WEBVTT 00:00:08.308 --> 00:00:08.942 Hello, 00:00:08.942 --> 00:00:12.746 I'm Margaret Coppin, the quality officer at r u p laboratories, 00:00:12.746 --> 00:00:15.882 and today we're going to be discussing compliance issues. 00:00:15.882 --> 00:00:22.055 The regulations I'll be covering part one which will go from the clear regulations 00:00:22.055 --> 00:00:25.558 through the quality management portion of the presentation. 00:00:25.825 --> 00:00:29.329 And then my colleague Jonathan Carr, the compliance officer, 00:00:29.462 --> 00:00:32.465 will be covering the rest of the topics listed here. 00:00:33.366 --> 00:00:36.903 Okay, so to start out, clear overview. 00:00:36.903 --> 00:00:40.173 What is clear, it is the Clinical Laboratory Improvement 00:00:40.173 --> 00:00:44.010 Amendments, which was established in 1988 to address 00:00:44.010 --> 00:00:47.781 both real and perceived quality issues within laboratory testing. 00:00:48.348 --> 00:00:51.684 A little fun sort of factoid for you is that, Clea 00:00:51.684 --> 00:00:55.688 started actually in the cytology laboratory where a congressman, 00:00:56.356 --> 00:01:00.994 had a wife who had a pap smear that had an incorrect result, 00:01:00.994 --> 00:01:02.395 which caused him to look 00:01:02.395 --> 00:01:06.266 a little bit more, in depth at what was going on in those laboratories 00:01:06.266 --> 00:01:09.469 and, making sure that we were all following the same standards 00:01:09.736 --> 00:01:13.773 and regulations and clear as test site neutral. 00:01:13.773 --> 00:01:16.810 And what that means is that all laboratories, 00:01:16.810 --> 00:01:21.781 regardless of where they are in the nation or the size or scope of the laboratory, 00:01:21.781 --> 00:01:26.119 are required to adhere to clear regulations and clear functions. 00:01:26.119 --> 00:01:29.522 Under the oversight of the center for Medicare and Medicaid Services, 00:01:29.522 --> 00:01:33.560 which is, within the Department of Health and Human Services. 00:01:33.793 --> 00:01:36.796 And Jonathan will get in a little bit more to this as well. 00:01:36.930 --> 00:01:40.200 But all of that is actually underneath the FDA. 00:01:42.535 --> 00:01:45.572 So, Clea, what are they responsible for? 00:01:45.572 --> 00:01:48.708 They register laboratories, they collect fees, 00:01:49.442 --> 00:01:53.880 they conduct on and off site, self inspections, and surveys. 00:01:53.880 --> 00:01:56.883 I, will get into a little bit more, 00:01:57.083 --> 00:01:59.619 what other agencies 00:01:59.619 --> 00:02:03.256 we may use to have these inspections, performed. 00:02:03.523 --> 00:02:05.191 And we'll get into that. 00:02:05.191 --> 00:02:08.695 They provide guidelines and training for the inspectors. 00:02:08.928 --> 00:02:12.165 They approve proficiency testing providers, and they accredit 00:02:12.165 --> 00:02:15.168 professional organizations. 00:02:15.502 --> 00:02:17.070 I won't list all of these here, 00:02:17.070 --> 00:02:20.607 but as you can see, there's a lot that is regulated by Clea. 00:02:20.874 --> 00:02:24.544 I think what is important to note is that the, 00:02:25.111 --> 00:02:29.916 all phases of laboratory testing are regulated by Clea. 00:02:29.916 --> 00:02:33.953 So it's not just the instruments and the people performing the testing. 00:02:33.953 --> 00:02:38.491 It's everything from ordering the test, specimen collection, 00:02:38.491 --> 00:02:42.529 performing the test and resulting those tests out. 00:02:42.529 --> 00:02:47.500 And what we also call as pre analytic, analytic and post analytic 00:02:47.500 --> 00:02:51.104 phases of testing, which we will also get a little bit more into, 00:02:53.373 --> 00:02:56.376 all Clea tests fall into three categories 00:02:56.376 --> 00:03:00.246 which are waived moderate and high complexity testing. 00:03:00.647 --> 00:03:05.051 And the way that this criteria is assigned 00:03:05.318 --> 00:03:10.590 is that I've got a list here of seven criteria, each 00:03:10.590 --> 00:03:15.695 one of these is assigned a point of score or a score of one, 2 or 3, 00:03:16.896 --> 00:03:21.000 and a score of 12 or less is a moderate complexity test. 00:03:21.234 --> 00:03:23.703 Above 12 is a high complexity test. 00:03:23.703 --> 00:03:26.706 And if you get one point, that's a waived test. 00:03:27.207 --> 00:03:30.476 And we'll start with what a waive test is, because that's sort of the easiest 00:03:30.476 --> 00:03:31.878 one to explain. 00:03:31.878 --> 00:03:37.217 So those are tests that are designed to work really, the same way every time. 00:03:37.217 --> 00:03:40.286 They don't need to be operated or performed by an MD 00:03:40.587 --> 00:03:43.590 or PhD or a medical laboratory scientist. 00:03:43.623 --> 00:03:46.526 The room for error is very low. 00:03:46.526 --> 00:03:50.830 And usually they're cleared for use at home by any one of us. 00:03:51.097 --> 00:03:54.801 So some examples are, you know, think of it like a home pregnancy test 00:03:54.934 --> 00:03:57.237 or a glucose monitor that can be, you know, 00:03:57.237 --> 00:03:59.572 you can monitor your glucose from anywhere. 00:03:59.572 --> 00:04:03.343 And then a more, relevant recent example is 00:04:03.343 --> 00:04:07.947 a, Covid test that has been released to perform at home. 00:04:07.947 --> 00:04:10.516 That just requires a very simple nasal swab. 00:04:13.786 --> 00:04:16.923 The big differentiator between moderate complexity 00:04:16.923 --> 00:04:20.493 and high complexity testing really comes down to personnel 00:04:20.493 --> 00:04:24.897 who can oversee that testing and who can perform that testing. 00:04:25.198 --> 00:04:28.835 So on the left, you'll see the moderate complexity testing. 00:04:29.335 --> 00:04:32.772 The the one list, the second listed, there is a technical 00:04:32.772 --> 00:04:36.242 consultant that's usually a person who's been trained on the bench. 00:04:36.242 --> 00:04:38.511 They have a high school diploma. 00:04:38.511 --> 00:04:41.514 And they understand the testing that they're performing. 00:04:42.015 --> 00:04:45.418 But but that's usually the extent of their qualifications. 00:04:45.752 --> 00:04:48.788 Over on the right, in high complexity testing, 00:04:48.988 --> 00:04:53.226 you'll see a technical supervisor and a general supervisor listed. 00:04:53.626 --> 00:04:56.863 So according to Clea, a technical supervisor 00:04:56.863 --> 00:05:00.333 is going to be a PhD or an MD, 00:05:01.401 --> 00:05:03.836 that has a board certification 00:05:03.836 --> 00:05:06.839 in the specialty field of testing. 00:05:07.473 --> 00:05:10.777 And then a general supervisor is really maybe what, 00:05:11.544 --> 00:05:14.314 some of you may become someday 00:05:14.314 --> 00:05:18.384 a, person with a medical laboratory science degree 00:05:18.785 --> 00:05:22.322 or someone who has a bachelor's degree in what we sometimes 00:05:22.322 --> 00:05:26.125 call the hard sciences, like chemistry or biology, 00:05:26.326 --> 00:05:32.298 as well as a categorical certification in the specialty area of testing. 00:05:32.465 --> 00:05:35.968 They're also required to have several years of experience performing 00:05:36.002 --> 00:05:40.373 testing on the bench, real hands on knowledge of the tests they're performing 00:05:42.008 --> 00:05:43.109 something else that's really, 00:05:43.109 --> 00:05:47.914 I think, important to note, from real life, is that any FDA method 00:05:47.980 --> 00:05:52.485 that's altered in any way is automatically considered a high complexity test, 00:05:52.485 --> 00:05:56.389 and it is subjected to the highest validation standards. 00:05:56.622 --> 00:05:59.625 When you alter an FDA method, 00:05:59.659 --> 00:06:03.162 that then becomes what we call a laboratory developed test. 00:06:03.563 --> 00:06:07.734 And FDA is really specific in their requirements. 00:06:08.101 --> 00:06:12.705 Temperatures, specimen types, all these things are outlined 00:06:12.705 --> 00:06:16.776 and specified in Kit instructions for FDA approved tests. 00:06:17.076 --> 00:06:21.547 And if you want to validate a test on anything aside from what is outlined 00:06:21.547 --> 00:06:25.818 in those FDA kit instructions, it's a high complexity test. 00:06:26.452 --> 00:06:29.222 A laboratory developed test and something 00:06:29.222 --> 00:06:32.225 to make note of as you, 00:06:32.291 --> 00:06:35.294 begin your career in laboratory leadership. 00:06:36.162 --> 00:06:39.265 Okay, I mentioned before that CLA is responsible 00:06:39.265 --> 00:06:42.101 for accrediting other agencies. 00:06:42.101 --> 00:06:45.571 And I want to explain a little bit what that means. 00:06:46.139 --> 00:06:48.441 So we're all required. 00:06:48.441 --> 00:06:52.111 All laboratories are required to meet clear requirements. 00:06:52.845 --> 00:06:57.183 But the way that we do that and most laboratories, opt to do it 00:06:57.183 --> 00:07:01.087 this way is by choosing to go through a third party 00:07:01.087 --> 00:07:04.590 that is granted what's called deemed status by CMS. 00:07:04.590 --> 00:07:08.461 So basically what all this means is that 00:07:08.628 --> 00:07:13.132 there are various agencies out there that will look at the clear standards, 00:07:13.232 --> 00:07:17.236 and they then design their own checklists 00:07:17.236 --> 00:07:22.074 or laboratory manuals or standards that align 00:07:22.074 --> 00:07:24.877 very closely with the Clea standards. 00:07:24.877 --> 00:07:28.681 And then Clea or CMS, I should say, reviews 00:07:28.681 --> 00:07:33.486 those standards and says, okay, if a laboratory is adhering 00:07:33.486 --> 00:07:37.857 to this third parties guidelines and adhering to all of their checklists 00:07:37.857 --> 00:07:43.529 and standards, then they sort of by proxy are going to be meeting 00:07:43.529 --> 00:07:47.133 Clea standards as well, which means we can say 00:07:47.133 --> 00:07:50.903 that they are a Clea accredited through this third party. 00:07:52.171 --> 00:07:52.939 It's really 00:07:52.939 --> 00:07:57.810 great to go that way because these third party agencies provide some really great 00:07:57.810 --> 00:08:02.315 and clear guidance for laboratories and make it much easier to understand 00:08:02.315 --> 00:08:06.018 the rules of the game and how to be, accredited. 00:08:06.919 --> 00:08:09.188 So I'm just going to touch on three 00:08:09.188 --> 00:08:12.959 of the voluntary accreditation agencies that are out there. 00:08:13.226 --> 00:08:18.297 The first one is the Joint Commission, and they accredit more than 80% of U.S. 00:08:18.297 --> 00:08:19.532 health care organizations. 00:08:19.532 --> 00:08:23.202 They actually accredit entire hospital systems, although they do have 00:08:23.202 --> 00:08:29.075 a component or a portion of their, program that is focused on laboratory. 00:08:29.075 --> 00:08:32.411 And that second bullet there, you can see that's the name of their 00:08:32.478 --> 00:08:35.481 laboratory accreditation manual. 00:08:35.481 --> 00:08:38.117 And their focus at the Joint Commission is on quality 00:08:38.117 --> 00:08:41.120 improvements to promote quality outcomes. 00:08:41.287 --> 00:08:45.491 The next one is Cola, the Commission of Office Laboratory 00:08:45.491 --> 00:08:49.262 Accreditation, not to be confused with Pepsi or Coke. 00:08:50.763 --> 00:08:54.567 But their manual is called the Laboratory Accreditation Manual. 00:08:54.567 --> 00:08:59.238 And they focus on education and problem solving in their program. 00:08:59.906 --> 00:09:02.174 And then the last one that I want to touch on 00:09:02.174 --> 00:09:05.311 is the College of American Pathologists, or Cap. 00:09:05.311 --> 00:09:10.082 And the College of American Pathologists has a variety of checklists and standards. 00:09:10.082 --> 00:09:13.352 They have what's called a lab general checklist. 00:09:13.519 --> 00:09:16.589 So that covers everything from human resources to it 00:09:17.056 --> 00:09:21.294 to facilities management, warehouse, things like that. 00:09:21.594 --> 00:09:25.932 But then they also have testing section, specific checklists 00:09:26.399 --> 00:09:30.937 that focus more in on the, specialty 00:09:31.137 --> 00:09:35.808 areas of testing and the unique nature of different types of laboratory tests. 00:09:35.808 --> 00:09:38.811 So there's a hematology section 00:09:38.811 --> 00:09:43.082 and anatomic pathology checklist, chemistry checklist. 00:09:43.082 --> 00:09:48.287 And, you know, each laboratory needs to understand what types of tests 00:09:48.287 --> 00:09:51.390 they're performing and which checklists those align with and make sure 00:09:51.390 --> 00:09:54.360 they're adhering to those standards in those checklists. 00:09:54.527 --> 00:09:57.196 And just like the Joint Commission, the College of American 00:09:57.196 --> 00:09:58.864 Pathologists emphasizes, 00:09:59.865 --> 00:10:01.834 overall quality management approach 00:10:01.834 --> 00:10:05.905 and continuous quality improvement for all phases of testing. 00:10:06.739 --> 00:10:10.142 And we will get into that a little bit more in the presentation as well, 00:10:10.142 --> 00:10:14.914 because I feel that the continuous improvement part of quality is really 00:10:14.914 --> 00:10:18.918 some of the funnest and most exciting parts of laboratory quality. 00:10:20.286 --> 00:10:23.289 Okay, so let's get into the cap inspection process. 00:10:23.689 --> 00:10:27.093 Every two years we have what's called a pure inspection. 00:10:27.093 --> 00:10:30.930 And the way Cap determines who your quote unquote peer 00:10:30.930 --> 00:10:35.201 is, is they look at the size and scope of the laboratory 00:10:35.201 --> 00:10:39.038 and match the laboratories up to similar institutions. 00:10:39.038 --> 00:10:43.342 It's never going to be a 1 to 1, but they try to get it to be pretty close 00:10:43.576 --> 00:10:47.747 so that the peer inspectors, when they come on site to inspect you, 00:10:47.913 --> 00:10:50.449 they understand the unique nature of the work 00:10:50.449 --> 00:10:53.352 that you're doing or some of the challenges that you may have. 00:10:54.353 --> 00:10:54.620 You know, 00:10:54.620 --> 00:10:58.424 smaller laboratories have very different challenges than large laboratories. 00:10:58.424 --> 00:11:01.360 Hospital laboratories are different than reference laboratories. 00:11:01.360 --> 00:11:05.998 And all of those need to be considered for even though the, 00:11:06.666 --> 00:11:09.602 you know, checklist standards are the same. 00:11:09.602 --> 00:11:12.805 The cool thing about the peer inspection process 00:11:12.838 --> 00:11:17.243 is that it's also an opportunity for us to learn so we can go 00:11:17.243 --> 00:11:20.913 and perform a peer inspection for some of our peers or peers. 00:11:20.913 --> 00:11:21.947 Come on site. 00:11:21.947 --> 00:11:25.317 And it's also a it's not only a great opportunity to tick the box 00:11:25.317 --> 00:11:29.555 and make sure that you are maintaining quality and your accreditation, 00:11:29.789 --> 00:11:32.692 but it's also a great opportunity to learn from one another 00:11:32.692 --> 00:11:35.928 and really share experiences and best practices. 00:11:37.096 --> 00:11:40.032 The inspection window starts three months prior 00:11:40.032 --> 00:11:43.736 to the accreditation or anniversary date. So, 00:11:45.071 --> 00:11:45.971 you've got three 00:11:45.971 --> 00:11:51.210 months from when your laboratory first obtained Tap accreditation, 00:11:51.343 --> 00:11:55.915 and any time within that three months your peer inspectors may show up. 00:11:55.915 --> 00:11:57.249 It's been a little bit different. 00:11:57.249 --> 00:12:02.421 Covid has introduced some, unique, workflows where now 00:12:02.421 --> 00:12:06.092 we're doing a lot more remote inspections, which have to be announced, 00:12:06.292 --> 00:12:10.930 but typically the inspectors can show up any time during that three month window. 00:12:10.930 --> 00:12:13.933 And you have to be ready to, host them 00:12:13.999 --> 00:12:18.070 and show them through your laboratories and how you are adhering to the standards. 00:12:19.305 --> 00:12:23.075 On the opposite year from this two year, peer inspection cycle, 00:12:23.776 --> 00:12:27.480 laboratories are required to perform a self inspection. 00:12:27.480 --> 00:12:30.716 So what we do at our institution is 00:12:30.716 --> 00:12:35.020 we will have senior level managers, residents, fellows, 00:12:35.755 --> 00:12:39.959 you know, more experienced people, pulled in to help perform 00:12:39.959 --> 00:12:43.796 the self inspection and that's a great opportunity to ensure 00:12:43.796 --> 00:12:46.899 that you're not letting anything slip over that two year window, 00:12:46.899 --> 00:12:49.435 and also to catch things that, you know, might, 00:12:50.536 --> 00:12:54.707 be evolving in the wrong direction over the course of those two years. 00:12:54.707 --> 00:12:58.310 And so the self inspection is equally as important as the peer 00:12:58.344 --> 00:13:01.347 inspection. 00:13:01.714 --> 00:13:02.214 Okay. 00:13:02.214 --> 00:13:05.284 Another component that clear regulates 00:13:05.284 --> 00:13:08.287 is proficiency testing or PT. 00:13:08.487 --> 00:13:11.824 And PT determines the performance of individual laboratories 00:13:11.824 --> 00:13:14.326 for specific tests or measurements. 00:13:14.326 --> 00:13:17.429 And it's used to evaluate laboratories continuing performance. 00:13:17.429 --> 00:13:21.500 So basically, these agencies will send you a specimen 00:13:21.500 --> 00:13:27.006 or a sample and you're you're required to perform testing on that specimen 00:13:27.239 --> 00:13:31.811 and then send your results back to the accrediting agency to receive a score. 00:13:32.178 --> 00:13:35.181 It's also called intra laboratory comparison. 00:13:36.816 --> 00:13:39.485 Pete is very highly regulated, 00:13:39.485 --> 00:13:43.322 and there's a lot of scrutiny that is applied to how Pete is handled. 00:13:43.322 --> 00:13:43.756 So we're going to 00:13:43.756 --> 00:13:47.526 spend a little bit of time talking about some of the regulations around Pete. 00:13:48.694 --> 00:13:49.461 The first one is 00:13:49.461 --> 00:13:53.332 just that clear requires that you participate in PT programs, 00:13:53.332 --> 00:13:58.237 but they have to be approved from, agencies, from Health and Human Services. 00:13:59.638 --> 00:14:02.474 And there's the, Code of Federal Regulations 00:14:02.474 --> 00:14:07.346 that you can look up to learn more about the Clea requirement for PT 00:14:08.647 --> 00:14:10.516 Pete samples must be treated 00:14:10.516 --> 00:14:13.519 and tested in the same manner as patient samples. 00:14:13.819 --> 00:14:17.289 There's the all common checklist item from the cap checklist 00:14:17.823 --> 00:14:20.826 to integrate it into your routine workload. 00:14:22.061 --> 00:14:25.064 Pete also must be, 00:14:25.097 --> 00:14:29.668 performed and rotated through all testing personnel in the laboratory. 00:14:29.668 --> 00:14:32.705 So I'm just going to pause and talk about this point and the previous 00:14:32.705 --> 00:14:35.708 one about integrating it into the workload. 00:14:36.442 --> 00:14:39.445 You can't, for example, when you get to a 00:14:39.712 --> 00:14:43.682 specimen in your laboratory, say, you know what, I'm going to set this one aside 00:14:43.816 --> 00:14:48.420 because my most skilled and talented medtech is coming on shift later tonight, 00:14:48.687 --> 00:14:52.892 and I'm going to have that person perform this test because I know he's 00:14:52.892 --> 00:14:55.895 going to get the best answer every time. 00:14:56.028 --> 00:15:00.366 Pete is designed to understand how your regular testing, 00:15:00.733 --> 00:15:04.203 is performing and ensuring that that quality is being maintained. 00:15:04.470 --> 00:15:08.340 And that's why you have to just integrate it into your regular testing processes. 00:15:08.574 --> 00:15:12.578 And among all of your regular personnel, all of your laboratory personnel, 00:15:14.346 --> 00:15:15.281 proficiency testing 00:15:15.281 --> 00:15:18.350 failures also must be investigated and corrected. 00:15:18.350 --> 00:15:21.854 So there again, is the all common, checklist for reference. 00:15:22.321 --> 00:15:25.457 You have to perform your investigation in writing. 00:15:26.058 --> 00:15:30.162 And when you are inspected, your inspectors will look at those. 00:15:30.162 --> 00:15:30.362 What? 00:15:30.362 --> 00:15:34.867 You know, what we call problem reports, for proficiency testing failures. 00:15:36.669 --> 00:15:38.504 And if you fail to attain the minimum 00:15:38.504 --> 00:15:41.540 satisfactory score for an analyte for three consecutive events, 00:15:42.007 --> 00:15:44.677 it may disqualify you from testing for that analyte. 00:15:44.677 --> 00:15:47.012 So you know the consequences are real. 00:15:47.012 --> 00:15:51.317 If your testing isn't performing as expected, and rightfully so, 00:15:51.350 --> 00:15:55.654 we want to make sure that all testing is maintaining a high level of quality, 00:15:55.854 --> 00:15:59.124 and that patients are getting the right and accurate results. 00:16:00.326 --> 00:16:03.762 Okay, so just a few more things about proficiency testing. 00:16:04.229 --> 00:16:07.533 Proficiency testing cannot be referred to another laboratory. 00:16:07.533 --> 00:16:11.270 So what that means is you can't send your proficiency 00:16:11.270 --> 00:16:15.908 testing specimens to another institution to have them perform testing. 00:16:16.141 --> 00:16:20.980 You also can't collaborate on results before you submit your results 00:16:20.980 --> 00:16:25.751 back to the accrediting agency to make sure that they're correct. 00:16:26.552 --> 00:16:29.822 Another point about PT is that, conversely, 00:16:30.122 --> 00:16:33.125 if your institution receives referred, 00:16:33.759 --> 00:16:36.428 you're required to notify CMS 00:16:36.428 --> 00:16:40.532 and the consequences for not notifying CMS of receiving 00:16:41.567 --> 00:16:43.802 proficiency testing from another institution 00:16:43.802 --> 00:16:46.805 can also be pretty severe. 00:16:48.741 --> 00:16:49.908 The other thing 00:16:49.908 --> 00:16:52.745 that is that all of your analytes really 00:16:52.745 --> 00:16:56.815 must have some sort of proficiency testing assigned to them. 00:16:57.082 --> 00:17:02.221 And often if there is, esoteric test or a test 00:17:02.221 --> 00:17:05.891 that is an offer widely in routine laboratory testing, 00:17:06.058 --> 00:17:08.894 you've got to get a little bit creative about how to do that. 00:17:08.894 --> 00:17:11.897 And a couple of options are 00:17:11.930 --> 00:17:17.169 to blind your specimens and send them to another institution. 00:17:17.169 --> 00:17:20.539 This is often called an inter laboratory exchange of. 00:17:23.008 --> 00:17:23.909 A third way, 00:17:23.909 --> 00:17:27.579 which is not necessarily the best way, is to, 00:17:28.013 --> 00:17:31.483 pull a previous specimen that you've, tested 00:17:31.483 --> 00:17:35.687 previously in your laboratory, blind the result of that specimen, 00:17:35.821 --> 00:17:40.526 and then retest it to make sure that your previous result aligns 00:17:40.526 --> 00:17:45.230 with your result on your blinded alternative performance assessment. 00:17:45.898 --> 00:17:51.103 This is the least ideal way, because if your analyte is shifting over 00:17:51.103 --> 00:17:55.674 time, you could be doing great at comparing with your previous result. 00:17:56.041 --> 00:18:01.447 But then, you may not necessarily notice if you've had a bias, a shift, 00:18:01.447 --> 00:18:05.217 or a trend over time, that you may not flag. 00:18:09.421 --> 00:18:10.456 Okay, so 00:18:10.456 --> 00:18:13.692 moving on to quality systems for non wave testing. 00:18:13.692 --> 00:18:18.931 In 2003, CMS revised subpart K and what they did 00:18:18.931 --> 00:18:23.035 is they consolidated the requirements for all non waived testing. 00:18:23.335 --> 00:18:26.538 And as we learned earlier non waive testing as either 00:18:26.705 --> 00:18:29.808 high complexity or moderate complexity testing. 00:18:30.275 --> 00:18:33.445 And they aligned all of their standards into a better 00:18:33.445 --> 00:18:36.448 organized path of workflow. 00:18:36.482 --> 00:18:39.751 They've developed their standard to align 00:18:39.751 --> 00:18:44.590 with pre analytical, analytical and post analytical phases of testing. 00:18:44.857 --> 00:18:46.892 And we talked about those a little bit earlier. 00:18:46.892 --> 00:18:51.263 So pre analytic as everything from specimen collection 00:18:51.263 --> 00:18:55.701 to ordering the test and submitting the test to the laboratory. 00:18:55.968 --> 00:18:58.737 Analytic is testing phases. 00:18:58.737 --> 00:19:01.740 All of the things that touch actual testing. 00:19:01.807 --> 00:19:04.810 Then post analytic is reporting results. 00:19:07.880 --> 00:19:09.181 So a couple more points 00:19:09.181 --> 00:19:12.151 about the revised subpart. 00:19:12.417 --> 00:19:15.854 CMS requires that test sites must have established 00:19:15.854 --> 00:19:18.957 policies and procedures to continually evaluate 00:19:18.957 --> 00:19:22.861 the effectiveness of all phases of their processes through quality. 00:19:23.395 --> 00:19:26.131 And then they also require that not only are 00:19:26.131 --> 00:19:32.037 you monitoring quality and having, processes to, 00:19:32.804 --> 00:19:37.442 monitor that quality proactively, you must also have a component 00:19:37.442 --> 00:19:41.113 that ensures continuous improvement through ongoing monitoring. 00:19:41.980 --> 00:19:45.317 And the way that we do that in the laboratory is through, 00:19:45.584 --> 00:19:49.354 quality management plan or a quality management system. 00:19:50.889 --> 00:19:52.658 And you can see here Cap has 00:19:52.658 --> 00:19:56.428 a lot of, guidelines in there, all, 00:19:56.728 --> 00:20:00.465 general checklist about quality management, 00:20:00.599 --> 00:20:05.737 what it should cover, how to do it, what they would like to see. 00:20:06.071 --> 00:20:08.440 These are all phase two. 00:20:08.440 --> 00:20:11.777 Which, you know, means that it's the next level of, 00:20:12.177 --> 00:20:15.714 a deficiency, if you're not adhering to these things. 00:20:15.714 --> 00:20:19.184 So. So what are some ideas for how do you manage quality? 00:20:20.052 --> 00:20:23.322 One way to do that is through appropriately 00:20:23.322 --> 00:20:26.325 defined quality indicators. 00:20:26.391 --> 00:20:30.762 And these indicators that are listed here are actually outlined in the Cap 00:20:30.796 --> 00:20:35.434 checklist as recommendations for indicators that you may want to adopt. 00:20:35.434 --> 00:20:40.105 These are not required again, because laboratories can have different 00:20:40.105 --> 00:20:44.042 focuses and different scope. 00:20:44.977 --> 00:20:48.046 It's okay to define indicators appropriate 00:20:48.046 --> 00:20:51.049 to the type of work that you're doing in your laboratory. 00:20:51.583 --> 00:20:55.020 So but you look at these patient specimen identification. 00:20:55.020 --> 00:20:58.757 So basically maintaining the ID of specimens through all phases 00:20:58.757 --> 00:21:01.760 of testing mislabel tracking. 00:21:01.760 --> 00:21:05.831 Mislabel events could be an indicator test order accuracy. 00:21:06.565 --> 00:21:10.302 If clinicians or providers are continually 00:21:10.302 --> 00:21:13.572 ordering the wrong test, that might be something you want to look at. 00:21:14.006 --> 00:21:15.807 And so on and so forth. 00:21:15.807 --> 00:21:18.977 One thing, that I think is important to highlight 00:21:19.311 --> 00:21:22.781 is that the recommended indicators outlined 00:21:22.781 --> 00:21:27.152 in the Cap accreditation, checklist align 00:21:27.219 --> 00:21:30.822 very well with these phases of testing 00:21:30.822 --> 00:21:33.859 that CMS has, also specified. 00:21:33.859 --> 00:21:38.997 You need to be monitoring pre and post analytic and analytic phases of testing. 00:21:41.933 --> 00:21:44.970 Another important way to ensure that you're managing 00:21:44.970 --> 00:21:49.074 quality in a laboratory is through reporting occurrences, 00:21:49.074 --> 00:21:52.577 which can be also called non conformance 00:21:52.678 --> 00:21:55.681 or errors in the laboratory. 00:21:55.847 --> 00:21:58.150 And I really want to pause here and talk 00:21:58.150 --> 00:22:02.387 about occurrence reporting, because not only is it a great way 00:22:02.387 --> 00:22:06.158 to be able to understand what's truly going on in the laboratory, 00:22:06.591 --> 00:22:10.562 but there's a right way to monitor this, 00:22:11.863 --> 00:22:13.699 activity as well. 00:22:13.699 --> 00:22:16.702 And that's through a just culture. 00:22:16.768 --> 00:22:20.005 It's important for those of you who are future 00:22:20.005 --> 00:22:23.175 laboratory leaders, to understand that 00:22:24.242 --> 00:22:29.047 you need to foster an environment of safety with your staff. 00:22:29.348 --> 00:22:32.050 They are the ones who really know what's going on. 00:22:32.050 --> 00:22:35.053 They're the ones who identify error prone processes. 00:22:35.120 --> 00:22:39.558 They identify when they themselves has made a mistake, and it's important 00:22:39.558 --> 00:22:43.328 for them to feel comfortable and safe to bring those concerns forward. 00:22:43.328 --> 00:22:46.631 The best thing you can have is somebody who said, oh, oops, 00:22:46.631 --> 00:22:51.136 I made a mistake and take that immediately to their supervisor so it can be fixed 00:22:51.303 --> 00:22:54.439 before it proceeds down through the other phases of testing. 00:22:55.273 --> 00:22:58.110 But then at that point, that's when you take a step back 00:22:58.110 --> 00:23:00.846 and you look at your processes and you think, 00:23:00.846 --> 00:23:03.548 what kind of an environment do we have? 00:23:03.548 --> 00:23:06.017 That is encouraging this type of mistake. 00:23:06.017 --> 00:23:11.623 And I guarantee you it is almost always going to be a process and not the person 00:23:11.723 --> 00:23:15.527 that is the root cause of the error that's happening in the laboratory. 00:23:15.527 --> 00:23:19.798 So we really need to depend on our people to identify 00:23:19.831 --> 00:23:23.635 these error prone processes to bring their concerns forward, 00:23:23.635 --> 00:23:26.571 to identify when they themselves have made a mistake, 00:23:26.571 --> 00:23:29.875 and then they should be rewarded by being asked, 00:23:29.975 --> 00:23:32.944 what are your ideas for making this better? 00:23:32.944 --> 00:23:35.414 Why do you think this is so error prone? 00:23:35.414 --> 00:23:38.717 What have you seen that you think maybe we could fix? 00:23:38.717 --> 00:23:42.654 Are there erroneous steps that are making this needlessly complicated? 00:23:43.288 --> 00:23:48.193 You be very surprised at how the folks doing the work really have those answers. 00:23:49.494 --> 00:23:52.497 And this is what's called a just culture. 00:23:55.500 --> 00:23:57.402 So, as I mentioned, 00:23:57.402 --> 00:24:02.941 you know, Clea and CMS not only require you to manage quality, 00:24:02.941 --> 00:24:06.678 but they also require you to continually improve. 00:24:06.912 --> 00:24:10.649 And a good strategy for continuous improvement is the plan. 00:24:10.649 --> 00:24:13.051 Do check act cycle. 00:24:13.051 --> 00:24:15.720 So you think about how, 00:24:15.720 --> 00:24:19.224 you would want to, you know, when you think about quality 00:24:19.224 --> 00:24:23.094 and your quality indicators and metrics, you're going to set up your systems, 00:24:23.795 --> 00:24:24.896 then you're going to do 00:24:24.896 --> 00:24:28.233 you're going to collect the data and see how well it works. 00:24:28.800 --> 00:24:30.068 And then after you've 00:24:30.068 --> 00:24:33.872 collected the data and monitored the new process for a little while, 00:24:33.872 --> 00:24:38.176 you're going to measure that and check it and report back and say, hey, how well 00:24:38.343 --> 00:24:43.615 did this, improvement or this process work? 00:24:44.382 --> 00:24:48.353 And from there you're going to act and improve on that. 00:24:48.353 --> 00:24:51.389 And I hope I don't make you dizzy here, but 00:24:51.389 --> 00:24:54.392 this should be, again, a continual process. 00:24:56.361 --> 00:24:57.662 And before I part, 00:24:57.662 --> 00:25:01.233 I wanted to leave you with a quote from Richard Branson. 00:25:01.500 --> 00:25:06.571 He's a multi multi-billionaire from the UK and entrepreneur, 00:25:07.405 --> 00:25:11.376 who I think is widely regarded as someone who really does 00:25:11.376 --> 00:25:14.379 understand continual improvement and quality. 00:25:14.613 --> 00:25:18.216 And, the quote is every success story is a tale of constant 00:25:18.216 --> 00:25:21.219 adaptation, revision and change. 00:25:21.319 --> 00:25:24.322 I've often heard that if you think that you've reached 00:25:24.322 --> 00:25:29.160 a state of perfection, or that you think you're you're good, you've got a problem 00:25:29.160 --> 00:25:32.864 because there is always going to be room to continuously improve. 00:25:32.864 --> 00:25:37.736 And, I would like to, leave you all with that message. 00:25:37.736 --> 00:25:39.170 And thank you for your time.