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

By Chris Centeno, MD /

Receive a Regenexx® Patient Info Packet by email and learn why it's a superior regenerative solution.

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.

Category: Uncategorized

Leave a Reply

Your email address will not be published. Required fields are marked *

3 thoughts on “In-House Regen Med Labs: Great Idea or Dangerous?

  1. Edward Dieguez Jr MD

    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.

  2. Elizabeth Bonet, PA-C

    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.

  3. Esther L. Reinart

    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.

Chris Centeno, MD

Regenexx Founder

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

Get Blog Updates by Email

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Regenerative procedures are commonly used to treat musculoskelatal trauma, overuse injuries, and degenerative issues, including failed surgeries.
Select Your Problem Area
Shoulder

Shoulder

Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. Before considering shoulder arthroscopy or shoulder replacement, consider an evaluation of your condition with a regenerative treatment specialist.

  • Rotator Cuff Tears and Tendinitis
  • Shoulder Instability
  • SLAP Tear / Labral Tears
  • Shoulder Arthritis
  • Other Degenerative Conditions & Overuse Injuries
Learn More
Cervical Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Knee

Knees

Knees are the target of many common sports injuries. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. Regenerative procedures can be used to treat a wide range of knee injuries and conditions. They can even be used to reduce pain and delay knee replacement for more severe arthritis.

  • Knee Meniscus Tears
  • Knee ACL Tears
  • Knee Instability
  • Knee Osteoarthritis
  • Other Knee Ligaments / Tendons & Overuse Injuries
  • And more
Learn More
Lower Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Hand & Wrist

Hand & Wrist

Hand and wrist injuries and arthritis, carpal tunnel syndrome, and conditions relating to overuse of the thumb, are good candidates for regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Hand and Wrist Arthritis
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb)
  • Other conditions that cause pain
Learn More
Elbow

Elbow

Most injuries of the elbow’s tendons and ligaments, as well as arthritis, can be treated non-surgically with regenerative procedures.

  • Golfer’s elbow & Tennis elbow
  • Arthritis
  • Ulnar collateral ligament wear (common in baseball pitchers)
  • And more
Learn More
Hip

Hip

Hip injuries and degenerative conditions become more common with age. Do to the nature of the joint, it’s not quite as easy to injure as a knee, but it can take a beating and pain often develops over time. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures.

  • Labral Tear
  • Hip Arthritis
  • Hip Bursitis
  • Hip Sprain, Tendonitis or Inflammation
  • Hip Instability
Learn More
Foot & Ankle

Foot & Ankle

Foot and ankle injuries are common in athletes. These injuries can often benefit from non-surgical regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Ankle Arthritis
  • Plantar fasciitis
  • Ligament sprains or tears
  • Other conditions that cause pain
Learn More

Is Regenexx Right For You?

Request a free Regenexx Info Packet

REGENEXX WEBINARS

Learn about the #1 Stem Cell & Platelet Procedures for treating arthritis, common joint injuries & spine pain.

Join a Webinar

RECEIVE BLOG ARTICLES BY EMAIL

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Subscribe to the Blog

FOLLOW US

Copyright © Regenexx 2019. All rights reserved. | Privacy Policy

*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.

LinkedIn
Email