Understanding CLIA and CAP Regulations to 
Advance Your Laboratory Career

Thank you, Alicia. I appreciate the opportunity to be here today. I just wanted to make 
sure that everybody is able to hear me loud and clear.
We can hear you. 
Perfect. All right. Moving on to the first slide, please. I will be addressing CLIA and CAP, 
and to go through the benefits of understanding this regulatory in order to advance a 
laboratory career. I will say that I have no conflicts of interest. And my only disclaimer is that 
the opinions and comments in this slide are not a reflection of my employer, Thermo Fisher 
Scientific. Next slide, please.
Today's learning objectives are going to focus on comparing and contrasting two 
regulatory bodies, CLIA and CAP, which many laboratorians are familiar with. We're going to list 
benefits of knowing regulatory requirements and describe how knowledge of these 
requirements can advance your career as a medical laboratory scientist. Next slide, please.
Starting out with CLIA, if you're working in the laboratory, you've probably heard this 
thrown around many times. This started way back in 1967, and it was revised big time in 1988, 
finally being voted on in 1992. This occurred because in 1987, a series of newspaper articles 
were bringing up health issues, and they were starting to question the laboratory quality and
the integrity. And this started with the cytotechnology area of the [INAUDIBLE] part of the 
laboratory.
So of course, when you open up a can of worms, you're going to be scrutinizing every 
portion of the laboratory. So congressional hearings were heard and the laboratories were 
investigated. If you type in CLIA into your search bar of any internet, you may not actually end 
up with the Clinical Laboratory Improvement Amendments. 
Typically if you type in CLIA, you're going to end up with the Cruise Lines — excuse me. 
Cruise Lines International Association. This is obviously not where you want to be. And one of 
the difficult parts is really honing into where to find information with regards to CLIA. Next 
slide, please. The CLIA Improvement Act was made to improve certification oversight of the 
testing of the entire country. This was focused primarily for human being testing. And also the 
standards focus on accuracy, reliability, and timeliness for clinical laboratory testing. Next slide, 
please. 
The issued document in 1992 highlighted CLIA's purposes of ensuring quality, preserving 
access to testing, especially for those in rural areas where it may become more of a problem, 
using of new technologies. So keeping up with the advances in technology, and then applying 
them to the clinical laboratory. Applying minimal standards based on test complexity. And 
we're going to discuss the different test complexities coming up in a few slides. And establishing 
a cost-effective requirement that are achievable for settings that perform testing. So this is 
looking at the cost regarded to patient and also the health care system. 
And that link at the bottom is where you can find an online edited version with regards 
to the CLIA responsibilities for laboratories. Next slide, please. 
While CLIA is the list of rules, the Centers for Medicare and Medicaid Services are the 
enforcers of the rules. This is the arm of our government system that is responsible for 
overseeing to make sure that quality is encompassed and monitored in the laboratory system. 
So again, CLIA is the list of rules, but CMS is the enforcer of these rules. Next slide, please. 
Now if you can imagine, having CMS oversee every laboratory — physician's laboratory 
office in the entire United States would be very cumbersome and overwhelming. So what CMS 
did was, they granted accreditation to various regulatory agencies to help them. So if you apply 
for your CLIA license, the first thing that you're going to get is a certificate of registration. And 
this is important to know, when you're walking into a laboratory to be looking for these 
certificates that should be visually, publicly displayed upon entering the building. 
This registration indicates that they have filed for recognition for CLIA, and they are 
requesting an inspection to come along. If the laboratory processes all the paperwork correctly 
and they are able to have their inspection, they then will receive a certificate of compliance 
from CMS. And again, this should also be publicly visible in the laboratory. 
On the other hand, laboratories have the option of going the certificate of accreditation 
route, and this is to go through organizations that CMS has deemed appropriate to conduct 
inspections on their behalf. Next slide, please. One of these organizations that achieved this 
accreditation is the College of American Pathologists, also known very widely in the laboratory 
field as CAP. 
They were acknowledged as having deemed status in 1994 by CMS, and they are 
recognized as having the most stringent and toughest standards with regards to laboratory 
quality. One thing to note is that the CAP is a pathologist-directed organization. And if you 
know anything about the hierarchy of laboratories, laboratories are overseen by pathologists 
with regards to medical testing. Next slide, please.
Another mention here is going to be for COLA. This is the Commission on Office 
Laboratory Accreditation. This is another regulatory agency that was deemed accreditation 
status in 1993 by CMS, but this is also a physician-directed organization. So in reviewing the 
two, CLIA versus CAP, having a different organization overseeing it sometimes leads to different 
standards or quality control methods. While many laboratories are COLA, the majority, 
especially those laboratories that are focused on molecular testing — they lean towards CAP. 
Next slide, please.
So why would people lean towards CAP? What does CAP have that CLIA doesn't? Well, 
for starters, there are discipline-specific test lists that are updated annually. This gives the 
laboratory more black and white standards to compare their quality to. Peer inspections are 
included as part of the CAP program. So internal inspections are done before the external CAP 
certifications are done.
Additionally, CLIA — or, excuse me, CAP also contains a proficiency testing program. We 
will discuss what this is and what the importance is, and why that combination with CAP's 
offerings is a benefit to laboratories. Next slide, please. 
So for those labs that focus on molecular testing, one of the reasons they choose to go 
with CAP is because CLIA is fairly outdated. We recently had some changes, but not with 
regards to the standards involving with molecular testing and advances in technology. 
Currently, CLIA only has two mentions of molecular, while CAP offers an entire molecular 
pathology checklist for their laboratories. And it really digs into various types of 
instrumentation and applications. 
For example, on the right coming from CAP, we have specific mention of next 
generation sequencing and also for arrays and different procedures that are not even remotely 
encompassed in the CLIA guidelines. And that is just due to the fact that CAP is certainly on top 
of the technology that's offered today, which if you remember, is one of the requirements for 
CLIA — is to make sure that technology is observed and used where most appropriate as times 
change. Next slide, please. 
Also within the CAP checklist are these nice boxes that point out instructions to 
inspectors, but also what types of questions that would be asked so labs have a better idea of 
what the inspectors are going to be looking for when they come in the door. CLIA's outline of 
standards is very black and white, which gives you a lot of options for flexibility. However, for 
those inspectors that are really going to hone in on specific questions regarding molecular 
technology or for, in this case, specimen collection and handling, the checklists are really nice to 
open up what type of appropriate measures need to be taken to be prepared and pass their 
inspection successfully. Next slide, please.
Here's another example of excerpts. On the left we have the CLIA standard, and on the 
right we have the CAP checklist. And again, you can see not only is the CAP checklist itemized 
with an explanation of what they are looking for, there are important notes that have been 
added in there. In addition, they even give a check of evidence of compliance, something 
specific that's documented in the laboratory that the inspector will be looking to make sure 
that this standard is met.
Additionally, you'll see in the lower right, there's also references. So this is scientific

based papers or guidances from Clinical Laboratory Standards Institute or other organizations 
to help provide evidence as how to tackle this checklist requirement. Next slide, please.
This is a diagram of the CAP inspection application process. So CAP is a membership 
program, so laboratories that would like to be part of the CAP program — they must go through 
this process in order to become CAP members, starting with, of course, an application which 
needs to be repeated. And then you have inspections that are on there. And then if you have —
excuse me, if you have deficiencies within that inspection, you need to review them, correct 
them, and then send in your corrections or prove that you've corrected them to CAP.
And once this first year is in the system, each year is going to be a different part of the 
review system. And there are requirements that you will have to do for CAP, whether it be peer 
inspection, or having a peer inspection, or different parts of the regulatory quality management 
system. So CAP does a really great job at keeping labs on top of things because they always 
have this constant process. Next slide, please. 
Why is it important to be familiar with these regulatory requirements? Regulatory is a 
huge part of the clinical laboratory. As anyone who's ever had medical treatment, whether it be 
for a family member or for yourself, you want to ensure that your loved one or yourself is 
getting the best treatment possible. And that means getting the right test ordered the first time 
and getting accurate results based on specimen collection.
So this is really important to not only the laboratory, but also as an informed consumer 
when you are looking to have your own laboratory tests done. But there are different types of 
test complexities that we must be aware of. There's waived, moderate complexity, and high 
complexity. And each of these test designations have with it specific testing personnel 
requirements, but also proficiency testing requirements that we are going to discuss further.
Why is it important to know all of these? Because as the laboratory population starts to 
turn over — and we've definitely seen a lot of people leave the laboratory field since the 
pandemic hit us, it's more and more important that we backfill individuals that are familiar with 
these regulations, because these regulations apply to every lab in the United States. And 
understanding how to maneuver through them helps not only laboratories for a hiring 
standpoint, but also for managers and supervisors that may be looking to fill advanced roles 
within their own company. Next slide, please. 
More reasons. So in addition to not only knowing those test designations of moderate, 
high complexity, and moderate complexity, you also need to know the difference between 
validation and verification. You must be familiar with your instrument maintenance, and also 
quality control measures. These are spelled out not only in the CLIA documents, but also in the 
CAP documents. 
And the reason that this is important is because verification and validation still cost 
money. This is long before a lab gets up and running live with patient testing in order to start 
making money on the tests that they're offering. You don't want to do any more red-tape 
testing than you have to, because you ultimately may be spending more money than had been 
budgeted to get a test up and running.
We are going to discuss verification and validation, and why they're important. If you're 
ever doing a training with a vendor or an instrument manufacturer, you want to make sure you 
get those maintenance records because you have to show to CAP and CLIA that you are staying 
within the guidelines that the manufacturer provided so that your instrument is well cared for 
and providing accurate results. Next slide, please. 
So looking at a big comparison, this question gets asked a lot. So while I used to be in 
the laboratory, I am now working with an analytical validation specialist team. So my 
responsibility is to help labs get up to speed with testing by helping them conduct their 
analytical validation or guidance for their verification. Labs need to understand what they have 
to test or what they need to do for their validations.
And while many labs are very proficient in this, we've definitely seen a decline in 
laboratories with fully-staffed individuals that know a broad range of this. The supervisors, the 
managers, HR — they're going to be more familiar with these types of things, but not 
necessarily every laboratory scientist at the bench level. So this is where people can brush up 
on this regulatory knowledge and really expand their career ideas or moving forward by getting 
to know how to do this.
Validations require different components than your verification. In a sense, verification 
is just saying, I would like to show that the instrument in the chemistry is performing as the 
manufacturer claimed. So you are verifying the manufacturer's claim as to this test that you're 
doing. Of course, you can go and do over and above verification, but this is the minimum 
required that is stated by CLIA. 
Validation is going to add some more components in there. And of course, this is very 
important for the high complexity testing because there are a lot more checkboxes to make 
sure that are incorporated before you're able to go live with the test. Next slide, please. 
Personnel qualifications. I would say that this is something that I had no idea about 
when I was working as a bench tech, because the different levels of complexity of testing 
provide different qualifications for these positions that are spelled out specifically in CLIA. So if 
you are looking to advance yourself to obtain a general supervisor position that is in a high 
complexity laboratory, you can go to these standards and find out exactly what you need. 
Do you have the education? Do you have the experience? Do you have the 
management? All of those items are addressed in the CLIA standards. And they may be very
vague, but yet also may also provide the opportunity for flexibility in terms of understanding 
and providing the information that they want. Next slide, please.
This is a chart of major CLIA regulatory milestones since the development of CLIA in 
1988. I will say that it is missing some of the more recent ones with regards to how laboratory 
testing is going to be regulated in the LDT section. So this will be being updated probably soon. 
But just to point out, when identifying the fact that CAP has more molecular requirements or 
regulations, that CLIA milestones only have four updates since its origination in 1988.
And if you can imagine, technology has really come a long way with regards to 
radiography and ultrasound technology and diagnostics in general. Molecular testing, 
multiplexing, singleplexing. Just looking at where we were a few years ago during the pandemic 
and putting in emergency use authorization testing in there also. Those types of things are not 
necessarily encompassed in the original documentation for CLIA. 
However, keep in mind that one of the CLIA standards is to provide continuing 
monitoring of laboratory performance and quality. So it should be expected that CLIA should be 
updating in order to keep with the times and the different quality systems now available. Next 
slide, please. 
Two of the standards that are very important to CLIA and CAP and COLA are proficiency 
testing and competency testing. And again, playing back into the fact that we have different 
levels of testing being moderate, waived, and high complexity, testing personnel also have 
different requirements in order to do that testing. But overall, the competency testing is 
responsible for the laboratory to make sure that every laboratory performing the test is 
competent and able to deliver accurate quality results in the end.
Competency testing evaluates the laboratory professional. Proficiency testing program 
evaluates the laboratory system. So you receive a sample that you are treating as a patient 
sample through the pre-analytic, analytic, and post-analytic stages of the laboratory system. 
Proficiency testing is very important because it is making sure that test samples are being 
handled appropriately from start to finish, and quality results are being generated by the 
technology in the laboratory. 
It is required that each lab must enroll in a proficiency testing program. As I mentioned 
previously, CAP has a proficiency testing program. However, you do not need to be a member 
of the CAP in order to participate in the proficiency testing program. I can't tell you how many 
times in the last three years I've walked into a laboratory and you ask them, are you CLIA or 
CAP certified, and they'll say, yeah, we're CLIA-CAP. Well, what they really meant was, they are 
CLIA certified, but they participate in the CAP proficiency test program.
Again, you don't have to be in both of them. You can be in one or the other. But it's 
important to recognize when a lab is participating in just the proficiency testing program and 
not the CAP membership itself. This is something that, if you recognize in your laboratory and 
you think it's an opportunity to move towards CAP accreditation, you can start with 
participation in the proficiency testing program as your first steps to be exposed to CAP, and 
then consider membership afterwards. 
But knowing the difference between these two types of testing and how to use that to 
move forward for, let's say, an internal promotion or even an external promotion, laboratories 
are in need of understanding how to perform this and the importance of doing so. And I do 
mean by laboratories that should have a protocol for completing their testing — their standard 
operating procedure. And proficiency testing should follow that SOP as written for the 
specimens for the laboratory unless CAP provides specific instructions on how to do a different 
preparation.
Once in a while, this will happen with samples that cannot be processed the same as a 
traditional patient sample. And that's just because the materials that CAP is using for testing 
may not be 100% biological in nature. They may be commercially derived or synthetic. Next 
slide, please. 
Quality system is a really big deal also. And again, if you're working with somebody 
that's relatively new in the laboratory or perhaps primarily on the bench and not aware of the 
entire quality system, this is another question series that we receive when we go on site and 
we're working with laboratories. They will also often ask us questions. What controls do we 
use? Or, how many times do we have to perform controls?
And the guidance that we can provide back to them is, what does your quality 
management system say? What have you established in your laboratory? And by adding new 
testing, how do you stay within those confines? This comes up a lot when we work with 
laboratories that are implementing new testing, and perhaps they've just hired new individuals 
to perform this testing and they're not familiar with the entire quality system. By pointing them 
back to a quality system, that points them back to their manager or their supervisor to make 
sure that anything that is coming within the training or this new testing is going to stay within 
this quality management system. 
And often we will get questions, but we cannot provide direct answers for this because 
we cannot possibly know every quality system of every laboratory. Yes, the generalities should 
be within the CLIA and CAP standards. However, it's not within our nature to provide guidance 
as how to handle questions like this. But again, this goes back to the CLIA standard that there 
must be a continuous process evaluation, monitoring, and improvement for the total testing 
system.
And again, that's the pre-analytic, the analytic and the post-analytic. Pre-analytic is 
everything that happens to the specimen prior to the actual testing. Analytic is the testing itself. 
And post-analytic is getting the results into a laboratory information system or out to the 
physicians to communicate to their patients. And that's how the testing process is broken 
down. Next slide, please. 
So moving into the analytic systems, this really is the heart of the clinical laboratory. This 
is where you can find all of the meat, if you will, for the policies and procedures that are 
needed. We often have to point back to this to customers, that written policies and procedures 
are necessary for each test. You cannot use one as a blanket for another one. 
Again, addressing verification versus validation, the lab should be setting up a system 
for how they are going to conduct verifications and how they are conducting validation so that 
each new or subsequent verification and validation that they bring in-house follows all of the 
appropriate procedures that they had already set in place.
Instrument maintenance and function checks. This is, again, important. Going back to 
proving that they are staying within the manufacturer's recommendations in order to assure 
best performance of and the life of the instrument. 
Control procedures. This is your positive. This is your negative. This is your negative 
template control. This is your positive extraction control. I'm sure many of these may sound 
familiar, but you need to have understanding of what different types of controls are you using? 
Are you using process controls or system controls? There are a lot of different terms, especially 
across the US and in various different sub-regions, that use different terms for controls and 
understanding. 
How those terms are used from lab to lab certainly gives you an advantage if you're 
looking to move out of one type of industry lab into more of a private doctor's lab, or perhaps 
even a research lab or something that works in conjunction with the medical hospital. Knowing 
how to use controls and how to best apply them is really important, but also to be cost 
conscientious. 
It's not always the easiest thing to throw all the controls on there so that you know you 
have everything right. There must be a cost component that's assessed in there, because if you 
out-cost your test so that there is no profit, you're going to basically run that test or that lab 
into the ground, per se, because you're not recouping your cost. So you have to be very careful 
the controls that you pick and how much they cost. Either they're commercially available or 
developable in house. But these are very common questions that are asked of us. 
Comparison of test results, also known as a method comparison. If you are running the 
same targets on more than one platform, you have to make sure that you're comparing them 
against each other. So if you have one test on a machine by vendor A, but you also test the 
same targets in a different panel on machine B, that same material should be tested to coincide 
that you are getting the same result for that.
And again, that's going to be analyte specific. It's not going to be all of the tests. If 
they're just testing, let's say, influenza A on one platform, and then you have a panel that 
includes influenza A, you must do a test comparison to see if those are coinciding or if they're 
discrepant results. 
Corrective actions. This falls into the quality management system. When something 
goes wrong in the monitoring process or in the live process, it must be documented. It must 
have notes. It must have root cause analysis. The point of having these corrective actions are to 
prevent the same problems from happening again. So that is why the quality management, 
observation improvement part is really important — because we want to stay on top of up-to

date technology or improvements or even recommendations that come from organizations —
lab testing recommendations. 
Test records are another important component of the analytic process. So this is, how 
long do records need to be retained? Can they be retained on a thumb drive or USB drive? Do 
they need to be centrally located? Can they cross through the LIS intranet or versus intranet? 
This is important because different tests have different retention.
Many of the genetic tests have at least a 10-year retention requirement, while there are 
some other basic tests that only have two years. So knowing the complexity of the test helps 
you understand the test record system. And so when you are implementing or building in a new 
test, you have the knowledge to figure out the most analytical part of this after the test is 
resulted and have been given out. And again, we have our analytic systems quality assessment 
for ongoing improvement. Next slide, please. 
So what are these benefits? So in looking at varying job responsibilities, you can serve as 
an internal inspector. You will be going to either your own hospital system or a sister hospital 
system in the area, and you'll be getting to see what other labs are doing. Other — excuse me. 
Other policies and procedures. This is definitely one way that I started to get my foot into the 
regulatory system, because it was relatively easy.
I was already going for the training for the instruments, and so I became the key 
operator and knowing its ins and outs. And I became the best person to write the policies and 
the procedure for that testing because I had gone through a manufacturer training. But I also 
knew how our internal laboratory information structure worked. So I could definitely build the 
procedure within the electronic health record system that we had for managing policy and 
procedures.
Managing staff competency. It's not easy for one person to monitor, let's say, a lab of 24 
or 25 — maybe even more. Labs often have different departments, and there are people within 
that department that have to manage staff competency. Competency is an ongoing thing. You 
have initial-hire
training, paperwork. You also have six-month paperwork or that competency testing 
that needs to be done. And then you have a year testing. 
And again, the different complexity of testing determines how much staff competency is 
required and the frequency by which it's required. So this is another way to slowly move into 
regulatory knowledge to be — excuse me — promotion eligible within your facility. If managing 
the staff competency is enough, there's always proficiency testing. Again, as every lab is 
required to do that, somebody must be in charge of getting the results recorded into the 
appropriate method, whether it's electronic or paper.
And somebody must make sure that they're organized, to make sure that no proficiency 
testing is missed, or that the results come back in a timely fashion and that they're 
documented. In addition, if there was a problem with the proficiency testing, an investigation 
needs to be done. Somebody needs to oversee what went wrong with that particular test and 
how to prevent a wrong interpretation moving forward. 
Again, verification and validations. Those are perfect ways to start advancing your 
career. Because again, you have to get familiar with all of the other things that we've talked 
about in order to make these work. And that's definitely an opportunity to show responsibility 
and also record keeping, but also taking on a lot of responsibility that can really help you shine 
in terms of what you're capable of.
With regards to external inspection opportunities — so if you thought you learned a lot 
by going to the sister lab that's part of your health system, going to other labs outside of your 
health system are also very interesting. You get to see how they are either doing it well or they 
are doing it poorly. And you can come back to your laboratory and discuss with your supervisor, 
hey, I saw this. This is working really great. We've been looking for another way to improve this.
So getting to see other laboratories is only a benefit — not only benefits to you because 
you are good to see how other things are working and, again, provide recommendations to 
make things better. Again, this is important part of identify, replicate, and implement different 
labs' achievements, and certainly learning from their failures at the same time without having 
to go through it yourself. 
Reimbursement has definitely become a hot topic over the last 10 years. The Palmetto 
MolDX program definitely is affecting clinical customers. There were new changes that were 
implemented in April of 2022 that are still having cascading events or cascading problems that 
have been occurring with this as labs have to adjust their panels and their offering within this 
constriction to make sure that they are going to meet reimbursement.
So if you're interested in the dollars and you are technically savvy because you 
participated in verification and validation, people are needed to address the MolDX technical 
assessments. And this is only going to become more prevalent as time goes on. While this 
program does not oversee all 50 states, it does oversee many of them. And if you happen to be 
in one of those states, it's good to understand what these requirements are and how they 
affect your laboratory. Next slide, please.
Again, looking at career advancement, this is not limited to internal, but also external. 
Again, participating in inspection and learning about verification processes and regulatory —
those certainly open doors to external opportunities. And we're going to talk about a few of 
those options coming up. 
Educational opportunities. This is another way that I started into benefiting myself and 
really broadening my knowledge. I took responsibility for teaching the new laboratory staff that 
came in, which meant that in order to teach them, I had to teach myself, which is where I 
learned the requirements for testing personnel and the different complexities of testing. 
And not only that, but you can go beyond just your laboratory staff internally, but you 
can become a adjunct instructor for MLT or MLS programs, which I've also done. I've been able 
to take all my experiences and be formal teachers. But we also touch on such things as 
regulatory. But understanding all educational in general is definitely a way to boost your career. 
And last but not least, of course, there's conferences, which is where we are today, as I'm 
presenting here to you on behalf of the CDC's OneLab Summit.
The quality management system — I think this quote gets used often: If you see 
something, say something. But it's very appropriate in this case, because nobody cares about 
the laboratory more than the laboratory people in it. If you meet with any laboratory individual 
that has really dedicated their life to this, they have gone through the educational. They have 
benefited and participated in professional societies. 
We care the most. We know how to navigate through the requirements. We want the 
best for our patient, but also for our profession. As someone who represents our profession, I 
want to be proud of what we do and how we do it. So knowing your lab's quality management 
system ensures continuous improvement of the performances and services. But again, while 
each lab has its own quality management system, there should be similarities between all of 
them. And some labs may do better than others. And you'll see that if you're able to participate 
in inspections. 
Next slide, please. So here is the summary of how all of these different things can 
advance the career. So, for example, we talked about different promotion opportunities. And 
this can be internal or it could be external. It could be even a different group within the same 
company. 
Regulatory agencies. Let's not forget that all of those inspections still need people to 
complete the inspections. We have CLIA, we have CAP, we have ASCP — American Society for 
Clinical Pathology. We have COLA. We have the Joint Commission. All of these agencies have to 
understand what's required of the laboratory. So if you really want to market yourself, perhaps 
to be one of those inspectors or to be responsible for approving paperwork for laboratories, 
regulatory agencies could be in your future.
There are many consulting companies that are out there. These are either large 
companies with many individuals, or even consulting companies consisting of one to two, 
maybe even three people. These people offer their services because they either stepped out of 
the laboratory or they are just looking for perhaps seasonal work, if you will, where they're just 
willing to help from time to time. 
They are not looking for full time employment, but they can help you get your standards 
in order so that you can pass your inspection. Or more specifically, people that are offering 
their services to help with validations. So if you are in a relatively young laboratory where not a 
lot of people have had experience with designing validations, you can reach out to consultants 
to help with this process. Healthcare biotech companies are also another one. Those vendors of 
the manufacturers of the machines that we have, and the chemistry — they all need laboratory 
individuals. Many people get hired with physical science or biological science degrees. But I will 
tell you from experience, having the know of regulatory for the clinical application has really 
been beneficial, not only to my team but also the company to make sure that the products that 
we are creating are of clinical quality and going to meet the required standards by CLIA. So we 
want laboratories to buy the equipment that is going to fall within the regulatory needs that we 
have. Next slide, please. 
And how does this all fit together? Well, knowing the laboratory system is going to 
improve me, but it's also going to improve our laboratory. But it's also going to improve the 
health care system as you volunteer or become part of an inspection system. So there's a lot of 
cross-travel in this. Knowing what's required in a quality system is going to help with inspection 
success. 
We want our laboratories to be successful. We want them to be accurate. We want 
them to be safe for patients. And it's going to take the heart and soul of individuals like us 
working in the laboratory to make sure that we have inspection success and we're meeting the 
quality that we want, not only for our customers, but also for ourselves. So in learning about 
inspections and learning about quality improvement, you can also modify your career goals. 
And other ideas. Again, going back to, is regulatory for you? Would you be interested in 
working for CAP or CLIA? Or, perhaps, are you interested in going for that technical supervisor 
position for high complexity? Knowing how to do all of this requires information, and knowing 
that information gives you the power to make steps towards the career goal that you were 
looking. Next slide, please.
Again, I would like to thank Alicia Branch and CDC OneLab for having me today, and I 
wish you all the best. And I'm open to any questions that may be coming in. Thank you.
Thank you so much. We'll take this time to answer a few questions. We'll try to answer 
as many as possible. If we do not answer your question today, we'll do our best to answer it via 
email. If you have any questions after today, please do not hesitate to email the CDC OneLab 
inbox at onelab@cdc.gov. Let's get started. So this person wants to know, just to be clear, labs 
can get accreditation from CLIA or from CAP. How does the lab decide from one over the other?
So from my experiences, labs will often start with CLIA just because that is the basic 
federal minimum standards that every lab has to meet. And as they get into more areas that 
they feel that they need more guidance into, especially in the molecular area, they may 
transition to CAP. However, know there is a monetary component because there is a 
membership requirement for that. And you also have to meet more stringent standards than 
what CLIA offers. So it's really the laboratory's choice. But I would say again, in my experience, 
many start with CLIA and then move on to CAP. Not saying that's the only way to do it. 
Well, there's a follow-up. So how often does CAP and CLIA inspections occur? 
That's a great question, because since the pandemic has occurred, I am not in tune as to 
whether or not they are back to their routine schedule. For us, my lab was every two years. I 
don't know if that has been different. I don't know if the virtual inspections have made things 
different. I don't know how back to, quote unquote, "normal" we are. But two years is a good 
number to keep in mind. And it may be even more depending on the organization you're 
getting invited to.
OK, let's see. I'll move to this one. This is a good one. We have a lot of international 
people on the call this week. So, does CLIA and CAP provide accreditation to laboratories 
outside of the US, or only for the US? 
That is another great question. I believe CLIA is bound to the US only. However, I know 
that ASCP — American Society for Clinical Pathology — they do have an international 
certification. So I feel that there may be information out there as to CAP's availability 
internationally. I'm not sure it would be a requirement as an international, but if a lab is 
interested in meeting those quality requirements, I would suggest reaching out to CAP to see if 
they could participate, even if it's only for educational challenges, since they are not within the 
regulations of the US.
This is a good one also. How will the FDA'S proposed ruling on the regulation of LDTs 
impact CLIA or CAP regulations? 
This has got a lot of personal answers that I'm nervous about. 
If not, we can send it to you by email, and you can respond that way. If that's better. 
Yeah, I think that would be a better one for email because there's definitely no right or 
wrong answers here.
All right. Thank you. We can provide that one for someone. Let's see. I'm trying to see. 
What is the main difference between the two? Someone wanted to know — if you don't have 
the answer, that's OK — if you knew the difference between the general technical supervisor 
and a general supervisor. 
I do not off the top of my head. They are spelled out in the regulations. 
And someone did confirm that CAP does do credit accreditations internationally. 
Wonderful. That's great to know. Thank you.
And they can even send the PT samples. This is a good one. Since AI has now become a 
big topic, do you think CAP will release any regs on AI? 
My instinct says, if anything's available long enough, that regulations will come down 
regarding them. I know that there's already been times where automation has been trying to 
replace laboratory professionals, and that can only get so far. I don't imagine that AI would be 
able to fully replace, but I imagine that there will be some components of it that get into the 
heart of the laboratory and will require regulation.
We'll take this one last one. Is it an obligation to wait 35 to 52 weeks? What if the lab is 
not able to complete any — is able to complete all NCs and ready for accreditation?
I believe that that's just giving you a range of the amount of time. Many of the labs that I 
work with, they get everything in line long before they actually put that application in so that 
they're on the cusp of the shorter timeline. But if they are in a position where they're not able 
to meet that timeline, they would need to request an extension.
OK, it looks like that's all our questions for today. And I thank you again, Leah, for 
sharing your knowledge and expertise with us today. And I'm sure that this was helpful for 
laboratory professionals who have — may be considering an alternative job career or how they 
can use their current skills and develop additional skills to do something different. So I thank 
you for presenting this information, and we look forward to hearing from you again soon on 
OneLab Network event.
Thank you. It was a pleasure. 
Thank you.
Thanks, Alicia and Leah.