Over the life of my career, I have utilized paper, Excel, Watson LIMS, Star LIMS, and most recently a custom, off-the-shelf (COT) program from Lockbox LIMS from Thirdwave Analytics to keep track of reagents, samples, and reference material. It is difficult, a little scary, and not for the faint of heart!
Even after 28 years, when asked where a sample or reference material to make a new set of controls and standards is, I still get a chill up my spine—and a fight or flight response—because what if we can’t find it? Honestly, it is bad enough when one of your lab mates comes up and asks. So when a client or the FDA asks for the audit log, and asks to be taken to the location, it is downright terrifying.
Transitioning a Process Can Be Hard
One thing I really enjoyed about working in small labs is (mostly) everything can be managed with paper and Excel. Unfortunately, many labs hold out too long before moving to a more advanced electronic solution because of the initial investment. When you start out looking at an all-inclusive system, you are looking at spending over $100,000. The next best option is spending time to build a COT system. Once the decision is made you must bring the system online and train everyone—and I do mean everyone—on the use of the new software and the importance of it. Inventory your storage units, import the data, re-inventory everything using the new reports, make corrections, and then finally go live.
After 3 months, even if it looks great, you should go back and check to run an inventory list of each storage unit and make sure you really have what you think you have. Unfortunately, I know from personal experience that it will not be correct, and it happens because of good intentions. Here are some common dialogues:
“The lab never used to require you to log into the inventory of all samples generated in the lab. Why should the scientist not just place the samples in the controlled inventory freezer?”
“I just needed to get a reference sample to make the stability samples and I did not have time to make the request, so I asked someone from management to unlock the freezer for me. Then did not document in my notebook where the material came from or remove it from the LIMS software.”
“Our client needed samples shipped ASAP, so we went into the freezer and physically removed them and forgot to document the removal.”
“There was a power outage and instead of calling the inventory management group we just moved everything out of the storage room and moved them to other storage units throughout the lab.” This one caused me to lose a few racks of samples for about a week.
“Sample management moved the samples to my freezer. I don’t have to document them moving to my work bench. I only throw out tubes when there is no sample left.”
“I just documented that freezer number because I knew it was the correct temperature the samples should be at. I did not notice the actual freezer number.”
In Sample Management, Compliance is Key The sad truth of sample management is that even with a nearly perfect electronic system that is easy to use, user compliance is everything and humans tend to find ways to make a mess of things. I was working in a high-throughput laboratory where individuals were running thousands of samples a week. They had the ability to scan a box of samples from sample management storage to their freezer shelf to their benchtop and back. Easy peasy—and the LIMS system would keep the chain of custody! The only problem was that people kept forgetting the scanning process, samples got lost, and the chain of custody was broken. Thankfully, most of the samples were found. But to mitigate the missed scanning, a paper form was generated. At each step, not only did the samples get scanned to a new location, two people had to sign off that it happened. It is a horribly inefficient method to correct these types of errors, but management did not want to disrupt the analysts’ work process and enforce the proper use of the electronic system.
Process Flexibility is Determined by You
If you are not going to enforce the proper use of your electronic chain of custody, you must create a paper chain of custody and then ensure that QC and QA are regularly confirming the use and compliance. Then to make the sample management group’s life more difficult, they must regularly reconcile all samples in their care manually until compliance is once more obtained. I recommend using the AQL system to determine the number of racks and boxes you must check.
There are many times that when a laboratory has not complied with the processes for too long, you end up needing to tighten the process so that it is so inflexible that the individuals must comply, or they do not get their samples to work. No one wants this—but when dealing with controlled samples, chain of custody is paramount. The last thing you want is the client or the FDA to request a sample disposition and you give them the freezer shelf and box ID—only for them to go to the freezer farm and find that it is not there.
Need Sample Management Support?
Do you find yourself in a position where your company needs help with sample management or LIMS? Process Alliance has the experience and expertise to provide you with the support you need—from implementation, to remedial corrections, to process vs. practice studies. To learn more, email us at pa.info@pa-engineering.com, or visit our website.