WEBVTT 00:00:00.033 --> 00:00:03.103 We were talking about, biologic product deviations 00:00:03.103 --> 00:00:06.106 and how errors are reported to the FDA. 00:00:06.206 --> 00:00:09.209 So when the FDA comes in for an inspection, 00:00:09.409 --> 00:00:13.813 they have all that information ahead of time, and they review it 00:00:13.813 --> 00:00:16.816 as part of their preparation for coming to your facility. 00:00:17.183 --> 00:00:20.487 So when they get here, they will, 00:00:21.888 --> 00:00:25.025 want to make sure that any corrective action that you said 00:00:25.025 --> 00:00:28.695 you were going to do, that you put in your report, actually happened. 00:00:30.330 --> 00:00:33.800 So they're going to look for what happens to the product. 00:00:33.800 --> 00:00:36.803 If you told them you quarantine the product, did you 00:00:37.170 --> 00:00:40.306 if you said you discarded the product, did you discard it? 00:00:40.740 --> 00:00:43.710 Where are the records that show that you discarded it? 00:00:44.210 --> 00:00:46.913 If we were notifying a patient physician 00:00:46.913 --> 00:00:49.916 for whatever reason, when did you notify them? 00:00:50.550 --> 00:00:53.286 Show me the documentation that you did that. 00:00:53.286 --> 00:00:54.587 And then counseling. 00:00:54.587 --> 00:00:58.058 Say we were going to discuss this error with this staff member. 00:00:58.058 --> 00:01:01.628 Or this person is going to undergo retraining for this process. 00:01:02.562 --> 00:01:03.063 We're going to 00:01:03.063 --> 00:01:04.731 they're going to look at that and expect for you 00:01:04.731 --> 00:01:07.167 to have the documentation showing that you did that. 00:01:07.167 --> 00:01:10.770 If you revised the procedure, if you revised a training module 00:01:10.770 --> 00:01:13.773 or a process at all, they're going to review the new process 00:01:13.840 --> 00:01:16.142 and want to see the old one versus the new one. 00:01:19.012 --> 00:01:21.481 So they will also look at the effectiveness. 00:01:21.481 --> 00:01:25.652 So to prevent this error we said we were going to change this process 00:01:25.885 --> 00:01:29.589 or we were going to retrain staff or whatever it was. 00:01:30.090 --> 00:01:31.024 So you did that. 00:01:31.024 --> 00:01:32.659 Did it really work 00:01:32.659 --> 00:01:36.262 or are you having the same issue still and what are you doing about it? 00:01:36.963 --> 00:01:39.566 So they'll, look at staff, 00:01:39.566 --> 00:01:42.569 they'll observe people doing their work. 00:01:42.669 --> 00:01:46.539 They'll generally they'll ask for the procedure, they'll record the procedure, 00:01:46.739 --> 00:01:48.108 or they'll ask for a copy of it, 00:01:48.108 --> 00:01:50.577 because most of our procedures are stored electronically. 00:01:50.577 --> 00:01:52.345 So will ask you to print it out, 00:01:52.345 --> 00:01:55.548 and then they'll go observe the people that are performing that. 00:01:56.149 --> 00:01:59.452 And they'll generally ask those people questions. 00:01:59.853 --> 00:02:03.623 They won't ask me or they won't ask the supervisor or the manager. 00:02:04.157 --> 00:02:05.191 They'll say, 00:02:06.192 --> 00:02:08.161 Susie, you're the one doing this. 00:02:08.161 --> 00:02:09.496 What are you doing? 00:02:09.496 --> 00:02:12.332 Please explain to me why you're doing that. 00:02:12.332 --> 00:02:15.869 So, in your careers, you're going to interact with, 00:02:16.569 --> 00:02:20.140 inspectors of all different types, and they're going to ask you the questions. 00:02:20.140 --> 00:02:23.143 They're not always asking management what the questions are. 00:02:23.810 --> 00:02:25.712 And then, 00:02:25.712 --> 00:02:28.114 they do review some audit reports. 00:02:28.114 --> 00:02:31.151 Some investigators don't like to look at audits, 00:02:31.151 --> 00:02:34.454 but they can look at internal audit reports. 00:02:34.954 --> 00:02:37.590 And then they review variance databases. 00:02:37.590 --> 00:02:40.994 So variances or anything where you didn't 00:02:40.994 --> 00:02:44.097 follow the procedure whether it was planned or not planned. 00:02:44.397 --> 00:02:46.733 So you can have an authorized variance 00:02:46.733 --> 00:02:50.970 where the medical director says in this situation we are knowingly 00:02:51.070 --> 00:02:55.708 not going to follow our standard operating procedure for whatever reason it is. 00:02:56.309 --> 00:02:58.645 So then you would document that as an authorized variance 00:02:58.645 --> 00:03:01.347 because you didn't follow what your procedure says. 00:03:01.347 --> 00:03:06.452 You can have any other any time you didn't follow your standard procedure, 00:03:06.452 --> 00:03:08.021 or there was a situation 00:03:08.021 --> 00:03:11.124 where there was some sort of deviation from normal processes. 00:03:11.391 --> 00:03:13.793 You want to, document that as a variance. 00:03:17.897 --> 00:03:18.431 So other 00:03:18.431 --> 00:03:22.135 agencies that inspect laboratories and RFP, 00:03:22.602 --> 00:03:26.439 so CMS and Clea, which we'll talk a little bit more about. 00:03:27.440 --> 00:03:29.075 Department of Justice can come in. 00:03:29.075 --> 00:03:30.743 The DEA can come in. 00:03:30.743 --> 00:03:35.648 The OIG inspects and, respond to HIPAA complaints. 00:03:35.882 --> 00:03:37.951 So if you have any kind of investigations, 00:03:37.951 --> 00:03:40.954 that way they can come in and you'll interact with them. 00:03:40.954 --> 00:03:42.155 So there's a lot or. 00:03:42.155 --> 00:03:43.223 I'm sorry, not though I do. 00:03:43.223 --> 00:03:46.292 The OCR is the one that does HIPAA complaints. 00:03:47.360 --> 00:03:50.096 Nuclear regulatory people, 00:03:50.096 --> 00:03:53.099 they can all come in and then you have state inspections as well. 00:03:53.466 --> 00:03:56.803 So certain states require that you be licensed 00:03:56.803 --> 00:03:59.806 and registered to do business in that state. 00:04:00.240 --> 00:04:03.376 So we have to be registered with every state that we do testing for. 00:04:03.543 --> 00:04:06.713 Mostly the states will accept 00:04:06.946 --> 00:04:10.049 your Clea registration and not come in and inspect you. 00:04:10.550 --> 00:04:11.851 New York is the exception. 00:04:12.785 --> 00:04:14.354 New York comes in every two years 00:04:14.354 --> 00:04:18.691 and does their own inspection for, testing labs 00:04:18.691 --> 00:04:22.895 that perform any testing for samples that come from New York or New York. 00:04:22.895 --> 00:04:25.898 Provider. 00:04:25.898 --> 00:04:27.600 So let's talk a little bit about Clea. 00:04:27.600 --> 00:04:28.635 Does anybody know? 00:04:28.635 --> 00:04:31.638 Have you guys heard about Clea before? 00:04:31.904 --> 00:04:36.042 So that's the clinical laboratory improvement amendments. 00:04:36.242 --> 00:04:37.610 And they are the federal law. 00:04:37.610 --> 00:04:40.613 They are what governs all clinical laboratories. 00:04:40.680 --> 00:04:44.017 So all aspects of the laboratory, not just transfusion. 00:04:44.250 --> 00:04:47.787 So transfusion has to comply with Clea and FDA regulations. 00:04:48.321 --> 00:04:51.324 And a lab if they are AB accredited, 00:04:51.858 --> 00:04:56.296 they can be found in title 42 of the CFR. 00:04:56.562 --> 00:04:59.732 All the FDA stuff we were talking about last week is entitled 21. 00:05:00.333 --> 00:05:03.102 So this is entitled 42. 00:05:03.102 --> 00:05:05.672 And the link will get you there. 00:05:07.006 --> 00:05:09.609 CMS is the agency 00:05:09.609 --> 00:05:12.345 that is in charge and governs Clea 00:05:12.345 --> 00:05:15.348 and does inspections for Clea. 00:05:15.682 --> 00:05:18.685 They have the right to come in and inspect 00:05:18.951 --> 00:05:21.954 and do just like the FDA does. 00:05:23.489 --> 00:05:25.591 So subjects that are covered by Clea 00:05:25.591 --> 00:05:28.561 are somewhat similar to what's covered by the FDA. 00:05:28.761 --> 00:05:31.764 So they have regulations for organization. 00:05:32.165 --> 00:05:34.233 Personnel who can do what testing. 00:05:34.233 --> 00:05:37.136 What type of education do you have to do? 00:05:37.136 --> 00:05:41.407 Whatever testing it is, whether it's high complexity, low complexity, 00:05:41.708 --> 00:05:44.610 way of testing, what type of personnel is allowed to do 00:05:44.610 --> 00:05:47.580 each type, who qualifies as a supervisor? 00:05:47.680 --> 00:05:50.583 Those type of regulations are all spelled out in Clea. 00:05:50.583 --> 00:05:53.653 They have regulations for equipment 00:05:53.653 --> 00:05:56.656 process control validations. 00:05:56.823 --> 00:05:59.826 The one thing that is unique to Clea that is not, 00:06:00.593 --> 00:06:03.096 in the FDA stuff that we talked about 00:06:03.096 --> 00:06:06.099 last week is proficiency testing. 00:06:06.165 --> 00:06:08.501 So proficiency testing is required. 00:06:08.501 --> 00:06:14.006 And that's when, you subscribe to some sort of, 00:06:15.575 --> 00:06:18.578 testing where you get an unknown specimen 00:06:18.578 --> 00:06:21.280 and you do the testing as if it was a patient, 00:06:21.280 --> 00:06:23.883 and then you're compared to your peers to make sure that you're 00:06:23.883 --> 00:06:25.952 putting out a quality result. 00:06:25.952 --> 00:06:28.921 So there are a lot of regulations, 00:06:29.088 --> 00:06:30.423 with proficiency testing. 00:06:30.423 --> 00:06:33.393 And one of the major ones is you can't refer it 00:06:33.393 --> 00:06:36.362 so referred TT is what they call it. 00:06:36.362 --> 00:06:39.132 And it, results in significant fines. 00:06:39.132 --> 00:06:42.468 And they can bar just like the FDA bars people. 00:06:42.835 --> 00:06:45.505 They will suspend the medical director. 00:06:45.505 --> 00:06:48.241 So the MD that's in charge of your lab 00:06:48.241 --> 00:06:51.878 from being a medical director for a certain period of time, 00:06:52.745 --> 00:06:56.115 if you're knowingly or unknowingly referring. 00:06:57.316 --> 00:07:00.420 So that can be an issue if you have a very automated system. 00:07:01.120 --> 00:07:05.358 So you get in a specimen and you run the assay, and then 00:07:05.725 --> 00:07:09.362 the standard is for your laboratory that if you get a result 00:07:09.462 --> 00:07:13.032 higher than such and such, or I automatically send it somewhere else 00:07:13.666 --> 00:07:16.903 to have that test confirmed or get a follow up testing. 00:07:17.170 --> 00:07:21.841 So if your process is very automated, there's a potential that your proficiency 00:07:21.841 --> 00:07:26.078 testing can automatically slip out of your laboratory. 00:07:26.345 --> 00:07:29.248 You're not knowingly or willingly referring it, 00:07:29.248 --> 00:07:32.752 but you referred it so you can be fined by CMS. 00:07:32.785 --> 00:07:35.788 It's usually in the millions dollar fines. 00:07:35.788 --> 00:07:38.791 Your medical director is, subject to penalty. 00:07:39.525 --> 00:07:42.862 That's why it's very, important that you set up 00:07:42.862 --> 00:07:45.865 your process to catch those so that they don't go out. 00:07:45.932 --> 00:07:49.802 And there are a lot of different agencies that offer proficiency testing. 00:07:49.802 --> 00:07:51.270 So you can order it through cap. 00:07:52.305 --> 00:07:55.308 There's code specialty ones, not. 00:07:55.975 --> 00:07:58.578 There are a lot of things, 00:07:58.578 --> 00:08:02.815 there are some agencies in Europe, and sometimes there's nothing available. 00:08:02.982 --> 00:08:05.084 So you have to do what's called an exchange. 00:08:05.084 --> 00:08:09.822 So you'll say, hey, Mayo, you're running this test and we're running this test. 00:08:10.089 --> 00:08:13.292 Let's exchange specimens and see what we get. 00:08:13.759 --> 00:08:17.263 So you have to have something, even if there's not a commercial proficiency 00:08:17.263 --> 00:08:20.266 testing available. 00:08:21.167 --> 00:08:23.302 So diem status, 00:08:23.302 --> 00:08:26.305 this is where an agency like SAP 00:08:26.439 --> 00:08:30.209 or AB, accreditation is called. 00:08:30.243 --> 00:08:31.944 They have what's called diem status. 00:08:31.944 --> 00:08:35.615 So Clea will say if you are Cap accredited, 00:08:36.182 --> 00:08:39.385 we feel that you have a quality lab and we're not going to come in 00:08:39.385 --> 00:08:41.521 and inspect you ourselves. 00:08:41.521 --> 00:08:44.790 So they can they could still come in if they wanted to, 00:08:45.157 --> 00:08:47.927 if they had a reason that they thought they wanted to come in 00:08:47.927 --> 00:08:51.631 and look at your laboratory, they could, but generally they don't. 00:08:52.064 --> 00:08:53.699 So a lot of laboratories have, 00:08:55.201 --> 00:08:56.335 accreditation through 00:08:56.335 --> 00:08:59.438 another agency, which gives them diem status with clear. 00:08:59.438 --> 00:09:02.441 So they don't have CMS inspectors coming in. 00:09:02.942 --> 00:09:07.413 So some of those agencies this is not, comprehensive list 00:09:07.413 --> 00:09:10.416 by any means, but AB is one called 00:09:10.583 --> 00:09:13.586 the Joint Commission. And, 00:09:14.120 --> 00:09:15.721 there is one for histo 00:09:15.721 --> 00:09:18.724 compatibility testing that is also has team status. 00:09:18.958 --> 00:09:22.562 A lot of laboratories use the College of American Pathologists, which is cap. 00:09:23.362 --> 00:09:28.367 So their goal like othing anyone else, is to improve the quality of the laboratory. 00:09:28.901 --> 00:09:31.904 And they do that through peer review and education. 00:09:32.138 --> 00:09:36.909 So the main difference between a government inspection 00:09:36.909 --> 00:09:41.080 like CMS or FDA versus Cap inspections is it's the peers. 00:09:42.114 --> 00:09:46.619 So whenever you're accredited by Cap, you are required 00:09:46.619 --> 00:09:50.590 to go and inspect other laboratories every two years. 00:09:50.957 --> 00:09:53.459 So you have to put together an inspection team 00:09:53.459 --> 00:09:57.897 and go to another laboratory that is generally similar to yours. 00:09:57.930 --> 00:10:01.100 So they like to group like laboratories together 00:10:01.467 --> 00:10:05.504 so that you're inspecting people that you have the knowledge base to cover. 00:10:06.138 --> 00:10:06.872 If they're, 00:10:08.107 --> 00:10:10.810 is an instance where you can't find anyone or there's 00:10:10.810 --> 00:10:13.813 no one in your laboratory that has an expertise to cover, 00:10:13.913 --> 00:10:18.351 say, histocompatibility testing or flow cytometry or something like that. 00:10:18.618 --> 00:10:22.188 GAAP will help you find an inspector from another facility 00:10:22.421 --> 00:10:25.091 to do that section of the inspection. 00:10:25.091 --> 00:10:27.727 But, the main difference is their peers. 00:10:27.727 --> 00:10:30.529 So it's a lot different interaction 00:10:30.529 --> 00:10:33.532 than you would have with a government inspector. 00:10:33.933 --> 00:10:36.669 And that's a lot of education for both parties. 00:10:36.669 --> 00:10:39.672 So you can go into a lab that you've never been in and say, 00:10:39.739 --> 00:10:43.009 see how they do it, and then you can have a discussion with them and say, really? 00:10:43.476 --> 00:10:44.644 That's a really good process. 00:10:44.644 --> 00:10:48.080 I think we might do that in our lab or this is how we do it. 00:10:48.547 --> 00:10:50.549 You might think about doing it that way. 00:10:52.251 --> 00:10:55.488 So, inspections are every two 00:10:55.488 --> 00:10:59.492 years and you get a three month window inspection window. 00:10:59.492 --> 00:11:01.994 So they'll come in, 00:11:01.994 --> 00:11:05.097 any time from January 1st to the end of March, 00:11:05.131 --> 00:11:08.534 or you'll have an inspection window that's three months before 00:11:08.534 --> 00:11:13.806 when you're required to be inspected so that you have some, some idea 00:11:14.173 --> 00:11:17.176 when they're coming, but the actual date is unannounced. 00:11:17.610 --> 00:11:20.613 You'll get a phone call about an hour before that session. 00:11:20.613 --> 00:11:23.983 Cap inspection team will be there in one hour. 00:11:27.486 --> 00:11:28.921 And then on the off year. 00:11:28.921 --> 00:11:30.990 So you get inspected every two years. 00:11:30.990 --> 00:11:34.794 And the year that you're not inspected by an outside facility, you are required 00:11:34.794 --> 00:11:38.297 to, conduct an internal inspection. 00:11:38.798 --> 00:11:43.169 And during that inspection, you still have to submit 00:11:43.169 --> 00:11:46.539 to KP any deficiencies that you find in your own processes. 00:11:47.039 --> 00:11:50.576 And a lot of times, in most laboratories, those are more thorough 00:11:51.277 --> 00:11:55.147 than the external things because people are familiar with the process 00:11:55.147 --> 00:11:58.818 and they can really drill down faster and a little bit easier 00:11:59.085 --> 00:12:02.254 than someone coming from the outside that's not familiar with your process. 00:12:02.488 --> 00:12:04.323 To see where any gaps may be. 00:12:06.392 --> 00:12:07.293 So gap 00:12:07.293 --> 00:12:10.329 puts their standards out in what are called checklists. 00:12:10.863 --> 00:12:14.433 They used to be formatted in a question type format. 00:12:14.934 --> 00:12:17.203 Now they're a declarative statement. 00:12:17.203 --> 00:12:21.307 So the laboratory will do this whatever the statement is. 00:12:22.141 --> 00:12:24.477 They're available on a PS website. 00:12:24.477 --> 00:12:27.012 They do get revise periodically. 00:12:27.012 --> 00:12:31.450 Generally it's been about every two years, every year and a half. 00:12:31.817 --> 00:12:34.720 They've done quite a bit of revisions recently. 00:12:34.720 --> 00:12:39.024 So it's been every year there's a new standards checklist. 00:12:39.391 --> 00:12:41.327 But it's nice when they publish their checklist 00:12:41.327 --> 00:12:45.397 because it says this is a standard that was changed and this is the part 00:12:45.397 --> 00:12:47.533 that was changed in it. Or this one is deleted. 00:12:47.533 --> 00:12:48.334 This one is new. 00:12:48.334 --> 00:12:51.570 So it's very easy for the laboratories to see 00:12:52.104 --> 00:12:56.342 what they need to address and what new standards might be out there. 00:12:57.176 --> 00:12:59.845 And the checklist provides a minimum standard 00:12:59.845 --> 00:13:02.882 so it doesn't tell you how you have to do something. 00:13:02.882 --> 00:13:05.551 Just like the FDA doesn't say how you have to do it, 00:13:05.551 --> 00:13:07.953 but it does say this is what you have to do. 00:13:07.953 --> 00:13:13.425 So you can get about something several different ways to meet the standard. 00:13:13.926 --> 00:13:16.929 You don't have to do it exactly the same as every other laboratory, 00:13:16.996 --> 00:13:20.132 but you do have to do something to address that particular standard. 00:13:22.568 --> 00:13:24.703 So again, they're declarative statement. 00:13:24.703 --> 00:13:26.071 And then they have a note section 00:13:26.071 --> 00:13:28.774 that can provide additional information if needed. 00:13:28.774 --> 00:13:32.278 And then there's an evidence of a compliance which is for the inspector 00:13:32.478 --> 00:13:35.714 that says this is the type of information you should be looking for 00:13:36.015 --> 00:13:39.518 when you go to the laboratory to show that they really do 00:13:39.552 --> 00:13:42.555 meet whatever standard this is. 00:13:43.422 --> 00:13:45.524 So they have two different phases 00:13:45.524 --> 00:13:48.527 of deficiencies in CP. 00:13:48.661 --> 00:13:54.133 So phase one are usually items that will likely not impact patient care. 00:13:54.667 --> 00:13:57.670 So they are a little bit less, 00:14:00.539 --> 00:14:01.707 It's still an issue, 00:14:01.707 --> 00:14:04.777 but it's not as risky as a phase two. 00:14:05.244 --> 00:14:08.180 So you do have to correct the deficiency, 00:14:08.180 --> 00:14:11.450 but you don't have to provide written proof to cap that. 00:14:11.450 --> 00:14:13.652 You corrected it. 00:14:13.652 --> 00:14:17.523 So with phase two's, they may seriously impact patient care. 00:14:17.823 --> 00:14:21.393 And you have to correct, these two deficiencies 00:14:21.393 --> 00:14:25.798 and you have to provide information about how you're going to correct it. 00:14:26.198 --> 00:14:26.932 Two CP 00:14:28.334 --> 00:14:29.468 and any, 00:14:29.468 --> 00:14:34.006 uncorrected phase two deficiencies can result in your, 00:14:34.740 --> 00:14:38.677 laboratory not being able to renew their accreditation. 00:14:38.878 --> 00:14:42.781 Now, if you're not accredited by CMS or any deemed agency, 00:14:42.982 --> 00:14:45.985 you cannot function as a clinical laboratory. 00:14:47.620 --> 00:14:49.521 There's also a recommendation section. 00:14:49.521 --> 00:14:52.057 So that's when, 00:14:52.057 --> 00:14:54.460 someone can come in and say, you know, this process 00:14:54.460 --> 00:14:57.463 I think meets the standard, but this is how I would improve it. 00:14:57.830 --> 00:15:00.332 So it is just that it's just a recommendation. 00:15:00.332 --> 00:15:02.368 You can say, yes, that's a great idea. 00:15:02.368 --> 00:15:03.402 I'm going to try that. 00:15:03.402 --> 00:15:06.405 Or you can say, no, I think my process is fine. 00:15:06.405 --> 00:15:09.875 I really don't think we need to implement whatever it is that you're suggesting. 00:15:10.075 --> 00:15:13.078 So you don't have to do anything with recommendations. 00:15:13.245 --> 00:15:15.247 But a lot of the times, 00:15:15.247 --> 00:15:18.884 they are quite good suggestions and you may want to implement part of it. 00:15:19.451 --> 00:15:20.252 Not all of it. 00:15:20.252 --> 00:15:24.290 Sometimes it's like, no, just because I do it differently than you, 00:15:24.623 --> 00:15:26.792 it doesn't mean my process isn't working. 00:15:26.792 --> 00:15:30.863 So you just kind of take those as an outside voice and implement when you want to, 00:15:32.765 --> 00:15:35.768 you can, with CP correct deficiencies on site. 00:15:36.335 --> 00:15:39.939 So if there was something that you can say, this particular reagent 00:15:40.239 --> 00:15:44.543 wasn't properly labeled, you can correct the label. 00:15:45.010 --> 00:15:48.647 The inspector will still document the deficiency that this, 00:15:49.748 --> 00:15:52.318 you weren't following the labeling standards 00:15:52.318 --> 00:15:53.752 and then it was corrected on site. 00:15:53.752 --> 00:15:56.655 So it's still listed as a deficiency for your laboratory. 00:15:56.655 --> 00:16:00.392 And the next inspectors that come in will know about that. 00:16:00.392 --> 00:16:05.331 So if you get a list of, previous deficiencies when you're an inspector. 00:16:05.597 --> 00:16:08.767 So you want to check those things because that was obviously a weakness 00:16:08.767 --> 00:16:09.835 for that laboratory. 00:16:09.835 --> 00:16:12.838 So you want to make sure that they've corrected whatever those issues were. 00:16:13.005 --> 00:16:16.475 So the corrected on sites are still listed as deficiencies, 00:16:16.675 --> 00:16:18.243 but you don't have to respond to them 00:16:19.478 --> 00:16:22.047 regardless of if they're phase one or phase two 00:16:22.047 --> 00:16:25.050 because you already corrected the issue. 00:16:25.718 --> 00:16:26.518 So information 00:16:26.518 --> 00:16:29.521 given to CP inspectors, they have your activity manual. 00:16:29.555 --> 00:16:33.492 So that is a generalization of every test that you do. 00:16:34.293 --> 00:16:38.197 So it doesn't necessarily list the specific method 00:16:38.197 --> 00:16:42.301 that you're doing for each testing, but it gives the inspectors an idea 00:16:42.301 --> 00:16:45.504 of what type of testing the complexity of your laboratory. 00:16:46.472 --> 00:16:50.209 They look at the volume of testing and how many FTEs. 00:16:50.342 --> 00:16:53.145 So how many people you have working in your laboratory. 00:16:53.145 --> 00:16:56.749 They get your organizational charts, list of previous deficiencies, 00:16:57.082 --> 00:17:00.085 a list of all the equipment that you have in your laboratory, 00:17:00.853 --> 00:17:03.155 and any issues you had with proficiency testing. 00:17:03.155 --> 00:17:09.628 So if you put in a survey and you, didn't do well compared to the other 00:17:09.628 --> 00:17:13.766 laboratories that were doing that testing on the same method that you're using. 00:17:14.700 --> 00:17:16.802 They call that a failed proficiency testing, 00:17:16.802 --> 00:17:20.406 and they're going to look at your process and see how did you respond to that. 00:17:20.806 --> 00:17:22.775 So did you look into the issue? 00:17:22.775 --> 00:17:24.043 Was it a clerical issue? 00:17:24.043 --> 00:17:25.811 Did I just transposed some numbers 00:17:25.811 --> 00:17:28.814 when I was entering the information into the CP website? 00:17:28.814 --> 00:17:32.451 Or is there an issue with my testing, and how did we investigate that? 00:17:33.485 --> 00:17:35.187 So inspectors are peers. 00:17:35.187 --> 00:17:37.890 So they're laboratories, 00:17:37.890 --> 00:17:40.893 and they are only required to do an online training. 00:17:41.360 --> 00:17:44.363 So the actual inspector type training 00:17:44.563 --> 00:17:47.332 is not as, 00:17:47.332 --> 00:17:50.335 in-depth as it would be for someone who's an, 00:17:50.436 --> 00:17:52.004 professional inspector 00:17:52.004 --> 00:17:55.574 that would come from the FDA or CMS, because that is their job. 00:17:55.574 --> 00:17:57.676 They do inspections all the time. 00:17:57.676 --> 00:18:01.513 So they're very highly trained and know they have like a sixth sense. 00:18:01.814 --> 00:18:05.851 If you have a weakness or if you give them a stack of 100 00:18:05.851 --> 00:18:09.021 pages, they're going to pull out the one page that has documentation error. 00:18:09.054 --> 00:18:12.224 They just have that knack about them. So, 00:18:13.459 --> 00:18:16.462 that's a little bit less so with the AP inspectors. 00:18:17.262 --> 00:18:20.833 So AB American Association of Blood Bank, since 00:18:20.833 --> 00:18:24.603 this is a transfusion kind of lecture, we'll talk about them a little bit. 00:18:24.603 --> 00:18:26.472 They're also a deemed agency. 00:18:26.472 --> 00:18:29.475 They only inspect transfusion services. 00:18:29.508 --> 00:18:32.878 So transfusion service blood service 00:18:32.878 --> 00:18:36.782 and any URL the reference laboratories, they'll come in and inspect. 00:18:38.150 --> 00:18:40.018 So AB inspectors are also 00:18:40.018 --> 00:18:43.856 your peers, but they have to be go through some specific training. 00:18:44.189 --> 00:18:47.192 I think it's a 2 or 3 day training every two years. 00:18:47.626 --> 00:18:48.260 And they have 00:18:48.260 --> 00:18:52.664 when you go as an AB inspector, you have to be trained with someone else. 00:18:52.664 --> 00:18:56.401 So if you're training inspector, you'll have someone who's a seasoned 00:18:56.401 --> 00:19:00.739 inspector with you to take you through the first 2 or 3 inspections that you do, 00:19:01.206 --> 00:19:04.209 and then you'll go and do them by yourself. 00:19:05.744 --> 00:19:09.681 So AB standards very closely mirror the cap. 00:19:10.582 --> 00:19:11.150 I'm sorry. 00:19:11.150 --> 00:19:17.523 The codified federal regulations, GMP and good tissue practices. 00:19:17.523 --> 00:19:21.426 So the very long verbose FDA language, 00:19:21.426 --> 00:19:24.997 the FDA, the AB standards are very short and concise. 00:19:25.330 --> 00:19:28.233 So they take that paragraphs of information 00:19:28.233 --> 00:19:31.803 and make it very simple for you to understand in the AB standards. 00:19:35.240 --> 00:19:38.243 So again, AB inspectors have additional training. 00:19:38.310 --> 00:19:41.747 You are informed of who your inspector will be 00:19:41.747 --> 00:19:45.050 several weeks before or even months before the inspection. 00:19:45.250 --> 00:19:48.387 So if you have a conflict of interest with that person, you can say, 00:19:48.921 --> 00:19:52.124 I would prefer that this inspector doesn't come to our laboratory 00:19:52.357 --> 00:19:54.326 because of whatever reason. 00:19:54.326 --> 00:19:57.329 And then they can sign a new inspector 00:19:57.496 --> 00:19:59.264 and they can, 00:19:59.264 --> 00:20:03.402 coordinate your AB assessments with your CP inspector assessment. 00:20:03.769 --> 00:20:06.939 So if you are accredited by both agencies, 00:20:07.206 --> 00:20:09.341 you can say you want them done at the same time. 00:20:09.341 --> 00:20:13.779 And then the AB inspector will also go through the CP checklist 00:20:14.179 --> 00:20:17.182 when they're doing the AB inspection. 00:20:19.117 --> 00:20:19.484 Okay. 00:20:19.484 --> 00:20:21.386 So if we have all these things 00:20:21.386 --> 00:20:24.389 and all these agencies and we have to comply with all of them, 00:20:24.856 --> 00:20:29.461 so what are the differences in all of the requirements. 00:20:29.461 --> 00:20:33.265 So this will just give you a little bit of an illustration about how they, 00:20:34.800 --> 00:20:35.801 show you 00:20:35.801 --> 00:20:38.804 the requirements that they have in each one. 00:20:39.671 --> 00:20:42.674 So this is, the standard 00:20:42.941 --> 00:20:45.744 from the FDA for equipment. 00:20:45.744 --> 00:20:48.280 So this is page one. 00:20:48.280 --> 00:20:50.148 So they say you have to have equipment 00:20:50.148 --> 00:20:53.185 and it shall be observed that it's working correctly. 00:20:53.185 --> 00:20:56.188 And all this legal language and very dry. 00:20:56.421 --> 00:20:59.424 And then they have tables still going, 00:21:00.392 --> 00:21:01.393 still going. 00:21:01.393 --> 00:21:04.730 So those are all the standards for equipment from the FDA. 00:21:05.964 --> 00:21:07.366 So clear. 00:21:07.366 --> 00:21:10.202 Very similar also in the code. 00:21:10.202 --> 00:21:14.039 So very long, very verbose, sometimes hard to understand 00:21:14.706 --> 00:21:16.341 but at least is a little bit shorter. 00:21:16.341 --> 00:21:18.610 So it was a I could fit it on one slide. 00:21:18.610 --> 00:21:21.313 So this is a cap standard. 00:21:21.313 --> 00:21:25.417 So TRM is transfusion medicine. 00:21:25.651 --> 00:21:28.654 It gives it a number and a phase two. 00:21:28.687 --> 00:21:30.722 And then it has the declarative statement in blue. 00:21:30.722 --> 00:21:31.723 And then any notes 00:21:32.958 --> 00:21:34.660 below it. 00:21:34.660 --> 00:21:37.195 So cap is much more concise. 00:21:37.195 --> 00:21:40.198 And then this is the FDA, the AB standard. 00:21:40.532 --> 00:21:43.535 It's a very short, very concise, easy to understand. 00:21:44.102 --> 00:21:46.305 If you're looking for a regulation. 00:21:46.305 --> 00:21:49.174 Sometimes it's best to start with a B, B standard 00:21:49.174 --> 00:21:52.311 because they will reference the FDA standard. 00:21:52.511 --> 00:21:55.080 So you can find in the code where you need to be. 00:21:55.080 --> 00:22:01.086 So you don't have to read through, pages and pages of very boring legal code 00:22:01.119 --> 00:22:04.122 to find what you're looking for. 00:22:05.123 --> 00:22:08.126 So in conclusion, FDA and, 00:22:08.827 --> 00:22:11.830 clear regulations are very long, hard to understand. 00:22:11.930 --> 00:22:15.133 Cap and AB, take that information and shrink it down 00:22:15.133 --> 00:22:18.136 and make it easier for you to understand and comply with. 00:22:18.970 --> 00:22:22.140 The interactions with inspectors are just fundamentally different. 00:22:22.841 --> 00:22:26.144 If you have an FDA inspector that shows up in a uniform 00:22:27.179 --> 00:22:28.547 and is there 00:22:28.547 --> 00:22:31.283 to inspect you for the next ten days, it's 00:22:31.283 --> 00:22:34.286 quite different than a peer coming in, 00:22:34.619 --> 00:22:38.323 to inspect you as an AB assessor or an FDA 00:22:38.623 --> 00:22:41.626 or a Cap inspector. 00:22:42.361 --> 00:22:44.763 So all of the agencies have the same goals. 00:22:44.763 --> 00:22:47.833 They want to improve quality, make sure everything is safe for patients 00:22:47.833 --> 00:22:50.836 and donors, and as an, 00:22:51.136 --> 00:22:55.240 laboratory, scientist, you will interact with some 00:22:55.240 --> 00:22:59.244 or all of these agencies as you progress in your careers.