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Julie Son: Hello, everyone, we're gonna give additional participants. Just a few more minutes to join and we'll get started.

 

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Julie Son: Okay, everyone. We can go ahead and get started. My name is Julie Sun, and I'm a consultant with guidehouse supporting Cdc's 1 lab initiative.

 

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Julie Son: 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@onelabatcdc.gov.

 

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Julie Son: 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 have a. We'll do a Q&A session at the very

 

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Julie Son: end of our presentation, and we'll review those questions and do our best to answer.

 

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Julie Son: Note that we've also posted the link to live captions in the chat.

 

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Julie Son: But please be sure to keep both the caption window open if you use it. In addition to this Zoom Meeting

 

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Julie Son: next slide, please.

 

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Julie Son: So for our agenda today we'll be start. We'll we'll start by discussing relevant one lab resources.

 

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Julie Son: Then we'll go through some introductions into today's presentation. We'll have about a 10 min Q&A session at the end. And then today's session will end with a discussion of upcoming network events

 

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Julie Son: 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.

 

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Julie Son: 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.

 

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Julie Son: But again, if you have a question for the presenter. Please use the Q&A function, and not the chat.

 

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Julie Son: 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.

 

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Julie Son: Lastly, please notify moderators. If you're experiencing technical difficulties or observe disruptive behavior.

 

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Julie Son: I'll now turn it over to our one lab partnership and promotions lead Meredith Reagan to share some of our new and relevant resources.

 

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Meredith Reagan: Thank you, Julie, appreciate everyone being here today. As Julie said, my name is Meredith Reagan.

 

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Meredith Reagan: I lead partnerships and promotions for one lab. 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.

 

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Meredith Reagan: So I'll start

 

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Meredith Reagan: with our point of care testing personal protective equipment toolkit. So this toolkit is based on Cdc recommendations and Osha Ppe standards.

 

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Meredith Reagan: 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.

 

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Meredith Reagan: We also have a blood or body fluid exposure job aid. This provides standard precautions to prevent exposure to blood and body fluids.

 

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Meredith Reagan: and, lastly, I am excited to share our instructions for performing external control testing.

 

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Meredith Reagan: 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

 

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Meredith Reagan: tests.

 

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Meredith Reagan: So with that, I will introduce our presenters.

 

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Meredith Reagan: So our 1st presenter is Teresa Snelling. Teresa has more than 20 years of clinical laboratory experience.

 

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Meredith Reagan: And she has also worked in multiple areas and various positions, including Bench Tech, Senior Tech and Education coordinator to management.

 

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Meredith Reagan: She has trained many professionals, including communicable disease specialists, laboratory assistants, phlebotomists, laboratorians and nurses.

 

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Meredith Reagan: 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.

 

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Meredith Reagan: She has also participated in developing and revising rules and regulations that govern the State's laboratory facilities.

 

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Meredith Reagan: and she mainly focused on enforcing regulatory rules and guidelines and training end users on compliance.

 

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Meredith Reagan: Teresa developed good laboratory practices for wave testing for the ready set test online training course

 

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Meredith Reagan: and the development of a booklet for individual quality control plans or Iqcp

 

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Meredith Reagan: she is currently also involved in Cleac planning and logistics, distribution and promotion of Qssb, so that's our quality and safety systems, branch training materials and the online training courses.

 

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Meredith Reagan: We'll introduce our second speaker.

 

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Meredith Reagan: 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.

 

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Meredith Reagan: 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 1st ready set test session, you may remember them. So looking forward to our second session, and I'll pass it over to you. Amanda.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Okay. Hello. 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 wave testing that are provided by the Cdc.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Like you heard. I'm Amanda Johnson, and I'm joined by my colleague, Teresa Snelling, who, you will hear from a little later. In the presentation.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Today we will give a little background on wave testing

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: the ready set test educational materials for wave testing.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: By the end of our presentation each learner will be able to identify the ready set test. Educational materials

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: as resources for wave testing.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: describe best practices to follow when performing wave testing.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: describe how to read and record test results

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: identify actions to follow when problems, including questionable test results, occur during the testing process.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: And lastly, recognize the ready set test educational materials, checklists, testing logs and job aids that can be used at testing sites.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: So with that being said, let's get started.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: So what a wave tests

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: wave tests are tests categorized as simple, having a low risk for erroneous results.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Wave tests include test systems that are cleared by the FDA

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: for home use and those tests that are approved for waiver under the clia criteria.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Wave tests can be performed without routine regulatory oversight, and they're often performed at the point of care

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: for the most current list of wave tests. You can always refer to the FDA list linked on this slide and in the chat.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: This list is continuously revised as new tests are waived by the FDA.

 

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Alicia Branch, PhD: Amanda, hold up a minute. The slides are not showing.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Okay, sorry about that. Let me see.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Okay, they're showing now.

 

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Alicia Branch, PhD: They are.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Okay? Which part did? What's not showing? I'll go back.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Was it

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: the slot?

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Sorry about that? You all?

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: So what are wave tests.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Tests are tests that are categorized. Weight tests are tests that are categorized as simple, having a low risk for erroneous results.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Wave tests include test systems that are cleared by the FDA, and those tests that are that are approved for waiver under the clia criteria

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: wave tests can be performed without routine regulatory oversight, and they are often performed at the point of care

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: for the most current list of wave tests. You can always refer to the FDA list that is linked on this slide and in the chat.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: And just to note the list is continuously revised as new tests are waived by the FDA.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: The clinical laboratory improvement amendments also known as Clia play a significant role in wave testing

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: by establishing standards and regulations to ensure accurate and reliable results.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Clia has very few requirements for wave testing and testing that is performed under a certificate of waiver.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: To perform wave testing a test site needs to enroll in the Clia program.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: pay a fee, and then obtain their certificate of waiver, which will be effective for 2 years.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and then follow any of the manufacturer's instructions for any test that they choose to perform without any modifications.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Test sites with a certificate of waiver are not routinely inspected. However.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: if Cms receives a complaint about a test site.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: That test site may be subject to an on-site survey

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: for more specific information and forms to use when applying for a clear certificate of waiver.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: refer to the clear brochure linked at the bottom of this slide and in the chat

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: the ready set test, educational materials and all of the resources for wave testing

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: offered by the Cdc can be found at the link on this slide

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: as a disclaimer. Some of the recommendations encompassed in these resources

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: exceed clear requirements for wave testing, however, following the recommended good laboratory practices that are mentioned in the resources

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: will likely lead to reliable high quality results while enhancing patient safety.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: The ready set Test booklet describes, recommended, recommended practices for physicians, nurses, medical assistants.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: pharmacists, and other individuals who perform patient testing under a clear certificate of waiver.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: The booklet includes forms and logs that can be used at test sites, and we will highlight those a little later in the presentation

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: as an accompanying resource. The self assessment checklist for good testing practices is also available for download.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: This checklist emphasizes recommended practices while highlighting what should be completed throughout all phases of the testing process.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Both of these resources can be downloaded from the previous link provided in the chat.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and if you would like a physical, hard copy, those can also be requested.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: We also offer

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: the readyset says, online course.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: This course is a scenario-based training where all the steps of the wave testing process are explained.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: a certificate of completion is provided to participants of the course who score at least 80% on the post test.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: This course can be used as a supplement when assessing the competency of testers, and if you need free Payce credit, this course does offer that at the completion, if needed.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: So now I will give an overview of the good testing practices that are included in the test section

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: of the materials. The ready and the set sections were covered during session one of our series.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and I invite you all to go back and watch session, one which can be referenced using the link in the chat.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: So let's assume you've already prepared your testing area, perform quality control. If it was indicated in the manufacturer's instructions

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and collected your sample.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Now, the testing phase would begin

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: when performing a test. You want to be sure to follow the proper testing steps

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: according to the manufacturer's instructions.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: in the exact orders they are listed.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: You want to ensure that Qc. Is acceptable prior to testing any patient samples.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: In the testing area.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: quick reference guides or color charts

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: are useful resources

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Also, you want to use timers if indicated and follow the required timing intervals

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: before reading test results.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Interpreting test results is a vital component of the testing process.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Reading the results too soon can cause invalid or false negative

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: results due to incomplete reaction of the sample and reagents.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: types of test results. So it's important to know what type of test result, the test system you're using will provide

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: test results are either quantitative, qualitative or a combination of the 2 where a numeric result is interpreted as a non-numeric result.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: quantitative results indicate the amount of a measured substance reported in specific measurement units.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: while qualitative results are interpreted as positive, negative, reactive, non-reactive or invalid.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Qualitative results identify the presence or the or absence of a particular substance condition

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: or microbial organism.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: When recording test results. Test sites want to ensure they are doing so accurately and according to the test sites. Policy test results should be kept as a part of the permanent record

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and include enough detail for easy retrieval of information if needed later.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and it, and exactly as described in the manufacturer's instructions

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: for qualitative results. You want to use full words or abbreviations rather than symbols.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: or the negative symbol.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: If you obtain an invalid or unacceptable result. You want to record that result. First, st

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: resolve the problem, retest, and then record the repeated result.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: but only report the final acceptable result to the patient record.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and corrected

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: some specific examples of possible problems that could affect test results

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: include improperly labeled samples, freezer or refrigerator failure, Qc. Failure or defective collection devices

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: some additional actions that you can take. If you do have invalid or questionable test results.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: you can always repeat the test, request, or collect a new sample if required.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and refer to the manufacturer's instructions, especially if you obtain a higher than or lower than reportable range result.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and then, of course, consult the person who oversees or directs testing

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: when reporting or issuing a test report. You wanna make sure that you're doing so

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: in a legible standardized

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: format, and you want to ensure that you report them in a timely manner according to your site. Specific procedure.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: If your laboratory reports results from referral laboratories or reference laboratories.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: You want to report any tests performed

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: on the from the on site test in a way that they are easily distinguishable from the reports from the referral laboratory.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Patient test reports should only be released to authorized persons, and in compliance with hipaa.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: When when verbal communication of test results are necessary. Test results should only

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: should be documented and then followed up with a written test report.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: So critical values are test results that require immediate treatment or evaluation by a physician.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Test. Sites should have an established system to assure

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: that critical values are addressed by defining what tests have critical values.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: All staff should be aware of what the critical values are, and how to promptly alert the physician

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and all staff should know how to document to when

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: document, when and to whom the critical values were reported.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: For some tests, confirmatory or supplemental testing may be necessary.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: The manufacturer's instructions should explain when additional testing is required.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Each testing site should have a written site. Specific procedure to ensure confirmatory or additional testing is performed, performed or referred

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: when needed

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: test sites should also maintain records of any referred test that would link the referred sample to the original patient sample

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: document. The referral laboratory. The test name, the date it was referred.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and document the test results when they are received back in the day of the final report.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: test sites should also document all steps of the testing process to ensure quality testing

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and to ensure that they can retrieve and verify information if needed. Later.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: assess test performance identify and resolve problems that could affect the test result

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and maintain patient and personnel information

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: logbooks, logbooks or electronic files can be used to document

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and maintain records.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: The person that oversees testing should periodically review all records.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Some examples include test order test results, confirmatory or additional test results, quality control results, test system failures, troubleshooting

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: and any corrective actions that were taken when problems were identified.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Verifying and maintaining quality in patient testing is just as important as all the other practices I've discussed today.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Assessing, testing quality requires planned systematic monitoring and evaluation of the testing process.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: One way to verify testing quality is with proficiency testing, also known as Pt.

 

187

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Amanda Johnson, MHSc., MLS(ASCP)CM: The Clia regulations do not require Pt. For wave testing.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: However, there are many benefits to participating in a Pt program. Some of those benefits include regular external checks on the quality of testing

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: comparison of performance with that of other participating sites.

 

190

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Amanda Johnson, MHSc., MLS(ASCP)CM: Opportunities to identify areas needing improvement

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: quality assessments are another voluntary way to maintain testing quality

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: depending on your site's needs, resources and practices. You may perform quality assessments, using a combination of internal and external processes.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Internal processes are processes for staff performing

 

194

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Amanda Johnson, MHSc., MLS(ASCP)CM: and overseeing, testing, to evaluate their current practices.

 

195

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Amanda Johnson, MHSc., MLS(ASCP)CM: Some of those options could include performing and documenting Qc.

 

196

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Amanda Johnson, MHSc., MLS(ASCP)CM: Reviewing Qc. Records and test records and documenting and reviewing problems and establishing a plan to improve those processes.

 

197

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Amanda Johnson, MHSc., MLS(ASCP)CM: External assessments are typically performed by outside party

 

198

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Amanda Johnson, MHSc., MLS(ASCP)CM: to evaluate current practices and offer educational opportunities.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Hey?

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Can everyone hear me?

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: Yes, sounds good.

 

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Alicia Branch, PhD: Yeah.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): So the ready set test

 

206

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): booklet includes checklist

 

207

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): testing logs

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and a host of job aids that are located in the appendix of the booklet. So I would

 

209

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): advise you guys to download it and use everything that you can

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): task checklist here

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): that you might want to use when you are preparing for testing.

 

212

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): It is good practice to review a pre-testing task checklist before starting your testing process.

 

213

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Using this checklist will assist.

 

214

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Bring the testing work area is ready.

 

215

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): fridge and testing temperatures are recorded, equipment is maintained, and all reagents and test kits are acceptable for use.

 

216

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Next slide, please.

 

217

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Next slide, please.

 

218

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): They're logs.

 

219

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): The manufacturer's instructions will indicate the acceptable temperature range

 

220

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): or storing your reagents.

 

221

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): storing your test kits.

 

222

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): storing your controls and for your patient sample

 

223

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): to ensure that a refrigerator, freezer, or room maintains the proper temperature.

 

224

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): It is important to check and record the temperatures daily.

 

225

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and before using the room.

 

226

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): This applies whether the refrigerator has or the freezer has temperature alarms, or if they are charts

 

227

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and digital loggers

 

228

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): or continuous temperature monitoring systems.

 

229

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): So you want to take your temperatures.

 

230

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Your facility. Your lab manager will inform you as to how to take those temperatures, whether you're gonna do it once a day, because you're only open

 

231

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Monday through Friday.

 

232

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): say 9 to 5, or if you're like a hospital, and you're

 

233

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): a 24 h facility. Some places say,

 

234

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): take the temperature every 8 h. So it's gonna really, truly depend on your facility and how

 

235

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): things are regulated for your facility.

 

236

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): The

 

237

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): ready set test booklet includes several examples of blank templates for testing sites that that can be used next page, please.

 

238

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Here we have temperature logs, room temperature logs and the maximum minimum temperature log.

 

239

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): So we'll look at the temperature log here.

 

240

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): We're going to do it by day. You're going to record the temperature daily.

 

241

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): You're gonna initial or sign that it was you that did it. And that's for 31

 

242

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): day month.

 

243

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Also, at the very bottom of the form. You will see where there's corrective action. Say, maybe you had a power outage.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): 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 and

 

245

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): controls.

 

246

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Goods

 

247

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): next slide, please.

 

248

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Pools of temperature logs.

 

249

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): This is one example, where?

 

250

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): you have multiple instruments on one page.

 

251

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and you can

 

252

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): say you have a refrigerator in hematology and one in micro and one in Coag, one in a sessioning, and you can label them

 

253

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and put your temperatures for every day of the week.

 

254

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): That's just an example.

 

255

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): These are located in the ready set test booklet.

 

256

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): If you download the booklet, this is in a Pdf form, you can print it out

 

257

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and have access to it.

 

258

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Next slide, please.

 

259

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Quality control logs.

 

260

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): clia requires for waived testing.

 

261

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Sites that you must follow the current manufacturer's instructions.

 

262

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): So whatever they say for your quality control. That's what you want to do.

 

263

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Refer to the manufacturer's instructions for specific Qc. Requirements for each test.

 

264

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Each testing site should determine the appropriate Qc. The frequency for each test system.

 

265

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): like I said before, some people will probably do it once a day, because you're only open during business hours.

 

266

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and sometimes people are doing it every shift. So make sure you follow the manufacturer's procedure.

 

267

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): 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.

 

268

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): the ready set test booklet includes qualitative and quantitative Qc. Log examples and blank templates.

 

269

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Next slide, please.

 

270

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): sample of Qc log.

 

271

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): And this is for qualitative test.

 

272

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): And when I used to teach at I would

 

273

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): tell my students qualitative.

 

274

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): The L is prominent, qualitative. So you're going to get a lettered result

 

275

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): meaning you're going to get like a positive negative reactive non-reactive.

 

276

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Those tests could be like a pregnancy test where it's going to be a positive test or a negative test.

 

277

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): it could be a rapid strep test where you're going to get a positive or a negative.

 

278

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): And this is just an example of how to log it in. And we got cold blood here, where it's saying positive or negative.

 

279

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Okay, next slide, please.

 

280

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): This is a quality control log showing quantitative test. And I used to my diddy for quantitative test is the end is prominent quantitative. So you're going to get a number

 

281

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): result.

 

282

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and that can be a glucose.

 

283

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): It could be

 

284

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Hemoglobin, hematocrit

 

285

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): or something that's gonna have a number.

 

286

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): Q.

 

287

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): It's showing a test. I can't make it out.

 

288

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): But it's showing you a test result that is numbered. And you want. Make sure you want to put the units here?

 

289

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): and like, I said, these are in the ready set test booklet. You can download the booklet and have access to the forms

 

290

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): next slide, please

 

291

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): the test result. Logs.

 

292

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): should be recorded. They should be legible and they should be completed

 

293

00:35:15.600 --> 00:35:24.550

Theresia Snelling, BS, MBA, MPM, MT(ASCP): filing all test result records in an organized easy to find manner, because you may have to go back and look something up later

 

294

00:35:25.600 --> 00:35:29.380

Theresia Snelling, BS, MBA, MPM, MT(ASCP): to assist several examples of blank

 

295

00:35:29.630 --> 00:35:33.510

Theresia Snelling, BS, MBA, MPM, MT(ASCP): template result. Logs are included for use

 

296

00:35:33.920 --> 00:35:35.840

Theresia Snelling, BS, MBA, MPM, MT(ASCP): at your testing site.

 

297

00:35:45.200 --> 00:35:46.420

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Okay.

 

298

00:35:47.040 --> 00:35:49.170

Theresia Snelling, BS, MBA, MPM, MT(ASCP): examples of

 

299

00:35:51.250 --> 00:35:57.880

Theresia Snelling, BS, MBA, MPM, MT(ASCP): patient result logs. And we both have. We have both the qualitative and the quantitative.

 

300

00:35:58.070 --> 00:36:01.999

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and they're in the booklet, so you can download them, and

 

301

00:36:02.190 --> 00:36:15.670

Theresia Snelling, BS, MBA, MPM, MT(ASCP): 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.

 

302

00:36:15.860 --> 00:36:18.710

Theresia Snelling, BS, MBA, MPM, MT(ASCP): you know your address and

 

303

00:36:19.610 --> 00:36:23.069

Theresia Snelling, BS, MBA, MPM, MT(ASCP): I think the lab director's name, the address

 

304

00:36:23.330 --> 00:36:31.689

Theresia Snelling, BS, MBA, MPM, MT(ASCP): the test that you're running, and the reportable or normal range. It should be on the log.

 

305

00:36:31.960 --> 00:36:35.779

Theresia Snelling, BS, MBA, MPM, MT(ASCP): If you have the advanced form of adobe, you should be able to

 

306

00:36:36.240 --> 00:36:39.199

Theresia Snelling, BS, MBA, MPM, MT(ASCP): put that on the form after you've downloaded it.

 

307

00:36:41.586 --> 00:36:43.609

Theresia Snelling, BS, MBA, MPM, MT(ASCP): The next page please

 

308

00:36:49.060 --> 00:36:50.520

Theresia Snelling, BS, MBA, MPM, MT(ASCP): result logs

 

309

00:36:50.700 --> 00:37:00.910

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and basically the same thing quantitative and qualitative test logs for. And I'm thinking, this is Qc.

 

310

00:37:01.180 --> 00:37:18.540

Theresia Snelling, BS, MBA, MPM, MT(ASCP): 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.

 

311

00:37:21.220 --> 00:37:23.670

Theresia Snelling, BS, MBA, MPM, MT(ASCP): okay, next slide, please.

 

312

00:37:24.660 --> 00:37:31.149

Theresia Snelling, BS, MBA, MPM, MT(ASCP): And this is an example of multiple test result. Logs.

 

313

00:37:32.600 --> 00:37:40.060

Theresia Snelling, BS, MBA, MPM, MT(ASCP): get with your facility and the regulatory agencies that oversee your site

 

314

00:37:40.450 --> 00:37:46.719

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and make sure this is something that you can use, but this makes it easy, like you could do.

 

315

00:37:47.540 --> 00:37:50.000

Theresia Snelling, BS, MBA, MPM, MT(ASCP): for like one day, if

 

316

00:37:50.190 --> 00:37:53.050

Theresia Snelling, BS, MBA, MPM, MT(ASCP): everything is on one bench you could put.

 

317

00:37:53.140 --> 00:37:58.959

Theresia Snelling, BS, MBA, MPM, MT(ASCP): 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.

 

318

00:37:59.910 --> 00:38:00.610

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Oh.

 

319

00:38:01.160 --> 00:38:06.019

Theresia Snelling, BS, MBA, MPM, MT(ASCP): but make sure it's a form that you can use. It is also in the book that you can download

 

320

00:38:06.440 --> 00:38:08.140

Theresia Snelling, BS, MBA, MPM, MT(ASCP): next slide, please.

 

321

00:38:10.490 --> 00:38:15.020

Theresia Snelling, BS, MBA, MPM, MT(ASCP): job aids and other wave testing results.

 

322

00:38:15.930 --> 00:38:20.130

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Okay, let's highlight a couple of them. Next slide, please.

 

323

00:38:21.270 --> 00:38:25.710

Theresia Snelling, BS, MBA, MPM, MT(ASCP): This is blood and body fluid exposure job aid.

 

324

00:38:25.750 --> 00:38:28.990

Theresia Snelling, BS, MBA, MPM, MT(ASCP): This is going to kind of talk you through.

 

325

00:38:30.700 --> 00:38:32.349

Theresia Snelling, BS, MBA, MPM, MT(ASCP): what you should do.

 

326

00:38:33.130 --> 00:38:35.600

Theresia Snelling, BS, MBA, MPM, MT(ASCP): It's standard precautions.

 

327

00:38:35.700 --> 00:38:38.610

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Cleaning up blood and body fluids

 

328

00:38:38.640 --> 00:38:44.560

Theresia Snelling, BS, MBA, MPM, MT(ASCP): always assume that whatever you're cleaning up is infectious, and act accordingly.

 

329

00:38:45.270 --> 00:38:54.929

Theresia Snelling, BS, MBA, MPM, MT(ASCP): To assist ready set test booklet includes blood and flow. But blood and body fluid exposure job aid

 

330

00:38:55.870 --> 00:38:59.270

Theresia Snelling, BS, MBA, MPM, MT(ASCP): which talks to you about what you should do and

 

331

00:39:01.420 --> 00:39:05.820

Theresia Snelling, BS, MBA, MPM, MT(ASCP): who you should notify, and all of that, if something happens.

 

332

00:39:10.010 --> 00:39:11.469

Theresia Snelling, BS, MBA, MPM, MT(ASCP): slide, please

 

333

00:39:13.070 --> 00:39:14.550

Theresia Snelling, BS, MBA, MPM, MT(ASCP): safety

 

334

00:39:15.850 --> 00:39:18.330

Theresia Snelling, BS, MBA, MPM, MT(ASCP): the A's. This is pretty much

 

335

00:39:18.370 --> 00:39:25.265

Theresia Snelling, BS, MBA, MPM, MT(ASCP): going to talk about putting your gloves on, taking them off,

 

336

00:39:26.040 --> 00:39:30.920

Theresia Snelling, BS, MBA, MPM, MT(ASCP): reducing contamination, preventing cross contamination.

 

337

00:39:30.950 --> 00:39:33.810

Theresia Snelling, BS, MBA, MPM, MT(ASCP): protecting you from infection.

 

338

00:39:34.300 --> 00:39:35.380

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and it

 

339

00:39:35.470 --> 00:39:37.240

Theresia Snelling, BS, MBA, MPM, MT(ASCP): assist with

 

340

00:39:38.040 --> 00:39:46.910

Theresia Snelling, BS, MBA, MPM, MT(ASCP): ensuring that staff understand safe glove use, and the the way to remove the gloves to

 

341

00:39:48.197 --> 00:39:52.729

Theresia Snelling, BS, MBA, MPM, MT(ASCP): kind of ensure you don't get infected from anything that may have

 

342

00:39:52.870 --> 00:39:55.040

Theresia Snelling, BS, MBA, MPM, MT(ASCP): come in contact with you gloves.

 

343

00:39:55.180 --> 00:39:57.260

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and that's in the booklet

 

344

00:39:58.590 --> 00:40:00.260

Theresia Snelling, BS, MBA, MPM, MT(ASCP): next slide, please.

 

345

00:40:03.540 --> 00:40:08.740

Theresia Snelling, BS, MBA, MPM, MT(ASCP): They're coming on disinfectant and antiseptic job aid.

 

346

00:40:08.950 --> 00:40:15.479

Theresia Snelling, BS, MBA, MPM, MT(ASCP): So this is going to talk to you about what you should use and how you should use it.

 

347

00:40:15.490 --> 00:40:24.910

Theresia Snelling, BS, MBA, MPM, MT(ASCP): It also gives you the formula for making up the Clorox bleach solution, which is a common disinfectant.

 

348

00:40:26.560 --> 00:40:31.360

Theresia Snelling, BS, MBA, MPM, MT(ASCP): I know the Cdc came out with this back in the eighties.

 

349

00:40:32.820 --> 00:40:35.913

Theresia Snelling, BS, MBA, MPM, MT(ASCP): dating myself now because we use this when

 

350

00:40:36.540 --> 00:40:47.330

Theresia Snelling, BS, MBA, MPM, MT(ASCP): When HIV and aids came out, and everybody was trying to figure out how to keep the counters and the lab equipment clean.

 

351

00:40:47.380 --> 00:40:50.089

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and it's 1 part

 

352

00:40:50.180 --> 00:40:51.300

Theresia Snelling, BS, MBA, MPM, MT(ASCP): bleach

 

353

00:40:51.580 --> 00:40:55.520

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and 9 parts water. You put it in a spray bottle, and

 

354

00:40:55.980 --> 00:40:57.610

Theresia Snelling, BS, MBA, MPM, MT(ASCP): it's good to go

 

355

00:41:01.030 --> 00:41:03.699

Theresia Snelling, BS, MBA, MPM, MT(ASCP): in the booklet so you can read further.

 

356

00:41:04.020 --> 00:41:05.670

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Next slide, please

 

357

00:41:08.000 --> 00:41:12.069

Theresia Snelling, BS, MBA, MPM, MT(ASCP): to test or not to test is a booklet

 

358

00:41:12.120 --> 00:41:17.120

Theresia Snelling, BS, MBA, MPM, MT(ASCP): just like ready set tests, but it's an an additional resource

 

359

00:41:17.350 --> 00:41:21.739

Theresia Snelling, BS, MBA, MPM, MT(ASCP): for individuals who want to implement and oversee

 

360

00:41:21.810 --> 00:41:23.680

Theresia Snelling, BS, MBA, MPM, MT(ASCP): waived, testing

 

361

00:41:23.690 --> 00:41:28.720

Theresia Snelling, BS, MBA, MPM, MT(ASCP): or offer new tests under a clear certificate of waiver

 

362

00:41:31.780 --> 00:41:34.119

Theresia Snelling, BS, MBA, MPM, MT(ASCP): to tester, not to test booklet.

 

363

00:41:34.930 --> 00:41:43.440

Theresia Snelling, BS, MBA, MPM, MT(ASCP): describes considerations and preparations needed prior to performing wave test.

 

364

00:41:43.590 --> 00:41:45.910

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Some of the topics in the book.

 

365

00:41:46.676 --> 00:41:49.809

Theresia Snelling, BS, MBA, MPM, MT(ASCP): overall, considerations for wave testing.

 

366

00:41:50.250 --> 00:42:00.630

Theresia Snelling, BS, MBA, MPM, MT(ASCP): testing, oversight requirements, regulatory requirements, testing location considerations, laboratory safety

 

367

00:42:00.760 --> 00:42:03.300

Theresia Snelling, BS, MBA, MPM, MT(ASCP): test selection, guidance.

 

368

00:42:03.670 --> 00:42:07.210

Theresia Snelling, BS, MBA, MPM, MT(ASCP): test personnel training and assessment

 

369

00:42:08.050 --> 00:42:10.670

Theresia Snelling, BS, MBA, MPM, MT(ASCP): instructions and procedures

 

370

00:42:10.830 --> 00:42:13.920

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and quality assessment options.

 

371

00:42:14.240 --> 00:42:21.439

Theresia Snelling, BS, MBA, MPM, MT(ASCP): A copy of this booklet can be downloaded from the link on this slide or links in the chat.

 

372

00:42:21.620 --> 00:42:24.519

Theresia Snelling, BS, MBA, MPM, MT(ASCP): and all of those things we just

 

373

00:42:24.530 --> 00:42:27.600

Theresia Snelling, BS, MBA, MPM, MT(ASCP): highlighted there. If there are

 

374

00:42:27.850 --> 00:42:35.519

Theresia Snelling, BS, MBA, MPM, MT(ASCP): job aids and forms, they'll be in the book, you can download them just like to test or not to test.

 

375

00:42:36.760 --> 00:42:40.030

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Next slide, please.

 

376

00:42:41.810 --> 00:42:43.450

Theresia Snelling, BS, MBA, MPM, MT(ASCP): In summary.

 

377

00:42:43.740 --> 00:42:50.199

Theresia Snelling, BS, MBA, MPM, MT(ASCP): ready set tests, educational materials, free resources, and job aids equipped

 

378

00:42:50.470 --> 00:42:55.929

Theresia Snelling, BS, MBA, MPM, MT(ASCP): the tester with good laboratory practices that help improve

 

379

00:42:55.960 --> 00:43:01.310

Theresia Snelling, BS, MBA, MPM, MT(ASCP): the quality of test results and enhance patient safety

 

380

00:43:02.070 --> 00:43:05.720

Theresia Snelling, BS, MBA, MPM, MT(ASCP): follow best practices when performing. Wave tests

 

381

00:43:05.830 --> 00:43:10.290

Theresia Snelling, BS, MBA, MPM, MT(ASCP): allows follow always follow the manufacturers.

 

382

00:43:10.550 --> 00:43:11.960

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Instructions

 

383

00:43:13.210 --> 00:43:19.550

Theresia Snelling, BS, MBA, MPM, MT(ASCP): record test results accurately and according to testing site policy

 

384

00:43:19.740 --> 00:43:22.140

Theresia Snelling, BS, MBA, MPM, MT(ASCP): for reporting results

 

385

00:43:22.910 --> 00:43:31.980

Theresia Snelling, BS, MBA, MPM, MT(ASCP): when problems occur. During the testing process document, the problem report to the person who oversees or directs testing

 

386

00:43:32.720 --> 00:43:40.360

Theresia Snelling, BS, MBA, MPM, MT(ASCP): in the event of questionable lab results. Repeat the test with a new sample

 

387

00:43:40.440 --> 00:43:41.930

Theresia Snelling, BS, MBA, MPM, MT(ASCP): if required.

 

388

00:43:42.580 --> 00:43:45.120

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Ready set test checklist

 

389

00:43:45.320 --> 00:43:50.459

Theresia Snelling, BS, MBA, MPM, MT(ASCP): testing logs and job aids are available for use

 

390

00:43:50.710 --> 00:43:51.640

Theresia Snelling, BS, MBA, MPM, MT(ASCP): at

 

391

00:43:51.860 --> 00:43:53.759

Theresia Snelling, BS, MBA, MPM, MT(ASCP): all your testing sites

 

392

00:43:55.630 --> 00:43:57.210

Theresia Snelling, BS, MBA, MPM, MT(ASCP): next slide, please.

 

393

00:43:59.890 --> 00:44:03.230

Theresia Snelling, BS, MBA, MPM, MT(ASCP): We're gonna open it up for questions.

 

394

00:44:04.710 --> 00:44:05.830

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Thank you.

 

395

00:44:07.740 --> 00:44:09.900

Alicia Branch, PhD: Thank you, Teresa and Amanda

 

396

00:44:09.960 --> 00:44:13.130

Alicia Branch, PhD: Amanda. If you could come back on screen, it'll be

 

397

00:44:13.320 --> 00:44:14.830

Alicia Branch, PhD: for Q. And A.

 

398

00:44:15.650 --> 00:44:21.599

Alicia Branch, PhD: We'll take a few minutes to answer as many questions as possible. If we do not get to your question today.

 

399

00:44:21.820 --> 00:44:41.110

Alicia Branch, PhD: feel free to email us@onelabatcdc.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.

 

400

00:44:42.400 --> 00:44:45.379

Alicia Branch, PhD: So let's go with the 1st question.

 

401

00:44:48.323 --> 00:44:49.589

Alicia Branch, PhD: They say.

 

402

00:44:50.750 --> 00:44:56.429

Alicia Branch, PhD: How often should you record the temperature only once in a day, or

 

403

00:44:57.100 --> 00:45:01.080

Alicia Branch, PhD: can we monitor the morning, app and afternoon and evening.

 

404

00:45:01.440 --> 00:45:04.920

Alicia Branch, PhD: so I guess a content of a continuous kind of monitoring.

 

405

00:45:07.970 --> 00:45:09.689

Alicia Branch, PhD: I don't know who wants to answer.

 

406

00:45:12.210 --> 00:45:23.199

Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

407

00:45:23.310 --> 00:45:37.829

Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

408

00:45:37.870 --> 00:45:43.460

Amanda Johnson, MHSc., MLS(ASCP)CM: it's probably a good practice to keep an eye on like room temperature just in case it's fluctuating.

 

409

00:45:43.890 --> 00:45:44.530

Amanda Johnson, MHSc., MLS(ASCP)CM: So.

 

410

00:45:47.340 --> 00:45:48.360

Alicia Branch, PhD: Let's see.

 

411

00:45:49.710 --> 00:46:02.969

Alicia Branch, PhD: 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

 

412

00:46:03.200 --> 00:46:05.719

Alicia Branch, PhD: all have different lot numbers.

 

413

00:46:06.930 --> 00:46:11.669

Alicia Branch, PhD: So I guess this is when you're trying to log log all of this information in.

 

414

00:46:11.850 --> 00:46:15.220

Alicia Branch, PhD: and I'm assuming your question is, what should you do.

 

415

00:46:23.080 --> 00:46:24.399

Theresia Snelling, BS, MBA, MPM, MT(ASCP): And probably

 

416

00:46:24.460 --> 00:46:27.660

Theresia Snelling, BS, MBA, MPM, MT(ASCP): log all of the lot numbers.

 

417

00:46:30.350 --> 00:46:31.290

Theresia Snelling, BS, MBA, MPM, MT(ASCP): Yeah.

 

418

00:46:31.940 --> 00:46:34.710

Theresia Snelling, BS, MBA, MPM, MT(ASCP): if they all came in the same kit.

 

419

00:46:37.840 --> 00:46:39.220

Alicia Branch, PhD: Yeah. And so

 

420

00:46:39.930 --> 00:46:41.430

Alicia Branch, PhD: there's a there's a

 

421

00:46:41.490 --> 00:46:44.263

Alicia Branch, PhD: this is a great question to ask.

 

422

00:46:44.790 --> 00:46:54.649

Alicia Branch, PhD: can you replace the components of a test kit like the swabs. Or if there's something happens, and you need to. Do, you know, replace something that's in a kit. Can you do that?

 

423

00:47:00.370 --> 00:47:03.685

Amanda Johnson, MHSc., MLS(ASCP)CM: I can take that one so no.

 

424

00:47:04.350 --> 00:47:13.649

Amanda Johnson, MHSc., MLS(ASCP)CM: 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.

 

425

00:47:13.730 --> 00:47:21.500

Amanda Johnson, MHSc., MLS(ASCP)CM: 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

 

426

00:47:21.650 --> 00:47:26.640

Amanda Johnson, MHSc., MLS(ASCP)CM: some tests and test systems have where you can order additional swabs.

 

427

00:47:26.943 --> 00:47:41.320

Amanda Johnson, MHSc., MLS(ASCP)CM: 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 wanna make sure you're using what's in the test, Kit, or what's in the manufacturer's instructions that you can use.

 

428

00:47:43.730 --> 00:47:45.620

Alicia Branch, PhD: This is a good one also.

 

429

00:47:45.820 --> 00:47:58.100

Alicia Branch, PhD: Do we have? Do we have to establish our own Qc limits for all control levels? Or is it acceptable. Follow simple, simply the manufacturers. Qc. Limits for wave test.

 

430

00:48:04.110 --> 00:48:06.310

Alicia Branch, PhD: I can read again if you, if you didn't.

 

431

00:48:07.140 --> 00:48:09.146

Amanda Johnson, MHSc., MLS(ASCP)CM: I was, I was gonna go ahead and answer

 

432

00:48:09.650 --> 00:48:10.210

Alicia Branch, PhD: Go ahead!

 

433

00:48:10.870 --> 00:48:17.839

Amanda Johnson, MHSc., MLS(ASCP)CM: Yeah. So for wave tests, you can follow the manufacturer's instructions. You don't have to establish Qc limits.

 

434

00:48:19.180 --> 00:48:26.799

Amanda Johnson, MHSc., MLS(ASCP)CM: Now, when you get over into non wave. That's something different. But for wave tests the manufacturer's instruction is instructions. Is your guide.

 

435

00:48:27.400 --> 00:48:32.143

Alicia Branch, PhD: We're gonna stay. We're gonna stay test, and we'll leave that one for network.

 

436

00:48:32.730 --> 00:48:33.180

Amanda Johnson, MHSc., MLS(ASCP)CM: Right.

 

437

00:48:35.350 --> 00:48:39.269

Alicia Branch, PhD: are external controls only required per lot

 

438

00:48:39.470 --> 00:48:40.580

Alicia Branch, PhD: or

 

439

00:48:40.660 --> 00:48:45.640

Alicia Branch, PhD: every open box, even if we already tested that lot.

 

440

00:48:47.760 --> 00:48:56.999

Alicia Branch, PhD: So they want to know if if the external controls are only required per lot or every open box, even if you already tested that lot.

 

441

00:49:06.520 --> 00:49:06.950

Amanda Johnson, MHSc., MLS(ASCP)CM: Oh, yeah.

 

442

00:49:06.950 --> 00:49:11.179

Theresia Snelling, BS, MBA, MPM, MT(ASCP): The external. Did the external controls come with the Kit

 

443

00:49:11.250 --> 00:49:12.389

Theresia Snelling, BS, MBA, MPM, MT(ASCP): cause it?

 

444

00:49:12.450 --> 00:49:16.380

Theresia Snelling, BS, MBA, MPM, MT(ASCP): I know, for wave testing. You usually have the controls

 

445

00:49:16.510 --> 00:49:17.930

Theresia Snelling, BS, MBA, MPM, MT(ASCP): with the kit.

 

446

00:49:19.640 --> 00:49:20.590

Alicia Branch, PhD: Yeah.

 

447

00:49:22.200 --> 00:49:29.189

Alicia Branch, PhD: So I'm I'm not gonna try to assume what they're they're asking. So whomever put this question in feel free to.

 

448

00:49:29.750 --> 00:49:31.040

Alicia Branch, PhD: I kind of clear, I think.

 

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Danisha M. Rivera Nazario, PhD: Perhaps take this one real quick.

 

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Danisha M. Rivera Nazario, PhD: So I would recommend following your manufacturer's instructions.

 

451

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Danisha M. Rivera Nazario, PhD: perhaps you will find information about, you know, testing, you know.

 

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Danisha M. Rivera Nazario, PhD: additional test kits from the same lot. So I would refer to my manufacturer's instructions.

 

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Danisha M. Rivera Nazario, PhD: 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.

 

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Alicia Branch, PhD: Okay. They they did say, yes. The box did come with the external controls.

 

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Alicia Branch, PhD: We'll take 2 more questions, and then I'll turn it back over

 

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Alicia Branch, PhD: to you, Meredith.

 

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Alicia Branch, PhD: How long should you keep the patient records.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: So typically patient records are kept for at least 2 years. But for some in some States, and for some specific tests there may be different requirements.

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: So I would recommend in this case to always check with you, like your local or your State Public Health Department

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: or if you are under accreditation organization. Check with them

 

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Amanda Johnson, MHSc., MLS(ASCP)CM: before you discard anything, and for you know, exact record retention, guidelines.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): And just for

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): an example.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): I do know that pediatric specimens are usually kept

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): like until the child is either 18 or 21.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): So if you're a pediatric facility, make sure you check with

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): your lab manager or the person in charge of testing before you get rid of your lab results

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): for surgical

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): testing. If someone's having surgery, I doubt if waived tests are going to be used for a patient going to surgery.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): But if that is the case.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): I don't know. A lot of surgery requirements are that you keep results for 5 to 7 years.

 

472

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): So you really have to

 

473

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): check with your facility.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): if it's just, you know, an adult record, you're going to your doctor. And

 

475

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): then, yeah, those those records are typically 2 years.

 

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Theresia Snelling, BS, MBA, MPM, MT(ASCP): But make sure you check with your facility.

 

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Danisha M. Rivera Nazario, PhD: And just to add, you know, as for clear, you know, record keeping requirements. Patient records should be retained for at least 2 years. However.

 

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Danisha M. Rivera Nazario, PhD: state regulation may have longer retention periods, so it it will be a good practice to review not only the clia requirements, but also your state requirements. When you're establishing retention.

 

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Danisha M. Rivera Nazario, PhD: policies in your facilities.

 

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Alicia Branch, PhD: Alright. Thank you so much, Amanda and Teresa, Teresa.

 

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Alicia Branch, PhD: and I'll turn it back over to you, Meredith.

 

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Meredith Reagan: Sounds good. Thank you, Alicia. So I'll get us wrapped up today.

 

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Meredith Reagan: so thank you very much. Again to our presenters, Amanda and Teresa. I really appreciate the insights and your presentations.

 

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Meredith Reagan: 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.

 

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Meredith Reagan: One lab is very feedback driven we wanna hear about your training needs and any thoughts you have about this session or other sessions you may have participated in. We do use your input to select topics

 

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Meredith Reagan: for future events, and to better understand the needs of this testing community.

 

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Meredith Reagan: And if you are looking to obtain pace, credit, and a certificate from this event, we encourage you to complete the ready set test. E-learning course.

 

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Meredith Reagan: That link is in the chat as well, and

 

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Meredith Reagan: we will share the QR code on the screen. So you can scan that with your phone and be directed to the course. And just as a reminder, we do post the slides for this presentation and any relevant links, and those will be posted on

 

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Meredith Reagan: one lab 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.