Many become anxious, not knowing what to do, when it comes to air/surface sample excursions. USP <797> is clear that any sample exceeding actionable levels must be thoroughly investigated to identify the source. Once the source is identified, action must be taken to remediate the source and then proven that the action was truly effective. This takes time and patience while review and observation of processes takes place.
Fundamentals:
Work Smarter, Not Harder
Don’t Make it Personal
No Perfect Way – Never 100%
Work Smarter, Not Harder by Being Proactive: This is my best advice to alleviate some of the anxiety over sample excursions. If possible, schedule air/surface sampling three days prior to monthly cleaning (monthly cleaning will be mandated in the upcoming revision of USP <797>). Doing this removes the stress from organizing an unscheduled cleaning and provides more opportunity to investigate and assess the excursion. Theoretically, if adequate and effective processes are in place, since the sample that exceeded actionable levels took place prior to the cleaning then any objectional growth should no longer exist (weather the excursion was isolated or throughout the entire suite). However, it is of upmost importance that assumptions be put aside and remember that there is still the requirement to identify the source, to put action into place and to prove that the action was credible.
Additionally, sampling in this way allows the facility the ability to resample the area in question “blindly” and immediately and gives more insight to the investigation. If a sample is returned and is not exceeding the actionable levels, this “might” indicate that the excursion is not due to an on ongoing issue but rather to something that occurred once at an isolated moment in time and just happened to be picked up. Conversely speaking, a repeat excursion “might” indicate an ongoing issue.
Note: Even if a sample comes back not exceeding actionable levels, the soured must still be identified, action applied, and proven that the action was effective.
Don’t Make it Personal: Keep in mind that it is not a matter of if growth will be recovered but when growth will be recovered. We are working in aseptic, ISO-Classified clean rooms (not sterile). Remember, it’s about patient safety and if growth is not being recovered, even exceeding actionable levels occasionally, authenticity of the sampling plan should be closely scrutinized by reviewing the sites sampled and the times at which samples are collected (please review previous blog posts for more information). An excursion now and then is expected in clean rooms designed for aseptic manipulations, performed by humans. Of upmost importance is what is done to correct and prevent future excursions, how IV personnel are educated after an excursion and what is done in between notification of excursion and resolution to keep patients safe.
No Perfect Way: Remember that nothing mentioned is 100% but instead introduces a place to start the investigation. Through progression from observations and questioning, the investigation should organically unfold and lead to the source.
With these fundamentals discussed, we will focus on some key principles on where to start the investigation for source identification:
Identification of excursion type: Air or Surface Excursion
Knowledge of the organism grown
Gram stain, morphology, and types
Identification of Excursion Type:
Air Sample Excursion: Excursions in air samples are primarily due to a failure in the facility build such as the HVAC not working appropriately, HEPA filters damaged or needing replaced, pressures failing, ACPH inadequate, etc.
For example, if employees are too hot (temperature/humidity), they may sweat and produce more microbial growth on the skin and shed more into the air. If it is too cold, condensation could form and may lead to standing water and production of water-loving gram-negative rods (highly pathogenic organism).
It should be mentioned that people can also cause an air sample excursion when processes are inadequate or not followed (garbing, hand hygiene, slow movements, minimal talking, etc.). However, remembering previous blog posts, air sampling must occur when the maximum number of people required for compounding are present. Therefore, if three people are needed to compound at any given time, testing must take place when three people are compounding. If rooms are unable to successfully pass sampling with the maximum number of people, then the “facility has failed” and must change to accommodate the maximum number of people, usually by increasing the ACPH. So yes, people do contribute to air excursions but if effective processes are in place, it is the facility that must change. Surface Sample Excursion: Almost always, surface samples exceed action levels due to people, inadequate processes, lack of adherence to process, such as cleaning, hand hygiene, garbing, or other behaviors related to people. The keys for any investigation are: - Observation of staff and workflow - Questioning of staff or any other parties who are privy to the occurrence (i.e., certifiers) Workflow will need to be observed to note anything that may have attributed to the excursion. Items may not be properly cleaned prior to introduction into the anteroom. An employee may be coming in to work right after playing with their dog or even snuggling with their infant before daycare drop-off. Observation is key to a swift and successful investigation that results in identification of the source. Along with observation, question employees to what may have happened on a particular day or of any ongoing issues they have noticed. Ask open-ended questions and allow the employees to tell you what they know. However, don’t assume that if they know the correct answer that the process is being followed. For example, if an employee can tell you the dwell time of cleaning products don’t assume that they observe the dwell time. Observation of the processes is vital to ensure that processes are followed as intended. Also keep in mind that USP introduces minimum standards. Often, cleanrooms are required to exceed these minimum standards to uphold their integrity to keep patients safe. If workload/volume has increased, more frequent use of sporicidal agents may need to be introduced, or even to include a second daily cleaning. Hand hygiene and garbing process and the frequency of cleaning throughout the workday should be closely observed in detail. Knowledge of Organisms Grown: Another avenue to follow is researching the very microorganism grown. We aren’t microbiologists but for our purposes this information is readily available by a quick, reliable internet search or by asking a microbiologist. Take note of where the organism is “usually” found and start to look there. Example: If an organism is associated with wood or drywall and there is construction in the facility, then perhaps the mitigation and containment protocols for the facility should be questioned for efficacy. Just remember, these are starting points. Organisms can grow in “unusual” places, so the usual places aren’t necessarily the source. However, knowing this can help lead the observation and questioning process down the right path. Gram Stains, Morphology, Type: Knowing an organism’s attributes can also help lead the investigation (refer to chart below).
Note: There can be a lot of overlap but again, these are simply starting points.
Example: Humidity or water sources should be looked at after recovery of a gram (-) rod or a fungus. Perhaps the sink is not functioning properly or not being cleaned effectively. Perhaps there is a refrigerator outside the anteroom that has a faulty drip pan and there is unseen growth on the floor where employees may track it in.
As another example, bacillus is one organism I love to hate. Bacillus is a VERY common organism recovered in IV rooms but if it is on the increase or if growth is seen in new areas there may be issues with the cleaning processes, perhaps specifically pointing to sporicidal use. Let’s refer to the chart and see what this is all about. Bacillus is a gram (+) rod and therefore associated with dirt/soil, etc., somehow brought in by people. Additionally, bacillus is a spore-forming organism. Therefore, if bacillus pops up all over controlled environments, it can possibly be tied to a lack of cleaning or employees not adhering to the dwell time for the sporicidal being used. For high-volume compounding, it may be necessary to even increase sporicidal use.
Once the investigation has led to the source, there are a couple more steps to close out the excursion:
Apply Corrective Action
Prove the Action was Effective
Once the source is identified, apply the corrective action: The corrective action is whatever was done to eliminate the source and to keep it from returning. For example, cleaning along with retraining, implementation of new or improved SOPs, addition of a second daily cleaning, replacement of a HEPA filter (if it was shown damaged), increased ACPH to accommodate more staff for compounding, etc. This list is endless and can be anything related to the findings for what caused the excursion. It is essentially a process or change that removed the source and to keep it from returning.
Now that corrective action has been applied, it’s time to prove that action was effective: Usually this is accomplished by retesting. However, trending plays an important role in showing that an action was successful. If the source returns, then identification of the source was not successful and/or rectified. Repeated excursions in the same area, especially with the same organism, may require professional help from an environmental microbiologist.
We cannot conclude this topic without remembering why we are doing all this. We must ensure the quality of our compounded sterile products and keep patients safe.
How to keep patients safe until resolution: The strictest rational must be acknowledged. An IV room suite is no longer in compliance with USP <797> if there is any growth that exceeds the standards in USP <797>, whether it’s at one isolated area or throughout the IV room suite. Therefore, being out of compliance, BUD should be decreased and reflective of a segregated compounding area. If a hood in out of compliance, and in absence of another hood to use, BUD reflective of immediate use will need to be implemented. Reinstatement of BUD should only occur once the proof that the action taken truly eliminated the source.
However, I’d like to introduce a bit of practicality and professional assessment, understanding that this is the opinion of the author and not detailed in USP <797>. It is also important to check with local county and state authorities, credentialling agencies and even the facility to see if there are specific direction on how to handle microbial excursions.
Many isolated excursions are a snapshot in time from some unintentional error, here one moment and gone the next. Our processes are in place to stop contamination from spreading throughout and often any given contamination (known or unknown) is quickly cleaned up from continuous use of sterile IPA 70% or cleaning solutions.
Growth of an organism that exceeds acceptable parameters of <797>, if isolated in the anteroom (specifically on the dirty side of the anteroom) may not require any alteration of workflow. More than likely, since it was found in one isolated spot, the processes in place have kept it from spreading and daily cleaning has most likely cleaned it up. This is a big assumption, and a solid case is needed to make this sort of statement. Remember, no excursion is closed until source identification is made and action is applied and proven effective.
On the other hand, if excursions are seen throughout the IV room suite it is time to take drastic action by altering BUD reflective of a segregated compounding area. Processes have failed in keeping the growth isolated and most likely the source remains unknown. At this point, a chance cannot be taken because the processes in place have allowed contamination to spread throughout the entire suite, increasing the chances of CSP contamination. Only when the source can be clearly identified and removed, and no longer poses as a threat for CSP contamination, should daily workflow and BUD assignment remain unaltered.
Any excursion can be frustrating but knowing where to start the investigation will organically lead to the source. Once the source is identified, eliminated (action applied), and the action is shown effective the experience can be drafted into and educational material that outlines why processes are in place and what happens when processes are not followed. The understanding gained from excursions is an invaluable educational piece that should be incorporated with every clean room plan. Understanding is the key to continuous and controlled compliance producing efficient workflow with increased patient safety.
If you are in need of professional assistance with unanswered microbial excursions in your controlled environments, I'd recommend contacting Abby Roth at Pure Microbiology, (610) 417-4795. Abby is an accomplished Environmental Microbiologist with knowledge and experience to identify unexplained source contamination.
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