If you read this blog you know that I often write about what I experience. This is a blog that’s been in my head for months, but a message from a medical provider knocked it loose. Today we’ll cover in-house processing labs and whether they’re better than bedside machines or if they’re dangerous if not done right. Let’s dig in.
Bedside Kits vs. In-House Processing
The vast majority of doctors use bedside kits to process platelet-rich plasma, bone marrow, or fat. The former is a simple affair where all you need to know is how to use the kit and where the “On” button lives. The latter is much more complex and also much more flexible. Meaning with an in-house regen med lab you can customize the sample more and create higher concentrations of cells than bedside machines. However, you also need to have some idea of what you’re doing, which regrettably for the vast majority of in-house labs is not the case.
The Regenexx Flexible Lab Platform vs. a Class or a Video
At Regenexx we’ve always used a Flexible Lab Platform (more on that in the video below). However, doing that right across many affiliates is a million dollar a year affair that takes a team of employees to train processors and monitor each site, as well as an entire R&D team. However, for the vast majority of doctors who have these labs in their practices, none of those controls exist. In fact, for them, what they know about processing came from a video or a weekend class. Let’s delve into how dangerous this can get.
The Message
The message that kicked this blog loose from my brain came from a medical provider who witnessed the following at a clinic with an in-house processing lab:
- Processing PRP in non-sterile tubes
- Using the wrong medical equipment to substitute for the proper and safer lab equipment
- Not using a sterile hood (Biologic Safety Cabinet or BSC for processing)
- Incorrectly making PPP and calling it PRP
- No physician-supervised QA program
- Protocols that were incorrect for producing the most basic orthobiologics
I’ve seen many of the same things myself and I’ve heard similar stories from other providers, so this information wasn’t new.
There’s quite a bit going on here. First, this is obviously a fly by night operation. They had sterility issues as PRP should only be processed in a Biologic Safety Cabinet and not at the bedside in an open fashion using the wrong equipment. They took out all of the platelets in the test tube and injected platelet-poor plasma while telling the patient they were injecting platelet-rich plasma. The doctor had no idea of the difference, even though he or she is the last link in that Quality Assurance chain. In summary, this is a DANGEROUS operation that is placing patients at risk and defrauding consumers in the process.
How Do You Do an In-House Lab Right?
From what I’ve observed, most in-house processing labs vary from ill-informed with poor quality management to outright dangerous as described above. Why? Let’s get into the details of what it takes to do this right. I’ll compare and contrast what we see out there with what we do at Regenexx.
All of the following needs to be dialed in to have an effective and safe in-house lab:
- Research and Development
- Equipment
- SOPs
- Training
- Quality Assurance
- Contamination Monitoring
Research and Development
Almost all clinics you could go to that have an in-house lab have zero R&D. Meaning, they took a weekend course or watched a video on how to process and there is no on-going development or testing even when the variables in the processing change.
Compare that to Regenexx, where we have a lab and clinical research team where we spend almost a million USD a year. On what? In part on continuously learning how to improve cell processing protocols. We also continuously test our assumptions about what we produce in our flexible lab platform and create new minimally manipulated orthobiologics to help our patients. Finally, we perform clinical research to ensure that what we produce works in real patients.
Equipment
At Regenexx, all of our labs are required to have their equipment validated by outside 3rd parties. Another example is an automated cell counter to determine the dose. Does the staff know how to use it? Is it working properly? Have the counts been validated against manual counts? At Regenexx we do all of this, at a clinic with an in-house lab, who knows?
SOPs
The SOP’s that run the Regenexx Flexible lab platform comprise about 1,000 pages in total and encompass almost 100 separate documents. The pic shown here is a tiny fraction of these that I was updating with our lab manager at Centeno-Schultz. However, having the documents is one thing, but you also need to test the processors on these documents to make sure they understand how to use them. Hence at Regenexx, we have developed those written tests for our processors.
Training
What if a processor leaves the clinic to take another job? At the average clinic, that processor learns from the last one, which can be like a bad game of telephone. At Regenexx, that new processor is required to be trained back at a central training facility by an actual expert.
At Regenexx, unlike these small clinics with labs, we have an actual training program with a curriculum for lab processors. That includes observational testing that they must pass. We have a camera in every hood where the processor can be monitored remotely for compliance with the protocols and sterile technique. We also perform on-site visits of all of our labs where experienced trainers go out and actually watch what’s being done.
Quality Assurance
At Regenexx we send out specialized processing blanks to make sure that the processor can achieve what we say they can without us looking over their shoulder. We also check up as described above.
Contamination Monitoring
At Regenexx, we send processing blanks out to make sure that the labs can process them without bacterial contamination. These are then grown out by a third party. We also require RODAC plate testing of the lab surfaces and air in the hood which is read out by a third party. Finally, we have rapid bacterial testers that can be used to quickly test any surface for bacterial contamination.
Quality Systems
In handling human tissues, the quality systems I’ve described are critical. Where are the quality systems in these small labs? As you see above, there’s real evidence that there are dangerous labs out there. Even the ones that aren’t outright dangerous don’t have the quality systems in place to protect patients. Hence these fly by night labs are low handing fruit for malpractice actions brought by patients, public health department shutdowns, or regulators trying to protect patients.
A Personal Message to Fly By Night Labs
If you don’t have ALL of the above quality systems in place, then PLEASE use a simple bedside kit system. If you still want to process your own samples, then you MUST have all of what I described here dialed in. If not, you DANGEROUS until proven otherwise.
The upshot? As a patient or physician, you need to make sure that the clinic you use has this stuff dialed in. If not, your medical license and your patients are at risk.
Agree with Dr Centeno 100%. So far we have only used the Emcyte system. I wonder which other ones I should look at that are affordable for a small practice.
Its ironic that these “fly by night” practices choose to attempt and replicate the protocols of using an open system because the cost of a butterfly needle and few vaccutainers is nothing compared to a 510 K approved, quality, closed system kit (approx $250). Of course, only if you disregard the necessity for all the required steps mentioned above, which significantly add to overhead.
But all of those “extras” can easily be omitted when your main concern is your profit margin instead of patient safety.
Each time I go in a Regenexx Clinic, I learn more and at Regenexx Las Vegas I became more aware of the importance of immaculate care with blood drawn, even prior to the vials going in the lab. By asking why the vials were being wiped down, I was told that even a speck of blood, ending up in the lab and not confined, risks contaminating someone else’s blood. This may be poorly explained, but my awareness of how careful and meticulous all your staff are, well, it just impressed me with knowing I was in the RIGHT place to be having someone work on MY body.