A New Chapter in Health-Care Design

The standards have risen for pharmaceutical compounding areas.

As of July 1 of this year, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will begin surveying these areas—where intravenous and other sterile solutions are prepared—for compliance with a new chapter in the 2004 United States Pharmacopeia-National Formulary (USP-NF).

According to ASHE (American Society for Healthcare Engineering), requirements listed in the new chapter, "USP Tests and Assays, Chapter 797, Pharmaceutical Compounding, Sterile Preparations" (USP-NF 797) include:

• Air quality of ISO class 8.
• Positive pressure to adjacent areas.
• An ante area separated from the controlled area by a physical wall in high-risk areas (medium- and low-risk areas do require an ante area, but it does not need to be a separate room).

"They're [JCAHO] trying to create a cleaner environment for compounding to reduce the risk of contamination of compounds used for oncology treatment," said Dan Dickenson, P.E., senior mechanical engineer with Ellerbe Becket, Minneapolis.

As such, he noted that mechanical design would have to be adjusted to meet the new requirements. "The impact on the mechanical side is fairly substantial," he said. "And architecturally, there are some issues with regard to cleanability of surfaces in the room, adjacencies of worktables and spatial relationships. And then [there's the task of] creating this separate, cleaner environment from the rest of the workroom, which in some cases, can be accomplished with a curtain track system to segregate the cleaner from the less-clean area."

In a recent northern Wisconsin project, deemed a low-to-medium risk environment, Ellerbe Becket employed the curtain track idea to separate the ante area from the compounding area. The HVAC system was then set up to supply the compounding area with HEPA-filtered air, which would migrate to the less-clean area. Low returns keep the airflow going down and away from the cleanest area of the room. Combining this system with some sort of pressure control from the room, Dickenson said, can help assure positive pressure to meet the pressure differential requirements.

Besides presenting new design challenges, Dickenson also noted that the upcoming compliance date for USP-NF 797 poses other problems for designers and owners. While he was made aware of the new requirements in January (USP released them last November), he said others may have been left out of the loop. Regardless of whether hospital administration staff were informed, in speaking to multiple ASHE members and facility managers recently, he discovered that many weren't aware of the new chapter until it appeared in ASHE's newsletter, ASH*E*Flash, in early April. As such, he thinks the requirements might take some by surprise. (According to JCAHO, it expects facilities to have determined if there are any significant risk areas by July 1 and suggests that they implement the more basic elements of the plan by that date. Facility-based requirements of USP-NF 797 only need to be planned for future implementation.)

Either way, new construction might have the advantage in this scenario. "It's not quite as difficult to respond if you're planning a new space; you can modify the space or systems before they are built to address the new requirements," Dickenson said. "[For] an existing space, you can see where the impact might be a lot greater."

Dickenson's advice to other designers is to become familiar with USP-NF 797's requirements and communicate with oncology and pharmacy personnel to make sure they understand the ramifications, then apply a solution to the facility that meets the requirements.

The solution, though, may depend on the existing systems, their capabilities and the type of treatment being administered.