When it comes to meeting accreditation standards, it’s more about the showing and less about the telling, experts tell The URAC Report.
The accreditation bar is set high for specialty pharmacies, as they should be to promote appropriate patient management, notes Heather Bonome, PharmD, director of pharmacy at URAC. “The standards are rigorous but that’s important because pharmacies provide so many critical patient services,” Bonome says. She and colleague Jennifer Richards, PharmD, JD, and a pharmacy accreditation reviewer at URAC, recently presented results of their survey of 10 URAC reviewers offering insights on challenges and ideas for those seeking accreditation in the complex world of specialty pharmacies at the Asembia Specialty Pharmacy Summit 2018.
It often comes down to tangible evidence and a clear trail of documentation. Many accreditation applicants “are doing the work [already], but they don’t properly document” their efforts, Bonome says.
That’s a problem. FDA and other regulatory bodies tend to take the approach “if it isn’t documented, it didn’t happen,” says Mark Snapp, a URAC pharmacy accreditation reviewer. “That really rings true in our job,” he says. “I can believe that they are doing things, but if there’s documentation, I have evidence that the tasks were completed.”
URAC accreditation offers rigorous, evidence-based standards, thought leadership, independent validation of quality, and a platform for continuous quality improvement. These values are clear to many industry players, evidenced in part by the pace of accreditation. There were just over 100 accredited entities in 2013 compared with nearly 600 so far in 2018.
However, there are some accreditation requirements that seem to come up again and again, Bonome says. “The same issues keep bubbling up, such as failure to maintain documentation of primary source verification of a new hire’s clinical license.”
In too many instances, for example, applicants don’t complete primary source verification (PSV) before the employee begins work. “They’ll do it on their first day of work, as opposed to knowing that their license is active and complete before allowing access to medication and patient information,” Snapp says. “That’s one of the most common problems I observe,” he adds. “They may complete the PSV eventually, but not in a manner that meets the intent of the standard.”
Another example: Many organizations rely heavily on accreditation consultants to manage the accreditation process for them. Too often that means the organizations end up not “owning their performance and processes,” Richards says. While the consultant input can be valuable, it should not be used in a vacuum.
“Don’t just take a template from a consultant” and rely on it as a cookie-cutter policy, Snapp echoes. “If you don’t participate in the creation of the policy and put your own stamp on it, you’re going to have a difficult time showing compliance and follow-through.”
Based on reviewer input from Bonome and Richards, accreditation applicants in the Desktop Review phase of the accreditation, tend to struggle most with documentation of quality improvement projects, telephone metrics, and cold chain management.
During the onsite Validation Review phase of the accreditation process, the experts cited human resources documentation and patient assessment documentation as two of the most common missed elements in an accreditation review.
Richards advises applicants to take advantage of reviewers by asking them more questions, “I guarantee you will learn something.”
“Reviewers can educate them about best practices” and common pitfalls to avoid, Richards adds. The number of URAC reviewers has grown from three to 10 in the past few years and that makes it even easier for reviewers to provide ample time and expertise. “They are there to help,” she adds.
The reviewers interviewed by URAC said “clear overall PnP” was the most important attribute contributing to accreditation success. Attending a URAC workshop or webinar was ranked second, with having clear processes for clinical documentation, and senior leadership support following closely.