By Tasha Jackson, B.S., PharmD, BCSCP – Editor at CriticalPoint
With my extensive experience as a designated person in a hospital pharmacy, I had to play the role of hygiene herald or garb guardian when it came to enforcing rules about staff personal hygiene, proper garbing, and even tattoo considerations. While USP lists “recent tattoos” among the conditions that may lead to a higher risk of contaminating the CSP and the environment, it does not provide additional perspective on how to continue compounding practices when your staff gets some fresh ink. No surprise; this means it’s up to the designated person to decide how to continue the compounding workflow while someone is in the process of healing from tattoo wounds, which consists of several stages of recovery.
As a practicing pharmacist for over 18 years…
I have many stories about the life of a designated person (DP) that include my fair share of wins and losses. Since today is National Tattoo Day, I’d like to provide some considerations that may help you on your day-to-day operational journeys and continued compliance.
National Tattoo Day recognizes the history, culture, and artists dedicated to tattooing. On this day, many plan to or impulsively get a tattoo (no judgement, of course). But in context of a compounding professional, this could not only temporarily affect staff roles but also have an effect on pharmacy workflow. Have you considered how some of your compounding staff are planning on celebrating?
Picture this
You’re wrapping up a morning huddle, and one of your day-shift compounders mentions that they got a new tattoo the day before. After hearing this, you pull your technician aside and inquire where the new tattoo is located. They show you a well-executed caduceus (the medical symbol with a staff and two snakes) on the inside of the wrist. Being a diligent DP, you have a few options to consider:
- Allow the staff member to continue their shift as scheduled
- Fire the staff member immediately for additional DP stress (just kidding)
- Restrict the staff member from sterile compounding activity
Hopefully, you’ve chosen option C. In addition to this option, we’ll discuss having alternate duties available for staff.
Let’s start with what USP Chapter 797 says
USP 797 states that, “Individuals that may have a higher risk of contaminating the CSP and the environment (e.g., personnel with rashes, recent tattoos, oozing sores, conjunctivitis, or active respiratory infections) must report these conditions to the designated person(s)”. This statement is simple and makes it easy to understand the importance of reporting these conditions to the DPs.
However, are staff actually taking this type of action? It’s just a small tattoo or even an aggravated skin abrasion; does pharmacy leadership really need to be bothered with this minuscule issue?
Yes, they do. In fact, our personal hygiene and awareness of skin, mucosal, and respiratory conditions are critically important and impact the success of a compliant sterile compounding environment. USP 797 also states, “The designated person(s) is responsible for evaluating whether these individuals should be excluded from working in compounding areas before their conditions have resolved because of the risk of contaminating the CSPs and the environment.”
As a designated person, USP requires you to act. Yet how can we evaluate our staff if they aren’t keen to tell us? Whatever the reason, we must invite our staff to be open with us about anything that can negatively affect the compounding environment, including those small or even not-so-small tattoos.
Review Compounding SOPs
CriticalPoint highlights the importance of the designated person(s) ensuring robust standard operating procedures (SOPs) are in place that address restricting staff from compounding activities when scenarios like this arise. Let’s review our top concerns when incorporating staff restrictions and alternate duty into SOPs;
- An SOP should define who evaluates and decides to remove the staff member from compounding activities. We all like to say it’s the designated person, but what happens if they are not available at that moment?
- What is the alternate duty assignment for the employee? It’s important to have redundant staff with up-to-date training and competency assessments. However, this is an often-missed element. The staff’s primary role is covered and well documented with competencies. Unfortunately, either the alternate-duty assignment isn’t adequately described (meaning training will likely have been lackluster) or the specific individual will lack the documented and described training despite having an alternate duty.
- SOPs should define when the employee is allowed to return to compounding activities. Naturally, you may be tempted to state “until the condition is healed,” but what does that mean, and who or what determines when the condition is healed? You must ensure that your SOP is very clear about this process and outlines the actions you must take to protect the CSPs and environment.
How do you intend to document the ways to monitor the staff member to ensure the condition is fully resolved?
Depending on the condition, documentation of the healing process can look quite different. If the person has an active respiratory infection, you are likely to have information from the medical professional treating the infection as to when they are no longer contagious and able to return to duty.
However, when there are cosmetic alterations involved, like tattoos or piercings, it’s unlikely you will have this sort of information available. In this situation, CriticalPoint recommends keeping a log of instances of when compounding personnel have been restricted from working in controlled environments and for tracking what stage the tattoo is in during its healing.
Typically, tattoos take anywhere from two to four weeks to heal and go through several stages. That new piece of art is an open wound and must be treated as such. You definitely want to restrict those with recent tattoos due to the inflammation and oozing that occurs, especially in the initial stages.
After this, the tattoo will then begin to flake, peel, and scab. This is particularly problematic for working in your compounding environment and drastically increases the risk of contamination based on the skin particles potentially exposed to the environment.
Final Thoughts for Tattoos and Sterile Compounding
CriticalPoint recommends facilities take the time to regularly review SOPs for potential gaps between operational activity and written policy, as well as creating SOPs for new obstacles that are encountered on their compliance journey.
Documentation is key to creating a successful quality program. Make sure when you’re restricting staff members due to their higher risk of contaminating the CSPs or environment, you document the time away from compounding as well as the resolution of the condition. Once the condition is fully resolved, store all documentation with employee files.
Every pharmacy role must be dedicated to patient safety. Meanwhile, there is so much more that goes into serving as a designated person. This role takes diligence and a watchful eye when having oversight of compounding staff and their conduct. Knowledge and understanding of the negative effects of conduct and work practices aren’t always inherent. Most importantly, teaching the ‘why’ behind the ‘what’ to staff members is paramount to the success of the culture and cleanroom environment.
Want to learn more about the non-compounding aspects of life as a designated person? Consider our designated persons training course, which will acquaint you with the USP changes and provide application-based opportunities to improve your pharmacy operations.