Practical and achievable standard operating procedures (SOPs) are the foundation of successful, safe, and efficient pharmacy practice. The long-term sustainability of any SOP calls for change to keep up with the evolution of healthcare practices. At the University of Kentucky Healthcare, revising our cleaning and disinfecting procedures to meet the 2023 update to USP <797> was necessary for compliance. However, it also created an opportunity to analyze our SOPs thoroughly for efficiency, effectiveness, and practicality across 11 sterile compounding areas throughout the enterprise. Further optimization was achieved by simultaneously collaborating with our cleaning supplier to ensure the best use of our cleaning products.

Lead with Fundamentals

All decisions involving cleaning and disinfecting practices should be rooted in USP General Chapters <797> and <800>; however, adherence to The Joint Commission and state board of pharmacy (BOP) requirements is equally important. Guidance from state BOPs and accrediting bodies may differ slightly or contain more specific information than what is found in the USP chapters. For hazardous drugs, it is important to also consult NIOSH and the EPA for guidance on cleaning residues of hazardous substances and disposing of materials used in their remediation.

Developing a cleaning and disinfecting policy and SOP is a multi-step process:

1. Develop ideal protocols to encompass all regulatory requirements.
2. Ensure the protocols are functional and accommodate real world operations.
3. Submit thorough SOPs that include applicable diagrams and checklists for internal review.
4. Once approved, disseminate SOPs and align educational policies.

Be sure to consider strategies for documentation and recordkeeping, in addition to the cleaning practices themselves. Include provisions in the policy detailing how staff is expected to track task progress and how to monitor training and task completion. We use a digital quality management system, but this can be achieved via other means. We also employed gap analysis tools available online to help evaluate our facility’s base level of compliance.

Involve other departments when relevant, such as the medication safety team, environmental services leadership, and the waste management department to ensure proper alignment with existing policies and SOPs. Take care to confirm that proposed cleaning processes do not contravene any existing health system mandates.

Leverage External Relationships

Resources outside our enterprise were invaluable for refining policies and procedures. The vendors that provide our cleaning agents and supplies were reliable partners in determining what agents and supplies would best fit our needs. They counseled us on the best use of their products and provided support regarding training and education. We also turned to the pharmacy community at-large, via the message boards of professional organizations, most notably ASHP. These communities are a place to brainstorm, share experiences and outcomes with other pharmacy professionals navigating the same challenges, and provide a wealth of knowledge, creative solutions, and new perspectives from which to view the regulations.

We began with addressing the USP <797> update that cleaning solutions used in PECs must be sterile, which required an investigation of new sterile cleaning products.¹ Our cleaning supply vendor came on site to discuss utilizing a mix of sterile and nonsterile products in the cleaning and disinfecting routine. We reviewed product samples and coordinated with the hospital supply chain team to update the warehouse ordering forms.

Practical Application

The fewer steps a task takes to complete and the more intuitive the process is, the more likely staff are to accomplish it reliably and routinely. Some key considerations for evaluating the functionality and practicality of the policy are:

• Facility Design:
  • Do staff need a ladder or step stool? Is there space to store it within the cleanroom suite? If it is kept outside the buffer area, how is staff expected to clean it, or other equipment, prior to introducing it to the area?
  • Are walls, ceilings, floors, and furnishings made of nonporous, untextured materials (ie, flat and smooth)? If not, special provisions need to be made in the policy outlining how to sufficiently clean them.
• Physical Space and Furnishings:
• Is there adequate space to maneuver mobile furnishings during cleaning? For stationary furnishings, is there sufficient distance from walls and other stationary equipment to allow for cleaning behind, between, and underneath?
• Staffing and Time Allotment:
  • Are there enough staff available to complete all the activities the policy requires within the allotted time? Measure the typical workload in the areas the policy will service against the current staffing levels to ensure that there are adequate people and time to support the normal patient care workload in addition to required compliance tasks.
• Materials and Supplies:
  • Are adequate supplies available to accomplish required regulatory tasks? Consider what staff needs to perform all the activities outlined in the new policy. In addition to cleaning solutions, staff may require ladders, mops, wipers, cleaning solutions, ergonomic or assistive devices (eg, tools to extend reach).

When evaluating the practicality of a given procedure, it is imperative to engage the staff who routinely work in these spaces. While we are the experts on what is required to achieve compliance, our operations staff are the experts on what is practical and sustainable given all the other tasks they are responsible for and any limitations the space or workflow might present. It is up to us to engage them, listen to their feedback, and find solutions to address their concerns and recommendations without compromising patient safety and regulatory compliance.

For example, our outpatient infusion pharmacy has one biological safety cabinet (BSC) that is 6 feet long, while our other BSCs are 4 feet long. In a BSC, the lower deck must be moved during terminal decontamination. Often, only one technician is working in that area. We discussed the following solutions with the outpatient infusion pharmacy staff to formulate a plan for how the terminal cleaning would occur to ensure the 6-foot BSC could be safely moved:

• Scheduling a time when additional staff are present to take the BSC out of service
• Providing guidance and training for the staff on how to safely maneuver the tray to avoid having to lift it out of the BSC
• Supply a transfer cart to put alongside the BSC, allowing the tray to be lifted, one side at a time, and shifted onto the cart

Ultimately, after deliberation with the outpatient infusion pharmacy staff, we determined the best option was to amend the SOP to clarify that terminal decontamination of the 6 ft BSC should occur when additional staff are on hand and should not be attempted alone. We identified times that would have adequate coverage and would minimize the impact on patient care. Left solely to administration, this might have gone unaddressed and led to frustration, noncompliance, and possibly injury amongst the staff.

Turn Research into Action

With the information gathered, we crafted the SOP for staff review. This SOP includes the following details for each cleaning and disinfecting agent:

• Intended use (ie, germicidal agent, sporicidal agent, sanitizing agent, hazardous drug deactivation agent)
• Active ingredient
• Sterile or non-sterile formulation
• Packaging information (ie, bottle or wipes)
• Dwell time
• Frequency
• Where to use the agent

The SOP also lists the cleaning tools used at our institution, including floor mops with microfiber covers, mop handles with non-shedding mop heads, and rolling mops with removable tacky sheets. Finally, we added a chart to the end of the SOP with the shelf life of each cleaning and disinfecting product. This list includes expiration dates for unopened product packages and expiration dates for opened product packages based on both chemical stability and product sterility.

The SOP was first reviewed by the pharmacy’s associate director of sterile products, followed by a review at the sterile compounding Designated Person meeting. This committee includes pharmacy technician managers, associate directors, directors, and compliance coordinators from all sterile compounding pharmacy areas and is led by the USP <797> compliance coordinator on a bimonthly meeting cadence. After the SOP was approved by this committee, it was distributed to all sterile compounding personnel and posted to the internal pharmacy services website for easy access by all pharmacy staff.

During this time, we also worked on updating our overarching policy on cleaning and disinfecting in sterile compounding areas. We revised this, and all other sterile compounding policies, to be compliant with the revisions to USP <797>. Our cleaning and disinfecting policy defines the various materials used for cleaning and disinfecting and the many areas where these activities must occur. It also lists the procedures for cleaning and disinfecting, including references to our personnel garbing and cleansing and safe handling of hazardous drug policies. We added a guide for cleaning and disinfecting the interior of each type of PEC on a daily basis (ie, moving from the cleanest part of the PEC to the dirtiest: ceiling, back, IV bar with hooks, sides, sash [if working in a BSC], and deck). Lastly, we included an action plan for staff to follow if the results from the recertification and environmental monitoring tests fail. See the FIGURE for a sample cleaning and disinfecting SOP.

Once the revisions were complete, this policy was presented to our pharmacy practice and policy committee for review and approval. This committee, comprised of representatives from all areas of the pharmacy department, meets monthly to review and approve new and existing policies. After policies receive approval from the PPP committee, they are posted to the University of Kentucky Healthcare Policy Manager website and are available to all employees, enterprise wide.

Click here to view the full version of this chart.

Translating Policy into Training

Once the SOP and policy were in place, these documents were distributed to all sterile compounding staff within the pharmacy services department. All new and existing sterile compounders must review this and other sterile compounding policies as a part of their initial training and ongoing competency requirements. We use the University’s online education platform to document completion of and compliance to didactic competency activities.

The SOP is available on our pharmacy services website and was sent to all pharmacy leaders to post for staff use whenever they need guidance on cleaning and disinfecting. For those who prefer visual aids, one- and two-page guides were created showing photos of the new cleaning and disinfecting products with direction on where and when to use them. These were laminated and posted in the sterile compounding areas to serve as quick references for use in real time. Lastly, each pharmacy is visited monthly to monitor for compliance and reinforce good habits with staff. Providing face-to-face interaction with frontline staff supports information retention, fosters a personal investment in achieving compliance, and allows staff to contribute to decisions and ask questions in a more relaxed and friendly setting.

Lessons Learned

Health systems are ever evolving; as such, no policy will be perfect or meet all needs until the end of time. Despite our best efforts, pieces of our policies and SOPs did not work as intended, and there were challenges that our staff faced that we did not predict. For example, timeframes for completing “per shift” and daily activities were originally written with the central pharmacy in mind, which operates 24/7. When the policy was released, we received questions about how to apply these task expectations to areas that are not open 24/7. We instructed staff in those areas to complete all cleaning tasks by the end of the business day for our ambulatory locations and by closing time for our satellite pharmacies that are not open overnight. These are easy updates made in our quality management system whenever hours of operation change for these areas. Making changes to a policy is never a sign of failure; it is simply another step on the journey toward the best possible compliance.

Staff are more likely to comply with a policy if they understand why they are being asked to do it and appreciate how it makes a difference to patients or improves processes. From a cognitive standpoint, it is much easier to incorporate habits into a routine, when the logic behind the change is clear.

Be open to constructive criticism and differences of opinion. One of the greatest strengths of any group is diversity in experience, background, and perspective. Being open to debate and deliberation on any points of contention in the policy results in a more comprehensive final product. It is much easier to hear out and address concerns in the approval process than it is post-implementation.

Conclusion

Policy creation is often a complex and ongoing process, given the variety of factors to consider, administrative processes to navigate, and sources available for consultation. Attention to detail and critical thinking about the organization’s workflows and capabilities are imperative, but no less important than open-mindedness, flexibility, and creativity. The more input you gather from varied perspectives, and the more feedback you incorporate from the end-users, the more effective the policy will be in the long term.

References

1. United States Pharmacopeia Gen-eral Chapter <797> Pharmaceutical Compounding – Sterile Preparations. USP 42-NF 37, 2023.

Sara Cambron, BS, CPhT, CSPT, is a pharmacy compliance coordinator and the USP <797> Designated Person at the University of Kentucky Healthcare Chandler Medical Center in Lexington, Kentucky. She oversees nonhazardous sterile compounding compliance for 12 sterile compounding locations across inpatient and ambulatory locations. Sara received a BS in agricultural biotechnology from the University of Kentucky and her CPhT certification in 2009 and her CSTP certification in 2017.

Kathryn (Katie) Plahn, BA, CPhT, CSPT, is a pharmacy compliance coordinator and the USP <800> Designated Person for the University of Kentucky Healthcare, Chandler Medical Center. She oversees all aspects of hazardous handling for the enterprise, including 4 negative pressure, hazardous sterile compounding locations. Katie received her CPhT designation in 2007 and her CSPT designation in 2018.

SIDEBAR

Our Organization

University of Kentucky Healthcare has 11 sterile compounding areas throughout the enterprise, comprising five cleanroom suites and six segregated compounding areas (SCAs). We service adult and pediatric populations receiving a diverse array of sterile products in inpatient and ambulatory settings, including but not limited to chemotherapy, biologic medications, gene therapies, investigational agents, radiopharmaceuticals, and surgical and procedural preparations.