Not everyone is cut out for cleanroom work. In any environment, the ability to identify employees with the right aptitude and attitude is critical to success; in the cleanroom this is acutely true as the wrong employee may not only detract from overall goals, but also can negatively impact the safety of the compounded products. Much of pharmacy’s recent efforts in the cleanroom have focused on USP <797> compliance and policy and procedure development. However, while important, cleanroom design, engineering control installations, and operational policies are not the cornerstones of a successful IV room. Rather, successful cleanroom practices are built by hiring and fostering the skills of staff members whose commitment to continuous improvement reflects their understanding of the driving reasons behind the rules and regulations.
Characteristics of Ideal IV Room Staff
There are certain fundamental skills that every successful compounding staff member must demonstrate. In addition to proficiency in basic mathematics and the physical dexterity to manipulate components and compound aseptically, technicians, pharmacists, and supervisors also must maintain a high level of self-awareness concerning their compounding behavior, be willing to admit when they have had a break in technique, and be able to follow through to correct the issue. Development and maintenance of strong aseptic compounding skills is equally important for sterile products pharmacists and managers. To observe and correct technique on a regular basis, pharmacists need a clear understanding that allows them to determine whether an observed variation in technique is acceptable before correcting it. Pharmacists and managers also must be able to model techniques that they desire from technicians.
Analytical and abstract thinking ability are essential, as understanding why the rules have been implemented is as important as following them. Cleanroom activities are purposely rule-driven to prevent contamination of the final product. Recognizing the goals behind the rules is crucial to avoid the development of bad habits. For example, the employee who cannot visualize particle spread is more likely to reuse his or her personal protective equipment inappropriately. Some technicians and pharmacists can perform well through memorization of correct procedures without a real understanding of why the rules exist, but this is not safe. Inevitably, a situation will occur in which the correct solution does not fit neatly into the rule that has been memorized. If the individuals involved at that moment cannot think through the problem, they will likely take an inappropriate action—not through any ill intent—but because they cannot apply the principles to a new set of circumstances. The goal is for employees at all levels to be committed to continuous learning and improvement. Choose staff members that demonstrate a willingness to ask questions, accept feedback, and continually refine their behaviors. Sterile product employees at all levels must understand the underlying principles behind procedures and be able to apply them to any set of circumstances to determine the correct course of action.
Attention to detail and meticulousness are useful characteristics at all levels. Effective IV staff members have the discipline to complete compounding tasks in the midst of distractions and can shift priorities quickly to adjust to changing or emergent patient needs. For example, the technician focused on a batch run must be able to maintain the same attention to detail for the last bag made as for the first, despite the repetitiveness of the task. The technician must have the ability to quickly get to a safe stopping point and hold in mind where he or she was with one process in order to shift priorities to prepare a stat item, and then return to complete the original work. Heightened attention to detail also can prevent unnecessary remakes. Personnel who are able to look at the entire label, including patient name and location, are more likely to recognize something that they have already made and question why it is being requested again before making it. Those who focus only on one part of the order, such as the drug and dose, will miss the opportunity to prevent waste. Similarly, technicians and pharmacists who develop a habit of assuming dose, fluid, or volume based on reading just the drug name are more likely to make errors. Changes from standard are particularly susceptible. For example, if the standard insulin drip is 100 units in 100 mL but there is occasional use of 250 units in 250 mL for patients with unusually high requirements, those who just read “insulin” are more likely to send the standard when the larger bag is ordered. Look for personnel who are accurate with other work and care about what they are doing.
Cleanroom personnel also must be able to tolerate working in a confined space while embracing a sense of responsibility for maintaining the environment. Very extroverted people may have difficulty staying inside a cleanroom for long stretches and are more likely to extend breaks as they get caught up with friends and coworkers outside the cleanroom. Talkative individuals are more likely to create distractions for others and may be less focused on their own tasks. Employees who are not invested in maintaining their environment will have difficulty following the cleaning regimens and are more likely to contribute half-hearted efforts. Anyone with an attitude that cleaning is beneath them will have difficulty adjusting to the requirements of a controlled environment. It is important to inform staff at the outset that a willingness to clean is a key part of the IV room responsibilities.
Requirements for Cleanroom Supervisors
For pharmacists supervising compounding activity, additional skills are necessary to oversee technician and workflow management. Supervisory staff must be able to maintain production timelines, reprioritize as necessary, and redirect activities effectively to meet regular deadlines as well as urgent patient needs.
Because cleanrooms operate in a rule-driven environment, managers must be able to maintain a disciplined operation. It can be tedious to consistently remind staff about rules and standard operating procedures (SOPs) associated with a well-run cleanroom, but it is vital. A manager must be willing to correct employees as any violation is noted, and formal observations must be conducted regularly. The manager must lead by example and follow all rules and procedures. For example, just as employees are not allowed to wear make-up in the cleanroom, neither may the manager, even if entering the cleanroom for a brief visit. Likewise, the manager should not bring beverages into the anteroom. Using your own unintentional violations as examples and communicating openly as to how the violation occurred will drive home the importance of doing so to employees and will help them see corrections for what they really are: tools to ensure adherence to rules that exist to maintain a clean environment and ultimately prevent harm to patients.
Ongoing Staff Training
After passing the initial assessment, staff should receive regular evaluations with continual feedback. Many of the softer skills can be assessed using evaluation forms asking trainers to rate punctuality, attention to detail, and acceptance of feedback or corrections. Training checklists are a useful tool for management to ensure that topics such as aseptic technique, airflow principles, SOPs, workflow, basic drug knowledge, and math skills have been covered with the trainee. However, checklists do not provide adequate documentation that training occurred, nor do they ensure that the employee comprehended the material. Whenever possible, develop and use written assessment tools to objectively document a basic level of competency. USP <797> includes several sample forms for assessing compounding personnel’s skills, which are a good starting point for building customized assessment tools.
Training a technician with prior experience in sterile products requires the same documentation of skills in the new environment. The experienced technician must pass the usual initial media fills and gloved fingertip sampling before compounding for patients in the new environment. For more experienced personnel, training should take less time and focus on what is unique to your practice and environment. For example, a technician experienced in horizontal airflow compounding may need specific retraining if your facility uses vertical flow. Other compounding specifics, such as syringe and needle selection standards, requirements for dilution, specific compounding equipment, and institution-specific procedures, need to be emphasized so that an experienced compounder can acclimate more quickly to the new environment.
Training pharmacists for sterile products work can be challenging as many graduate pharmacy school with little practical sterile product experience. Their training should mirror technician training, including media fills and fingertip assessments. In addition, sterile products pharmacists require specific training in:
It is critical that the sterile products pharmacist be thoroughly versed in the reasons behind the SOPs and committed to enforcing compliance with the technical staff. Encourage this by incorporating pharmacists into the room maintenance routine and provide them with some assigned responsibility in addition to overseeing the maintenance done by the technical staff.
Ongoing competency assessments required by USP <797> provide opportunities to objectively document an employee’s skills and correct bad habits. Media fill tests should be observed by a senior technician or pharmacist and observations documented. The requirement for at least an annual written competency assessment provides a mechanism for managers to foster an environment of continual learning and improvement and an opportunity to create targeted questions to evaluate understanding of recent changes in practice, as well as a continuing understanding of basic principles.
USP <797> establishes minimum requirements for fingertip tests and air sampling. If it is possible to test more frequently, the results can be used to detect issues and correct them expeditiously. At Cleveland Clinic, we conduct active air sampling and fingertip assessments for high-risk compounders on a monthly basis. If the resources are available, conducting these samplings weekly (with monthly fingertip assessments for medium and low risk compounders) would provide a better picture of staff habits than the annual or semiannual testing required by <797>.
Air samples exceeding action limits often signify a lapse in cleaning rigor or may indicate a need to clean a particular area more frequently. For example, a high traffic section of an anteroom or the surfaces near a busy pass-through may need to be cleaned more often than required by USP <797> in order to keep the bio burden in that area under control. The clear evidence provided by a failed air sample plate is usually enough motivation to get personnel back on track with their cleaning.
Frequent fingertip assessments can provide insight into the employee’s awareness of touch contamination and hand and glove hygiene practices. Failed fingertip samples should be addressed quickly by reeducating and retesting the employee. Some positive fingertip tests may be the result of inadequate cleaning of vials or other compounding materials; however, more often it is an indication that the employee is not practicing adequate hygiene, such as frequently sanitizing gloves. The technician may have a habit (usually subconscious) of touching their person (ie, exposed skin, mask, eyeglasses, etc) with their gloves and then not sanitizing the gloves immediately. If a compounder has repeat fingertip sample failures, he or she should be removed from compounding duties. The policies of the organization should support such action.
Cleanroom work may be attractive to employees for the wrong reasons. If there is a pay premium for working in the IV room, most technicians will request this training. In smaller departments, training every employee may be necessary to ensure full coverage on all shifts; large departments, however, should avoid this approach and look to specialization. In order to build and maintain the requisite skill set, trained technicians should work in the sterile product area for at least half of their shift. Constantly cycling staff through the IV room can have an adverse effect on skill maintenance and possibly, on end product quality. In addition, each trained staff member represents an ongoing commitment of time and resources for completion of regular competency assessments. Committing resources to a specific group of qualified and dedicated employees will ensure improved efficiency and effectiveness.
At the outset of compounding training, make it clear that this type of work is not for everyone. If a trainee finds that he or she does not enjoy the environment or the expectations, they should refocus their efforts on other duties. Forcing unwilling staff into these positions increases the risk of errors and creates interpersonal strife within the work group. Keep in mind that an employee’s successful initial assessment (ie, media fill, gowning competency, fingertip sampling) does not necessarily indicate that employee’s long-term viability in the sterile products environment. It is important also to assess the employee’s ability to deliver on other characteristics, such as analytical thinking, ability to focus and prioritize, and willingness to manage maintenance tasks.
Fostering an environment where each team member understands his or her role in maintaining a controlled environment is key to sustaining compliance to the SOPs. Make it a regular practice to verbalize positive observations and present routine corrections in a low-key manner. Write thank you notes for specific accomplishments, such as maintaining or improving metrics. One of my proudest moments as a sterile products manager was when my team came to me with a plan to assume the daily floor cleaning because they were not satisfied with the efforts of our environmental services personnel. By developing a culture of continual improvement, we are able to avoid complacency.
Angela Yaniv, PharmD, the assistant director of pharmacy for sterile products, has been managing sterile products at Cleveland Clinic in Cleveland, Ohio since 2007. She also manages the Taussig Cancer Institute pharmacy. Yaniv received both her bachelor and doctor of pharmacy degrees from the University of North Carolina.
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