Infection prevention best practices for infusion providers: The pharmacy cleanroom
当它comes to drug safety, how you handle hazardous drugs (HDs) is just as important as how they're consumed.
A pharmacy cleanroom helps limit risks to healthcare workers and minimize contamination from contacting critical sites. But to make a pharmacy cleanroom effective, its design must bear certain best practices in mind. This includes guidelines for cleanroom infection prevention compliance set out in U.S. Pharmacopeia's (USP) General Chapter <800>, which provides a concise blueprint for creating safe and sterile cleanrooms in a variety of clinical settings.
Here's what to know about creating a USP-compliant pharmacy cleanroom, including helpful tips for meeting updated HD handling standards.
What is USP <800> and whom does it affect?
If you're involved in the handling of HDs, there's a good chance USP <800> guidelines apply to you.
Every year, about 8 million U.S. healthcare workers are potentially exposed to HDs.1By setting out standards for the proper handling of these drugs, USP <800> helps mitigate the risk of exposure, keeping healthcare workers and patients safe and preventing the release of hazardous materials into unprotected areas. The更新的需求,在德生效cember 2019, apply to facilities that store prepare, handle, transport or administer HDs, as well as the personnel responsible for each task.
In standardizing these protocols, USP <800> helps protect those vulnerable to exposure. It can also take much of the guesswork out of how to design a pharmacy cleanroom, covering essential factors such as airflow, temperature, ease of use and facility and engineering controls.
Best practices for cleanroom infection prevention compliance
There are many factors to consider when determining an HD pharmacy cleanroom's layout and design features. And though USP <800> does leave some room for differentiation, it also establishes a number of conditions the cleanroom should meet in order to make sure the space is sterile and secure.
If you're designing a new cleanroom (or updating an existing one), follow these best practices to remain compliant with updated USP standards and provide your workforce and patients with a safe environment.
Manage airflow directions
All sterile HD pharmacy cleanrooms must have at least two rooms: ananteroomand anISO Class 7 buffer room. Equally crucial, the anteroom should maintain positive pressure while the buffer room maintains negative pressure. This traps harmful particles in the buffer room and prevents them from traveling into the anteroom and out into any general areas.
Have a pressure test performed in both rooms to determine whether you're meeting USP <800> standards. If you're not, you're likely going to require updates to your facility's HVAC system, plus improvements to the seals of doors, windows, ceilings and walls. The cleanroom is also going to require pressure gauges for the ongoing assurance of airflow compliance.
Consider the workflow
当它comes to USP <800> design, buffer room and anteroom compliance is as much about ease of use as it's about physical space requirements. In the anteroom, that means designated spots for handwashing, personal protective equipment (PPE) and waste disposal. And in the buffer room, all steps related to sterile compounding, including HD packaging and storage, require workflow accommodations.
In addition to maintaining separate areas for each task, rooms should have intuitive layouts that don't put any real or perceived barriers in the way of the intended workflow. Account for staff mobility and equipment placement when optimizing the workflow of the anteroom and buffer room and create workflow guidelines that keep everyone on the same page about how and where to perform tasks.
Keep room temperature steady
Temperature is a major factor in compliant cleanroom design. It's especially vital for maintaining HD stability, though staff comfort is also key. For compliance purposes,USP <800> states that the temperature of the buffer room cannot exceed 68 degrees Fahrenheit. Monitor buffer room humidity closely too and keep it at 60%.2
Check the status of temperature and humidity in your pharmacy cleanroom regularly and keep clear documentation of both elements. Also note that though there are no USP <800> guidelines for anteroom temperature and humidity, you'll still want to set and maintain standards so your staff remains comfortable in and out of PPE.
Stock USP-compliant cleaning products
Keeping both sterile and non-sterile HD rooms clean is a top priority. Just as crucial is cleaning them with the appropriate products, whether you're disinfecting, decontaminating, deactivating or just engaging in general cleaning practices.
All cleaning agents, PPE and respirators must adhere to USP <800> requirements.3Most of the time, USP compliance notation appears right on the packaging, though not always. If you're not sure if a specific product is compliant, head to the manufacturer's website and/or contact the manufacturer directly to confirm one way or the other.
Check out our related article,Infusion therapy best practices for safe patient interactions, for information on how to continue infection prevention best practices through to your time with the patient.
Tackle the big challenges first
In terms of meeting USP <800> design guidelines, some requirements may prove easier to meet than others. Start then with requirements that demand whole-building solutions, such as those related to engineering, room layout and your HVAC system. From there, you can move on to other compliance necessities, such as cleaning agents and staff protocols.
Your existing infrastructure is going to play a big role in how quickly you're able to adapt, assuming you need to adapt at all.Your ultimate goal: meet USP <800> requirements and do so in a controlled way so that you can maintain compliance over time. Try to identify any challenges to creating this controlled environment and list all potential types and routes of exposure so you can mitigate risk as much as possible.
Don't neglect staff training
A pharmacy cleanroom is a living environment. As you optimize for USP <800> compliance,make sure you standardize your HD handling procedures and provide comprehensive training for all cleanroom personnel.
Every individual with a role in your sterile and non-sterile HD compounding rooms should receive sufficient training in their job functions before they receive, label, package, transport, dispose of or otherwise engage in the handling of HDs. Likewise, all staff should receive thorough training in USP-compliant PPE and cleaning standards.
As you go about the design and standardization process, ask staff for feedback about the current and planned state of the cleanroom. You may find you can garner some useful insight about ease-of-use preferences or unanticipated barriers to safety and efficiency. You'll also get a chance to bring everyone on board with your USP <800> initiative, making sure that not only is your design up to standards but your team is, too.
1:https://www.cdc.gov/niosh/topics/hazdrug/default.html
2:https://www.ashrm.org/system/files/media/file/2019/07/USP-800_MONOGRAPH_FINAL_DIGITAL.pdf
3:https://www.pppmag.com/article/2511
Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.
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