Hello, everyone, and thank you so much for joining our OneLab Network event today. We're going to give 

additional participants just another minute to join in, and then we'll get started on today's session. Thank 

you again so much for joining. 

All right. I think we have a good number of attendees here now. Again, thank you so much for joining our 

OneLab Network event today. My name is Chelsea Parsons, and I'm a consultant with Guidehouse, 

supporting the CDC OneLab Initiative. 

I just want to go through a couple of notes before we get started today. If you're having any technical 

issues during the session, you can feel free to email our inbox. It's onelab@cdc.gov. That's 

onelab@cdc.gov. You'll see that address just popped up in the Chat. 

If you have any questions throughout the session, though, related to the material, you are more than 

welcome to drop those into the Q&A function. You should see in the bottom black ribbon of your Zoom 

screen, there is a Q&A function. You can feel free to put questions in there throughout the entirety of the 

session. 

We do have some time reserved at the end of this session to go through some questions with our 

presenter Penny Keller today. So we'll try to get to as many as we can. If you have questions that come 

up later following the session, you can also email those to us at onelab@cdc.gov. 

If you need to use closed captions today, we'll have them available. You can see in the Chat there's a link 

for those closed captions. The only thing you need to keep in mind is to keep this Zoom window open as 

well as the closed captions window so please use that if needed. 

So let's go ahead and look at our agenda for today. We're going to introduce you to some new and 

relevant OneLab resources, some new stuff that's come out recently. And then our OneLab lead Alicia 

Branch will give an intro to our presenter today, Penny Keller. 

And then she will get into that session proficiency testing final rule. We'll save a little time for that Q&A at 

the end, and then we'll give you a heads-up on our next upcoming event later in the month. So I will now 

turn it over to our OneLab Network lead, Alicia Branch, to share some of our new and relevant resources. 

Alicia. 

Thanks, Chelsea. Before we begin the main presentation, I would like to take a moment to share two new 

CDC OneLab REACH training courses. The first is titled "Fundamentals of Laboratory Safety." This is a 

basic level e-learning course, and it will introduce you to some hazards you may encounter while working 

in a clinical and public health laboratory, ways to mitigate risk, and the proper response to incidents. 

The next new CDC laboratory training course is entitled "Fundamentals of Methylene Chloride Safety." 

This, too, is a basic level course, and it provides information on chemical properties and the adverse 

health effects of using methylene chloride, or dichloromethane, in clinical and public health laboratories. 

You can register for these courses now on OneLab REACH. The links have been placed in the Chat. 

Next, I will read two disclaimers and then follow up by introducing today's speaker. The slide decks may 

contain presentation material from panelists not affiliated with CDC. Presentation content from external 

panelists may not necessarily reflect CDC's official position on the topics covered. And, next, CDC and 

our presenters wish to disclose that we have no financial interest or other relationships with the 

manufacturers of commercial products, suppliers of commercial services, or commercial supporters. 

And now I'm excited to introduce today's speaker. Next slide, please. Her name is Ms. Penny Keller. 

Penny is the Acting Technical Advisor in the Division of Clinical Laboratory Improvement and Quality at 

the Centers for Medicare and Medicaid Services. Today's speaker is Ms. Penny Keller. 

Thank you, Alicia, for the introduction. Let me start my slides. OK. And let me-- Alicia, let me know if it 

looks OK. 

Yes, it does. 

Thank you. So good morning, everyone, or early afternoon, depending on where you're joining us. It is my 

pleasure to be joining you today on the OneLab forum and presenting on this very informative and 

important topic of the proficiency testing final rule, CMS-3355-F. I am with the CMS Division of Clinical 

Laboratory Improvement and Quality. 

Our division is responsible for the CLIA program, which addresses the regulations requirements for our 

clinical laboratories that are CLIA certified. The next slide is our standard disclaimer slide. I won't read 

everything, but basically the disclaimer slide is informing you that the presentation is basically providing 

information. If you are interested in the actual regulatory language and the CLIA regulations, please go to 

the original source documents, and that can be found on the CLIA website. 

So my objectives today, after the presentation, I'm hoping that you'll be able to remember what the 

effective dates for the PT Final Rule are-- and I'll also read this-- and be able to describe what the 

requirements are regarding the microbiological PT changes, the non-microbiology PT changes, 

requirements for the testing of specimens related to the PT referral for waived tests, and also the changes 

to the PT program providers, which provide the PT packages and samples and events to our clinical 

laboratories. OK. The PT Final Rule, as I mentioned-- you can also google it and find it under CMS-3355-

F for Final Rule-- was published in the Federal Register on July 11, 2022, so that was last year or last 

summer. There are direct links to the Federal Register notice for those who want to take a look at that. 

There's also a link to the Final Rule as it's laid out, and then we also provide a fact sheet and a QSO 

memo related to the Final Rule. So there are direct links in the presentation for you to take a look at, if 

you wish. 

So for those of you who are not familiar with the CLIA program, all CLIA certified laboratories are required 

to perform proficiency testing by the CLIA regulations. That is sort of like a test to evaluate the 

laboratory's accuracy or ability to perform a test accurately. That's usually given three times a year by the 

proficiency testing providers. 

And the laboratory will test those PT specimens. We return the PT results and then be evaluated on your 

performance, and you get a score. And we review those scores and evaluate those scores when we're 

doing an on-site survey. So that's in a nutshell what our proficiency testing requirements are for CLIA 

laboratories. 

So a brief history at a glance of the development of this Final Rule, so the PT proficiency CLIA regulations 

have not been updated since CLIA 88 was enacted, and the final regulations were published in 1992. So 

it's been a while since the proficiency testing CLIA regulations were looked at and updated. So back in 

2010, the CLIA Act, which is our CLIA advisory committee, recommended that we move forward with 

revising the proficiency testing regulations. And from then, CMS and CDC formed a team to work on 

developing the revised rule that you see today. 

The CMS-CDC team also met in 2012 with the PT program providers to get their input on what should be 

updated. And then the proposed rule with the period for public comment was published February 4, 2019. 

And as we are aware, we had a period where we were really busy with the public health emergency 

priorities. 

So the public comment period was extended to January 18, 2022, to allow the public to be able to have 

adequate time to review and provide comments. And once that was done and we collected and reviewed 

the comments, we worked on moving from the proposed rule to developing the Final Rule. And it was 

finally published last year, July 11, 2022. Moving onto the next slide. 

So the regulations, which you're familiar with, are found in subpart H and subpart I of the PT Regulations, 

and the regulations are 493.2 and 493.801 through 493.959. So those are basically the subpart H and 

subpart I PT requirements. So those are effective July 11, 2024, so that's next summer, and that is a two 

year effective date from when it was published last year. 

The amended regulations, that 493.2 and 493.25, were effective August 10, 2022, actually. And those 

amended regulations are related to the laboratories for performing the non-waive moderate high 

complexity tests. They are also performing PT on their waived testing, if they're performing waived tests. 

All right, moving on. 

The Final Rule addresses proficiency testing changes to the microbiology specialty. There are also 

changes to the non-microbiology proficiency testing requirements. And under that, we did have some 

updates in the definitions. We also had some additions of analytes and a few deletions of current 

analytes, and we also updated the criteria for the acceptance performance for those regulated analytes. 

We also have changes to the testing of the specimens related to the referral for the waived tests, as I 

mentioned. And then also there are changes to the PT program providers in the Final Rule. For the 

general microbiology proficiency testing changes, we now require the types of services listed for each 

microbiology subspecialty. We moved from these being very specific to adding a more general list of 

organisms to reflect the current practices that occur with our clinical laboratories. 

There's also an evaluation of the laboratory's performance, and that was updated. And the PT program 

providers must now attempt to grade using both the participant and the referee laboratories before it 

determines that the specimen is ungradable to achieve consensus. There's also a requirement for the 

mixed culture for the PT program providers, which has been lowered from a mixture of 50% to 25% for 

the bacteriology, the mycobacteriology, and the mycology subspecialties. The laboratories are also 

required to report PT results for the microbiology organism identification to the highest level that they 

report the test results on their patient specimens. 

For the subspecialty of bacteriology, the requirement is that the annual PT program content must include 

representatives of the following major groups of medically important, aerobic, and anaerobic bacteria, if 

appropriate for the sample sources. And these would include the gram negative bacilli, the gram positive 

bacilli, the gram negative costai, and the gram positive costai. And also under the subspecialty of 

bacteriology, rammsteins should include both the stain reaction and the morphology. 

We also require at least two PT samples per event for a susceptibility or resistance testing. And it should 

include one gram positive and one gram negative organism with a predetermined pattern of the 

susceptibility or resistance to common antimicrobial agent. We also removed references to resistance 

testing and the requirement for the antimicrobial susceptibility testing of select bacteria. 

Under the subspecialty of mycobacteriology, the requirement is the annual proficiency testing program 

content must include the mycobacterium tuberculosis complex and the mycobacterium other than the 

tuberculosis, if appropriate for the sample sources. We are also requiring at least two PT samples per 

event for the susceptibility or resistance testing, including mycobacteria that have a predetermined 

pattern of susceptibility or resistance to common antimicrobial bacterial agents. Under the subspecialty of 

mycology, again, the annual PT program context must include the following major groups of medically 

important fungi, anaerobic, actinomyces, if appropriate for the sample sources, and these include the 

yeast or yeast-like organisms, molds that include dematiaceous fungi, Dermatophyte, dimorphic fungi, 

hyaline hyphomycetes, and mucormycetes, anaerobic actinomycetes. And, again, under the subspecialty 

of mycology, we are requiring direct antigen testing. 

Under the subspecialty of parasitology, again, the annual PT program content must include the intestinal 

parasite and blood and tissue parasites, if appropriate, for the sample sources. And under the 

subspecialty of parasitology, we are requiring direct antigen testing. Moving onto the subspecialty of 

virology, the annual PT program content must include respiratory virus, herpesvirus, enterovirus, and 

intestinal virus, if appropriate, for the sample sources. Again, here we are requiring direct antigen testing. 

Now I'm going to move on to the nonmicrobiological proficiency testing changes in the Final Rule. So 

under the specialty of hematology, we have units of reporting for the prothrombin time includes now 

seconds and INR. Laboratories must report prothrombin time in the same manner as they will report the 

test results for their patients. Laboratories who are performing both the cell counts and the differentials 

must enroll and participate in both for their PT. Criteria for the acceptance performance for the cell 

identification has now changed from 90% to 80%, and that is in alignment with the acceptable 

performance for the other analytes. 

Under toxicology, the programs must provide samples that cover the full range of samples that could 

occur in the patient specimens. Under immunohematology, the criteria for the acceptable performance 

for unexpected antibiotic detection has been revised from the current 80%. It is now 100%. 

And in the definitions, we had two new terms, acceptance limits and peer group. We've also revised our 

current definition of target value. So acceptance limit now means the symmetrical tolerance plus or minus 

around the target value. Now keep in mind, we revised the definition of target value. That's in the current 

regs. 

Peer group means a group of laboratories whose testing process utilizes similar instruments, similar 

methodologies, and/or reagent systems and is not to be assigned using the reagent lot number level. So 

the target value definition has been updated. Target value for quantitative test means, number one, if the 

peer group consists of 10 participants or greater, target value means all participant responses after 

removal of outliers, that is, those responses greater than three standard deviation from the original mean, 

as applicable. Target value is established by a definitive method or reference method or, if a definitive 

method or reference method are not available, the mean of a peer group. Or, number two, target value for 

if the peer group consists of fewer than 10 participants, the target value is the mean of all participant

responses after the removal of outliers, as defined in paragraph 1 of the definition above, unless 

acceptable scientific reasons are available to indicate that such an evaluation is not appropriate. 

Moving onto the added and deleted analytes. These are the criteria that we used in determining which 

analytes should be added or deleted. The first one, we consider the current availability of the proficiency 

testing materials that are out there and the number of proficiency testing programs that are offering the 

proficiency testing analytes. We also considered the volume of the patient testing performed nationwide. 

We looked at the impact on the patient health and/or public health. We also considered the cost and 

feasibility of implementation of these proficiency testing analytes to the laboratory. 

I'm not going to read all of them. But we added 29 analytes in the final PT reg. Three of them, as you can 

see, are in general immunology. There are 14 new analytes added under the routine chemistry. And there 

are nine new analytes added to endocrinology, and there are three new analytes for toxicology. 

And there are five analytes that we deleted from our current list of analytes that are. We also updated the 

subtest performance criteria found in subpart I. Most limits have now been changed from standard 

deviations to percentage based limits, which reflect the current method that's out there or practice that's 

out there of evaluating acceptable performance. 

There's also a criteria for fixed concentration units, which were added to the fixed percentage units, and 

this addresses those analyzer tests that involve lower concentrations. And there are three examples here 

where that is applicable, the total bilirubin, the thyroid-stimulating hormone, and the lithium. So as you 

can see there's a percentage acceptance criteria as well as fixed units for evaluating that. 

And moving onto the PT referral for waived tests, the update in the Final PT Rule aligns with the current 

CLIA statues or statutory law with the PT referral regulations. And this is, as I mentioned before, related 

to the moderate and high complexity testing laboratories that are also performing waived tests. Waived 

tests are not required to enroll for PT. However, if you are performing PT for waived tests, you will be held 

to the same requirements for non-waived PT testing. And, therefore, that means that it is not excluded 

from the PT referral. 

Moving on, other changes involve changes to the PT program providers who provide the PT events to our 

clinical laboratories. They are required to have a minimum of 10 laboratory participants for each specialty, 

subspecialty, and an analyzer test when seeking their re-approval. The PT program providers currently 

are required to submit an annual package for the upcoming calendar year. And CMS reviews that and 

provides feedback as part of the re-approval. 

Technical and scientific responsibilities must be a private non-profit organization or a federal or state 

agency or an entity acting as a designated agent for the federal or state agency. An example of a 

technical scientific responsibility would be reviewing and analyzing the PT results and providing PT 

performance scores. CMS may also require an on-site visit for our PT programs for initial applications that 

require approval or when problems are encountered during a re-approval of any of our HHS-approved PT 

programs. 

We may also require proficiency testing programs to reapply for approval using the process for an initial 

application, if we encounter significant problems during the re-approval process. CMS will notify the 

programs of its withdrawal of approval in certain cases. And that would be in cases where the program 

fails to meet any of the PT program a criteria or requirements or when the PT program provides false or

misleading information with respect to any of the information that is necessary in the re-approval. 

And I'm at the end of my presentation. For those of you who are not aware, there are ways to reach our 

division. We have an email address, labexcellence@cms.hhs.gov. 

Also we have a CLIA website that has a lot of educational information as well as information on how to 

apply for a CLIA Certificate. Proficiency testing program lists, contacts for the state agencies, accrediting 

organizations, all of that useful information can be found on the CLIA website. We also have a CLIA 

communication listserv that you can sign up for it, and you'll get notifications anytime we put out any 

news, such as the Final Rule for the proficiency testing that went out last year. 

And for those of you who are tech savvy and like to scan QR codes and go directly to the website, we do 

actually have a QR code that you can scan. And it will go directly to the CLIA website there that I 

mentioned about. And that's the end of my presentation. 

I do thank you for your time and patience, and I hope the presentation provides some useful information. 

Thank you very much. I'm going to turn it over to Alicia. 

Thank you, Penny. We'll take a few questions. I'll start with the first one. The first one, it says, "Does this 

include primary care health care centers that perform in-house tests in in-house labs?" 

So whether you're a primary care site or a hospital or any site, if you are performing testing on patients, 

then you are required to be CLIA certified. And the type of CLIA certificate depends on what type of test 

you're performing. So if you are performing tests that are only waived tests, meaning that the FDA has 

approved that test as waived for CLIA purposes, then you're required to have a certificate of waiver. 

And for waived tests, you're not required to perform proficiency testing, although it's really good lab 

practice, if you want to see how your quality-- if you want to monitor the quality of the test and the test 

performance and your laboratory personnel. If you are performing non-waived, moderate, or high 

complexity testing at your site, regardless of the type of site, you are required to either have a certificate 

of compliance or certificate of accreditation. If you are performing a non-waived, moderate, or high 

complexity test, you are required to perform proficiency testing for all the non-waived tests that you 

perform at that site. I hope I answered the question. 

OK. The next one is, "If new regulations go into effect in July, 2024, does this mean that the lab will be 

required to have PT already in place to meet these standards? PT programs generally make changes at 

the beginning of each year, not the middle." 

Excellent question, and I'm glad you brought it up. So the effective date is next year, but we recognize 

that the PT programs generally put out the new PT catalogs with their current analytes, and it will have 

the new analytes in the fall. And the laboratories enroll at the beginning of the calendar year, so we 

recognize that. 

So the implementation date of the Final Rule for the laboratory will be January the 1st, 2025. So be aware 

that after January 1, 2025, if you're not enrolled, if you're performing any of the new analytes that are in 

the Final Rule, and you are not enrolled in it, you will be considered in noncompliance and could be cited. 

So, however, the PT program should provide in their catalog when you get it in the fall prior to that what 

the new analytes are, so that transition should be somewhat seamless for the laboratories. Thank you. 

The next one is, "What does it mean to require direct antigen testing?" 

So that depends on the methodology that you're performing. But I don't know how to explain. I'm going to 

have to come back and come up with a more definitive clarification of what that involves. 

That's fine. 

Thank you. 

OK. This one says, "For the micro susceptibility changes, you mentioned that the susceptible challenges 

need to have a predetermined pattern of susceptibility. Can you elaborate on what this means?" 

So those criteria or changes are applicable to the PT provider programs. So when they're creating the 

challenges with the PT specimens for the laboratories, they need to include those requirements for the 

specimens that they provide. And that should be somewhat familiar with the PT program providers, and 

we will be working with them for clarification if they need it. 

OK. Let's see. "Does CMS plan to update the current approved PT provider list for 2024?" 

So the PT program provider list is actually up to date. We have not received any new applications 

regarding that. If there's any entity out there that's interested in becoming a PT program provider, you're 

more than welcome to reach out to us. And we'll look into how to get that started for you. 

OK. This participant asks, "There is a mentioned criteria for PT changed from 90% to 80%." They want to 

know why. "Does it mean the performance is poor or just the criteria is just too high?" 

Well, if I understand the question correctly, that change is not implying that we're accepting poor quality 

tests. But the current acceptable score is 80% for laboratories for the other analytes. And so we wanted 

to be consistent, and so that's why we lowered that to 80% to be consistent with our other analyte 

requirements. Thank you. 

Let's see. How much time do we have? We'll take a couple of more. Let's see. "Is the move from SD to 

percentage going to be applied to all PT testing?" 

Yes, so the updated acceptable performance is a change for all the PT program providers. So they will be 

moving from the SD that's currently in subpart I to the percentage. 

OK. Let's see. 

I'll go to this next one.

Oh, this is an interesting one. They said, "Waived testing is sometimes the Wild, Wild West. Why is PT 

not required for waived testing for quality assurance?"

That's a very good question, and I can only answer it from a regulatory perspective. So when the statutory 

law was passed in the '88, the only requirement for waived testing facilities is that they must register, 

meaning get a CLIA certificate of waiver. And you have to have a laboratory director designated. 

But there are no additional requirements, such as proficiency testing or on-site survey requirements. So 

we do look at the certificate of waiver sites if there are complaints. But, generally, most of the CLIA 

regulations are focused on the moderate and high-complexity non-waived testing, which rightly so they 

are the more complex diagnostic tests. Thank you. 

You're welcome. Let's take one more. "In response to failed CMS regulated analytes, does the response 

to the failure require the PT program used for troubleshooting to be CMS approved?" 

OK. So I'm going to try to answer it the best as I understand it. But the laboratory actually receives an 

unacceptable score, less than 80%, there are CLIA regulations in subpart K for quality assurance and 

such that the laboratory should be investigating the failure and attempting and making resolutions and 

enacting procedures that will mitigate for that in the future, looking back at their patient testing from the 

period from a previous proficiency test period to the proficiency testing failure, to ensure that the patients 

have been looked at. But these are all laboratory procedures that they should be aware of. 

As far as the proficiency testing providers, they do provide the laboratory scores to CMS. So we are 

looking at that when we are looking at your laboratories, and the states are monitoring the oversight of 

their CLIA facilities. And when the inspector goes on-site, they will be looking at your records to see if you 

reviewed it and how you addressed it if you have a failure. And there are requirements if you have a 

laboratory for the laboratory if they have a failure if you have two consecutive ones in a row that you 

should be contacting your PT program provider for another alternative one or doing an alternative 

accuracy assessment to address the two PT event failures. I hope that answered the question. 

So thank you again, Penny, for joining us and presenting on a very, very hot topic. I think this has 

definitely been our probably highest participation for a OneLab Network event, and I'm hoping to be able 

to have you join us again. 

Thank you very much for having me. It's my first time on the OneLab forum, so I feel honored. Thank you. 

If we didn't get a chance to answer your question today, and you have not put it in the Chat as 

anonymous, if you could, please send us an email at onelab@cdc.gov. Again, send your email with your 

question to onelab@cdc.gov. We are offering one PACE credit for today's webinar. To receive PACE 

credit, you visit the link and the passcode posted in the Chat and complete the evaluation within two 

weeks. You will receive an email containing these instructions if you miss the link and the passcode in the 

Chat. 

We would like to take a brief moment and highlight our next upcoming OneLab Network event that's 

occurring on September 26th at 12:00 noon Eastern Standard Time. The title is "How to Plan for 

Burkholderia Pseudomallei Exposure Cases: A Laboratory Perspective." This presentation will explain the 

role of laboratory professionals in detecting B. pseudomallei in clinical specimens and how to plan for 

possible exposure cases. This will be presented by Dr. Lisa Speiser and Erin Graf from the Mayo Clinic. 

The registration for this event has been posted in the Chat.

We would like to also highlight our OneLab Summit that's coming up on October the 3rd through the 5th.

The OneLab Summit is a free annual virtual event that connects laboratory professionals in real time to 

support a unified response to laboratory education and training needs. To register for the OneLab 

Summit, the link has been also posted in the Chat. 

As a reminder, the slides with the links will be posted on the OneLab REACH site within the next two 

weeks. Again, I'd like to thank you for joining us today, and I look forward to you joining us on September 

the 26th. Have a great rest of your day.