95% USP Adherence at Ascension Is a Team Effort

Complying with compounding guidance is an onerous task for any institution, but rolling out a standardized compounding compliance program across 146 health systems and achieving 95% adherence is Herculean— and a feat that Ascension can claim to have achieved.

According to Shewan Aziz, RPh, PhD, the vice president of pharmacy at Ascension Texas, in Austin, the key to his facility’s success has been implementing standardized system-level guidance while also meeting the needs of individual hospitals.

The path to near-perfect USP compliance at Ascension started in 2012, when the organization created a compounding subcommittee. The committee, which consisted of compounding experts from individual Ascension hospitals, scoured existing compounding guidance documents, literature and best practices issued not only by USP but also by the National Institute for Occupational Safety and Health, the Occupational Safety and Health Administration, and state boards of pharmacy, Dr. Aziz said. Using these sources, the task force developed two Ascensionspecific guidelines: one for nonhazardous compounds and one for hazardous compounds.

The guidelines outline best practices for everything from IV room contamination management to use of compounding robotics, IV workflow systems and standardized closed system drug-transfer devices for chemotherapy, Dr. Aziz noted.

The subcommittee also created documents that include compliance tips and “pearls,” he added, and they developed standardized policies and procedures that individual hospitals could implement, as well as training and competency assessment modules they could use for their staff.

When it came to procuring funds for capital projects, the national team also provided this to each hospital, helping them design and build USP-compliant IV rooms.

To further enhance the safety of compounded drug management, the national compounding subcommittee even created auxiliary warning labels with handling instructions for all IV hazardous drug preparations, and they built in hazardous drug alerts for automated dispensing cabinets and electronic medication administration systems, Dr. Aziz said.

Finally, the team developed key performance indicators and compounding metrics to help individual hospitals ensure they are complying with the national-level guidance.

“In 2012, before we undertook this standardization initiative, we had 55% compliance with USP <797>, and that’s gone up to 95% today,” said Dr. Aziz, noting that the outlying 5% of hospitals are expected to be compliant with the Ascension compounding guidance by August 2021.

Dr. Aziz said he expected the system to be prepared for USP General Chapter <800> compliance and any additional changes that might be contained in the revised USP <795> and <797> chapters once they are finalized and made official. “Given all the work and effort that has gone on at our hospitals to adhere to our own compounding guidances, we will be ready to meet all compounding standards when the USP appeals are resolved,” Dr. Aziz explained at the ASHP 2020 Midyear Clinical Meeting and Exhibition. “Our

TJC’s Top Reasons For USP Noncompliance

The reasons for noncompliance with USP compounding standards change from year to year, ranging from inadequate competency assessments to incomplete environmental testing. But “one thing we continue to see that hasn’t changed since day one is that those responsible for compounding are not taking the time to fully review their testing certification reports,” said Robert Campbell, PharmD, the director of clinical standards interpretation for hospital and ambulatory programs at the Joint Commission, in Oakbrook Terrace, Ill.

“Too often, facilities getting the testing done do not hand the results to leadership, or pharmacy leadership takes a look at the front page of a report and does not look at the nuts and bolts of the report’s findings,” Dr. Campbell said at the ASHP 2020 Midyear Clinical Meeting and Exhibition.

Dr. Campbell pointed to several top reasons for noncompliance, including: • Personnel: a lack of competency assessments completed, a lack of didactic testing scoring and incomplete initial competency assessments. • Products: drug shortages leading to changes in compounding products that are not accompanied by necessary changes to environment and beyond-use dating, and a lack of proper labeling. • Environmental standards: incomplete testing and certification reports and improper resolution of these report results. —D.W.

see USP ADHERENCE, page 20