Jan 28, 2022 OneLab Network Event Transcript
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Date of session: 1/28/2022
CHELSEA PARSONS: All right, welcome, everyone. We can go ahead and get started. My name is Chelsea Parsons. And I’m a consultant with Guidehouse supporting the CDC OneLab initiative.
I just want to mention a couple of things before we dive into the webinar. If you’re having any technical issues throughout the session, feel free to send an email over to firstname.lastname@example.org. That’s email@example.com. Someone from our team’s going to be monitoring that inbox in case anyone needs some assistance.
If you have questions throughout the presentation, please feel free to insert those into the Q&A function. You’ll see that down in the bottom banner where it says Q&A on your Zoom program. That’s where you can input any questions. Our team will be receiving them. We are going to have a 15-minute Q&A session at the very end of the webinar, where we’ll try and address as many of those questions as possible.
Please note that I’ve posted a link to live captions in the chat. If you need closed captions throughout the presentation, you can access them through that link as well as the ID code that comes with them. The only thing is if you’re going to keep those open for the presentation, please be sure to keep the Zoom link open as well. You’ll need to have both browsers up in order to follow along.
So let’s go ahead and jump into our agenda. All right, so, today, we’ll start out by introducing our presenters. We’re going to talk about some of the new and featured OneLab resources that we want to let you guys know about. We’ll get them to our main presentation of the updated storage and shipping guidance for submission to CDC infectious disease laboratories. And we’ll end out with that Q&A that I mentioned.
So let’s go ahead and get into our presenters. So if many of you have joined these presentations before, you know Dr. Triona Henderson Samuel. She’s a board-certified and clinical laboratories subspecialty-trained physician and pathologist.
She’s directed hospital-based clinical laboratories. And she has a passion for patient safety and laboratory quality improvement. She’s currently a public health physician in the Division of Laboratory Systems. And she is our OneLab Network lead.
Dr. Atis Muehlenbachs is a board-certified clinical and anatomic pathologist. He’s currently the CLIA lab director for the CDC Atlanta Infectious Disease Laboratories.
And we have Meredith Korth joining us. She’s a quality and clinical compliance specialist. She’s a contractor with Booz Allen Hamilton. And she’s currently supporting the CLIA laboratory director for the CDC Atlanta Infectious Disease Laboratories.
And we’ll have Marla Petway and Elizabeth Berkow helping facilitate the Q&A at the end of our session. Marla is a biologist. And she’s currently the team leader for the Specimen Triage and Tracking Laboratory at CDC. And, finally, Elizabeth Berkow is the clinical laboratory scientific lead within the Infectious Disease Laboratories at CDC.
So thanks, everyone, for joining us today. And thank you to all our presenters. Like I mentioned, please be sure to use that Q&A function when questions arise throughout the presentation. And now I’m going to pass it over to Dr. Henderson Samuel from CDC’s Division of Laboratory Systems.
TRIONA HENDERSON SAMUEL: Thank you so much, Chelsea. And hello, everyone. And thank you for joining us today for our session. Before we dive into the main presentation, I really wanted to explain to you what OneLab is since we have so many new people who have recently joined our network.
OneLab is an initiative that started out to strengthen interconnections between clinical, public health, and CDC laboratory education and training professionals to collectively support rapid large-scale responses. We have since expanded the initiative to include bridge, train, and sustain a capacity-building community among public health and clinical laboratory communities. Beginning in October of 2020, the DLS OneLab Network team designed and implemented promotion, engagement, and communication plans to form a new network with the long-term goal of creating capacity-building communities of practice.
In February of 2021, the team launched the OneLab Network whose members have the responsibility for education and training within clinical laboratory professional organizations, such as ASCLS and AACC, manufacturers, commercial laboratories, and hospitals. The OneLab Network currently has over 2,000 members. And there are many exciting things in the works, including new resources to aid in your everyday roles and the launch of a brand-new, free learning management system called OneLab Reach. Look out for communication from our team. And check the website for updates on all resources, presentations, and events.
Before we get into the main presentation, I’d like to take a moment to orient you to some of our new resources. DLS offers several packaging and shipping resources, our e-learning courses, packing and shipping dangerous goods, what the laboratory staff must know, several job aids available in PDF and Word format, including one for laboratory test requests, shipping papers, [INAUDIBLE] motor vehicle courier train or cargo ship, IATA, air or US mail, packing category A, B, and exempt human or exempt animal specimens, and labeling, marking, and documenting requirements, and the SARS-CoV-2 specimen packing and shipping job aid. Check out our CDC’s quick reference guide which is available in PDF and PowerPoint version.
OneLab is also developing a specimen shipping job aid that describes how to maintain proper specimen temperature conditions when shipping specimens for testing submissions to the CDC. It is important that laboratories submitting biological specimens to the CDC properly pack the biological specimens so that the appropriate storage temperatures are maintained. This specimen shipping job aid is scheduled for release next month, February 2022.
For your information, before we begin, this presentation is informational and does not satisfy requirements for packaging and shipping certification. As a reminder, today’s audio, transcript, and slides will be posted online afterwards so that you will have access to the hyperlinks and the existing resources. Additionally, my team and I will be monitoring the Q&A section in case you have any questions throughout this presentation, I will now hand it over to Dr. Muehlenbachs to start off the presentation.
ATIS MUEHLENBACHS: OK, hi. So thank you, Triona and OneLab Network for this opportunity to present today. So we’ll be covering a few topics. And our discussion will focus on the steps that submitting laboratories should follow when preparing specimen shipments to maintain their proper temperatures during transit to our centers for Disease Control Infectious Disease Laboratories.
And we will cover how the CDC infectious disease laboratories define temperature categories for those submissions, including ambient, room temperature, refrigerated, and for frozen specimens. And we will cover very briefly how we measure and document the temperature of specimens upon receipt during the accessioning process and what that means for specimens that do not meet the intended transport conditions.
So, before we get started, it’s important to add a disclaimer to this. This following information is not a substitute for the required training that’s required to pack and ship infectious substances. And it is not intended to supersede federal regulatory standards.
And submitters should refer to guidance and federal regulatory standards external to this presentation for the transport of biological specimens. For example, IATA, Department of Transit, et cetera. So– sorry, International Air Transport Association, IATA regulation, a dangerous good certificate of training is required for any person who submits dangerous goods to a public carrier for transportation.
So our CDC infectious disease laboratories accept specimens from state and some local public health laboratories and other federal agencies for analysis. And, for appropriate processing, specimens from private health care providers and institutions should be submitted to the local state health department laboratory for the appropriate state, county, and city that the laboratory and the patient reside in. Specimens not physically routed through public health laboratories should be submitted with public health laboratory awareness and approval and with the appropriate public health laboratory information on the CDC specimen submission form.
Thank you. So, yeah, passing it on now to Meredith Korth. Thank you.
MEREDITH KORTH: Thank you, everyone. Good afternoon. We’re now going to go ahead and go over the general steps that should be followed in order to prepare a specimen shipment to CDC.
And, as you can see here, there are four basic steps. First, determine the mode of the transport for the package. So this would be commercial, courier, local courier, et cetera.
Second would be determining the classification of the package contents. So is it infectious, noninfectious, exempt?
The third step is to pack the specimen properly and in compliance with regulations as are determined by steps one and two. And you’ll see we’re going to focus a lot on step three throughout the rest of this presentation. And then the final step four is ensuring the package is properly labeled, marked, and documented. And, again, this is based on determinations from steps one and two.
OK, so step one again is determining the mode of transport that will be used. Keep in mind that specimens should be shipped by overnight shipping when possible or if it is required for the specific test being requested. The mode of transport dictates the federal transport regulations that should be followed for shipping. And submitters should review federal regulatory standards external to this presentation for the transport of biological specimens, so IATA, DOT, et cetera.
So then step two is determining the classification of the shipment. So submitters should reference external regulatory standards if you’re uncertain of the specimen classification. There are three classifications for biological specimens, category A, category B, an exempt specimen. Please refer to the training required to obtain a dangerous codes certificate for more information on what constitutes each of these three classifications.
And, on this slide, you can see we’ve shared two links to decision trees that CDC has developed to aid submitters in determining classification of their substance. So there’s a separate decision tree for shipping by air and then shipping by motor vehicle, courier, or by ground.
OK, so this is step three packing the shipment. And this is where we’re going to be spending most of our time today. Steps one, two will determine many of the packing requirements, including the types of packaging, labels, required paperwork. And, again, we keep saying this, but submitters should reference IATA’s packing instructions for more information on these requirements, the specific requirements. But, in addition to these requirements, we need to be ensuring that specimen shipments are being packed to maintain the proper temperature of the specimen during transit, which I would go into further detail in the next few slides.
Before we talk about temperature, though, I wanted to go over some terms that we’re going to be using today. And this is for shipping terminology. And, as you can see, we have a diagram on the screen for you. And I’ll point out a few of the terms that we’re going to be covering.
The first, there should be a primary receptacle for the specimen. So this should be a glass, metal, plastic leakproof, shift-proof container that houses the submitted specimen. In this case, you can see it’s a specimen tube.
Next, there should be secondary packaging. So this is a leakproof, shift-proof packing material that seals, cushions, and surrounds the primary receptacles. And, here, we’re showing this as a specimen bag. Then there should be a secondary container, which consists of a sealable Styrofoam cooler that makes up the outermost layer of secondary packaging.
Finally, there should be the rigid outer packaging. So this is that rigid outermost packaging that’s typically a cardboard box. And that houses the primary receptacles, secondary packaging, and secondary container.
I’ve also included cold pack on here. And we are defining a cold pack as a reusable, leakproof gel or solid refrigerant that’s used to maintain temperature within a shipping container during transit. And so cold packs can be frozen, refrigerated, or room temperature.
So, speaking of temperatures, CDC has standardized temperature definitions. And so for– when we are referring to something as frozen, we were saying that is at or below minus 20 degrees Celsius. Refrigerated would be within the range of 2 to 8 degrees Celsius. Room temperature is within the range of 15 to 25 degrees Celsius. And, when we refer to ambient, we’re speaking to the temperature being equal to the surrounding environment.
So, before packing a submission, the submitter should have already determined the temperature at which the specimen should be shipped according to the specific instructions for that specimen type for that laboratory test. The submitter should then reference the CDC-defined temperature ranges for specimen storage and transit to decide on proper specimen shipping conditions and materials relevant to that temperature.
So, now, I’m going to walk through examples of packaging for those categories of temperature we just discussed. But I want to note that it is important to note here that these are only examples. I’m not going to be able to illustrate every shipping condition and unique packaging variation. And so just please keep that in mind. And to also note that the main goal of packaging a specimen to maintain temperature is to get the specimen to CDC at that predetermined intended temperature to avoid specimen rejection and ensure the accuracy and reliability of the testing results.
So we’re going to start by talking about frozen specimens and shipping frozen specimens. So frozen shipping is ideal for many submissions to CDC. And it’s one of the easier temperature ranges to maintain during transit.
Specimens should be frozen before shipping. This is key to maintaining a frozen specimen during transit. Secondary packaging must be surrounded by an outer secondary container, such as the Styrofoam cooler, with walls that are at minimum 2 inches thick.
Within the secondary container, the sealed secondary packaging should be surrounded with a sufficient amount of dry ice to keep the specimen frozen. It’s important to note here that surrounding the secondary packaging on all sides with the dry ice has shown to improve the length of time the specimen remains frozen during transit. So we’re talking top, sides, and bottom here.
So I want to give a couple reminders about dry ice and when using the dry ice to maintain frozen specimens during transit. Please keep in mind that the dry should not come in contact with the primary receptacle. It should not be used as a substitute for padding. Shipping frozen must not adversely affect the specimen that is being shipped. And that, as a general rule, a minimum of 5 to 10 pounds of dry ice would be required for an overnight shipment.
OK, so now we’re going to switch over into discussing shipping refrigerated specimens. So some specimens require refrigerated storage and shipping conditions. This temperature range can be difficult to maintain during transit, especially in the warmer months of the year. The submitter should first ensure that specimens are at 2 to 8 degrees Celsius before packing.
And then we need to ensure that secondary packaging is surrounded by an outer secondary container with walls that are, again, at a minimum 2 inches thick, so the Styrofoam cooler. Then we need to surround the sealed secondary packaging. An example here is the sealed biohazard bag with refrigerated or frozen cold packs and further insulation. And keep in mind, please do not use damaged or leaking cold packs or wet ice.
So, as a reminder, cold packs are reusable, leakproof gel or solid refrigerant. Sometimes they’re called gel packs. Sometimes they’re called ice packs. And that cold packs can be frozen, refrigerated, or room temperature. And, to use for packing specimens at refrigerated temperatures, the cold pack should be refrigerated or frozen.
It is crucial for the submitter to consider the distance and expected duration of travel as well as the season and external temperatures to decide whether refrigerated or frozen cold packs should be used. So, for example, where overnight shipping is not available and/or during summer months, submitters may opt to include those frozen cold packs.
So, now, we’re going to talk about room temperature and shipping room-temperature specimens. Some specimens require room temperature storage and shipping conditions. This temperature range may also be difficult to maintain during transit, again, especially in warmer or cooler months of the year.
The submitter should ensure that specimens are at 15 to 25 degrees Celsius prior to packing and shipping. And that here’s where we’re going to then talk about the use of room-temperature cold packs to maintain the proper temperature within the secondary container and to insulate the specimen during shipping. That secondary packaging should be surrounded by an outer secondary container. And, for dried, samples, for example, dried blood spots or preserved slides, a secondary container may be omitted. Instead, you would place the dried samples into a sealed secondary envelope or container, along with the room temperature cold packs.
So shipping ambient specimens. Some specimens require ambient storage and shipping conditions. Submitter should ensure that specimens are at ambient temperature prior to packing and that this submission does not require temperature-maintaining materials such as cold packs.
So we’ve gone through step 3 and the packaging of the materials. We’re now on to the final step, step four, which is the labeling, marking, and documenting. The mode of transport and classification, as was determined in the previous steps, will determine the proper mode of labeling and marking as well as documentation needed for the outer packaging.
So, once packages arrive at CDC, they’re received and sorted at CDC’s Centralized Specimen Triage and Tracking Laboratory. During the accessioning process, the condition of the package and its contents is recorded. This includes the temperature of the specimen, which is captured using an infrared thermometer. The condition of the package and specimen including temperature is used as a determining factor for specimen acceptance.
So, to conclude, our mission is to work closely with our public health partners and to support the mission of public health doing so with great laboratory science. Specimen transport is a key component of the specimen life cycle. This guidance is intended to ensure that specimen integrity is maintained during transit.
The reliability and accuracy of a laboratory’s test are dependent on the quality of the samples it receives. To ensure the reliability and accuracy of our laboratory tests, specimens that do not meet the established acceptance criteria upon arrival will be subject to rejection.
We’d like to think a few different groups here, the Office of the Deputy Director for Infectious Diseases, including Beth Berkow and Wendi Kuhnert-Tallman, the Division of Laboratory Systems, particularly the graphics and communication teams in the Training and Workforce Development branch, and the Specimen Triage and Tracking team, including Marla Petway. I’m now going to hand it back to [INAUDIBLE].
INTERVIEWER: Thank you so much, Meredith and Atis, for your informative presentation. Now we’re going to spend a few minutes answering some of your questions. And I want to thank everyone in advance for putting them in the Zoom Q&A. If we don’t get to your question by the end of today’s session or if you have more questions after today’s presentation, please send an email to firstname.lastname@example.org.
All right, so let’s get into our first question. First question for the team is, how does your laboratory ensure that packages maintain their intended temperature upon receipt?
ELIZABETH BERKOW: Hi, thank you. I’ll take that first question. So, unlike many state and other public health laboratories, CDC does not operate a courier system that could maintain and ensure temperature packages during transport. So, instead, we’ve implemented infrared temperature recording at the time of specimen accessioning when packages are opened. And, through this process, we ensure that only those specimens which meet the appropriate specimen condition at the time of accession and get accepted for testing.
When we piloted our temperature-monitoring procedure, our accessioning team observed that specimens shipped on cold packs intended to arrive refrigerated between 2 and 8 degrees Celsius temperature range had a high rate of arriving to us above that. And, therefore, we’ve shifted our guidance for many of our primary specimen types which can be frozen should be frozen and then shipped on a sufficient quantity of dry ice. Like Atis said at the beginning of the talk, we ask that specimen submissions go through or with the approval of state or local public health labs. And this will help ensure specimen condition and transport are coordinated appropriately for that particular test.
INTERVIEWER: Awesome, thank you, Beth. Could you expand on what a frozen cold pack is? We got some questions in the Q&A about what that was. Is it–
ELIZABETH BERKOW: Sure, so it’s very important that our terminology is used consistently with our public health laboratory colleagues. So a cold pack product is a reusable– it’s a leakproof gel or solid refrigerant. And it’s used to maintain temperature within a shipping container during transit.
In line with the manufacturers of those cold pack products, we use that term “cold pack” as a noun. It can also be called a gel pack and ice pack. But cold pack is the most commonly used term to describe that product.
And, as Meredith discussed earlier during the talk, cold packs can be frozen, it can be refrigerated, or they can be kept at room temperature, depending on its needed use. So, therefore, a room-temperature cold pack is a standard, commercial cold pack that’s held at room temperature. And it’s used to prevent a specimen from freezing or being exposed to excessive heat during transport.
And, similarly, a refrigerated cold pack is a cold pack that has been held refrigerated. The use of a refrigerated cold pack helps prevent a specimen from excessive heating during [INAUDIBLE].
INTERVIEWER: Awesome, thank you, Beth.
ELIZABETH BERKOW: Mm-hmm.
INTERVIEWER: OK, so dry ice may not be readily available for us. What should we do?
ELIZABETH BERKOW: We’ve heard that from many of our public health partners. And, like I said earlier, the CDC infectious disease laboratories do not have a courier service. And so we’re dependent on specimens being packed and transported appropriately by each of our public health jurisdictions.
Using dry ice is the most reliable way to assure that our specimens which should be transported frozen arrive to CDC frozen. Frozen cold packs are not reliable. And, unfortunately, as we’ve stated, specimens which are received in inappropriate condition are subject to rejection. So our guidance remains to work with your state or local public health laboratories for specimen submissions to CDC.
INTERVIEWER: Great, thank you. Next question I see here is, are the standardized temperature definitions standard for all labs or just definitions used at CDC?
ELIZABETH BERKOW: So we have taken a variety of sources, including the test that we use, the FDA cleared and approved test package inserts. And we’ve adopted these temperature ranges, as Meredith described them earlier in the talk, for our purposes. They are and should be mostly universal, frozen being at or below minus 20, refrigerated within the range of 2 to 8 degrees Celsius, and room temperature within the range of 15 to 25 degrees Celsius.
INTERVIEWER: Great, thank you. I’m seeing a lot of questions about infrared thermometers. What make and model of infrared thermometers do you use? And where do you get them from?
ELIZABETH BERKOW: There are a large selection of manufacturers’ infrared thermometers that provide this product that can be used in public health laboratories. We do not recommend a specific supplier or manufacturer.
INTERVIEWER: OK, great, thank you. What standards is the specimen triage and acceptance unit held to? E.g., CLIA?
ELIZABETH BERKOW: I’m going to turn this question to our team lead for the specimen triaging and tracking team, Marla Petway. Perhaps she’s not on the call. Atis?
MARLA PETWAY: No, I’m here.
ELIZABETH BERKOW: Apologies.
MARLA PETWAY: So, yeah. So the acceptance criteria for the specimens is based on the CDC specimen management policy. But specimens submitted specifically for CLIA testing will be accepted based on the CLIA regulations.
And it would be a case-by-case decision made by the laboratory that’s doing the testing for that sample. So that acceptance criteria is based on the specific test. And it is based on the sample for that test.
INTERVIEWER: Great, thank you, Marla. Next question I see here is, do you have any additional recommendations for packing to ensure specimens maintain their temperatures? We have tried to follow past guidance. But I’ve had challenges.
ELIZABETH BERKOW: We understand that as well. So, for frozen submissions, what would be considered a sufficient quantity of dry ice, it’s going to vary depending on the size of the package, the transport time to CDC, and the season of the year, so outdoor temperatures. We recommend planning to use 5 to 10 pounds of dry ice in a good-quality insulated container that’s up to 15 quarts.
This should keep the contents frozen for a 24-hour period. You would then multiply the amount of dry ice by this rate if the shipment will be in transit longer than 24 hours or if the container is larger than that. For refrigerated submissions, we recommend cold packs cover all sides.
It’s also a good time to point out that CDC does not accept routine shipments on weekends or holidays. So we ask that submitters make sure that the package will arrive between Monday and Friday.
INTERVIEWER: Great, thank you, Beth. And where should people get their shipping supplies from? Is their preferred vendor?
ELIZABETH BERKOW: No, just like with other products that we may be using, there’s a large selection of vendors. And we don’t recommend any specific supplier. We just recommend that the supplies meet the standards of the regulations that you’re shipping under.
INTERVIEWER: Great, thank you. Next question is, which carrier can be used for P&S category A biological material? I think this is related to the vendor question as well? But can you comment on that?
ELIZABETH BERKOW: Thanks, Marla, are you able to answer a question about which specific commercial shipper can use that? You’re on mute, Marla. Marla, I’m sorry, you’re on mute.
MARLA PETWAY: Oh, sorry. Could they provide a little bit more clarification on that question? I’m missing the P&S part of it that they’re asking?
INTERVIEWER: Which carrier can be used for, I’m guessing, packaging and shipping category a biological material?
MARLA PETWAY: Oh, OK, so most of the commercial vendors will do that shipping and packing– will do that service and provide those materials. So you can get it, the actual materials from the commercial vendor– from the commercial courier as well. So they do provide those supplies. I can’t name specific commercial couriers.
INTERVIEWER: Thank you so much. A follow-up question to shipping, does it help to add frozen cold packs with dry ice packages to help maintain temperature if the package is delayed by transport companies, such as UPS or FedEx? They use dry ice bricks from a CO2 tank.
ELIZABETH BERKOW: Mm-hmm. So– go ahead, Marla.
MARLA PETWAY: Oh, OK, so I was just going to say, for that, I would not combine the cold pack, the frozen cold packs and dry ice together. They would just need to use a sufficient quantity. So if it’s going to be a longer period of time, then they would have to plan to use more dry ice than the 5 to 10. That covers you for about one day.
So if it’s going to be two days, then they would maybe have to think about going to using 10 to 20 pounds of the dry ice. So they would just have to use them more if they suspect that there might be delays in delivery. More dry ice is always better than less dry ice.
INTERVIEWER: And, Beth, did you want to add to that answer as well?
ELIZABETH BERKOW: I was going to say the same thing. We do not recommend the use of frozen cold packs with dry ice. Thank you.
INTERVIEWER: Thank you, both. Next question is, how is temperature and contents documented? And how are these used as rejection criteria? Could you name an example?
ELIZABETH BERKOW: Sure, so, when a specimen arrives in Marla’s lab, as the package is being opened and these specimens are being accessioned, the team takes the temperature of the specimen and documents in our electronic limb system. And the laboratory who performs that test receives that temperature. And so they know whether or not the temperature at which the specimen arrived falls within their predetermined, validated, acceptable specimen conditions. And that is then used to determine whether or not that specimen can be accepted for testing or potentially subject to rejection.
INTERVIEWER: Great, thank you. I think this next question was a follow-up question to another one. But what about confirmed select agents and/or risk group for agents?
ELIZABETH BERKOW: Great question. Atis, do you want to take this one? So that’s actually– I’m wondering, Marla, if you just want to comment some of the select agent processes. I know a lot of those pass through stat lab to our select agent laboratories.
MARLA PETWAY: Right, so the way that the select agent works, those actually bypass our laboratory. So those internal temperatures and that monitoring will be done by the receiving laboratory. Following the standard practices that– the same practices that we do in stat. So those would actually go directly to the receiving laboratory. But the same criteria would apply.
ATIS MUEHLENBACHS: Thank you.
INTERVIEWER: Great, thank you. Next question, have you considered recommending the use of high-low monitors to be included in the box to track temperature ranges over the course of shipping?
ELIZABETH BERKOW: So that is a possibility. We know that there are laboratories who’ve incorporated that into their systems, particularly public health laboratories who do have courier systems. That is not something that we are exploring at this time.
INTERVIEWER: OK, great, thank you. The next question I’m seeing is here, can you explain about the import permits and the forms that have to be submitted with the samples?
ELIZABETH BERKOW: So import permits are a little bit different than the documentation that we– for domestic submissions to our laboratories. The documentation that goes with our domestic shipments that arrive at CDC are either the 50.34 forms which can be filled out electronically or via C-Store or a GFAT template, which is provided by the CDC point of contact. And that document has some key elements which cannot be submitted without filling it out.
But there’s additional elements as well that are very important for us to collect, such as the date that that specimen was collected. We record the date that it was received here at CDC. Our submitter should also include the specimen type and when that package is opened and accessioned, either by stat laboratory or the individual laboratories. The condition of that package is recorded with that information as well.
INTERVIEWER: Great, thank you. This next question is a little bit technical. But it says, if a specimen intended to arrive at refrigerated temperature of 2 to 8 degrees Celsius but arrives at 9 or 10 degrees Celsius, does that mean it must be rejected? Or hopefully a technical supervisor or clinical consultant will have some flexibility to accept it as an exception.
ELIZABETH BERKOW: So it depends on the–
ATIS MUEHLENBACHS: So, I mean, this– I think we’re talking about multiple jurisdictions of laboratories, both clinical and public health laboratories across the United States here. But we do know for lab, if we’re talking specifically for the infectious disease laboratories of CDC Atlanta, we’re held to the requirements under CLIA. And our policies and procedures and testing follows what our methods are validated for. So thank you.
ELIZABETH BERKOW: And I’ll add on to that that the specimen condition is determined by [AUDIO OUT] possibilities. If the test is in an FDA-cleared or -approved assay, then the instructions for use for that test will include the conditions at which the specimen must be stored, transported, and maintained at prior to testing. For tests which are laboratory developed, our laboratories have determined the temperature in the specimen condition through stability testing as a part of method validation. And so, to accept a specimen for testing, it has to be in line with the predetermined conditions for that test.
INTERVIEWER: Great, thank you, both. I’ve seen several questions about slides and audio after the call. And I just want to remind folks that we’ll be posting these to our website in a couple of weeks. So we will be sharing the slides.
I’m not seeing any other questions for the team. So I think we can go ahead and transition this back over to Triona to close this out. And I want to say thank you again to everyone for presenting and answering the questions.
TRIONA HENDERSON SAMUEL: Thank you so much, [INAUDIBLE]. And thank you to our guest speakers, Atis and Meredith, for your presentation and for the robust discussion from our attendees. As a reminder, as [INAUDIBLE] just said, all of these slides and the links will be posted to our website, cdc.gov/onelab within the next two weeks.
We will also be sending out communication to our network members once this new guidance is available online. So if you are not a member of the OneLab network, please sign up. We look forward to sharing more information regarding our next OneLab event, as well as where to find the information for today’s meeting. We look forward to our continued collaboration and being able to assist you in all of your training needs. Thank you, and have a great day.