USP Compliance Remains A Focus of TJC Surveyors

Like most things in 2021, this year’s Joint Commission compounding pharmacy surveys will take a different tack, based in part on the practice pressures of COVID-19. The main developments are a continued delay in enforcement of recent updates to USP’s chapters on compounding and hazardous drug handling and a pandemic-related interim guidance for compounding pharmacies.

For pharmacies that scrambled to obtain funding to build cleanrooms and update existing segregated compounding areas (SCAs) to meet requirements for the 2019 revision of USP General Chapter <797> guidance on sterile compounding, USP’s decision to consider stakeholder appeals for more expert deliberation on the new revision was reassuring. “The organizations that were not able to get the funding for such significant projects can breathe a sigh of relief that their current setup is adequate to keep them in compliance with USP <797>,” said Susan Reed, RPh, a pharmacy consultant at Steve Hirsch and Associates, in Fountain Valley, Calif.

In contrast, organizations that had upgraded their facilities to comply with the 2019 revision will likely meet or exceed the 2008 version from a structural perspective, Ms. Reed noted during the virtual ASHP 2020 Midyear Clinical Meeting and Exhibition, while in her former role as a consultant at Joint Commission Resources Inc.

One of the more stringent rules in the 2019 USP <797> revision is a requirement that anterooms and buffer rooms be supplied with HEPA-filtered air through outlets located at the ceiling level, with returns placed low on the walls, Ms. Reed noted. In addition, unlike the 2008 revision of USP <797>, which only permits low-risk nonhazardous compounding in SCAs, the latest revision allows hazardous drug compounding in SCAs, assuming facilities are upgraded, she said.

“The two revisions address sterile product compounding differently,” Ms. Reed explained. Whereas the 2008 revision categorized sterile products by the number and type of ingredients used in the preparation, the 2019 revision still under expert review categorizes compounded sterile products by the location in which products are prepared.

USP Chapter <800>

Organizations that have geared up to comply with USP <800> can continue with early adoption and ask

r’s Jo oi in nt veys w wi ill pract ti ice c nts ar re a p pdates s to o ous dr rug dance e for o surveyors to assess their adherence to this chapter, according to Ms. Reed. She stressed, however, that they should expect scrutiny of everything from staff training and competencies to receipt of product, through to compounding preparation and appropriate use of personal protective equipment (PPE).

One detail that surveyors will want to see in place for organizations requesting assessment for USP <800> compliance is that an individual has been designated to oversee hazardous medication compounding, Ms. Reed noted. “This individual needs to ensure that staff that handle and prepare hazardous medications receive appropriate training, including [on] the appropriate use of PPE for their role,” she said.

“The individual needs to work with a multidisciplinary team to perform an assessment of risk for hazardous medications and to determine proper handling, including PPE for receipt and storage, product preparation, disposal, and decontamination and cleaning requirements,” Ms. Reed added.

USP Interim Guidance During Pandemic

USP has made exceptions to some rules during the COVID-19 pandemic. For example, to help with management of drug shortages, pharmacies may perform mediumrisk compounding in SCAs until the public health emergency is declared over, Ms. Reed noted. “However, if you’re

Technicians at Massachusetts General Hospital prepare daily compounded sterile preparations.

see TJC SURVEYORS, page 8

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following this interim guidance, make sure that when the pandemic has cleared, you return to the 2008 revision of USP <797>,” she cautioned.

Interim guidance issued by USP during the pandemic includes these other allowances: • For as long as the public health emergency continues, institutions may extend beyond-use dating for low- and medium-risk, nonhazardous compounded sterile preparations that have been prepared in an SCA to 12 hours at a controlled room temperature, or 24 hours when refrigerated (bit.ly/3958yjq). • If there are PPE shortages, organizations may conserve PPE by storing garb in a way that minimizes contamination, maintain garb within the perimeter of the SCA, or use other measures that USP has outlined (bit.ly/3165IX3). • Pandemic-era interim guidance also allows organizations to delay recertification of primary and secondary engineering controls as long as these controls are being continuously monitored, and assuming the time between certifications does not exceed 12 months. • If there is a shortage of sterile 70% isopropyl alcohol, institutions may compound the product in-house.

“USP understood that organizations have really been challenged in maintaining compounded sterile areas and coping with limited product,” Ms. Reed said, urging facilities to increase the frequency of personnel monitoring to every six months while adhering to interim guidance to ensure they are maintaining standards of performance.

With the exceptions listed, organizations need to comply with all the usual USP rules, she reminded meeting attendees. This year, surveyors will be looking to make sure: • there is standardized training in place for staff who prepare and verify compounded sterile preparations; • annual assessments for donning and doffing garb are done; • gloved fingertip sampling is performed; and • media-fill challenges and didactic assessments are conducted.

Training on Surveyors’ Radar

Surveyors will want to see that staff members who perform surface cleaning are adequately trained and have documented competency in this task, and that they clean surfaces in the correct sequence using only products approved by the organization, Ms. Reed added.

Another aspect of compounding compliance that surveyors will be placing emphasis on this year is ensuring prior certification reports have been reviewed for completeness, and that positive culture results from air and surface sampling have been addressed.

“Perhaps the most common area of noncompliance with regard to engineering controls is staff or pharmacy leadership not knowing how to read certification reports and not acting on the results,” Ms. Reed said. Remediation strategies need to be documented, and contaminated surfaces and air samples should be retested, she stressed.

Although the Joint Commission has found that organizations do a “really good job training staff and assessing their competencies, some have been challenged in documenting [such efforts],” she noted. For example, “organizations that still use paper documents in particular tend to have a problem if they group their papers by date rather than individual, because it makes it difficult to retrieve the information in a timely manner. By filing paper-based competencies by individual, all tasks completed can be found in a single record and location.”

USP Compliance at MGH

Paul Baker, PharmD, the compounding compliance coordinator at Massachusetts General Hospital, in Boston, said he and his colleagues are making sure they have all the proper documentation for compliance in place this year. This is particularly important given that some surveys are being conducted virtually, he noted, and this shifts surveyor attention away from direct observation and toward checking documents.

“We’ve gotten everything in order by conducting internal audits of our documentation pertaining to certifications, environmental monitoring, scheduled tasks, cleaning logs and other items,” Dr. Baker told Pharmacy Practice News.

Monthly Meetings

To be certain his facility is complying with USP requirements, Dr. Baker and his team hold monthly meetings to review documentation and results of reports and update standard operating procedures (SOPs). “Each of our five compounding pharmacies’ managers of record, their lead technicians, the quality compliance team and the chief pharmacy officer have a seat at the table.”

Another strategy that the team uses to increase the likelihood of full compliance with USP standards ahead of a survey is auditing reports that have been issued by vendors’ engineering control certifiers. The team is making sure this equipment is being tested to current standards and is properly calibrated, Dr. Baker said.

“For our environmental monitoring, too, we work with a third-party vendor to ensure that sampling frequency, selection of sites and media use, for example, meet or exceed the USP standard and follow SOPs,” he noted.

Mock quarterly audits, in which a member of the compliance team observes personnel to see if SOPs are being followed as written, also have been useful in identifying potential issues with compliance, Dr. Baker said. “These [drills] have helped us to ensure that what is written in procedures is practiced by staff.” —David Wild

The sources reported no relevant fi nancial disclosures.