Specialty Pharmacies Can Streamline the Auditing Process with the Proper Tool

A universal planning tool could help bridge the gap between quality programs and compliance programs.

For health-system specialty pharmacies, one of the problems with making the leap from an internal quality program to an external compliance program is that there are no universally available tools or processes for health-system specialty pharmacies to maintain compliance.

At Tuesday’s session Improving Health-System Specialty Pharmacy One Audit at a Time, attendees saw firsthand the results from a team that developed a tool to do just that. The tool uses 16 key components to measure the effectiveness of a health-system specialty pharmacy program.

Lisa Kumor, accreditation and residency coordinator of specialty pharmacy services at the University of Illinois Hospital and Health Sciences System, said a quality program includes metric identification and tracking, the establishment of measurable goals, and the design of quality improvement initiatives.

She defined a compliance program as a system of processes, polices, procedures, and controls that ensure compliance with all applicable rules, regulations, contracts and policies governing the actions of the organization. Kumor said health-system specialty pharmacy systems need both quality and compliance programs, and using a designated tool can help bridge the gap from one to the other.

“We have all of these stakeholders we need to answer to who require data to be recorded at various frequencies to remain in good standing with their organization,” she said. “So we need a quality process in place to produce these metrics as well as an ongoing compliance process for performance management. What our group quickly realized is that we don’t have a universally available tool to help us maintain this process along the way.”

The 16 compliance elements included in the team’s auditing tool cover five main categories: human resources, patient management, operations, patient experience, and regulatory and quality.

Rushabh Shah, systems director for specialty and home delivery pharmacy at UNC Health, said one of the most important best practices he learned while developing the tool was the need for preparation and communication with those who will be reviewing the health system.

“If you have a huge health system or you have affiliates that have been partnered with your health system, you want to make sure that you have appropriate documentation ahead of time,” he said. “I would highly recommend you talk to your reviewer ahead of time. They’re very flexible, they’re very understanding. I would highly recommend that you be very upfront and transparent with your reviewers.”

Highlighting the patient management process, Elizabeth Rightmeier, manager of quality and accreditation for specialty pharmacy with the University of Rochester Medical Center, said one of the most important aspects of patient care documentation is to simply keep it feasible.

“We started out using an accreditation template and quickly had to shorten the list of items to audit, based on that which we actually have direct control over,” she said. “The other thing is to limit the number of records to audit once someone is compliant, so if it’s confirmed in the first year upon hiring that someone is compliant, then we’ll reduce the number.”

Rebecca Nugent, clinical lead for operations and specialty pharmacy at Nationwide Children’s Hospital, said she learned a similar lesson about shipment tracking and testing. She said it’s best to just keep it simple.

“When Children’s Hospital was first accredited in our quality meetings, we actually reviewed every single medication event that occurred over the quarter in detail,” she said. “However, as we grew, this became burdensome and less meaningful. Now the quality committee just looks at trends. We may highlight a few key events where there was an action taken or a change that occurred, but this has been much more meaningful to our specialty pharmacy.”