Ready, Set, Test: Patient Testing Is Important 
08/29/2024

>> HOST: … and non-waived test systems.  With that I will pass over to you Amanda.  
Thank you.   

>> AMANDA JOHNSON: Thank you.  Can you all see me?  Everything looks good?   

>> HOST: Yes.   

>> AMANDA JOHNSON: Okay, perfect.  Good afternoon, everyone.  We appreciate 
the opportunity to present to you all today.  For today p's presentation, we will focus on 
the ready, set resources for waived testing.   
I'm Amanda Johnson and joined by Theresia Snelling.  And you'll hear from her in the presentation. 
We're from the Division of Laboratory Systems at the CDC.  And the 
resources which provide the basic training necessary to safely and accurately perform 
waived testing on test sites regardless of location can get the right results. 
Today we'll be discussing waived testing and the education to realize for 
waived testing.  In the interest of time, we will highlight the ready and set sections in 
the ready, set, test education to realize.  The test section and all other forms and logs 
included in the materials will be highlighted during October's one test lab event.  More 
information on that session will be provided at the conclusion of the presentation. 
And for the learning objectives, by the end of the presentation, the learners 
can explain what the waived test and is and CLIA.  And waived testing.  And describe 
best practices to follow when preparing for testing.  Describe test order and sample 
collections and identify best practices to safely perform waived testing. 
With that, let's get started.  What are waived tests? They are simple, having 
a low risk erroneous results. And they are cleared from the FDA for home use and 
under the CLIA criteria.And for the most list of waived tests or adding to our testing menu, refer to 
the list on the slide and here in the chat.  This is continuously revised as waived by the FDA. 
The CLIA play a significant role in waived testing by standards and 
regulations to ensure accurate and reliable results.  CLIA has the waived testing and 
they need to enroll in the program, and obtain the certificate of waiver.  And then follow 
the manufacturer’s instructions. 
The testing sites with waiver are not routinely inspected, however if there is a 
complaint or it is determined a site testing is not waived, CMS can inspect that site.  
For more information and forms to use for CLIA certificate of waiver, refer to the CLIA 
link at the bottom of this slide and in the chat. 
Waived testing results are most commonly used to diagnose disease, 
prognosis and monitor a patient's health status.  It is performed in health settings, 
Doctors’ offices and it is being performed at nursing homes, clinics, and jails. 
And waived tests are simple and have a low risk of incorrect result.  But this 
does not mean they are completely error proof.  Errors can occur in the testing 
process.  And when manufacturer’s instructions are not followed and when testers are 
not familiar with the test system. 
Testing sites can reduce the likelihood of incorrect test results by cultivating 
an environment where all testers have good testing practices.  The ready set test 
education to realize are available to help. 
So,  with that being said, I will now highlight the ready, set, test education 
materials.  These specific resources and testing offered by the CDC can be found at 
the link on this slide and also in the chat. 
So,  the ready, set, test, education materials are free resources that provide 
the training to safely and accurately perform waived testing.  The booklet describes 
recommended practices for physicians, nurses, medical assistants, pharmacists and 
those who may not have healthcare background.  And the booklet has forms and logs 
that can used at testing sites. 
A resource, the self-assessment checklist is available and this heights what 
should be checked or completed throughout the testing process.  Both of these 
resources can be downloaded from the previous link dropped in the chat. And you can 
also request hard copies, if you would like. 
We also offer a free ready, set, test online course.  This course is a scenario 
based training where the steps of the waived testing is explained.  A certificate of 
completion is provided to those scoring an 80% of the test.  And this is assesses the

competency of testers and you can access this course by scanning the QR code or 
referring to the link in the chat. 
So,  now, we will give an overview of the ready and set sections of the 
materials to provide a prove for testing sites that maybe interested in these resources. 
Prepare for testing.  Before you're ready to start a testing process, you 
should take all necessary steps to prepare and ensure your steps are accurate.  The 
most available resource to properly premiere for the waived testing process is the 
manufacturing and instructions.  Studies show that most problems of waived testing 
result in failing to follow and understand the information in the manufacturer’s instructions. 
Here we have practices to follow when preparing for testing.  You want to 
routinely clean and dry work surfaces before and after testing.  Ensure all testing is 
performed in a well-lit and clean dry area.  It's a good practice to check temperatures of 
the testing, and storage areas.  And check supplies regularly to ensure you have 
reagents, and record any expiration dates, discard any reagents or test kits. 
Ensure all test kits components and their reagents are from the same kit lock.  
Do not mix or combine reagents.  Inspect for damage, discoloration or contamination 
and discard. If any agents require preparation, you should prepare the reagents according 
to the manufacturer’s instructions.  Allow time for refrigerated reagents, test kits, or 
patient samples to room temperature prior to performing patient testing. 
If indicated in the manufacturer’s instructions for any type of equipment to 
use, you want to perform the equipment collaboration checks as needed.  And then 
lastly, a good practice to always disinfect the surfaces with the appropriate disinfectant 
before performing any test procedure whenever contamination is visible and before 
leaving the testing area after all testing has been completed. 
When preparing for testing, it's a good practice to review a pretesting 
checklist before starting the testing process.  This specific checklist is included in the 
ready, set, test booklet as appendix A.  And it will ensure that the testing area is ready, 
all storage and testing temperatures have been recorded.  Equipment is maintained 
and all reagents and test kits are acceptable for use. 
The CLIA certificate of waiver requires that all testing sites follow the most 
current version of the manufacturer’s instructions.  Manufacturers may update or 
change their guidance periodically and instructions from different manufacturers may 
differ for the same type of test.  For example, glucose.  To ensure the most current 
and appropriate test instructions are being used a copy of the manufacturer's 
instructions should always be on hand for easy reference.  With each shipment of 
reagents or test kits, should check for changes.  And any updates, the test site should

replace the previous instructions with the new version and file the old for a record.  It's 
important to record all changes in the manufacturer's instructions to all testers and to 
the had person who directs or supervisors testing. 
It's not acceptable to make changes to manufacturer's instructions.  With 
changes it is no longer considered waived. And manufacturers may provide quick instructions. 

These instructions are intended to supplement the manufacturer's instructions but not replace. 

If updated, check the quick reference instructions.  They may also have been updated or need to 
be updated. Quality control is important when preparing for the testing process.  And it is 
required when indicated in the manufacturer's instructions.  Quality control testing 
ensures the tests being performed will yield the results as expected.  It alerts users 
when the testing process occurs.  The manufacturer's instructions will explain, when, 
why and how, to perform QC testing. 
Waived tests include two types of quality control:  Internal and external 
controls.  Internal controls also refer to as built in or procedural controls determine 
whether the test is working as it should.  The test sample amount is adequate for the 
test to perform properly. The sample is moving through the test strip or device correctly. 
And if the electric functions of the instruments are working. 
External controls determine if the entire process is being performed correctly 
from sample to interpretation of the results.  External controls will also indicate if the 
control values are within the expected ranges, printed on the instructions or manual. 
External controls are liquids or other similar to patient samples and they may 
be included with the test kit system or they may need to be purchased separately. 
Who should perform QC testing and how often?  The same personnel who 
performs patient testing should perform QC testing.  Quality controls should be treated 
as a patient sample.  Again, refer to the manufacturer's instructions for the test system 
is essential to know when and how often quality controls should be performed. 
Your testing site should perform QC as least as often as the manufacturer's 
instructions and as common as each new shipment of reagents or test kits, any 
changes in lot numbers or each testing. 
It's also important to consider additional factors when determining how often 
your test site needs to perform quality control.  Such as the ability of the test, 
environmental changes which can cause QC testing to spoil, and the competency and 
skill of your testers. 
If unexpected, out of range, or invalid quality results are obtained, it should

be identified.  When troubleshooting QC results, check to see if the manufacturer's 
instructions are being followed correctly. Look for possible sources of air, you reagents 
being outdated or your control materials outdated.  Check if the reagents, test kits or 
materials have been stored properly. You want to make sure the controls and reagents 
haven't been cross contaminated by switching caps or mixing the reagents. 
This is often seen at test sites when the caps high and negative controls 
maybe swapped. 
Follow the steps in the matter's instructions or in your site specific procedure 
if your test site has one.  You can contact the manufacturer, the technical 
representative, or the person who directs or supervises the testing for additional assistance. 
Once the problem has been identified and corrected, repeat QC testing if the 
QC results are acceptable, repeat the patient samples and then report the final results. 
I know I've shared a lot of information so far.  So I think it's a good time for 
us to pause for a quick knowledge check for.   
This scenario, you're working at a 
testing site that performs waived testing under a CLIA certificate of waiver.  The 
manufacturer's instructions for a waived test site require quality control daily. Before 
testing for the day, you perform quality controls using the quality control material near 
the test system.  The results are unexpected or valid.  What next steps?  A, or B, 
check the manufacturer's instructions to ensure the testing process was performed 
correctly.  C, inspects the test kit, quality control materials for possible sources of error, 
or B & C.  I see people are answering.  Giving everybody a few more minutes -- I'm 
sorry -- a few more seconds. 
All right.  The correct answer is D and 92% of you got the correct answer. 

>> THERESIA SNELLING: Okay.   Now that we have covered how to prepare for 
testing.  We will move into our other considerations and steps you should take before 
testing the sample. 
We're going to start with set.  Next slide, please. 
The test order.  The first thing you want to consider is the testing order.  
Closely examine the test order.  If there is a question about whether the order is 
correct, check with the individual who ordered the test.  Accurate patient identification 
is critical when collecting the patient sample because patient's names can be similar 
and they can also be the exact same name. 
So,  you want to make sure you have two patient specific identifiers such as

the patient's name and their date of birth.  This is a good laboratory testing practice and 
it will insist you in ensuring the test is ordered and collected from the correct patient.  
Next slide, please. 
Consult with the patient.  Enhancing patient awareness regarding any 
information that may impact their health or the accuracy of the test is essential.  So you 
want to prepare the patient for sample collection by first consulting with them regarding 
any pretesting instructions or information. 
Some tests require preparation by the patients such as fasting.  So the first 
thing you want to do is ask them if they've eaten anything that day and more than likely 
they'll say no, I haven't eaten anything.  And then you'll want to ask them if they've had 
anything to drink.  Because they don't consider that cup of coffee as fasting.   
Ask them those questions. For some tests, medications may interfere substances. 

You want to ask what medicines they be taken that day.  Verify the patient has followed the 
recommended instructions before conducting the sample.  And note any of the 
manufacturer's instructions. 
For the test ordered, it had helpful to ensure the patient understands the 
importance of the test being ordered and what it means to their health.  Ultimately, 
some test results, patient counseling maybe beneficial. 
I know when I was a bench tech, we would send patients for mental health 
counseling if they were getting an HIV and AIDS test.  Next slide. 
Collecting the sample.  Quality patient samples are critical for accurate and 
reliable test results.  The sample collectors should understand the type of sample 
needed for the test and the collection process.  Manufacturer instructions provide all 
necessary collection, handling and storage information.  Do not test a sample that is or 
has been improperly collected or improperly handled. 
When a test is approved for both waived and non-waived testing, use the 
manufacturer's instructions may include testing performed for more than one sample 
type.  However, waived tests may only be performed using unprocessed samples.  
Those acceptable include whole blood, a finger stick. If it is a puncture it's an 
anticoagulated blood sample, a nasal swab, or aspiration, a stool sample, a saliva or 
oral fluid, or gastric biopsy. These are examples of unprocessed samples. 
When labeling your sample -- sorry, your next slide [Chuckles] when labelling 
your patient sample, label immediately after collection with at least two unique patient 
identifiers, the name, date of birth, to prevent sample mix up. 
It is a good practice to also include the date and the time that the sample was

collected and you could include the initials of the person who is actually collecting the 
sample. Tests requires the sample be applied directly to the test device or to the test 
to set.  Label the test device.  Or put the name on the cassette before you collect the 
sample.  Next slide, please. Okay. 

Using collection devices.  Collection devices are essential to 
sample collection, and sample collectors must use them in accordance with the current 
manufacturer's instructions.  This means, only use the swabs that come inside the 
sample collection kit.  Or referred to as the test kit.  Using the appropriately sized 
finger stick and vena puncture collection devices for your patient and only use it once. 
Some collection devices ensure the delivery of the correct sample volume 
while some contain additives that are needed for the test to work correctly. 
Safe considerations for testing.  It is also good testing practice to follow safe 
work place practices while performing waived testing.   
This includes handling all blood 
and blood fluids as if they are infectious.  Using the required PPE and safety devices.  
Do not -- (Indiscernible) in the testing area.  Be cautious during the testing process to 
reduce potential exposure to mucus membranes. 
So don't scratch your nose or anything.  Wear goggles or face shields to 
protect against aerosols or droplets exposure.  Avoid using needs or lancelets if 
effective alternatives are available.  Avoid recapping needles, transferring body fluids 
between containers, or opening blood tubes. 
Properly dispose of used sharps and puncture proof sharps containers.  In 
the event of an exposure, please report to your supervisor or the person who is 
overseeing or directs testing to ensure the appropriate follow-up care is received. 
Bio hazard waste.   All testing sites must comply with local, state, and 
federal requirements for the safe disposal of biohazard waste generated from sample 
collection and testing.  Hazardous waste cannot be disposed of with regular trash.  
Instead, proper biohazard waste disposal bags and containers should be used. 
As a good testing practice, each should have site specific procedures that 
comply with their local, state and federal requirements for safe disposal of biohazard 
waste.  If you don't have a prepare and you're unsure what to do at this point, you can 
contact a local hospital or clinic and they may be useful resources for information about 
regulated waste disposal. 
During the testing process, the biohazard bags and containers used for 
disposal and contaminated materials should be in close proximity to the testing.  It 
should be upright throughout the use.  They should routinely be replaced and never 
overfield them.  Should be constructed to contain all contents and prevent leakage of 
fluids during handling, storage, transportation, and/or shipping.

They should be labeled or color coded to indicate biohazard waste. And 
when you're completely done with them, they should be closed before removal to 
prevent spillage or protrusion of contents before handling.  Next slide, please. 
I think we're on the knowledge check.. 
So,  this is our final knowledge check.  The scenario in question for today 
asks, you are collecting a throat swab from a patient at your testing site.  What best 
testing practices would you follow to ensure the sample is collected properly and from 
the correct patient? 
A, only use a swab from the test kit or sample collection kit for the test 
ordered. 
B, check at least two unique patient-specific identifiers to verify the patient 
and the test order. 
C, follow the test kit's manufacturer p's instructions for sample collect. 
Or D, all of the above. 
And it's the end of poll is coming up.  And 98% of you got it right.  All of the 
above.  D, all of the above. 
Thank you.  Thank you for participating. Next slide. 
This is summary of ready, set, test.  Or ready and set. 
The educational materials are resources to provide testers the basic training 
necessary to safely and accurately perform waived testing.  Prepare for testing by 
taking all necessary steps to ensure your resource or results are accurate.  Always 
follow the manufacturer's instructions, and reference the instructions for when, why, and 
how to perform QC testing.   Before collecting a patient sample, confirm the test order 
and verify the patient's identification.  Use the appropriate collection device for your test 
system and patient.  And follow safe working practices to reduce risk of exposure. 
Okay.   Next slide. 
Now we will have -- I guess a brief discussion or Q&A period.  

 
>> HOST: Thank you, Theresia and Amanda.  We will take a few minutes to answer as 
many questions as possible.  If we don't get to your question today, we'll do our best to

answer it, if you have not submitted anonymously.  If you have a question after today's 
webinar, e-mail 1 lab@CDC.gov. 
Let's take some time.  Let's see.  I'll try to move that off my screen. Let's 
see, um, what do we have in the box? 
I don't see anything in the box.  Let's start with, what recommendations do 
you have to ensure testers are trained properly to perform waived tests?   

>> AMANDA JOHNSON: I'll take that question.  First you want to ensure that all testers 
have read and understand the manufacturer's instructions and any site specific 
procedure if your testing site has those.  For hands on, I recommend the training from a 
more experienced tester who can explain and demonstrate the testing process.  After 
they've completed the hands on training, the new tester should be able to also 
demonstrate the testing process correctly while a more experienced person watches.  
And this should all happen prior to them reporting any patient results.  And then, of 
course, you want to document and have them file a record of their training. 

>> HOST: Thank you.  Next question.  Do you recommend an annual competency for 
waived tests?  Or those who perform waived tests?  Do you think an annual 
competency is necessary?   

>> AMANDA JOHNSON: You want to take that one?  

 
>> THERESIA SNELLING: Yes, I believe that is required to have annual competency. 
So you just basically watch them do the test, sign off that you've seen them do X 
number of tests that your facility has.  If you're only doing two or three waived testing, 
you watch them do all three, you can sign off and say they met standards. And it needs 
to be documented and kept on file. 

  
>> HOST: Let's see. This is an interesting one.  Waived tests can be performed in 
patient's home.  Is it still required to have an office to perform waived tests?   

>> AMANDA JOHNSON: Waived tests can be performed anywhere.  So no, it is 
not -- it is required, though, to have a clear certificate of waiver.  So that is one thing 
that you should be mindful of.  But yeah.   Waived tests can be performed anywhere.  
And we're increasingly seeing them performed in places you wouldn't expect.  So home 
is fine.   

>> HOST: Let's see.  This is a great one.  Is there a limit to the number of an analyte 
tests -- I'm not sure -- CW certificates.  And does a test that has multiple results count 
as one analyte?  Or each as separate?  

 
>> AMANDA JOHNSON: I don't think there is a limit?  Theresia, correct me if I'm wrong. 

I don't think there is a limit for waived testing.  As far as for the analyte if there 
is glucose, potassium, those are considered a separate analyte.  I know some new 
waived testing on the market for COVID are considered a separate analyte.

    
>> THERESIA SNELLING: On the website that is analyte that is waived 

 
>> HOST: And each one should be recorded separately.  

>> THERESIA SNELLING: Mmm-hmm.  

 
>> HOST: Is it required that only people who do patient testing do the QC?  Some 
clinics like to have a person do a QC but they never do a patient test.   

>> THERESIA SNELLING: If CMS finds out about that that, that's not a good thing.  

 
>> AMANDA JOHNSON: Exactly.  I was going to add that in.  But I've seen that in 
some of the clinics I oversee.  They wanted a person that did a QC and other people 
for the rest of the day.  That's not a good practice.  CMS would probably tell you if they 
had to coming up, QC is performed by the person doing patient testing.  So you should 
be able to QC and you should have a record that you can do QC.   

>> HOST: Okay.   So no need for a physical office.  And I think the bigger question is 
if they're actually doing patient samples, they should not be doing that at their home.  If 
that's the question -- just a follow-up to the one about since you can do waived testing at 
home, you don't need a physical lab to do it.    

>> THERESIA SNELLING: When I heard that I was thinking of a visiting nurse to do a 
glucose on you or rapid COVID test if it's a visiting nurse.  A waived tests, it needs to 
be QC and needs to be documented.  But if you're running -- I -- I -- 
(Cross talk)  

>> THERESIA SNELLING: If you're doing it in the parking lot like with COVID testing, 
then, yes, you need a CLIA certificate.  If you're a visiting nurse, you need the CLIA 
certificate.   

>> HOST: This one, I think has a little bit of layers to it.  Someone asked, where can 
they find the resources that you mentioned today?  

>> AMANDA JOHNSON: So I know during the first a couple of slides, the link should 
have been dropped in the chat.  I can re-paste it in as well.  All our resources are on 
the CDC waived testing website.  And the ready, set, test materials are there and other 
resources for waived testing.   
This is not the only resource that we have available to 
help you in your waived testing labs. 

  
>> HOST: I have a question.  How should those who actually perform point of care

testing, the waived test at home, dispose of that test and the specimens?  Is it okay to 
put it into the regular trash can?  Or should they be traveling with, at home a biohazard 
bag?   

>> THERESIA SNELLING: Um --  

>> AMANDA JOHNSON: Um -- 

 
>> THERESIA SNELLING: That one is deep.   If you're performing your own -- you are 
the patient, and you are a diabetic and you're doing your own testing on yourself, you're 
going to throw that in the trash.  But if you're a visiting nurse and going from patient to 
patient, I would expect for you to have, um, a sharp's container with you, I would think.  
But ask -- um, ask your superiors.   

>> HOST: And we'll take this one last question, should waived tests user conduct a risk 
assessment before performing the test?  I don't know who wants to take that one 
[Chuckles]  

>> THERESIA SNELLING: You'll have to read that again, I didn't understand it. 

  
>> HOST: Should those who actually perform waived tests, should they conduct a risk 
assessment before they begin?  

>> AMANDA JOHNSON: So it's not required --  

>> THERESIA SNELLING: It's not required.  It's a good idea  

>> AMANDA JOHNSON: It's probably a good idea to just assess your area and look for 
any risk that could happen if you perform waived testing.  But it's not required for 
waived testing. 

>> HOST: That's all the time we have questions for.   
I'll turn back over to Meredith.   

>> FACILITATOR: Thank you, Alisha, and I would like to thank our presenters Theresia 
and Amanda, we appreciate you being here today.  As we wrap up, I want to let you all 
know we have a follow-up to today's event.  We invite you to join our second session 
on October 2nd.  That'll be at the same time noon to 1 eastern. And Theresia and 
Amanda will present on that session as well.  We will provide the registration link in the 
chat. And let's go ahead to the next slide, please. 
And I want to invite you all to complete the evaluation for this event and use 
the link in the chat.  We are feedback based.  We welcome your thoughts and input on 
your training needs and feedback on one lab test, so we can build out this community 
and our resources to better support you and your work.  We use your feedback to 
select future topics and better understand your needs.  Next slide, please.

Thank you.  So if you are interested in obtaining pace credit and certificate 
from this event, please complete the ready, set, test E learning course.  That's a 
companion to the session we had.  There will be a QR code on the screen to redirect 
you to the course.  It's available online.  And as a reminder, we post the slides and any 
links to CDC.gov-one lab.  The turnaround time is usually a couple of weeks from the 
event.  So just continue to check back.  We do hope you'll join us for the second part 
of this session.  And thank you all for participating.  And hope you all have a wonderful 
rest of your day. 
[End of Webinar]