Q&A with Patricia C. Kienle, RPh, MPA, BCSCP, FASHP
Director of Accreditation and Medication Safety
Cardinal Health

Pharmacy Purchasing & Products: We see from the Pharmacy Purchasing & Products’ State of USP <800> Survey data1 that HD spill drills are rarely conducted in the pharmacy and almost never occur on patient units (see FIGURE 1). Why aren’t spill drills a more common occurrence?

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP: With hazardous drug (HD) handling, the pharmacy is focused on the processes surrounding compounding and then delivering the agents to nursing to ensure safe administration. Unfortunately, there may be no person at the facility tasked with greater oversight of the process, including conducting spill drills. While spills are an unusual occurrence, they are significant events that require advance planning to ensure an effective response. Quite often staff assumes if a spill occurs, there will be someone else to take care of it. While that may be true, the devil is in the details—and a spill drill lets you analyze the effectiveness of your response in a detailed way.

PP&P: Which staff members should be included in a spill drill?

Kienle: Conducting an on-site spill drill is always an eye-opening experience for all involved. Therefore, it is important to think of these drills as a team sport. Rather than limiting drills to pharmacy staff only, include oncology nursing, facilities, environmental services, and anyone else in the organization who may respond to a spill. This will give you a full picture as to how staff responds, allow you to identify whether the spill kits are easily accessible and sufficiently stocked, and determine if the policies are thorough and easy to follow. Once the drill is complete, an evaluation of the results will provide an opportunity to update and adjust training materials as necessary.

There is a common misconception that if a spill occurs, staff simply need to grab the spill kit and the problem will be resolved. A drill will point out any deficiencies in that approach, such as materials missing from the kit, or a lack of appropriately sized gloves and gowns. Staging a drill delivers a very effective visual exercise that brings any planning deficiencies to light.

PP&P: What instruction does USP <800> provide regarding HD spill drills?

Kienle: While USP <800> sets the standard regarding HD handling and essentially requires each entity to be able to handle anything that happens in the HD process, they do not provide detailed instructions for spill drills. The reason behind this is that each state has different regulations and different environmental requirements; therefore, USP <800> directs entities to refer to the applicable laws and regulations. In addition to state regulations, OSHA requirements need to be met.

Nevertheless, there is no need to start this process from scratch. The ASHP Guidelines on Handling Hazardous Drugs2 provide an excellent section on responding to spills, which includes a checklist of spill kit components (see Figure 2). Combining this well-vetted resource with best practices will help you establish an effective spill response.

PP&P: What is the process for determining if your spill kits are sufficient?

Kienle: Start by reviewing the ASHP Guidelines on Handling Hazardous Drugs and then review your current status: Do you have adequate spill kits in the appropriate places? Examine the contents of the spill kits: Are the supplies appropriate for the types of spills you expect your staff to handle? Most people use one of the commercially available spill kits, and that’s fine to start, but it will likely require supplementation.

I recently conducted a spill drill at an outpatient oncology unit where pharmacy and nursing had worked together to develop a comprehensive policy. We conducted the drill at the end of the day after the patients had left in order to avoid inciting any fear. Red paper was placed on the floor to indicate a doxorubicin spill and we asked staff to respond. The policy was followed exactly; the area was cordoned off and the spill response team for HDs was summoned. Once the team opened the spill kit, they found extra small gloves and an extra large gown. The gloves did not fit the hands of the responder from Environmental Services and three nurses could easily share the gown at once. It was immediately evident that the spill kit required supplementation.

While the commercial kits are convenient, review their contents upon receipt. Consider adding additional sizes of gloves and gowns; determine if additional cleaning solutions, decontamination solutions, or sterile water for decontamination are required; and evaluate whether more absorbent pads are necessary. Note that with the addition of supplemental products, it may be necessary to store the spill kit in a larger plastic bin. If any products (eg, gloves) have expiration dates, that information must be tracked. The ASHP Guidelines on Handling Hazardous Drugs provide an excellent resource in Appendix I—Recommended Contents of HD Spill Kit.

Finally, consider how the spill kit products will be wasted. Because yellow containers are designated for trace chemotherapy waste only, spill cleanup will likely require a black RCRA container.

PP&P: Is there value in creating a checklist after the policy has been written?

Kienle: It is important to recognize that the midst of a crisis is not the time to read through a detailed policy. I recommend including a laminated checklist in (or otherwise attached to) the spill kit, which walks staff through the steps they must take. The checklist should cover key issues, such as isolate the area and remove any patients; put on PPE and place the kit’s sign indicating no one should enter the area; contain the spill; call the appropriate responders, etc. Train staff to utilize the checklist as a two-person job: one person reads the steps, while the other executes them.

PP&P: How do you determine the frequency at which drills should be conducted?

Kienle: I recommend following the rule of thumb for other emergencies, such as a cardiovascular code or malignant hyperthermia. Spill drills typically occur when onboarding a new person to establish their baseline competency, and then annually thereafter. Each facility should determine the specific frequency that is appropriate for their practice. Facilities that conduct their annual in-service as a live event can include spill drills as part of the process.

PP&P: What information should be documented following a spill?

Kienle: Every hospital or clinic will have their own incident report process that should be followed. Certainly if anyone was exposed to the spill, be it a patient, family member, or employee, it is critical to understand what next steps are required, from going to the emergency department to reporting to employee health.

PP&P: Where should spill kits be located?

Kienle: Spill kits need to be available wherever HDs are handled. If the HDs are received on a loading dock, a kit should be available there. The pharmacy receiving area, which is often remote from the compounding area, needs its own kit. Of course the compounding area and the administration areas will need kits. In addition, consider any HD transporting that occurs; for example, if chemotherapy is delivered to separate sites, the person transporting the HDs must have a spill kit in their vehicle and be properly trained on its use. Note that training for transport staff can be as straightforward as how to segregate the contaminated area, contact the spill response team, and maintain oversight of the area until the response team arrives. If the transport covers significant mileage, it is also important to check with your state’s Department of Transportation, as they may have additional requirements.

PP&P: When can a spill be handled directly and when does it require escalation to the spill response team?

Kienle: This decision needs to be delineated in the policy and procedure. Typically, a small spill is defined as anything less than 5 mLs or 5 grams, which can often be handled directly. Some facilities use the rule of thumb that anything that can be cleaned up with a single spill kit can be handled directly; beyond that, the spill response team should be called. Consider the type of product that has spilled; for example, a spill of an investigational drug on the floor may require a stronger response than a few drops of chemotherapy spilled in the hood. (Note that unless you are going to flood the HEPA filter, the hood should be left on during a spill response. As a negative pressure device, it will keep the toxin away from the compounder or spill response team member.)

Consider contacting your waste hauler once a significant spill has occurred to ensure your processes comply with applicable state and federal waste regulations.

PP&P: Should wipe sampling be undertaken after a spill has occurred?

Kienle: While wipe sampling is not required by USP <800> after a spill, I recommend including this step within the policy and procedure. Without wipe sampling, it is difficult to ensure that a spill has been completely cleaned.

Nevertheless, it is important to consider the type of spill in deciding whether to undertake wipe sampling. A small spill in the hood is likely to be adequately cleaned by pharmacy staff. Conversely, if a liter bag comes apart on a patient chair in the infusion center, wipe sampling should follow the cleanup process.

PP&P: Should staff training surrounding spill management be documented?

Kienle: Yes. When staff members are onboarded or beginning to work in oncology areas for the first time, spill management needs to be part of that training and be documented. This training should encompass everyone in the pharmacy, oncology nurses, and environmental services, at a minimum.

Utilize both experiential and didactic approaches. Web-based training can cover the policies and procedures, with the spill drill serving as the experiential component. Not every staff member needs to participate in the drill; it is equally effective to have staff watch their co-workers in this situation. Another option is to film the drill and share the video with the staff.

PP&P: Are there any scenarios that are more likely to lead to spills?

Kienle: No, any misstep can lead to a spill. A mistake can certainly occur while mixing in the hood. Yet, there is more risk on the administration end because a connection can come apart, there could be leakage when hanging a bag, or a puncture could occur. Therefore, it is particularly important to take a team approach with spill drills; do not conduct them solely in the pharmacy.

PP&P: Do spill drills provide any additional benefits to the institution?

Kienle: Consider that CMS expects hospitals to look at high-risk processes on a fairly frequent basis. Spill drills certainly fall under this category, so there is a double benefit to conducting these drills. Not only are safe practices improved in the facility, but spill drills can also serve as a performance improvement activity under CMS requirements and accreditation organization standards, as they create a high-risk, interdisciplinary process that leads to staff improvement.

References

1. State of USP <800> Survey. Pharm Purch Prod. 2020
2. ASHP Guidelines on Handling Hazardous Drugs. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/handling-hazardous-drugs.ashx. Accessed March 23, 2020.

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, director of accreditation and medication safety for Cardinal Health, is a member of the USP Compounding Expert Committee and chair of the Hazardous Drug Subcommittee, although her comments herein are her own and not official information from USP.