In-House Regen Med Labs: Great Idea or Dangerous?

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

Processing blood or bone marrow takes specialized equipment like a Biologic Safety Cabinet (BSC) (that you use), pipettes, sterile tubes, special centrifuges, cell counters, etc… However, not only does it take special equipment, but you have to make sure the equipment works as advertised. Let’s just talk about the BSC. It has HEPA filters that clean the air that need to be periodically changed. The hood itself must be validated annually through special tests. Using the hood and cleaning it takes a specialized process.

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

SOP stands for “Standard Operating Procedure”. This is basically a highly detailed manual for everything done in the lab, from processing patient samples to cleaning the hood, to emptying the trash. Almost none of these labs I see out there have SOPs that would survive even the most basic lab audit.

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

A processor that works in one of these labs needs to be extensively trained. Most of these labs have processors that took a weekend course or watched a video. In addition, they need to be constantly monitored to make sure they know how to process samples safely. This requires testing and observation. Who is monitoring a lab in a tiny office? Nobody.

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

Is the processor really doing what they should to produce what the clinic claims? In the example above, the clinic said it was producing PRP which is concentrated platelets in plasma, but really produced PPP which has few if any platelets. At these small labs, there’s no one to check.

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 these small labs, there is no one to check to make sure that the lab isn’t producing samples laced with dangerous bacteria. How would you know if you were a patient?

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.

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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