades, “We look for a declaration of death note with the date and time of pronouncement signed by the person(s) required under the relevant state law. At times, we may ask to review a donor hospital’s written policy for pronouncement of death if the state law is not prescriptive. We’re not routinely reviewing the clinical determination. But if we identify something of concern, such as documentation of brain stem reflexes while reviewing the declaration of death note, we would refer it to the MPSC for additional review and guidance, as we would with any identified patient safety concerns.”
Training opportunities in UNOS Connect can also keep staff up to date and help them understand requirements. Rhoades also recommended sharing effective practice information with peers in the OPO community – through visits to other facilities, listservs or conferences. “Don’t isolate yourself – things change quickly.”
Improvement is key
Rhoades said that while recent changes make the survey more efficient, the overarching goal is to help members identify and act on areas of improvement. “We’re making improvements to make it less about ‘we’re coming here and combing through everything,’ and making it a more collaborative, valuable process for them.”
OPO professionals are responding positively to this approach. “This type of review is different from what we have from others,” said Nickels. “This is working toward improvement and making sure we’re working toward improving patient safety.”
In return, site surveyors are encouraged by the response to recent surveys and the commitment of OPOs to quality management. “In general, OPOs have improved,” said Smith. “Their DDRs, their data submission, their scores have improved. There are a lot of great things going on within the OPOs themselves.”
