"Ready? Set? Test!" Patient Testing is Important. Get 
the Right Results. Session 2 

Okay, everyone. We can go ahead and get started. My name is Julie Son, and I'm a 
consultant with Guidehouse supporting CDC's OneLab initiative. A couple of notes about the 
webinar before we dive in: if you are having any technical issues throughout, feel free to email 
the OneLab inbox for support at OneLab@CDC.gov. If you have questions throughout the 
session insert them into the Q&A function below by clicking on the Q&A icon. And we'll do a 
Q&A session at the very end of our presentation, and we'll review those questions and do our 
best to answer. Note that we've also posted the link to live captions in the chat. But please be 
sure to keep the caption window open, if you use it, in addition to this Zoom meeting. 
Next slide, please. So, for our agenda today we'll start by discussing relevant OneLab 
resources, then we'll go through some introductions into today's presentation. We'll have 
about a 10 minute Q&A session at the end, and then today's session will end with a discussion 
of upcoming network events. For today's webinar we'll be leaving the chat feature open for 
your engagement. When utilizing the chat box please keep in mind the appropriate rules of 
engagement. Feel free to use the chat to connect with others by reacting to what you're 
hearing, sharing experiences, and asking questions to fellow participants. But, again, if you 
have a question for the presenter, please use the Q&A function, and not the chat. Additionally, 
please engage with respect and professionalism. Any inappropriate language, improper 
conduct, or any form of discrimination may result in removal from the webinar. Please ensure 
that your comments are relevant to the topic, and if a moderator gives direction regarding chat 
behavior please comply accordingly.  
Lastly, please notify moderators if you're experiencing technical difficulties or observe 
disruptive behavior. I'll now turn it over to our OneLab partnership and promotions lead, 
Meredith Reagan, to share some of our new and relevant resources.  
Thank you, Julie. Appreciate everyone being here today. As Julie said, my name is 
Meredith Reagan. I lead partnerships and promotions for OneLab, so any of the social media 
content you might see, any of the emails you might receive, any of the web content — my 
team is responsible for those products. So, before we get started today, I want to share 3 
resources related to today's presentation. So I'll start with our point-of-care testing personal 
protective equipment toolkit. So this toolkit is based on CDC recommendations and OSHA PPE 
standards. You'll find that it includes helpful information and suggestions that you can use to 
adapt and use PPE components within non-laboratory settings or facilities. 
We also have a blood or body fluid exposure job aid. This provides standard 
precautions to prevent exposure to blood and body fluids. And, lastly, I am excited to share our 
instructions for performing external control testing.  
So this job aid provides guidance on best practices for quality testing results and will 
help you accurately complete quality control logs for both qualitative and quantitative tests. So 
with that, I will introduce our presenters. So our 1st presenter is Theresia Snelling. Theresia 
has more than 20 years of clinical laboratory experience. And she has also worked in multiple 
areas and various positions, including Bench Tech, Senior Tech, and Education coordinator to 
management. She has trained many professionals, including communicable disease specialists, 
laboratory assistants, phlebotomists, laboratorians, and nurses. And has trained them in 
laboratory techniques, best practices, and regulatory guidelines. She is a former state agency 
CLIA director, and in that role she directed a program of laboratory surveyors who monitored 
federal certification and state licensure of laboratory facilities.  
She has also participated in developing and revising rules and regulations that govern 
the state's laboratory facilities. And she mainly focused on enforcing regulatory rules and 
guidelines and training end users on compliance. Theresia developed good laboratory 
practices for Waived Testing for the Ready? Set? Test! online training course and the 
development of a booklet for Individual Quality Control Plans or IQCP. She is currently also 
involved in CLIAC planning and logistics, distribution and promotion of QSSB, so that's our 
quality and safety systems, branch training materials and the online training courses.  
We'll introduce our second speaker. Thank you. So our second speaker today is Amanda 
Johnson. Amanda is a clinical laboratory scientist at CDC. Here, in the division of laboratory 
systems, she has a diverse background in the clinical laboratory which spans more than a 
decade across Federal and private health care facilities. So before she came to CDC. Amanda 
served as a point-of-care coordinator at the US Department of Veterans Affairs, where she 
oversaw a comprehensive program that encompassed both waived and non-Waived test 
systems. So we're really happy to have both of these speakers here. If you were here on our 
first Ready? Set? Test! Session, you may remember them. So looking forward to our second 
session, and I'll pass it over to you, Amanda.  
Okay. Hello again, everyone. We appreciate the opportunity to present again to you 
today. For today's presentation, we will highlight the Ready? Set? Test! resources for Waived 
Testing that are provided by the CDC. Like you heard. I'm Amanda Johnson, and I'm joined by 
my colleague, Theresia Snelling, who, you will hear from a little later in the presentation. 
Patient testing is important, and with the assistance of the free Ready? Set? Test! resources 
which can equip testing personnel with good testing practices that help improve the quality of 
test results while enhancing patient safety. All test sites, regardless of where they're located, 
can get the right results.  
Today we will give a little background on Waived Testing the Ready? Set? Test! 
Educational materials for Waived Testing, and we will give an overview of the test section as 
well as the checklist, testing logs, and job aids, that are provided for test sites. By the end of 
our presentation each learner will be able to identify the Ready? Set? Test!, educational 
materials as resources for Waived Testing, describe best practices to follow when performing 
Waived Testing, describe how to read and record test results, identify actions to follow when 
problems, including questionable test results occur during the testing process, and lastly, 
recognize the Ready? Set? Test! educational materials, checklists, testing logs, and job aids that 
can be used at testing sites. 
So with that being said, let's get started. So what are Waived Tests? Waived Tests are 
tests categorized as simple, having a low risk for erroneous results. Waived Tests include test 
systems that are cleared by the FDA for home use and those tests that are approved for waiver 
under the CLIA criteria. Waived Tests can be performed without routine regulatory oversight, 
and they're often performed at the point-of-care for the most current list of Waived Tests. You 
can always refer to the FDA list linked on this slide and in the chat. This list is continuously 
revised as new tests are waived by the FDA. Amanda, hold up a minute. 
The slides are not showing. Okay, sorry about that. Let me see. Okay, they're showing 
now. They are. Okay? Which part did? What's not showing? I'll go back. Sorry about that you 
all.  
So what are waived tests? Waived tests are tests that are categorized as simple, having 
a low risk for erroneous results. Waived tests include test systems that are cleared by the FDA, 
and those tests that are approved for waiver under the CLIA criteria. Waived tests can be 
performed without routine regulatory oversight, and they are often performed at the point-of
care. For the most current list of waived tests you can always refer to the FDA list that is linked 
on this slide and in the chat.  
And just to note the list is continuously revised as new tests are waived by the FDA. The 
Clinical Laboratory Improvement Amendments, also known as CLIA, play a significant role in 
waived testing by establishing standards and regulations to ensure accurate and reliable 
results. CLIA has very few requirements for waived testing and testing that is performed under 
a certificate of waiver.  
To perform waived testing a test site needs to enroll in the CLIA program, pay a fee, and 
then obtain their certificate of waiver, which will be effective for 2 years, and then follow any 
of the manufacturer's instructions for any test that they choose to perform without any 
modifications. Test sites with a certificate of waiver are not routinely inspected. However, if 
CMS receives a complaint about a test site, that test site may be subject to an on-site survey. 
For more specific information and forms to use when applying for a CLIA certificate of waiver 
refer to the CLIA brochure linked at the bottom of this slide and in the chat. The Ready? Set? 
Test! educational materials, and all of the resources for Waived Testing offered by the CDC can 
be found at the link on this slide. As a disclaimer, some of the recommendations encompassed 
in these resources exceed CLIA requirements for waived testing, however, following the 
recommended good laboratory practices that are mentioned in the resources will likely lead to 
reliable high-quality results while enhancing patient safety. 
The Ready? Set? Test! Booklet describes recommended practices for physicians, nurses, 
medical assistants, pharmacists, and other individuals who perform patient testing under a 
CLIA Certificate of Waiver. The booklet includes forms and logs that can be used at test sites, 
and we will highlight those a little later in the presentation. As an accompanying resource, the 
self-assessment checklist for good testing practices is also available for download. This 
checklist emphasizes recommended practices while highlighting what should be completed 
throughout all phases of the testing process. Both of these resources can be downloaded from 
the previous link provided in the chat. And if you would like a physical, hard copy, those can 
also be requested. 
We also offer the Ready? Set? Test! online course. This course is a scenario-based 
training where all the steps of the waived testing process are explained. A certificate of 
completion is provided to participants of the course who score at least 80% on the post test. 
This course can be used as a supplement when assessing the competency of testers, and if you 
need free P.A.C.E. credit, this course does offer that at the completion, if needed. 
So now I will give an overview of the good testing practices that are included in the test 
section of the materials. The ready and the set sections were covered during session one of 
our series and I invite you all to go back and watch session one which can be referenced using 
the link in the chat.  
So let's assume you've already prepared your testing area, performed quality control if 
it was indicated in the manufacturer's instructions and collected your sample. Now, the testing 
phase would begin. Navigating this part of the process means knowing how to perform the 
test, being able to identify and resolve problems and interpreting, recording and reporting the 
test results. When performing a test you want to be sure to follow the proper testing steps 
according to the manufacturer's instructions in the exact orders they are listed. You want to 
ensure that QC Is acceptable prior to testing any patient samples. And it's a good practice to 
have the manufacturer's instructions. The site-specific procedure or the quick reference guide 
provided with the test system in the testing area. 
Quick reference guides or color charts are useful resources when performing a test or 
interpreting the results, but remember that they do not replace the full manufacturer's 
instructions, as they are usually just a portion of the instructions. Also, you want to use timers 
if indicated and follow the required timing intervals before reading test results. Interpreting 
test results is a vital component of the testing process. And again, your most reliable and 
comprehensive resource. To ensure that you correctly read and understand a patient's test 
results is the manufacturer's instructions.  
Reading the results too soon can cause invalid or false negative results due to 
incomplete reaction of the sample and reagents. Reading a test after the time given in the 
manufacturer's instructions, can also lead to false positive results, false negative results, or 
invalid results. So again, use timers for any time step during the testing process to prevent 
invalid or false negative results. Types of test results. So it's important to know what type of 
test result, the test system you're using will provide test results are either quantitative, 
qualitative or a combination of the 2 where a numeric result is interpreted as a non-numeric 
result. 
Quantitative results indicate the amount of a measured substance reported in specific 
measurement units. While qualitative results are interpreted as positive, negative, reactive, 
non-reactive or invalid. Qualitative results identify the presence or the or absence of a 
particular substance condition or microbial organism. When recording test results. Test sites 
want to ensure they are doing so accurately and according to the test site's policy. Test results 
should be kept as a part of the permanent record and include enough detail for easy retrieval 
of information if needed later. 
Some good testing guidelines for recording results include, if it's a quantitative result, 
you want to be sure that you record it, using the appropriate unit of measure, and exactly as 
described in the manufacturer's instructions. For qualitative results, you want to use full words 
or abbreviations rather than symbols. So, for example, if it's a positive or negative test, you 
want to write out the full word, or use the abbreviation instead of using the plus symbol or the 
negative symbol. If you obtain an invalid or unacceptable result, you want to record that result 
first, resolve the problem, retest, and then record the repeated result, but only report the final 
acceptable result to the patient record.  
So sometimes problems can occur during the testing process that may involve the 
samples, equipment or testing material. And all of these can affect the test results. These 
problems should be documented, reported to the person who oversees or directs testing, and 
corrected. Some specific examples of possible problems that could affect test results include 
improperly labeled samples, freezer or refrigerator failure, QC failure, or defective collection 
devices. By effectively capturing and tracking this type of information you can identify trends 
that may reveal more problems in the testing process at your site.  
Some additional actions that you can take. If you do have invalid or questionable test 
results. You can always repeat the test, request, or collect a new sample if required and refer 
to the manufacturer's instructions, especially if you obtain a higher than or lower than 
reportable range result. And then, of course, consult the person who oversees or directs 
testing when reporting or issuing a test report. You want to make sure that you're doing so in a 
legible standardized format, and you want to ensure that you report them in a timely manner 
according to your site-specific procedure. 
If your laboratory reports results from referral laboratories or reference laboratories. 
You want to report any tests performed from the on-site test in a way that they are easily 
distinguishable from the reports from the referral laboratory. Patient test reports should only 
be released to authorized persons, and in compliance with HIPAA. When verbal 
communication of test results are necessary. Test results should be documented and then 
followed up with a written test report. And if your test site uses electronic medical records or 
laboratory information systems to issue test reports always follow the site-specific procedure 
for guidelines on how to report results.  
So critical values are test results that require immediate treatment or evaluation by a 
physician. Test sites should have an established system to assure that critical values are 
addressed by defining what tests have critical values. All staff should be aware of what the 
critical values are, and how to promptly alert the physician and all staff should know how to 
document, when, and to whom, the critical values were reported.  
For some tests, confirmatory or supplemental testing may be necessary. The 
manufacturer's instructions should explain when additional testing is required. Each testing 
site should have a written site-specific procedure to ensure confirmatory or additional testing 
is performed or referred when needed. Site-specific procedures should include specific 
instructions on how to order additional tests with examples of how to complete the request 
forms if you're sending it to a referral laboratory. How to contact the referral laboratory if 
necessary, how to collect and label the sample, and then how to safely transport and ship the 
sample to the referral laboratory. Test sites should also maintain records of any referred test 
that would link the referred sample to the original patient sample. Document the referral 
laboratory, the test name, the date it was referred, and document the test results when they 
are received back in the day of the final report. 
Test sites should also document all steps of the testing process to ensure quality testing 
and to ensure that they can retrieve and verify information if needed later. Assess test 
performance, identify and resolve problems that could affect the test result, and maintain 
patient and personnel information logbooks. Logbooks or electronic files can be used to 
document and maintain records.  
The person that oversees testing should periodically review all records. At the bottom 
of this slide are some examples of records that should be maintained for easy retrieval and 
access of information. I won't read them all. But you essentially want to have records that 
cover the full testing process from order to result. Some examples include test order test 
results, confirmatory or additional test results, quality control results, test system failures, 
troubleshooting and any corrective actions that were taken when problems were identified.  
Verifying and maintaining quality in patient testing is just as important as all the other 
practices I’ve discussed today. Assessing, testing quality requires planned systematic 
monitoring and evaluation of the testing process. One way to verify testing quality is with 
proficiency testing, also known as PT. The CLIA regulations do not require PT. For Waived 
Testing. However, there are many benefits to participating in a Pt program. Some of those 
benefits include regular external checks on the quality of testing comparison of performance 
with that of other participating sites. 
Opportunities to identify areas needing improvement quality assessments are another 
voluntary way to maintain testing quality depending on your site's needs, resources and 
practices. You may perform quality assessments, using a combination of internal and external 
processes. Internal processes are processes for staff performing and overseeing, testing, to 
evaluate their current practices.  
Some of those options could include performing and documenting Qc. Reviewing Qc. 
Records and test records and documenting and reviewing problems and establishing a plan to 
improve those processes. External assessments are typically performed by outside party to 
evaluate current practices and offer educational opportunities. 
Possible options for external reviews include undergoing voluntary inspections by peers 
or consultants, subscribing voluntarily to a Pt. Program, or exchanging samples with other test 
sites who use the same test method as your site to compare results. I will now pass it over to 
Teresia, who will give an overview of the checklist testing logs and job aids available for test 
sites.  
Hey? Can everyone hear me? Yes, sounds good. Yeah. So the Ready? Set? Test! Booklet 
includes checklist testing logs and a host of job aids that are located in the appendix of the 
booklet. So I would advise you guys to download it and use everything that you can task 
checklist here that you might want to use when you are preparing for testing. It is good 
practice to review a pre-testing task checklist before starting your testing process. Using this 
checklist will assist in making sure the testing work area is ready. 
Fridge and testing temperatures are recorded, equipment is maintained, and all 
reagents and test kits are acceptable for use. Next slide, please. Temperature logs. The 
manufacturer's instructions will indicate the acceptable temperature range for storing your 
reagents, storing your test kits, storing your controls, and for your patient sample. To ensure 
that a refrigerator, freezer, or room maintains the proper temperature. It is important to check 
and record the temperatures daily. And before using the room. This applies whether the 
refrigerator has or the freezer has temperature alarms, or if they are charts and digital loggers 
or continuous temperature monitoring systems. 
So you want to take your temperatures. Your facility. Your lab manager will inform you 
as to how to take those temperatures, whether you're going to do it once a day, because 
you're only open Monday through Friday. Say 9 to 5, or if you're like a hospital, and you're a 
24-hour facility. Some places say, take the temperature every 8 hours. So it's going to really, 
truly depend on your facility and how things are regulated for your facility. 
The Ready? Set? Test! Booklet includes several examples of blank templates for testing 
sites that that can be used next page, please. Here we have temperature logs, room 
temperature logs and the maximum minimum temperature log. So we'll look at the 
temperature log here. We're going to do it by day. You're going to record the temperature 
daily. You're going to initial or sign that it was you that did it. And that's for 31-day month. 
Also, at the very bottom of the form. You will see where there's corrective action. Say, maybe 
you had a power outage. You know, here in Georgia we have, you know, the thunderstorms, so 
I don't know what happens in your facility or in your area. But if there's something wrong with 
your temperature, you definitely want to log it in and say what you did, and how you fixed it, 
and how you kept your reagents and controls good. 
Next slide, please. Examples of temperature logs. This is one example where you have 
multiple instruments on one page. And you can say you have a refrigerator in hematology and 
one in micro and one in Coag, one in a sessioning, and you can label them and put your 
temperatures for every day of the week. That's just an example. These are located in the 
Ready? Set? Test! Booklet. 
If you download the booklet, this is in a Pdf form, you can print it out and have access 
to it. Next slide, please. Quality control logs. CLIA requires for waived testing sites that you 
must follow the current manufacturer's instructions. So whatever they say for your quality 
control. That's what you want to do. Refer to the manufacturer's instructions for specific Qc. 
Requirements for each test.  
Each testing site should determine the appropriate Qc. The frequency for each test 
system. Like I said before, some people will probably do it once a day, because you're only 
open during business hours. And sometimes people are doing it every shift. So make sure you 
follow the manufacturer's procedure. 
The frequency of your Qc. Cannot be less than what's stated in the manufacturer's 
procedures, it can be more, but it cannot be less. The Ready? Set? Test! Booklet includes 
qualitative and quantitative QC. Log examples and blank templates.  
Next slide, please. Sample of QC log. And this is for qualitative test. And when I used to 
teach I would tell my students qualitative. The L is prominent, qualitative. So you're going to 
get a lettered result meaning you're going to get like a positive negative reactive non-reactive. 
Those tests could be like a pregnancy test where it's going to be a positive test or a negative 
test. It could be a rapid strep test where you're going to get a positive or a negative. And this is 
just an example of how to log it in. And we got occult blood here, where it's saying positive or 
negative.  
Okay, next slide, please. This is a quality control log showing quantitative test. And I 
used to my diddy for quantitative test is the n is prominent, quantitative. So you're going to get 
a number result. And that can be a glucose, it could be hemoglobin, hematocrit, or something 
that's going to have a number. Q. It's showing a test. I can't make it out. But it's showing you a 
test result that is numbered. And you want to make sure you put the units here. And like, I 
said, these are in the Ready? Set? Test! Booklet. You can download the booklet and have 
access to the forms. 
Next slide, please. The test result logs should be recorded. They should be legible and 
they should be completed filing all test result records in an organized easy to find manner, 
because you may have to go back and look something up later. To assist, several examples of 
blank template result logs are included for use at your testing site. 
Okay. Examples of patient result logs.  We have both the qualitative and the 
quantitative and they're in the booklet, so you can download them, and hopefully you'll be 
able to make use of them. The blank forms. If you have the advanced form of Adobe, you 
should be able to download it, and because it's a requirement to put, you know your address 
and I think the lab director's name, the address, the test that you're running, and the 
reportable or normal range, it should be on the log. If you have the advanced form of Adobe, 
you should be able to put that on the form after you've downloaded it.  
The next page please. Result logs and basically the same thing quantitative and 
qualitative test logs for, and I'm thinking, this is Qc. And you'll have in the booklet you're going 
to have where we show you how to do it, explain basically how it should be recorded on the 
form, and then you'll have blank forms that if you have advanced Adobe Acrobat, you should 
be able to download and work with. 
Okay, next slide, please. And this is an example of multiple test result. Logs. Get with 
your facility and the regulatory agencies that oversee your site and make sure this is something 
that you can use, but this makes it easy, like you could do. For like one day, if everything is on 
one bench you could put. You know, all the tests that you've done for that one day, and it 
would have all the patients and everything for one day. Oh. But make sure it's a form that you 
can use. It is also in the book that you can download.  
Next slide, please. Job aids and Other Waived Testing Resources. Okay, let's highlight a 
couple of them. Next slide, please. This is blood and body fluid exposure job aid. This is going 
to kind of talk you through what you should do. It's standard precautions. Cleaning up blood 
and body fluids always assume that whatever you're cleaning up is infectious, and act 
accordingly. To assist Ready? Set? Test! booklet includes Blood and Body Fluid Exposure job aid 
which talks to you about what you should do and who you should notify, and all of that, if 
something happens. Slide, please. Safety: Gloves Job Aids. This is pretty much going to talk 
about putting your gloves on, taking them off, reducing contamination, preventing cross 
contamination protecting you from infection and it assists with ensuring that staff understand 
safe glove use, and the way to remove the gloves to kind of ensure you don't get infected from 
anything that may have come in contact with your gloves. 
And that's in the booklet. Next slide, please. The common disinfectants and antiseptics 
job aid. So this is going to talk to you about what you should use and how you should use it. It 
also gives you the formula for making up the Clorox bleach solution, which is a common 
disinfectant. I know the CDC came out with this back in the eighties. Dating myself now 
because we used this when HIV and AIDS came out, and everybody was trying to figure out 
how to keep the counters and the lab equipment clean. And it's one part bleach and nine parts 
water. You put it in a spray bottle, and it's good to go in the booklet so you can read further. 
Next slide, please to test or not to test is a booklet just like Ready? Set? Test!, but it's an 
additional resource for individuals who want to implement and oversee waived, testing or 
offer new tests under a CLIA certificate of waiver. To Test or Not to Test? booklet describes 
considerations and preparations needed prior to performing waived tests. 
Some of the topics in the book: overall considerations for waived testing, testing 
oversight requirements, regulatory requirements, testing location considerations, laboratory 
safety test selection, guidance, test personnel training and assessment, instructions and 
procedures, and quality assessment options.  
A copy of this booklet can be downloaded from the link on this slide or links in the chat 
and all of those things we just highlighted there. If there are job aids and forms, they'll be in 
the book, you can download them just like To Test or Not to Test.  
Next slide, please. In summary, Ready? Set? Test!, educational materials, free 
resources, and job aids equipped the tester with good laboratory practices that help improve 
the quality of test results and enhance patient safety. Follow best practices when performing 
waived tests; always follow the manufacturer's instructions. Record test results accurately and 
according to testing site policy for reporting results. When problems occur during the testing 
process, document the problem, report to the person who oversees or directs testing. In the 
event of questionable lab results repeat the test with a new sample if required. Ready? Set? 
Test! checklists, testing logs, and job aids are available for use at all your testing sites.  
Next slide, please. We're going to open it up for questions. Thank you. Thank you, 
Theresia and Amanda. If you could come back on screen, it'll be for Q&A. We'll take a few 
minutes to answer as many questions as possible. If we do not get to your question today. Feel 
free to email us at OneLab@CDC.gov, and we also have a few QSSB members who are online 
to answer questions. So you'll notice that a few of the questions that were asked during the 
presentation have been answered. So let's go with the first question. 
They say, how often should you record the temperature only once in a day, or can we 
monitor the morning, app and afternoon and evening. So I guess a content of a continuous 
kind of monitoring. I don't know who wants to answer. I'll take that one. So in my experience. 
You can monitor it all day. So if you do have a continuous monitoring system, as we kind of 
mentioned. That's good, because it's going to track the whole day. But a lot of places will just 
check the temperature in the morning. However, if it's the summer winter, a lot of 
temperature variations are going on in your area. It's probably a good practice to keep an eye 
on like room temperature just in case it's fluctuating.  
So. Let's see. This is a good one. What information is necessary when the manufacturer 
has a different test lot number from the box, and each item, for example, the test device or the 
reagents all have different lot numbers. So I guess this is when you're trying to log all of this 
information in and I'm assuming your question is, what should you do. And probably log all of 
the lot numbers. Yeah. If they all came in the same kit. Yeah. And so this is a great question to 
ask. 
Can you replace the components of a test kit like the swabs. Or if something happens, 
and you need to replace something that's in a kit. Can you do that? I can take that one so no. 
The swabs that come in the test kit may be made of a different material than the swab that 
you would use if you replaced it with another one and that could affect the test results. So you 
want to only use the swab that comes in the test kit, or a lot of some tests and test systems 
have where you can order additional swabs.  
Separate from your test kit like, if you run out or you feel like, you know, you might run 
low on what comes with the kit. So yeah, you want to make sure you're using what's in the test 
kit, or what's in the manufacturer's instructions that you can use.  
This is a good one also. Do we have to establish our own QC limits for all control levels? 
Or is it acceptable to follow simply the manufacturer's QC limits for waived tests? I can read it 
again if you didn't get it. I was going to go ahead and answer.  
Go ahead! Yeah. So for waived tests, you can follow the manufacturer's instructions. 
You don't have to establish QC limits. Now, when you get over into non-waived, that's 
something different. But for waived tests the manufacturer's instructions is your guide.  
We're going to stay with test, and we'll leave that one for network. Right. Are external 
controls only required per lot or every open box, even if we already tested that lot?  
So they want to know if the external controls are only required per lot or every open 
box, even if you already tested that lot? Did the external controls come with the kit? 
I know, for waived testing you usually have the controls with the kit. Yeah. So I'm not 
going to try to assume what they're asking. So whomever put this question in feel free to come 
off mute. I think I can perhaps take this one real quick. So I would recommend following your 
manufacturer's instructions. Perhaps you will find information about, you know, testing, you 
know. Additional test kits from the same lot. So I would refer to my manufacturer's 
instructions. And also, if your laboratory facility have any established policies on this, you must 
follow your laboratory's policies and procedures, but my 1st choice will be to look at my 
manufacturer's instructions.  
Okay. They did say, yes. The box did come with the external controls. We'll take 2 more 
questions, and then I'll turn it back over to you, Meredith. How long should you keep the 
patient records. So typically patient records are kept for at least 2 years. But in some states, 
and for some specific tests there may be different requirements.  
So I would recommend in this case to always check with you, like your local or your 
State Public Health Department or if you are under accreditation organization. Check with 
them before you discard anything, and for you know, exact record retention, guidelines. And 
just for an example. I do know that pediatric specimens are usually kept like until the child is 
either 18 or 21. So if you're a pediatric facility, make sure you check with your lab manager or 
the person in charge of testing before you get rid of your lab results. For surgical testing, if 
someone's having surgery, I doubt if waived tests are going to be used for a patient going to 
surgery.  
But if that is the case. I don't know. A lot of surgery requirements are that you keep 
results for 5 to 7 years. So you really have to check with your facility. If it's just, you know, an 
adult record, you're going to your doctor. And then, yeah, those records are typically 2 years. 
But make sure you check with your facility. And just to add, you know, as for CLIA, you know, 
record keeping requirements. Patient records should be retained for at least 2 years.  
However, state regulation may have longer retention periods, so it will be a good 
practice to review not only the CLIA requirements, but also your state requirements. When 
you're establishing retention. Policies in your facilities. Alright. Thank you so much, Amanda 
and Theresia. And I'll turn it back over to you, Meredith. 
Sounds good. Thank you, Alicia. So I'll get us wrapped up today. So thank you very 
much again to our presenters, Amanda and Theresia. I really appreciate the insights and your 
presentations. And for all of you who attended. Thank you for participating in this webinar. We 
do encourage you to complete the evaluation for this event, we'll share the link in the chat. 
OneLab is very feedback driven we want to hear about your training needs and any 
thoughts you have about this session or other sessions you may have participated in. We do 
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event, we encourage you to complete the Ready? Set? Test! e-learning course. That link is in 
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presentation and any relevant links, and those will be posted on OneLab REACH within the 
next 2 weeks. And we really appreciate your participation today and hope you have a 
wonderful Wednesday. Thank you very much for being here.