Even a minor lapse in identification, documentation, or laboratory can have significant consequences. Therefore, embryologists must develop systems that minimise risks while ensuring every procedure is performed with consistency, traceability, and accountability. This article explores the quality management practices that help laboratories maintain high standards of safety, accuracy, and clinical excellence.
Quality management is not only about preventing mistakes but also about preparing laboratories to respond effectively when unexpected situations arise.
Preventing Sample Mix-Ups Through Proper Identification
Another scenario that I came across along the way that I know happened to multiple labs in the earlier days of PGT were scenarios similar to this one, where PGT for aneuploidy diagnosis for advanced maternal age was performed. The MD ordered that embryo number three be transferred for a frozen embryo transfer. And the patient has a miscarriage at 11 weeks and they do follow-up genetic diagnosis of the products of conception.
And those products of conception indicate aneuploidy. So what happened? So was the genetic testing lab, did they have a misdiagnosis? Was the embryo mosaic? Did the IVF lab mix the patient samples at the time of cryopreservation? Did the IVF lab thaw the wrong embryo? There are a lot of different possibilities that you can work your way through. In this particular case, I know of labs that had, fortunately it wasn't my lab, but they had thawed embryo number three, was transferred, but it was embryo number three from the wrong cycle.
And I went back through some of our data. This is actually a case from Yale where, again, a real-life scenario, and we didn't mix this up and I'll explain why it didn't get mixed up. This particular patient had biopsies done.
This is back in 2018:
- First cycle, she had embryo number one and two.
- Second cycle, she had embryo number one and two.
- Third cycle, she had one, two, and six biopsied.
Then we had one and four. So, we're up to four number ones.
Here's five number ones. So out of all the cycles that she had, she had five number ones. So, by just transferring embryo number one, that's a big recipe for a mix-up.
So I always kick back to our clinical team. You need to have a biopsy date or a unique identifying number. And it's really important how you do that in your specific lab can be up to you.
But certainly with the various cryolabels and Brady labels, you can put a lot of information on those labels. So you can put the patient's name, husband's name, medical record number, embryo number, patient's date of birth. This is a unique cycle number, what stage it was that was frozen. This is the unique cryo number for that particular straw that relates to that particular embryo, and then the freeze date. So really crucial steps to make sure that the right embryo and that you're communicating properly with the clinical team.
Quality Management: Preparing for the Unexpected
I'll give you one other quick example of a QM scenario, and that is, this was actually a lab that I was off-siting, and we had liquid nitrogen alarms, and the service tech had been in to add and repair probes.
And the embryologist had gone through and pulled all the probes to test, and they said, yeah, yeah, yeah, everything works, all the local alarms sounded. And I said, okay, let's prove it to me. I want you to like pull the probes, and I want it to call through to me.
And when we went through all the probes, we got to like tank F, and tank F never called me. And what happened was the service tech, they had an old redundant probe. So when they pulled the probe, it gave a local alarm, but that particular one didn't go around the corner and relay to the telephone alarm system. So when they pulled the local alarm, it alarmed, but it never would have called anybody at night. So it's really important to follow those steps all the way through to the alarm system calling you, not just giving that local alarm.
Beyond individual incidents, long-term laboratory success depends on creating systems that encourage consistency, accountability, and continuous improvement. Modern Embryology Courses in Bangalore, India increasingly emphasises collaboration, benchmarking, and mentorship, recognising that continuous learning is essential for maintaining high laboratory standards.
Building a Culture of Quality and Safety
So again, quick summary, crucial components, it's really important to have clear communication between the clinical team and the IVF lab team, clear communication between the lab and the genetics lab, very neat and clear records.
Again, really important. It's important to leave those breadcrumbs because the work that we do can be in our tanks for 10 plus years. And I'm hoping to be retired 10 years from now.
Hopefully Mitch is probably going to be retired 10 years from now. And it's really important for us to leave those clear signs of what's in our tanks. I recently last summer was discarding embryos that were from 1987.
So we had embryos that were frozen in glass ampules. So they can be around for a long time. So clear records are important, systematic accessioning and unique identifiers are important and multiple identifiers, not just a name, not just the date of birth.
So it's important to evaluate your workflow back to receiving the eggs in the sperm. And it's really important to own the near misses and see those near misses and revise your SOPs to catch or avoid potential future errors. So really be introspective about it.
Don't be traumatised by it, but be constructive about it and put new protocols in place to alleviate that. So we have to have clear documented orders about which embryos to transfer. And last minute changes to plans, try and avoid those whenever possible.
And I know it's impossible but, and we're victim to it all the time as embryologists, but push back on those whenever you can so that you have clear orders and you're not rushed to do things at the last minute. Have a documented SOP on how last minute changes of plans are communicated. So finally, double and triple identification of samples.
Again, unique accessioning numbers for each procedure, every step for a retrieval accessioning number, a cryo number, a transfer number so that you can have those all accession. Include the cryo date and the embryo number. Have two embryologists or a witnessing system.
And when you implement a witnessing system, you need to be very thoughtful about all the steps that you put into that witnessing system, because it's very easy to miss a step and feel secure with a witnessing system that may not catch every step of your protocols. Document with an initial or sign off or an electronic witness. And that's a CAP thing.
Chain of custody is a big thing for CAP inspections. Verbally say the names as you move from dish to dish. That's a really good safety thing to do because if you're moving from dish to dish and you're reading the names off and you say Jane Doe and you move to Jane Doe, Jane Doe number one, Jane Doe number one, if you're in a different dish, you're going to catch it.
So I'm a big proponent of saying things verbally out loud. Use video on all the microscopes in the lab so there's a lot of transparency. And have the PGT report and the ID by the MD and the patient before transfer.
So every time we do an embryo transfer, we review the actual label from the straw with the patient. We show the patient the PGT report and we confirm that yes, we're going to transfer embryo number three. This is the report that shows that embryo number three is normal.
While internal quality systems are essential, continuous improvement also comes from leaning
Learning Through Collaboration and Benchmarking
And then we'll show you the dish with your name on it and confirm it's you again. So finally to help us all improve between labs, we need cross comparisons between labs and transparency and open dialogue about our data and our performance. So find some friends.
Hopefully these networking sessions will bring this around so you can sort of feel out the people in the sessions. And if you don't feel comfortable doing it in the breakout session, feel free to contact us. Most of us in the group are pretty open.
Sometimes we're busy so we might not get back that day, but most of us are open to having dialogue. So if you call up, I mean, I used to have an infertility counsellor that would call me and say, so this is what the patient's telling me. Does this make sense to you? And we would talk through.
So find some friends with some experience and latch onto the mentorship that is out there for you. So solid quality control for laboratory factors, temperature control of all the stages and your culture conditions, looking at blastulation rates. And one of the things that the egg banks do very well is they're tracking and they're sharing performance and the genetic testing labs are tracking and sharing performance.
Our performance is sort of out there in SART data, but SART data is so complicated. It's not really easy to compare. So, you know, be transparent, ask, you know, ask people what their data is and see if you can get some good comparisons for yourself.
Final Thoughts
So finally, I think, again, important for those cross comparisons between labs, transparency, solid quality control for laboratory factors. Yeah. So, and then I'm going to leave you, we didn't even touch what a sperm might be going through in your lab.
However, technical skills in themselves and scientific knowledge are not sufficient to create a successful embryo lab. To have reproducible results, you need strong quality control processes, good communication, adequate documentation, witness procedures, and a mindset geared toward continual learning and improvement.
Each embryo worked on in the laboratory signifies the desire of a patient to establish a family. Through adopting strict quality standards, learning from near misses, laboratory performance benchmarking, and collaboration, embryologists can be part of the process of creating safer laboratories.
Those who wish to take their proficiency to the next level with the help of a Fellowship in Reproductive Medicine in India need not only to gain an understanding of science, but also to become knowledgeable about quality management practices. These two components are the backbone of high-quality embryology.
The Medline Academics' Fellowships in Embryology and Fellowships in Reproductive Medicine program serves as an extensive resource for those who wish to become experts in the field of Assisted Reproductive Technology. These fellowships were designed using the hybrid learning approach in Bangalore where students can learn by participating in both online interactions and clinical experience simultaneously. Using a curriculum that incorporates science, laboratory skills, quality management, and clinical practice based on research, Medline Academics equips future professionals in fields such as doctors, embryologists, scientists, nurses, and counsellors for a fulfilling career in reproductive medicine. Prospective professionals seeking Embryology Training in India, Fellowship in Reproductive Medicine in India, and information regarding Embryology Course Fees may access these courses to find out which one is best suited to their career goals.
An important factor that differentiates Medline Academics fellowships from others is the possibility to get hands-on experience in clinics at Dr. Kamini Rao Hospitals, which is one of the most renowned IVF hospital in Bangalore specializing in reproductive medicine. The institution was established under the guidance of Padma Shri Prof. Dr. Kamini A. Rao, who is famous for his innovations in IVF treatments. By going through the structured process of clinical training, the trainees will be able to witness laboratory processes in action and learn from skilled embryologists and fertility experts. This blend of classroom education and clinical experience will make up for any gap between theoretical knowledge and practice of embryology.
Discover the Fellowship in Embryology at Medline Academics. Get all the information about the program format, admission requirements, Embryology Course Fees, and batch starting dates from the official website or by contacting the admissions department directly.