WEBVTT 00:00:08.366 --> 00:00:09.300 Hello and welcome 00:00:09.300 --> 00:00:12.900 to this presentation on Clear Regulations. 00:00:13.333 --> 00:00:18.666 My name is Lauren Pearson and I am a laboratory director with air U.P. 00:00:19.000 --> 00:00:21.133 and the University of Utah. 00:00:21.133 --> 00:00:24.833 I wanted to point out that all of the information that I will be 00:00:24.833 --> 00:00:27.833 presenting today can be referenced 00:00:28.333 --> 00:00:31.333 at the CDC website. 00:00:33.266 --> 00:00:34.666 And I'd like to take a moment 00:00:34.666 --> 00:00:37.900 and show you where to find this resource. 00:00:38.633 --> 00:00:41.033 This is the home page 00:00:41.033 --> 00:00:44.200 for the centers for Disease Control and Prevention. 00:00:44.666 --> 00:00:47.333 They have a laboratory 00:00:47.333 --> 00:00:50.333 clinical Laboratory improvement amendments 00:00:50.933 --> 00:00:53.433 page dedicated entirely 00:00:53.433 --> 00:00:56.433 to clear law and regulations. 00:00:56.833 --> 00:01:02.066 What I want to point out to you is this section titled Clear Regulations 00:01:02.400 --> 00:01:05.366 and a link to the standards and certification 00:01:05.366 --> 00:01:08.366 for laboratory requirements. 00:01:09.133 --> 00:01:12.900 I use this site as a reference on a regular basis. 00:01:13.266 --> 00:01:18.600 It is the electronic Code of Federal Regulations and it is kept current. 00:01:18.766 --> 00:01:22.766 You can see that it was most recently updated on August 4th. 00:01:24.300 --> 00:01:25.066 One nice 00:01:25.066 --> 00:01:28.533 aspect of this website is that everything is hyperlinked. 00:01:29.000 --> 00:01:32.000 So you can scroll down to the table of contents here. 00:01:32.833 --> 00:01:36.933 Find the general heading for the information that you're looking 00:01:36.933 --> 00:01:40.700 for, and be taken right away to the section of interests. 00:01:42.100 --> 00:01:44.933 I always like to point out this resource 00:01:44.933 --> 00:01:49.833 to people when I give this lecture about clear regulations. 00:01:50.466 --> 00:01:53.866 First, a brief outline of the information we will cover today. 00:01:54.733 --> 00:01:57.900 We'll talk about clear and regulatory hierarchy, 00:01:58.633 --> 00:02:01.633 different types of clear certificates, 00:02:01.733 --> 00:02:04.733 general accreditation requirements, 00:02:04.766 --> 00:02:06.966 proficiency testing 00:02:06.966 --> 00:02:09.966 facility administration for laboratories, 00:02:10.033 --> 00:02:14.333 quality management systems, and lastly personnel requirements. 00:02:14.700 --> 00:02:18.433 And some of these areas will be discussed in greater detail than others. 00:02:18.866 --> 00:02:22.800 Just remember that for any of the topics, if you'd like a little bit 00:02:22.800 --> 00:02:25.366 more information, you can always go back to that 00:02:25.366 --> 00:02:28.766 electronic code of federal regulations that I just showed you. 00:02:31.033 --> 00:02:31.500 So let's 00:02:31.500 --> 00:02:34.733 start out with a basic discussion about clear. 00:02:35.233 --> 00:02:41.433 So what is clear clear is clinical laboratory improvement amendments. 00:02:42.066 --> 00:02:45.733 It's a program that's administered by CMS, 00:02:46.066 --> 00:02:49.066 which is the centers for Medicare and Medicaid Services. 00:02:50.066 --> 00:02:52.800 Congress passed clear 00:02:52.800 --> 00:02:55.933 with clear amendments in 1988. 00:02:56.433 --> 00:03:00.300 And the purpose of this was to establish basic quality 00:03:00.300 --> 00:03:03.900 standards for patient laboratory testing. 00:03:04.400 --> 00:03:09.466 So clear does not apply to research testing. 00:03:10.633 --> 00:03:15.533 So clear regulates laboratories again that test patient specimens. 00:03:15.966 --> 00:03:17.666 And what it does is it mandates 00:03:17.666 --> 00:03:20.966 that all laboratories meet applicable federal requirements 00:03:21.566 --> 00:03:25.700 and have a certificate or a license, if you will. 00:03:25.733 --> 00:03:28.733 You can think of it that way to operate. 00:03:28.766 --> 00:03:33.633 And again, the bottom line here, the purpose is to ensure that laboratories 00:03:33.633 --> 00:03:38.733 are producing accurate and reliable test results for patient care. 00:03:41.833 --> 00:03:43.100 So each lab that's 00:03:43.100 --> 00:03:46.100 conducting testing on patient specimens 00:03:46.133 --> 00:03:50.266 must be either clear, exempt, or possess 00:03:50.266 --> 00:03:53.266 one of five types of clear certificates. 00:03:54.233 --> 00:03:58.466 Let's talk briefly for a moment about the clear exempt category. 00:03:58.933 --> 00:04:02.766 In the United States, there are a handful of states that have 00:04:02.766 --> 00:04:07.933 more stringent regulatory requirements than what is in the clear standards. 00:04:08.633 --> 00:04:12.066 A great example that many of us are already familiar 00:04:12.066 --> 00:04:15.066 with is New York State. 00:04:15.200 --> 00:04:16.866 If your laboratory resides 00:04:16.866 --> 00:04:19.866 in a state such as New York, 00:04:20.166 --> 00:04:22.600 then you are clear, exempt 00:04:22.600 --> 00:04:25.833 and do not have to possess a clear certificate. 00:04:27.333 --> 00:04:30.200 But the majority of state are not clear. 00:04:30.200 --> 00:04:31.866 Exempt. 00:04:31.866 --> 00:04:34.400 So we have clear certificates 00:04:34.400 --> 00:04:37.400 in order to operate. 00:04:37.666 --> 00:04:40.666 So there's five types of certificates. 00:04:41.333 --> 00:04:43.466 And there's an example 00:04:43.466 --> 00:04:46.500 of a clear certificate visible on this slide. 00:04:49.200 --> 00:04:50.266 The most basic 00:04:50.266 --> 00:04:53.933 clear certificate is called a certificate of waiver. 00:04:54.200 --> 00:04:57.233 And that's the second to last one on this slide. 00:04:57.933 --> 00:05:01.033 A certificate of waiver is obtained 00:05:01.033 --> 00:05:05.400 by a laboratory or a physician office, for example, 00:05:05.700 --> 00:05:08.533 where only waived testing 00:05:08.533 --> 00:05:11.533 is going to be performed. 00:05:13.800 --> 00:05:16.800 A certificate of registration. 00:05:17.266 --> 00:05:21.000 The very first one is a type of certificate 00:05:21.000 --> 00:05:26.100 that a laboratory obtains when it first opens for business. 00:05:26.466 --> 00:05:30.933 It's basically letting CMS know that it is a new entity 00:05:30.933 --> 00:05:33.933 that is open for patient testing. 00:05:34.800 --> 00:05:36.866 A certificate of compliance 00:05:36.866 --> 00:05:39.866 is a clear certificate that is issued 00:05:40.266 --> 00:05:44.500 when a laboratory has been inspected by CMS 00:05:44.933 --> 00:05:48.433 and has been deemed to be compliant 00:05:48.600 --> 00:05:51.600 with all sub standards. 00:05:51.633 --> 00:05:54.366 And we'll get to detail about 00:05:54.366 --> 00:05:57.366 what those sub standards are. 00:05:57.366 --> 00:06:02.033 A certificate of accreditation is a certificate that is awarded 00:06:02.300 --> 00:06:06.900 when a laboratory has been inspected by a deemed agency. 00:06:07.400 --> 00:06:10.400 For example, the College of American Pathologists 00:06:10.766 --> 00:06:15.300 and been found to be in compliance with all standards for testing. 00:06:16.533 --> 00:06:17.800 The very last 00:06:17.800 --> 00:06:21.066 type is a certificate for provider 00:06:21.066 --> 00:06:24.066 performed microscopy procedures. 00:06:24.733 --> 00:06:27.766 And that's a unique certificate that is most 00:06:27.766 --> 00:06:30.900 commonly used in the physician office setting. 00:06:32.166 --> 00:06:33.900 And that certificate 00:06:33.900 --> 00:06:37.533 confers the ability of that site to perform 00:06:37.966 --> 00:06:42.700 provider perform microscopy procedures such as a wet mount. 00:06:43.500 --> 00:06:46.500 And in addition to that, waived testing. 00:06:47.866 --> 00:06:49.500 So for laboratory 00:06:49.500 --> 00:06:52.800 that conducts moderate complexity testing, 00:06:53.300 --> 00:06:56.300 a certificate for PPM or 00:06:56.400 --> 00:06:59.400 a certificate of waiver would not be appropriate. 00:06:59.400 --> 00:07:02.733 You really have to obtain a certificate 00:07:02.733 --> 00:07:06.400 of accreditation or a certificate of compliance. 00:07:06.766 --> 00:07:09.900 Before we move on, I'm briefly going to talk 00:07:09.900 --> 00:07:12.900 about categorization of assays. 00:07:13.000 --> 00:07:17.366 So two big buckets here waived and non waived. 00:07:17.900 --> 00:07:22.066 I briefly mentioned waived testing on the previous slide. 00:07:22.600 --> 00:07:26.933 But wave tests are a category of tests that are for the most part 00:07:27.600 --> 00:07:30.000 provided at the point of care of the patient. 00:07:30.000 --> 00:07:32.100 And some common examples would be 00:07:33.500 --> 00:07:35.633 bedside glucose or 00:07:35.633 --> 00:07:38.633 a urine pregnancy dipstick testing. 00:07:39.900 --> 00:07:44.666 Non wave testing encompasses assays of moderate complexity. 00:07:44.666 --> 00:07:48.700 It does include the category of provider perform microscopy 00:07:49.166 --> 00:07:51.766 as well as high complexity testing. 00:07:51.766 --> 00:07:56.766 So moderate complexity testing includes many FDA approved assays. 00:07:57.033 --> 00:08:01.933 High complexity testing would, for example, include laboratory developed 00:08:01.933 --> 00:08:05.733 tests, as well as an FDA approved assay 00:08:05.733 --> 00:08:08.733 that has been modified by a laboratory. 00:08:09.700 --> 00:08:13.366 So big picture a laboratory may perform only wave tests, 00:08:14.066 --> 00:08:16.600 non wave tests, or any combination 00:08:16.600 --> 00:08:19.600 of the above. 00:08:20.700 --> 00:08:22.600 It's important to know 00:08:22.600 --> 00:08:26.800 what category your test is in in order to determine 00:08:27.000 --> 00:08:31.166 which type of a certificate is appropriate for your lab. 00:08:32.533 --> 00:08:34.200 So how do we determine 00:08:34.200 --> 00:08:37.200 whether a test is waived or non waived. 00:08:37.700 --> 00:08:41.200 This is determined during premarket approval. 00:08:41.866 --> 00:08:46.466 The manufacturer goes through the process of premarket approval with the FDA. 00:08:47.200 --> 00:08:50.200 And when the information is submitted 00:08:51.000 --> 00:08:55.166 the diagnostic tool is scored 00:08:56.566 --> 00:08:58.166 based on 00:08:58.166 --> 00:09:00.933 its complexity in a number of categories. 00:09:00.933 --> 00:09:04.133 And you can see on the list that I have provided here. 00:09:04.900 --> 00:09:08.000 But the idea is that the higher 00:09:09.300 --> 00:09:13.133 the complexity or the more expertise is required 00:09:13.500 --> 00:09:16.300 to operate the test, 00:09:16.300 --> 00:09:19.300 maintain it, or to interpret the results, 00:09:20.600 --> 00:09:22.400 more than likely it's going to be 00:09:22.400 --> 00:09:25.400 in that non waived category. 00:09:29.100 --> 00:09:31.466 We're going to only briefly discuss 00:09:31.466 --> 00:09:34.466 provider perform microscopy. 00:09:35.066 --> 00:09:37.066 This is a unique group of tests. 00:09:37.066 --> 00:09:40.966 As I mentioned typically these are done 00:09:40.966 --> 00:09:43.966 in the physician office setting. 00:09:44.400 --> 00:09:46.933 There are specific criteria 00:09:46.933 --> 00:09:50.000 in the clear regulations which define 00:09:51.000 --> 00:09:54.833 what procedures constitute provider. 00:09:54.833 --> 00:09:57.833 Perform microscopy. 00:09:57.933 --> 00:10:00.100 And here are a few. 00:10:00.100 --> 00:10:04.433 So the exam must be performed by a practitioner using a microscope. 00:10:05.100 --> 00:10:08.000 Typically practitioner is limited 00:10:08.000 --> 00:10:11.900 to physician physician assistant nurse practitioner. 00:10:13.633 --> 00:10:14.300 The procedure 00:10:14.300 --> 00:10:17.300 must be categorized as moderately complex. 00:10:17.400 --> 00:10:21.533 The specimen is typically labial and requires limited processing. 00:10:22.600 --> 00:10:27.233 And as one would ascertain from the primary instrument 00:10:27.233 --> 00:10:31.133 being a microscope, typically there really aren't good control 00:10:31.133 --> 00:10:34.833 materials available for whatever the test is. 00:10:36.500 --> 00:10:40.833 So to perform p m, a lab or a physician office 00:10:40.833 --> 00:10:44.066 must obtain the appropriate certificate 00:10:44.733 --> 00:10:47.133 and meet applicable requirements. 00:10:47.133 --> 00:10:50.200 And lastly, they need to allow themselves 00:10:50.200 --> 00:10:53.200 to be subject to inspection. 00:10:53.366 --> 00:10:56.500 If you're interested in seeing the defined list of procedures 00:10:56.500 --> 00:11:00.100 that qualify under this category, you can refer back to that website 00:11:00.100 --> 00:11:03.100 that I showed you at the beginning of the presentation. 00:11:07.533 --> 00:11:08.600 So at any time 00:11:08.600 --> 00:11:11.900 CMS can actually withdrawal accreditation from a laboratory. 00:11:12.500 --> 00:11:15.233 Doesn't matter if that laboratory has been inspected 00:11:15.233 --> 00:11:19.866 by CMS itself or has been inspected by a deemed agency. 00:11:21.000 --> 00:11:22.333 CMS can take adverse 00:11:22.333 --> 00:11:25.366 action against the lab for a number of reasons. 00:11:26.166 --> 00:11:30.100 But just to give you an example, if the laboratory 00:11:30.366 --> 00:11:35.266 fails to participate successfully in proficiency testing, 00:11:35.700 --> 00:11:38.700 that would be grounds for revocation of a certificate. 00:11:40.033 --> 00:11:41.833 Another example might be 00:11:41.833 --> 00:11:45.500 a referral of proficiency testing material. 00:11:45.566 --> 00:11:48.566 We'll talk about that later in the presentation. 00:11:48.900 --> 00:11:51.833 Let's spend some time talking about proficiency testing. 00:11:51.833 --> 00:11:54.800 And again, from here on out in the presentation 00:11:54.800 --> 00:11:57.766 we're going to focus on noninvasive testing. 00:11:57.766 --> 00:12:01.966 Each laboratory must enroll in a proficiency testing program. 00:12:02.333 --> 00:12:05.900 And you'll hear me use the word term just to abbreviate. 00:12:06.366 --> 00:12:10.733 That meets the clear criteria and is approved by the government. 00:12:11.800 --> 00:12:16.133 And you must enroll in proficiency testing for each specialty 00:12:16.133 --> 00:12:20.233 and subspecialty for which you are seeking a certification. 00:12:20.233 --> 00:12:21.600 As a laboratory. 00:12:21.600 --> 00:12:25.200 There's a defined list of proficiency testing providers 00:12:26.100 --> 00:12:30.300 who are approved to supply proficiency testing material. 00:12:32.266 --> 00:12:35.266 Very importantly, labs must authorize 00:12:35.466 --> 00:12:39.333 the release of their proficiency testing performance data 00:12:39.766 --> 00:12:42.766 to CMS. 00:12:43.200 --> 00:12:46.833 So, for example, going back to enrollment 00:12:48.133 --> 00:12:50.166 in my laboratory, 00:12:50.166 --> 00:12:53.566 I want to be certified in the area of hematology. 00:12:53.933 --> 00:12:57.066 So within that area I have to make sure that I'm enrolled 00:12:57.633 --> 00:13:03.166 in an approved program for each subspecialty area. 00:13:03.166 --> 00:13:07.133 In hematology, for example, it wouldn't be acceptable for me 00:13:07.400 --> 00:13:10.933 to enroll in PT for the CBC test, 00:13:10.933 --> 00:13:13.933 but not enroll in part for 00:13:14.800 --> 00:13:18.133 a body fluid cell count in differential test 00:13:18.133 --> 00:13:21.133 that is also offered in that area. 00:13:21.400 --> 00:13:24.400 There are very specific rules for testing 00:13:25.400 --> 00:13:27.466 samples. 00:13:27.466 --> 00:13:29.466 Nuclear is very prescriptive 00:13:29.466 --> 00:13:32.700 for how this is supposed to be managed. 00:13:33.566 --> 00:13:36.066 Proficiency testing samples 00:13:36.066 --> 00:13:40.066 must be integrated into the laboratories regular patient workload, 00:13:40.633 --> 00:13:45.333 and they must be tested by personnel who routinely perform patient testing. 00:13:46.633 --> 00:13:47.433 The laboratory 00:13:47.433 --> 00:13:51.666 director has to attest to this routine integration 00:13:51.900 --> 00:13:54.900 by physically signing paperwork that comes 00:13:55.166 --> 00:13:58.166 with the proficiency testing kits. 00:13:59.133 --> 00:14:01.033 These samples in the kit 00:14:01.033 --> 00:14:05.500 must be tested using the laboratories primary routine methods. 00:14:05.900 --> 00:14:09.866 In other words, you can't keep an instrument in the rear 00:14:09.866 --> 00:14:14.200 corner of the lab that you know is a high performing 00:14:15.466 --> 00:14:17.633 one of your best instruments 00:14:17.633 --> 00:14:21.800 and reserve that just for proficiency testing purposes. 00:14:21.833 --> 00:14:26.400 No, you have to test the samples as you would any patient sample. 00:14:27.866 --> 00:14:31.200 And then in terms of standard operating procedure, 00:14:31.500 --> 00:14:35.166 we try to treat proficiency testing material 00:14:35.166 --> 00:14:40.833 the same way we would treat patient material in terms of the number of times 00:14:40.833 --> 00:14:43.833 the number of replicates that we would, 00:14:43.866 --> 00:14:46.866 test the kit material. 00:14:47.366 --> 00:14:50.000 There are rare exceptions where you can't 00:14:50.000 --> 00:14:53.966 treat proficiency testing material the same as patient samples. 00:14:55.500 --> 00:14:57.666 This next piece is important. 00:14:57.666 --> 00:15:00.300 The laboratory must document the handling, 00:15:00.300 --> 00:15:03.300 preparation, processing, etc. 00:15:03.766 --> 00:15:06.766 for each phase of the testing. 00:15:08.266 --> 00:15:12.333 And very, very importantly, there can be no inter laboratory 00:15:12.333 --> 00:15:16.100 communication about the proficiency 00:15:16.100 --> 00:15:19.100 testing material or the results. 00:15:19.800 --> 00:15:25.500 And labs cannot send proficiency testing 00:15:25.500 --> 00:15:30.866 material outside of their laboratory to another laboratory for any reason. 00:15:32.133 --> 00:15:33.900 So going back to a point 00:15:33.900 --> 00:15:36.900 I made just a moment ago, 00:15:37.100 --> 00:15:38.933 if it is a test that you would 00:15:38.933 --> 00:15:41.933 normally have a reflex set up 00:15:42.000 --> 00:15:46.033 such that a result would, would, 00:15:47.166 --> 00:15:49.666 for a patient would normally result 00:15:49.666 --> 00:15:52.833 in a portion of the sample being sent 00:15:53.833 --> 00:15:57.366 for confirmation, for example, to a different laboratory. 00:15:57.366 --> 00:16:00.366 That absolutely cannot happen with proficiency testing. 00:16:00.800 --> 00:16:06.900 So that's an example of a departure from the normal patient integration 00:16:07.066 --> 00:16:10.366 or a normal procedure for a patient sample 00:16:10.766 --> 00:16:14.100 compared to what is allowed with proficiency testing. 00:16:19.133 --> 00:16:19.533 We're going to 00:16:19.533 --> 00:16:22.533 transition here to a different topic. 00:16:22.633 --> 00:16:25.966 And that is how to administer a laboratory. 00:16:25.966 --> 00:16:28.433 According to Clea. 00:16:28.433 --> 00:16:31.233 Clea has a lot of detail 00:16:31.233 --> 00:16:34.266 about what must be accomplished 00:16:34.800 --> 00:16:39.600 may specifically state that the laboratory must have adequate space, 00:16:39.900 --> 00:16:44.100 ventilation, and utilities necessary for conducting patient testing. 00:16:44.100 --> 00:16:46.533 And that makes sense. 00:16:46.533 --> 00:16:48.966 The director has to make sure 00:16:48.966 --> 00:16:53.100 that there are sufficient equipment, instruments, reagents, etc. 00:16:53.100 --> 00:16:56.700 available and that the lab is in compliance 00:16:56.700 --> 00:17:00.433 with any of the local state requirements. 00:17:02.266 --> 00:17:05.266 For example, occupational health and safety 00:17:05.866 --> 00:17:09.533 safety procedures must be established, accessible 00:17:10.233 --> 00:17:13.500 and observed to ensure protection from hazards, 00:17:14.000 --> 00:17:17.000 chemical, biological, etc. 00:17:17.900 --> 00:17:21.400 and Clea also specifies 00:17:22.166 --> 00:17:25.266 that laboratories have to retain records 00:17:25.800 --> 00:17:28.800 for a prescribed period of time. 00:17:29.133 --> 00:17:32.133 Same thing with specimens. 00:17:32.933 --> 00:17:36.266 This is a very high level overview of facility administration. 00:17:36.266 --> 00:17:37.200 According to Clea. 00:17:38.300 --> 00:17:41.300 So briefly let's talk about retention requirements. 00:17:41.666 --> 00:17:45.533 This tends to be a hot board question 00:17:45.933 --> 00:17:49.200 for the, pathology board exams. 00:17:50.233 --> 00:17:53.166 We are says that labs must 00:17:53.166 --> 00:17:56.300 retain records for a minimum of two years. 00:17:57.300 --> 00:18:00.300 Examples under this 00:18:00.433 --> 00:18:03.700 umbrella would include things like test requisitions, 00:18:04.266 --> 00:18:07.266 procedures, analytics, system records. 00:18:07.266 --> 00:18:11.166 So that encompasses everything from quality control 00:18:11.166 --> 00:18:14.633 data to calibrations, etc. 00:18:15.300 --> 00:18:18.200 proficiency testing records and records 00:18:18.200 --> 00:18:22.000 for your quality assessment or quality management system. 00:18:23.400 --> 00:18:26.900 Many institutions have their own internal standards for this, 00:18:27.733 --> 00:18:31.333 but this is the minimum you must retain for two years. 00:18:31.333 --> 00:18:34.900 At minimum, you can always retain for longer than that 00:18:35.366 --> 00:18:38.033 depending on your needs. 00:18:38.033 --> 00:18:41.033 There are some exceptions to that two year minimum, 00:18:41.933 --> 00:18:44.933 and those include immuno hematology reports, 00:18:45.366 --> 00:18:48.266 pathology test reports 00:18:48.266 --> 00:18:51.400 or those they say ten years after the date of reporting. 00:18:52.800 --> 00:18:55.800 So think surgical pathology in that category. 00:18:56.066 --> 00:18:58.966 Cytology slide preparations must be retained 00:18:58.966 --> 00:19:02.100 for at least five years from the date of the examination. 00:19:03.300 --> 00:19:06.300 Histo pathology slides are ten years. 00:19:07.100 --> 00:19:10.100 Specimen blocks at least two years. 00:19:13.366 --> 00:19:16.766 Okay, onto the next major topic. 00:19:16.766 --> 00:19:17.266 And clear. 00:19:17.266 --> 00:19:20.266 And that is the quality system. 00:19:21.900 --> 00:19:22.366 Korea 00:19:22.366 --> 00:19:25.933 actually prescribes that labs have to have a quality system. 00:19:25.933 --> 00:19:30.000 And it makes sense because Korea is all about maintaining 00:19:30.133 --> 00:19:34.033 a minimum standard of acceptable quality to keep patients safe. 00:19:35.233 --> 00:19:39.400 According to Korea, labs must establish and maintain written policies 00:19:39.400 --> 00:19:44.033 and procedures to implement and then monitor a quality system. 00:19:44.033 --> 00:19:48.500 And it must encompass all phases of testing, so that includes 00:19:48.500 --> 00:19:52.500 the pre analytic, analytic and post analytic aspects. 00:19:53.533 --> 00:19:57.900 And that last piece the quality the monitoring of the quality system 00:19:58.166 --> 00:20:03.500 is actually really important because that is how laboratories 00:20:04.000 --> 00:20:06.833 determine whether or not 00:20:06.833 --> 00:20:10.833 they are providing a high standard of care to patients, 00:20:11.233 --> 00:20:14.366 and also reassure themselves that 00:20:15.366 --> 00:20:18.366 they are doing so in a timely manner, 00:20:18.900 --> 00:20:21.900 and that patient safety is maintained. 00:20:23.100 --> 00:20:26.766 So the quality assessment component is really to help you identify, 00:20:27.500 --> 00:20:30.200 evaluate and resolve any problems 00:20:30.200 --> 00:20:33.200 that come up. 00:20:34.500 --> 00:20:35.733 Quia lists 00:20:35.733 --> 00:20:38.733 many standards for the quality system. 00:20:39.466 --> 00:20:41.900 Standards is the term terminology 00:20:41.900 --> 00:20:46.066 that Clea uses for its requirements. 00:20:47.066 --> 00:20:50.400 Those of us that are accredited by the College of American 00:20:50.400 --> 00:20:55.466 Pathologists are more familiar with the term checklist requirements. 00:20:56.700 --> 00:20:58.933 So you can think of the standards as similar 00:20:58.933 --> 00:21:01.933 to the checklist requirements, at least in concept. 00:21:02.900 --> 00:21:06.600 The quality system standards include patient confidentiality, 00:21:07.100 --> 00:21:10.200 specimen identification and integrity, 00:21:10.766 --> 00:21:13.866 complaint investigations, communications 00:21:15.000 --> 00:21:17.966 competency assessment for the personnel 00:21:17.966 --> 00:21:20.700 proficiency testing performance. 00:21:20.700 --> 00:21:24.433 And then lastly, the General Laboratory systems quality assessment. 00:21:24.733 --> 00:21:28.133 That's the piece that I was describing on the previous slide. 00:21:30.766 --> 00:21:31.500 We're going to dive in 00:21:31.500 --> 00:21:34.500 a little bit more on the standards 00:21:34.500 --> 00:21:38.066 within each of the three main phases of the testing process. 00:21:39.200 --> 00:21:42.200 First, the pre analytic quality standards. 00:21:43.100 --> 00:21:46.100 There are several requirements in this area. 00:21:46.633 --> 00:21:50.033 Again, the idea here is that we have to monitor 00:21:50.033 --> 00:21:54.233 and evaluate the overall quality of the pre analytic process 00:21:54.600 --> 00:21:57.866 so that we can correct any issues that we identify. 00:21:58.766 --> 00:22:02.700 An example of some of the standards the test requests, 00:22:03.433 --> 00:22:06.266 having the appropriate patient identifiers 00:22:06.266 --> 00:22:09.300 on the test requests etc. 00:22:09.866 --> 00:22:12.600 and then having a well vetted process 00:22:12.600 --> 00:22:15.933 for people to submit specimens 00:22:16.600 --> 00:22:19.600 for specimen processing, etc. 00:22:20.033 --> 00:22:23.033 just to list a couple examples. 00:22:24.300 --> 00:22:24.866 The next 00:22:24.866 --> 00:22:28.400 major portion of the testing process, 00:22:28.400 --> 00:22:32.300 or the next phase of testing is the analytic systems quality piece. 00:22:32.300 --> 00:22:35.533 And this is where laboratories tend to spend the bulk of their time 00:22:36.400 --> 00:22:38.400 in terms of resources. 00:22:38.400 --> 00:22:40.800 And the standards in this area are numerous. 00:22:40.800 --> 00:22:42.366 And I'm not going to read them all to you. 00:22:42.366 --> 00:22:45.133 But this is really where we get into 00:22:45.133 --> 00:22:48.966 performance validation of instruments and assays, 00:22:50.500 --> 00:22:53.500 maintenance and function checks of instruments, 00:22:53.666 --> 00:22:56.433 calibration procedures, quality 00:22:56.433 --> 00:22:59.433 control procedures, etc.. 00:23:01.066 --> 00:23:04.033 This is really the bread and butter of 00:23:04.033 --> 00:23:07.033 of what we do in lab medicine. 00:23:07.600 --> 00:23:11.166 And the last phase of testing the post analytic phase. 00:23:11.600 --> 00:23:14.066 Here's what Korea has to say about that. 00:23:14.066 --> 00:23:18.500 The standards in this area primarily have to do with the test reporting. 00:23:19.166 --> 00:23:21.566 So they say that the lab has to have 00:23:21.566 --> 00:23:25.900 an adequate system in place to make sure that results and other 00:23:25.900 --> 00:23:30.800 patient data are accurately sent from the lab 00:23:31.666 --> 00:23:34.666 to the provider. 00:23:34.733 --> 00:23:38.266 And they go so far as to to specify 00:23:38.266 --> 00:23:41.566 what needs to be in the test report, which is helpful. 00:23:42.300 --> 00:23:45.466 And there is a component in there about timeliness 00:23:45.466 --> 00:23:48.466 of the availability of that information. 00:23:50.700 --> 00:23:54.700 One thing to know is that if you are being inspected by CMS, 00:23:55.733 --> 00:23:58.733 you will be asked to produce 00:23:59.166 --> 00:24:04.200 records of any and all of these components as part of that process. 00:24:04.200 --> 00:24:08.100 So you need to be able to retrieve this type of information 00:24:08.100 --> 00:24:11.100 very easily. 00:24:12.833 --> 00:24:15.833 We're going to transition again now to talking about personnel. 00:24:16.366 --> 00:24:17.033 And I realize 00:24:17.033 --> 00:24:20.766 that many of these components feel a little bit just jointed in the sense 00:24:20.766 --> 00:24:25.066 that it's sort of like, okay, we're talking about proficiency testing 00:24:25.066 --> 00:24:28.466 one minute and then quality management the next minute. 00:24:28.966 --> 00:24:31.800 But I really just wanted to take you 00:24:31.800 --> 00:24:35.600 through the major categories of concepts 00:24:35.600 --> 00:24:38.666 that are encompassed in the clear regulations. 00:24:40.500 --> 00:24:40.800 Okay. 00:24:40.800 --> 00:24:42.600 Back to the personnel piece. 00:24:42.600 --> 00:24:45.600 And again this is focusing on non waived testing. 00:24:47.900 --> 00:24:51.500 And we'll focus on moderate and high complexity. 00:24:52.900 --> 00:24:57.266 Let's start out with the discussion about laboratory director qualifications. 00:24:58.266 --> 00:24:59.700 The laboratory director must 00:24:59.700 --> 00:25:03.133 be licensed by the state in which the laboratory is located. 00:25:04.333 --> 00:25:07.800 And there are different educational backgrounds 00:25:08.366 --> 00:25:11.366 by which one can qualify for this position. 00:25:12.333 --> 00:25:17.466 They can be physician trained and certified in anatomic or clinical 00:25:17.466 --> 00:25:21.200 pathology, or both, with laboratory 00:25:21.200 --> 00:25:24.200 training consisting of at least a year 00:25:24.700 --> 00:25:27.700 supervising noninvasive testing. 00:25:27.700 --> 00:25:30.366 So for me, for example, D.O. 00:25:30.366 --> 00:25:33.200 trained and I completed a residency program. 00:25:33.200 --> 00:25:36.200 So I qualify for that reason. 00:25:37.466 --> 00:25:41.233 I have many colleagues who are PhD trained 00:25:41.233 --> 00:25:45.766 in chemical, physical, biological or clinical laboratory science 00:25:45.766 --> 00:25:48.833 and are also certified by their professional organization 00:25:49.833 --> 00:25:54.166 and have the requirement for laboratory directors 00:25:54.166 --> 00:25:59.700 with this education background is that they also have at least one year 00:26:00.200 --> 00:26:03.200 directing or supervising non way of testing. 00:26:05.033 --> 00:26:08.200 So the pattern that you're going to see here is really 00:26:08.200 --> 00:26:12.700 there's an education component for the degree and the certification. 00:26:12.700 --> 00:26:16.466 And then there's an experiential component that goes along with it. 00:26:17.633 --> 00:26:20.066 Individuals that have a master's 00:26:20.066 --> 00:26:24.633 or a bachelor's degree can also qualify to be a laboratory director. 00:26:24.633 --> 00:26:27.600 But typically 00:26:27.600 --> 00:26:31.066 they are required to have a longer experiential component 00:26:31.066 --> 00:26:34.166 compared to the other two options that I covered. 00:26:35.200 --> 00:26:38.200 So that's for moderate complexity. 00:26:38.766 --> 00:26:41.166 For high complexity testing. 00:26:41.166 --> 00:26:43.833 The education requirements are the same as moderate. 00:26:43.833 --> 00:26:49.233 The difference here is just that there is a longer experiential component. 00:26:49.233 --> 00:26:52.233 So instead of it being one year, it's a minimum of two years 00:26:52.800 --> 00:26:55.133 directing high complexity testing. 00:26:55.133 --> 00:26:58.133 In this case. 00:26:59.433 --> 00:27:03.000 Before we get into the other categories of personnel. 00:27:03.000 --> 00:27:06.100 I'm just going to briefly talk about what is the responsibilities 00:27:06.100 --> 00:27:09.100 of the lab director, because this can be, 00:27:09.233 --> 00:27:14.100 you know, a confusing area for staff who may not know 00:27:14.466 --> 00:27:18.200 really what their medical director or what the laboratory director does. 00:27:19.333 --> 00:27:19.933 And according 00:27:19.933 --> 00:27:22.933 to clear, the lab director is responsible 00:27:22.933 --> 00:27:26.400 for the overall operation and administration of the lab. 00:27:27.366 --> 00:27:31.033 So they are vicariously responsible for everything that happens in that lab. 00:27:32.133 --> 00:27:35.766 They're responsible for employing competent personnel to perform testing. 00:27:36.566 --> 00:27:40.566 They're responsible for making sure that accurate and reliable 00:27:40.566 --> 00:27:44.400 patient test results are reported in a timely fashion. 00:27:45.066 --> 00:27:46.066 And they're responsible 00:27:46.066 --> 00:27:49.066 for making sure the lab is compliant with all of the regulations. 00:27:50.433 --> 00:27:54.166 The lab director can perform the duties of all of the other lab 00:27:54.166 --> 00:27:57.500 personnel, as long as they're trained and competent in that area, 00:27:58.500 --> 00:28:02.733 and they must be accessible to the lab for onsite telephone 00:28:02.733 --> 00:28:05.733 or electronic consultation as needed. 00:28:06.933 --> 00:28:09.300 Each individual lab director may direct 00:28:09.300 --> 00:28:12.300 no more than five laboratories. 00:28:12.533 --> 00:28:15.000 All right. Let's briefly talk about 00:28:16.300 --> 00:28:17.100 the personnel 00:28:17.100 --> 00:28:20.100 requirements for other clear, defined roles. 00:28:20.800 --> 00:28:23.633 Technical consultant and clinical consultant 00:28:23.633 --> 00:28:27.600 are two other planned to find roles as technical consultant. 00:28:27.933 --> 00:28:31.500 That individual must possess a current license in the state 00:28:31.500 --> 00:28:32.600 where the lab is located. 00:28:32.600 --> 00:28:36.600 They can be physician trained, or they can be PhD or master's 00:28:36.600 --> 00:28:37.600 degree trained again. 00:28:37.600 --> 00:28:40.600 There's an experiential component as well. 00:28:41.166 --> 00:28:43.700 Technical consultant is typically responsible 00:28:43.700 --> 00:28:46.933 for the technical and scientific oversight of the laboratory. 00:28:48.066 --> 00:28:51.133 There can be quite a bit of overlap in these roles as you. 00:28:51.266 --> 00:28:54.233 You'll start to see as we go through them. 00:28:54.233 --> 00:28:56.100 And that'll largely depend 00:28:56.100 --> 00:28:59.100 on how your institution is set up 00:28:59.100 --> 00:29:04.800 and how everything is is delegated and what what resources are available, 00:29:04.800 --> 00:29:06.700 what the 00:29:06.700 --> 00:29:09.700 what the reporting structure looks like, 00:29:09.800 --> 00:29:11.933 how large the team is, etc.. 00:29:13.200 --> 00:29:16.000 Clinical consultant 00:29:16.000 --> 00:29:17.500 is fairly similar. 00:29:17.500 --> 00:29:19.200 Similar. 00:29:19.200 --> 00:29:22.666 That individual can be a qualified laboratory director 00:29:24.266 --> 00:29:27.033 and they 00:29:27.033 --> 00:29:29.033 they may be used for clinical 00:29:29.033 --> 00:29:32.100 consultation to the laboratory clients 00:29:32.100 --> 00:29:35.200 regarding diagnosis, treatment, management of patient care. 00:29:36.600 --> 00:29:38.966 So depending on the institution you think about okay, 00:29:38.966 --> 00:29:41.800 well what's a medical director or what's a laboratory director. 00:29:41.800 --> 00:29:45.166 And seems like there's a lot of overlap with these roles. 00:29:45.166 --> 00:29:48.166 And that is certainly true. 00:29:48.400 --> 00:29:50.266 The medical director role 00:29:50.266 --> 00:29:53.600 and can end up being somewhat of a combination of these roles. 00:29:53.600 --> 00:29:59.800 But would be, in my perspective, somewhat of a combination 00:29:59.800 --> 00:30:02.933 between a clinical consultant and a technical consultant. 00:30:06.600 --> 00:30:09.366 How about testing personnel? 00:30:09.366 --> 00:30:12.800 Testing personnel must have a current license as well. 00:30:13.866 --> 00:30:16.100 And they can have a bachelor's degree 00:30:16.100 --> 00:30:19.233 in clinical laboratory science or medical technology. 00:30:21.433 --> 00:30:22.800 Or they can have a high 00:30:22.800 --> 00:30:26.400 school diploma or equivalent with documented training. 00:30:26.733 --> 00:30:31.066 They can have, equivalent of an associate's degree or a two year degree. 00:30:31.633 --> 00:30:34.633 And they're typically responsible for specimen processing, 00:30:35.500 --> 00:30:38.500 performing testing and reporting patient results. 00:30:39.100 --> 00:30:42.100 Well, that is the end of our presentation today. 00:30:42.166 --> 00:30:45.166 Again, the goal here was just to introduce you 00:30:45.600 --> 00:30:48.566 to the big categories 00:30:48.566 --> 00:30:51.833 of information that are contained in the clear regulations. 00:30:53.166 --> 00:30:56.166 It's important for all laboratories to be aware 00:30:57.166 --> 00:30:59.233 of the requirements. 00:30:59.233 --> 00:31:02.800 And just a quick reminder that if you'd like 00:31:02.800 --> 00:31:06.733 additional information about anything that I presented today, 00:31:07.166 --> 00:31:10.200 you can always go back to the CDC website 00:31:10.666 --> 00:31:13.800 and read to your heart's content. 00:31:14.000 --> 00:31:15.666 Thank you for your attention today.