Commentary
Article
Cost-Effective Strategies to Drive USP Compliance in Outpatient Oncology
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While waiting for budgetary approvals, there are some simple initiatives outpatient oncology practices can initiate that yield high rewards and quick wins yet cost little more than an investment of time.
After many delays, updated minimum practice standards defined in United States Pharmacopeia (USP) Chapters <797> and <800> became enforceable by regulatory agencies in November of 2023.1,2 Compliance with these regulations is key to maintaining the safety of both patients and employees within all health care settings, and there are many moving parts that must come together when meeting requirements.
Pharmacist holding a clipboard | Image credit: © Masque | stock.adobe.com
Operating in outpatient oncology settings presents unique challenges, especially for practices without a licensed pharmacy where a state Board of Pharmacy provides consistent direction and oversight. Feedback from these practices reveals a lack of clarity regarding which regulations to follow, who will be regulating compliance, and the consequences of noncompliance. Furthermore, the absence of pharmacist expertise complicates the interpretations and implementation of these requirements.
It is crucial for such practices to proactively seek cost-effective solutions to achieve and maintain compliance with USP standards. Although regulators will expect full compliance, some practices may find difficulty in gaining immediate capital support for costly hardware, ventilation adjustments, and construction or space renovations. Fortunately, while waiting for budgetary approvals, there are some simple initiatives outpatient oncology practices can initiate that yield high rewards and quick wins yet cost little more than an investment of time.
Dedicating Time to Critical Initiatives Drives Cost-Effective Compliance
Ensuring full USP compliance necessitates a financial investment for outpatient practices, irrespective of the presence of a licensed pharmacy, largely influenced by their specific environment and location. Achieving proper engineering controls can be extremely expensive. And today, a path for additional reimbursement from payers for the added costs of items such as closed system transfer devices or personal protective equipment (PPE) currently does not exist.
Achieving compliance for pressure gradients, air changes per hour, and particulate counts within classified spaces has been found to be associated with high costs and difficult to operationalize quickly, especially if the outpatient space is under a short-term lease.
Despite existing financial obstacles, there are cost-effective initiatives that can be implemented immediately to significantly enhance patient and employee safety, thereby improving the overall state of control within the practice environment. Allocating the resource of time to the following activities will greatly advance the road to full compliance.
Employee Education and Training
One area that does not receive nearly the time and attention it deserves is the task of providing thorough training on a consistent basis to employees preparing sterile preparations and who handle hazardous drugs as part of their job requirement. It is important to realize that just because something is written in a dusty book of policies, it may not extrapolate to safe practices being executed by employees on a daily basis.
USP Chapter <800> created the position of a designated person responsible for overseeing all hazardous drug handling, and the recent updates in Chapter <797> created a similar position focused on sterile compounding, facility operations, training, validation, and maintaining standard operating procedures and competencies.1 The preferred approach is to have a single designated person fulfill a dual role within the practice.
Selected to oversee all aspects of USP compliance, the designated person must be well-trained and equipped with the necessary resources for success, including adequate dedicated time to perform responsibilities. Several organizations offer in-depth education and training at a reasonable cost, including the American Society of Health-System Pharmacists, the USP, and the American Pharmacists Association.3-5 Many continuing education courses are also available that provide opportunities in targeted areas. The designated person should be thoroughly knowledgeable about USP Chapter Standards, as this position is responsible for performing an overall gap analysis of existing practice workflows and processes. This informative tool reveals deficits and oversights which provides critical information needed to create a comprehensive plan on how to achieve compliance.
USP does not restrict who can serve as the designated person, but it does offer guidance on suitable candidates for this role. Ideal candidates are those with a comprehensive understanding and practical knowledge of operations, who hold positions of influence, are actively involved in the environment, and can accurately assess performance. Therefore, pharmacists, technicians, nursing directors, clinical directors, or practice administrators may be selected to serve in this capacity.
The designated person must develop a training curriculum that includes both didactic and hands-on components and is responsible for ensuring each employee is properly trained. Successful training must be documented through a competency framework on an annual basis. Only through the completion of competencies can employees demonstrate they are knowledgeable and can fully follow the requirements for compliance.
Relationship Building
Building a strong rapport with key stakeholders is another area that plays a major role in achieving successful compliance and requires only an investment in time resources. Key relationships to foster, particularly within outpatient oncology settings, include the executive director, CEO or practice president, the medical director or physician owner, the controller or chief financial officer, the pharmacy director or lead technician, and the nursing director or clinical director. These relationships are critical to achieving compliance. It is also essential to find the right balance of stakeholder buy-in and ownership among these collaborations. This ensures voices are not only heard, but that essential roles are represented when developing the path towards compliance.
Practice leadership will often have final approval for alignment with USP compliance, especially with additional full-time employees, whereas someone who oversees financials will control approvals for capital expenditures such as clean room renovations, technology implementation, and hardware replacements. Because preparation and administration actions are typically managed by 2 separate teams, it is crucial that leaders within both pharmacy and nursing departments are firmly aligned to ensure accountability for daily tasks.
Critical Workflow and Process Enhancements
Following a gap analysis, most designated persons will recognize cleaning and decontamination, use of PPE, and waste disposal as areas requiring attention, the importance of which cannot be overstated. The terms “cleaning,” “decontamination,” and “disinfection” are often confused. The use of isopropyl alcohol in the hood, cleanrooms, and designated areas is not considered cleaning and does not provide decontamination. Isopropyl alcohol is a disinfectant, and additional agents such as detergents and sporicidals must be incorporated as part of an effective cleaning plan. Furthermore, cleaning responsibilities should not be performed only when convenient or when time permits; they must be completed consistently and documented according to a defined plan.
Another critical area of compliance is hand hygiene and the use of PPE by employees. Proper hand hygiene, including washing the hands with soap and hot water, must be performed at various stages within the workflow. This includes when donning and offing PPE, prior to and after compounding and administering drug therapy, when receiving hazardous drug inventory, prior to and after cleaning, when attending to hazardous drug spills, and when managing waste.
Regarding PPE, employees must have access to the necessary equipment to perform their duties safely and an accountability system should be in place to ensure PPE is properly worn and disposed of after use. PPE serves as the last line of defense to protect employees when other safety measures fail. The requirements for PPE vary depending on the task and whether the drug being handled is hazardous. Common PPE includes exam gloves, chemoprotective gloves, gowns, pleated masks, N-95 masks, respirators, hair covers, and shoe covers.1,2 With the stabilization of the PPE supply chain, all PPE should now be considered disposable and not reused by employees.
A third critical workflow step requiring review is the assignment of proper beyond-use dating (BUD) to punctured vials and final preparations, based on the environment where they were manipulated or prepared. USP Chapter Standards provide clear guidance on assigning BUDs for immediate use; category 1, 2, or 3; and final preparations.1 When assigning a BUD, proper aseptic technique by compounding personnel is essential. All preparations must be accurately labeled with the BUD to inform employees when a product is no longer viable. Clear storage guidelines must be established for preparations that will not be used immediately.
Compliance Is a Continuous Journey
Ensuring compliance is frequently a lengthy and complex journey, filled with numerous expected and unexpected challenges. Fortunately, practices are able to develop and execute many cost-effective compliance initiatives that only require an investment in time resources rather than dollars and cents. But these initiatives can only be successful if adequate dedicated time is allocated to the key players, such as the designated person for compliance and the practice stakeholders responsible for the compliance plan.
Practices should always be working toward a goal and considering what can be done today versus what must wait until later. A useful strategy is to focus on low cost and easy lifts that provide great rewards, while discussing long-term budget expenses with key stakeholders. Regardless of how the action items are prioritized, it is critical to always connect each change with how it will positively impact patients and employees through the reduction of exposure to contamination. Craft the story and be prepared to share it with both internal and external stakeholders.
Lastly, keep in mind that workflows and processes are consistently changing in today’s ever-evolving health care landscape. Compliance will be a moving target, with the introduction of new hazardous drugs, hiring of new employees, development of new technologies, and expansion into new environments. To succeed and address these challenges, practices must remain agile and ready to adapt as necessary.
