USP 797 and USP 800: 8 common mistakes to avoid when complying
The revisions to USP 797 and new USP 800 standards will go into effect December 1, 2019.
The revisions to USP 797 and new USP 800 standards will go into effect December 1, 2019. Over the course of 2018, the Henderson Engineers’ team of experts has evaluated nearly a hundred facilities across the country to prepare their pharmacies for this deadline. During this time, we’ve discovered the only way to make these projects successful is to not just to understand the content of these standards, but the processes inside spaces as well.
Our clients have tasked us with providing the best path to compliance for each facility and avoiding some of the hidden pitfalls. Henderson’s experts have compiled a list of the 8 most common mistakes they’ve seen while reviewing existing facilities for USP 797 and USP 800 compliance.
1. Not creating space for non-sterile hazardous drug (HD) compounding.
Much of pill crushing or manipulation of non-sterile HDs is currently being performed on the patient floor by nurses. While previous standards have not required staff to perform these functions in a negative pressure environment, USP 800 requires these functions to be performed in a negative pressure segregated compounding area and within a powder hood. Because this is a new compliance issue, many hospitals have not quantified the extent of how much it impacts the hospital or pharmacy workflow. This not only requires additional space within the pharmacy, but also a hospital-wide procedure adjustment.
2. Assuming all the hazardous drugs can be stored in the HD buffer room.
Many designs try to eliminate the need for a separate HD storage room by storing hazardous drugs in the negative buffer room. USP 800 allows this, but only for drugs that will be used for sterile compounding. This fails to consider the non-sterile hazardous drugs which will need to be stored in a separate, negative pressure storage room. By transporting non-sterile hazardous drugs through sterile spaces, the pharmacy increases the risk of cross contamination. Consideration should also be given to storing all drugs outside the HD buffer room. Removing all refrigerators and most storage shelving can help to provide a more cleanable space helping to reduce the risk of room contamination.
A comprehensive, long-term design requires a full understanding of which non-sterile hazardous drugs are utilized within a facility and where manipulation will be performed. The non-sterile HD compounding and HD storage room can be within the same physical space, creating a more efficient floor layout. The hospital can also perform a NIOSH (National Institute for Occupational Safety and Health) risk assessment for specific drugs where storage in the negative pressure segregated compounding area (SCA) is not practical.
3. Improper sink location, prohibiting proper gowning procedures from being followed.
USP 797 specifies when hand washing should occur in the gowning procedure. This requires a line of demarcation within the ante room, separating the ante room into clean and dirty areas across which shoe covers must be donned with handwashing and further gowning on the clean side. Many designs place the sink on the “dirty” side of the line of demarcation to keep the sink the required one meter from the HD buffer room door, but this does not allow for the proper gowning procedures. If this is the case the pharmacy may need to expand the size of their ante room to have enough room to relocate the sink so proper gowning procedures can be followed.
4. Not providing a means to maintain space pressure over the life of the rooms.
USP 800 has put a high and low limit on the room pressures in the HD buffer room. Maintaining a consistent pressure setting within these spaces makes the ability to adjust airflow over the life of the room even more critical. Dedicated terminal units for the supply and return/exhaust for each space makes it easier to adjust the airflow through the building control system without accessing the pharmacy ceiling space. Additionally, any exhaust fans or supply fans associated with a HEPA filter should be equipped with the ability to adjust fan speed as the filters load.
5. Installing lay-in ceiling within a compounding room.
While a lay-in ceiling system is not in violation of USP standards, the standard outlines proper sealing requirements. Tiles must be caulked to the grid and the grid must be caulked to the wall. This additional caulking creates a sealed, clean environment, but also eliminates many of the accessibility benefits of a lay-in system. If the facility utilizes a gypsum board ceiling, any access panels must be gasketed and sealed to help maintain space pressure and cleanability.
6. Not extending the wall surrounding the compounding area to deck.
With the reduced range of room pressures now allowed, a properly-sealed room is more important than ever. Reducing the amount of airflow differential and possible sources of contamination is only achieved by correctly sealing the space. It has proven easier to seal the fewer penetrations in a vertical wall than every sprinkler head, speaker, or fixture in a ceiling.
7. Placing HEPA filters in ductwork in lieu of ceiling.
Many existing facilities placed a central HEPA filter within a duct to provide reduced maintenance; however, we have found that these create more opportunity for contaminants to enter the space. The ductwork downstream of a HEPA filter is rarely cleaned along with the room, so the amount of contamination passing around the inline HEPA filter will continue to grow and be difficult to rectify. If HEPA filters are installed at the ceiling diffuser, there are less areas for potential contamination as most are addressed during regular room cleaning. Proposed revisions to USP 797 now require HEPA filters to be located at the ceiling, so this must be updated in any facility. When adding a HEPA filter diffuser, verify provisions for leak testing of the filter have been established within the space.
8. Assuming the dedicated HD receiving area can be shared with the HD storage room.
It seems to make sense that space could be saved by utilizing the HD storage room to receive hazardous drugs, but potential infection control concerns need to be considered. At this point, most shipments do not separately designate hazardous drugs on the shipping containers. This means all containers need to be opened in this separate receiving room. In addition, many facility infection control departments would be concerned with opening shipping containers in the same location of unpacked drug storage.
Complying with these standards is not only vital for regulatory compliancy, but also for the safety of staff and patients. It is important to engage partners who know the interact relationship between the pharmacy’s design and proper compounding procedures to avoid the common pitfalls compliance with USP 797 and 800. By understanding how the space is used, the project team will be able to design a pharmacy that complies with these standards and serves the hospital’s unique needs. Have you experienced issues reaching compliance while updating these spaces? Contact Henderson Engineers with any questions.