The Importance of Trending in USP <797> Compliance
USP <797> is often talked about as though compliance is a “pass/fail” test. Either CFU counts are exceeded or they are not. However, the USP <797> mentions data trending several times throughout the standard. In this post, we will look at what data trending is, how it’s used to promote patient safety, and how and when it’s required.
What is USP <797> Trending?
Data trending isn’t a new concept. Businesses focused on continuous improvement use it to assess performance and identify latent challenges. Is productivity going down? More training may be needed, or a piece of equipment may need recalibration. Trending “catches” the issue before it becomes a problem.
Data trending is also useful for putting things in their proper context. If a student comes home with a C on a report card, is that good or is that bad? If they’re typically getting straight A’s, the C may be a sign that something is “off” in the child’s life. Maybe too many video games are disrupting sleep habits. On the other hand, if the student has been struggling to get passing grades, a C can be cause for celebration.
Likewise, data trending also helps compounding pharmacies ensure patient safety and adherence to USP <797> standards. In the case of an exceedance, documenting data trends is a required component. But even without an exceedance, data trending can alert the team to issues such as the need for more training, better environmental controls, or improvements in processes – before these latent issues result in an exceedance or a patient injury.
3 Data Trending Requirements Spelled Out in USP <797>
USP <797> can get very prescriptive in some areas and less so in others, leaving it up to the compounding pharmacy to assess their risks and design a quality control program that addresses them. Below are three sub-sections of USP <797> that mention data trending in the context of microbiological sampling. While the language below is often a summary of the text, we’ve called out when it uses the word “must” vs “should.”
Section 6.1 General Monitoring Requirements - Sampling data must be reviewed regularly to detect trends. Furthermore, additional sampling must be conducted “in response to identified trends (e.g., repeated positive gloved fingertip and thumb sampling results, failed media fill testing, or repeated observations of air or surface contamination.”
Section 6.2.3 Viable air sampling data evaluation and action levels - CFU counts must be evaluated to identify adverse results or trends. If an exceeded is discovered, a corrective action plan must be developed in line with the CFU count and the microorganism recovered. This investigation should include an evaluation of trends.
Section 6.3.3 Surface sampling data evaluation and action levels – The language here is the same as for viable air sampling. CFU counts must be evaluated to identify adverse results or trends. The exceedance investigation should include an evaluation of trends.
Any data trending that “must” be done is clearly an explicit requirement. I’d argue that “should” is a pretty strong statement as well. If there is an adverse event and the pharmacy didn’t do what it “should,” they’re going to have to explain why. Frankly, since you’re already collecting the data, I don’t know why any pharmacy would choose NOT to review it in the event of an exceedance.
While we’re on the subject of data trending, let me also provide another plug for genus identification. I wrote a post several months ago on the importance of genus identification. If all you’re looking at is CFU counts, you don’t know as much about the “trend” as you should. For instance, in one sample, your colonies might be all Micrococcus luteus. In the next sample, the CFU count remains the same, but the colonies are a completely different microorganism, such as Aspergillus. Even if there isn’t an exceedance, you may have a quality control issue that needs to be addressed. Without genus identification, you might not have a clue.
Is Yours an Effective Quality Control Program?
It’s been said, by me as well as others, that USP <797> is a “standard of minimums.” By that we mean the United States Pharmacopeia (USP), the standards body that created USP <797>, has left a lot of details up to the pharmacy. However, it’s important to keep in mind that Section 6, the section that covers microbiological monitoring, starts with these words:
An effective microbiological air and surface monitoring program provides information on the environmental quality of the compounding area. In addition, an effective microbiological air and surface monitoring program identifies environmental quality trends over time, identifies potential routes of contamination, and allows for implementation of corrective actions to minimize the risk of CSP contamination.
This language leaves little doubt as to how the USP views data trending. While they’re willing to let individual pharmacies determine some aspects of their program based on their risk assessment, data trending is not optional.
Have Questions?
As usual, we’ve simplified the topic of data trending to cover it in one blog post. If you have detailed questions about trending, such as what to track, how to implement it, or what the results mean, we’d love to hear from you. Data trending is an incredibly critical component of a USP <797> quality control program, and we’re happy to work with clients to help ensure their success.
