CLIA Proficiency Testing (PT) Final Rule, CMS-3355-F
This presentation will provide information on the CLIA Proficiency Testing (PT) Final Rule which was published in the Federal Register Notice on July 11, 2022. The presentation will describe the required PT added and deleted analytes (substances), the criteria for acceptable performance, and PT program administrative processes.
- Identify educational and other resources available through the OneLab Network.
- State the effective dates of the PT Final Rule provisions.
- Describe the finalized requirements for Microbiology and Non-Microbiology changes.
- Describe the finalized requirements for PT referral for waived test changes.
- Describe how to apply the regulatory changes to their work.
Penny Keller, BS MB(ASCP)
Acting Technical Advisor
Division of Clinical Laboratory Improvement and Quality
Centers for Medicare and Medicaid Services
CHELSEA PARSONS: Hello, everyone, and thank you so much for joining our 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 Network event today. My name is Chelsea Parsons, and I'm a consultant with , supporting the CDC 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 email@example.com. That's firstname.lastname@example.org. 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. 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 email@example.com.
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let's go ahead and look at our agenda for today. We're going to introduce you to some new and relevant resources, some new stuff that's come out recently. And then our 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. I will now turn it over to our Network lead, Alicia Branch, to share some of our new and relevant resources. Alicia.
ALICIA BRANCH: Thanks, Chelsea. Before we begin the main presentation, I would like to take a moment to share two new CDC 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 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.
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.
ALICIA BRANCH: Yes, it does.
PENNY KELLER: 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 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 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. there are direct links in the presentation for you to at, if you wish.
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.
a brief history 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. 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 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.
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 bacilli, the bacilli, the gram negative , and the gram positive . And under the subspecialty of bacteriology, 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 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 , 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 , 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 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 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 [INAUDIBLE]. We also updated the subtest performance criteria found in subpart I. Most limits have now been changed from standard deviations to limits, which reflect the current method that's out there or practice that's out there of evaluating acceptable performance.
There's also a 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 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, firstname.lastname@example.org.
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, 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 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.
ALICIA BRANCH: Thank you, Penny. We'll take a few questions. [INAUDIBLE]. 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?"
PENNY KELLER: 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 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.
ALICIA BRANCH: OK. The next one is, "If new regulations go into effect in 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."
PENNY KELLER: 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.
ALICIA BRANCH: The next one is, "What does it mean to require direct antigen testing?"
PENNY KELLER: 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.
ALICIA BRANCH: That's fine.
PENNY KELLER: Thank you.
ALICIA BRANCH: 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?"
PENNY KELLER: So those 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.
ALICIA BRANCH: OK. Let's see. "Does CMS plan to update the current approved PT provider list for 2024?"
PENNY KELLER: So the PT program provider list is 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 how to get that started for you.
ALICIA BRANCH: 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 just too high?"
PENNY KELLER: 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.
ALICIA BRANCH: 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?"
PENNY KELLER: 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.
ALICIA BRANCH: OK. Let's see. [INAUDIBLE].
I'll go to this next one. [INAUDIBLE].
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?"
PENNY KELLER: 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 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.
ALICIA BRANCH: 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?"
PENNY KELLER: 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.
ALICIA BRANCH: So thank you again, Penny, for joining us and presenting on a very, very hot topic. I think this has our probably highest participation for a OneLab Network event, and I'm hoping to be able to have you join us again.
PENNY KELLER: Thank you very much for having me. It's my first time on the OneLab forum, so I feel honored. Thank you.
ALICIA BRANCH: 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 email@example.com. Again, send your email with your question to firstname.lastname@example.org. 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 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 Exposure Cases: A Laboratory Perspective." This presentation will explain the role of laboratory professionals in detecting B. 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.