/Metadata 132 0 R/Outlines 299 0 R/PageLayout/OneColumn/Pages 4479 0 R/StructTreeRoot 362 0 R/Type/Catalog>> endobj 4487 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 4488 0 obj <>stream Photos displayed are for illustrative purposes only. a. ID NOW delivers results in minutes where they're needed most during COVID-19. DOCX Abbott BinaxNOW Testing Competency - Training Checklist Notification to CMS and yourclinic accrediting organizationof intent to perform COVID-19 testing using the Abbott ID NOW analyzer under the FDA EUA for COVID-19. Point Of Care Forms - Bassett Healthcare Network Clinical Laboratories The purpose of the study is to evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19device to detect SARS-CoV-2 infection among children aged 0-<18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as . The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. RXqGfhdP)bkfhp.F!0!\ % d,W+EB9,g053051%2973b[2 wg Hi@ (n@Z(13~?V@1& For full functionality of this site it is necessary to enable JavaScript. %PDF-1.5 % COVID-19 Product Insert. Here are the instructions how to enable JavaScript in your web browser. %PDF-1.5 % PDF VERSION - Federal Bureau of Prisons This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Abbott ID Now - Training/Orientation Trainee: Date of Training: Test Name: COVID-19/SARS CoV-2 : Trainer: This document is used to verify that the Trainee responsible for running the COVD-19 test has reviewed the Online Training modules and received sufficient training to include the following: lcKjs.&g$=HP^CGB*oWSXu4V?Tjilp?yTT)#JL-dyB~&%fomy:qIJ. They have higher throughput <> Preform a Quality Control Test and/or patient test on self/coworker with Super User Supervision 8. ` ` ` ` ` t t t 8 8 t CP 4 J ( r r r > O O O O O O O Q T O ` O ` ` r r 4 O ! 4485 0 obj <> endobj PDF Policy and Procedure 3. Review of Abbott ID NOW Pre- and Post- Test Information for Clients Document 4. Review Abbott ID NOW COVID -19 POCT Assessment Form for COVID-19- Symptomatic testing document 5. 1. SIZE OF A TOASTER. Determine HIV-1/2 Ag/Ab Combo. Search for condition information or for a specific treatment program. The ID NOW test has emerged as a critical part of the fight against COVID-19, allowing fast diagnosis with results in minutes. The ID NOW platform combines the benefits of speed and accuracy for the fastest molecular results in the market. <>>> et al. What does this mean? POC Maintenance Record : 2/13/2023: POC Regional Health Centers and Tests Chart. a. Learn about the many ways you can get involved and support Mass General. RAPID TESTING CAN GET PEOPLE THE RIGHT TREATMENT. As long as the barcode on the ID band scans, it is acceptable to use for testing. A Leader in Rapid Point-of-Care Diagnostics. The Abbott ID NOW is an example of a mobile molecular POC device for COVID -19. The portable, rapid molecular ID NOW COVID-19 test has emerged as a critical part of this arsenal, allowing fast diagnosis with results in 13 minutes or less in a variety of locations such as physicians' offices, urgent care clinics and other point-of-care locations. There are templatesin the, Competency frequency: Initial training, 6-months, and annually thereafter. The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. They have been authorized by the FDA under an emergency use authorization for use by authorized laboratories. At Physicians Immediate Care, ID NOW helps them slow the spread of COVID-19. Abbott requires new usersto perform 1 positive and 1 negative/blank test controls prior to testing. b. We use cookies and other tools to enhance your experience on our website and 112 No. Isolation Precautions in Healthcare Settings 798 0 obj <> endobj Customer uses existing API to pull data into customer LIS/EHR where applicable hb```b``Ve`e``efd@ A+E- Based on your current location, the content on this page may not be relevant for your country. Larger POC platforms, such as the Cepheid GeneXpert Xpress, another example of a POC device that can be used for COVID -19, are often based in hospitals and medical centers. Insert the (+) or (-) control swab into BOTTOM HOLE and firmly push upwards so that the swab tip is visible in the TOP HOLE. 193 0 obj <>stream <8uFy6]Z+4\``wty/YPXQ.Fy5*Wv=?iC{u^nje(}a,_oMp1=;g=P#g|NerC?[=[2UraNy6?S\0CI~'+xMy5 IN REAL WORLD TESTING, ID NOW ACCURATE, RELIABLE. POC I-STAT Training/Competency Checklist: 4/15/2021: POC Bassett Clinics and Tests Chart. This test has been authorized by FDA under an EUA for use by authorized laboratories. 1. . A Leader in Rapid Point-of-Care Diagnostics. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Standard Universal Precautions should be adhered toat all times, Office of Clinical and Preventive Services - 08N34 A&B, Office of the Director/Congressional and Legislative Affairs Staff - 08E37A, Office of the Director/Diversity Management and Equal Employment Opportunity Staff - 08E61, Office of the Director/Executive Secretariat Staff - 08E86, Office of the Director/Public Affairs Staff - 08E73, Office of Direct Service and Contracting Tribes - 08E17, Office of Environmental Health and Engineering - 10N14C, Office of Information Technology - 07E57B, Office of Resource Access and Partnerships - 10E85C, Office of Urban Indian Health Programs - 08E65C, U.S. Department of Health and Human Services, Exit Disclaimer: You Are Leaving www.ihs.gov, National Laboratory Professionals Council (NLPC), 120006456 v01 ID NOW COVID-19 CLSI More Packet, Shared templates - SOP, Training, and other implementation documents, Occupational Safety and Health Administration (OSHA), MMWR Good Laboratory Practices for CLIAWaived sites, 120004872 v04 ID NOW Performance Best Practices, Abbott ID NOW COVID19 Test Validation Form, COVID 19 Competency Assessment Mod High Complex, SCRSDS-0196 v4 Alere and ID NOW Positive and Negative Controls, SCRSDS-0275 v1 ID NOW COVID-19 Test Base SDS-US, TB000041 v1.0 Important Product Notice ID NOW COVID, Barcode Label COVID_19 QC Patients Results Log, ID NOW COVID-19 Technical Brief April 2020-Sample Type Labeling UpdateV2, SCRSDS-0274 v1 ID NOW COVID-19 Elution Buffer SDS-US. The tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Risk Assessment. Learn about career opportunities, search for positions and apply for a job. Rotate (twirl) swab shaft 3 times CLOCKWISE (to the right). 2 0 obj RALS LiNK - Abbott ID NOW COVID-19 | Abbott Point of Care Let us help you navigate your in-person or virtual visit to Mass General. At Physician's Immediate Care, same high confidence in accuracy of results. This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada. MoreCDC guidelinesfor COVID-19 can be found using the following links. Abbott - A Leader in Rapid Point-of-Care Diagnostics. 884 0 obj <>stream 21. (2003) Impact of the Rapid Diagnosis of Influenza on Physician Decision-Making and Patient Management in the Pediatric Emergency Department: Results of a Randomized, Prospective, Controlled Trial. Reliable test results depend on many factors, conformity to test design. 10/19/2020. Positive and Negative Control Swabs. POC:Piccolo Electrolyte Panel Reagent/QC Log: . We have remained at the forefront of medicine by fostering a culture of collaboration, pushing the boundaries of medical research, educating the brightest medical minds and maintaining an unwavering commitment to the diverse communities we serve. Competency must be verified by competent trainer, by performing the testing procedure outlined by Abbott. Specimen handling and collection training 7. ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. The ID NOW COVID-19 rapid test delivers high-quality molecular positive results in as little as 5 minutes, targeting the coronavirus (COVID-19) RdRp Gene. Copyright 2007-2023. How TO USE SOLUTION If surfaces are dirty, they should first be cleaned with detergent or soap and waterprior to disinfection with HALT solution. FACT SHEET FOR HEALTHCARE PROVIDERS - Food and Drug Administration Ensure your site has a valid CLIA ceritificate on file. Template log sheetscan be found under the Abbott IFU, Test Product Insert, CLSI folder >, Training of all users on the Abbott ID NOW analyzer using the 8 modules provided by Abbott, Competency of individuals need to be assessed using the appropriate requirements per your CLIA certificate, accrediting organizational requirements and/or local policyrequirements. Information for Laboratories Do not remove swab. ID NOW: THE FOREFRONT OF COVID-19 TESTING. Laboratory Biosafety ID NOW COVID-19 2.0. hb```b``Vb`e``fd@ A+&fZlU7. %PDF-1.5 Sites would need to ensure the following steps are completed prior to use of the Abbott ID NOW analyzer for patient testing of COVID-19: For diagnostic testing of specimens conducted outside of a BSL-2 laboratory, such as rapid respiratory testing performed at the point of care, use Standard Precautions to provide a barrier between the specimen and personnel during specimen manipulation. Title: Abbott ID Now Competency Assessment Effective date: 29/10/2022 Author: A. Bromley Checked by: M. Ribeiro Approved by: M. Ribeiro Page 1 of 1 Title: COPY Laboratory Requirements | COVID-19 - Laboratory Medicine *For Product Labeling documents, such as the Package Insert, Quick Reference Guide, SDS sheets and CLSI documents, please visit our e-IFU website. DOC COPY - Royal United Hospital PDF Abbott ID NOW - Training Procedure for Symptomatic Testing - Yukon Testing location should be reviewed to ensure minimal traffic for testing location, separate room if possible, location should be near asink and eyewashstation. REDUCING RISK BY DIAGNOSING WITH RELIABLE RAPID TEST. Peel off adhesive liner from the right edge of the test card. PPE training 6. PERC Health Canada COVID-19 - Full Text View - ClinicalTrials.gov (BLUE) and G3+ (BLUE) are now considered high complexity tests due to lack of FDA categorization. Contact Sales Technical Support Overview Benefits Helpful Documents Why is it important to make sure the patient ID band is replaced when a patient is transferred in from other facility? OVERVIEW; FINANCIALS; STOCK INFO; . PDF FACT SHEET: Implementation of Abbott ID NOW COVID-19 - APHL c. Send the completed POC Corrected Report Form to the lab. Competency Exam Initial Competency Semi-annual Competency Annual Competency (CY: _____) Follow up This exam is to be performed upon Initial Orientation & Training and Competency; twice in the first year of practice; and annually thereafter. Microtech Star Wars Collection, Cartier Juste Un Clou Ring Small Vs Regular, Abandoned Farms In Michigan For Sale, Why Don't I Like Being Touched By My Family, Articles A
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April 9, 2023
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abbott id now competency assessment

Here are the instructions how to enable JavaScript in your web browser, One Abbott solution for patient testing, result capture and data reporting, Isolation Precautions in Healthcare Settings, Emergency Use Authorization of Medical Products and Related Authorities. Explore fellowships, residencies, internships and other educational opportunities. b. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area. %%EOF Please see ID NOW Instrument User manual for additional operating environment requirements. Find out more about this innovative technology and its impact here. The General Hospital Corporation. stream %%EOF Z{sB[u.j(t\G#Hu F+Aal+ 5N# J FzPxT, JdA5dr.u+%c6l+"jQP) #u(FJ #uVDHi"zDLQyhE.3 &ztxFJ)1`l5td#z$ z%HJG R{8djdlRg U]S[W_PX"YHE.ud]$"YH6E)MldS$"gdF3\|NMVEw^:&V?jr+8^"MB"r;*i(. POC Abbott ID Now QC Log: 2/18/2021: POC HemoCue Hgb QC Log (Form will be sent by POC with QC Material.) Updated as of 12/08/2022 . 2/27/2020. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. Point-of-care tests are critical to help fight the novel coronavirus pandemic. For procedures with a high likelihood to generate aerosols or droplets, use either a certified Class II Biological Safety Cabinet (BSC)oradditional precautions to provide a barrier between the specimen and personnel. US Centers for Disease Control (CDC) Coronavirus (COVID-19) Webpages endstream endobj 4486 0 obj <>/Metadata 132 0 R/Outlines 299 0 R/PageLayout/OneColumn/Pages 4479 0 R/StructTreeRoot 362 0 R/Type/Catalog>> endobj 4487 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 4488 0 obj <>stream Photos displayed are for illustrative purposes only. a. ID NOW delivers results in minutes where they're needed most during COVID-19. DOCX Abbott BinaxNOW Testing Competency - Training Checklist Notification to CMS and yourclinic accrediting organizationof intent to perform COVID-19 testing using the Abbott ID NOW analyzer under the FDA EUA for COVID-19. Point Of Care Forms - Bassett Healthcare Network Clinical Laboratories The purpose of the study is to evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19device to detect SARS-CoV-2 infection among children aged 0-<18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as . The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. RXqGfhdP)bkfhp.F!0!\ % d,W+EB9,g053051%2973b[2 wg Hi@ (n@Z(13~?V@1& For full functionality of this site it is necessary to enable JavaScript. %PDF-1.5 % COVID-19 Product Insert. Here are the instructions how to enable JavaScript in your web browser. %PDF-1.5 % PDF VERSION - Federal Bureau of Prisons This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Abbott ID Now - Training/Orientation Trainee: Date of Training: Test Name: COVID-19/SARS CoV-2 : Trainer: This document is used to verify that the Trainee responsible for running the COVD-19 test has reviewed the Online Training modules and received sufficient training to include the following: lcKjs.&g$=HP^CGB*oWSXu4V?Tjilp?yTT)#JL-dyB~&%fomy:qIJ. They have higher throughput <> Preform a Quality Control Test and/or patient test on self/coworker with Super User Supervision 8. ` ` ` ` ` t t t 8 8 t CP 4 J ( r r r > O O O O O O O Q T O ` O ` ` r r 4 O ! 4485 0 obj <> endobj PDF Policy and Procedure 3. Review of Abbott ID NOW Pre- and Post- Test Information for Clients Document 4. Review Abbott ID NOW COVID -19 POCT Assessment Form for COVID-19- Symptomatic testing document 5. 1. SIZE OF A TOASTER. Determine HIV-1/2 Ag/Ab Combo. Search for condition information or for a specific treatment program. The ID NOW test has emerged as a critical part of the fight against COVID-19, allowing fast diagnosis with results in minutes. The ID NOW platform combines the benefits of speed and accuracy for the fastest molecular results in the market. <>>> et al. What does this mean? POC Maintenance Record : 2/13/2023: POC Regional Health Centers and Tests Chart. a. Learn about the many ways you can get involved and support Mass General. RAPID TESTING CAN GET PEOPLE THE RIGHT TREATMENT. As long as the barcode on the ID band scans, it is acceptable to use for testing. A Leader in Rapid Point-of-Care Diagnostics. The Abbott ID NOW is an example of a mobile molecular POC device for COVID -19. The portable, rapid molecular ID NOW COVID-19 test has emerged as a critical part of this arsenal, allowing fast diagnosis with results in 13 minutes or less in a variety of locations such as physicians' offices, urgent care clinics and other point-of-care locations. There are templatesin the, Competency frequency: Initial training, 6-months, and annually thereafter. The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. They have been authorized by the FDA under an emergency use authorization for use by authorized laboratories. At Physicians Immediate Care, ID NOW helps them slow the spread of COVID-19. Abbott requires new usersto perform 1 positive and 1 negative/blank test controls prior to testing. b. We use cookies and other tools to enhance your experience on our website and 112 No. Isolation Precautions in Healthcare Settings 798 0 obj <> endobj Customer uses existing API to pull data into customer LIS/EHR where applicable hb```b``Ve`e``efd@ A+E- Based on your current location, the content on this page may not be relevant for your country. Larger POC platforms, such as the Cepheid GeneXpert Xpress, another example of a POC device that can be used for COVID -19, are often based in hospitals and medical centers. Insert the (+) or (-) control swab into BOTTOM HOLE and firmly push upwards so that the swab tip is visible in the TOP HOLE. 193 0 obj <>stream <8uFy6]Z+4\``wty/YPXQ.Fy5*Wv=?iC{u^nje(}a,_oMp1=;g=P#g|NerC?[=[2UraNy6?S\0CI~'+xMy5 IN REAL WORLD TESTING, ID NOW ACCURATE, RELIABLE. POC I-STAT Training/Competency Checklist: 4/15/2021: POC Bassett Clinics and Tests Chart. This test has been authorized by FDA under an EUA for use by authorized laboratories. 1. . A Leader in Rapid Point-of-Care Diagnostics. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Standard Universal Precautions should be adhered toat all times, Office of Clinical and Preventive Services - 08N34 A&B, Office of the Director/Congressional and Legislative Affairs Staff - 08E37A, Office of the Director/Diversity Management and Equal Employment Opportunity Staff - 08E61, Office of the Director/Executive Secretariat Staff - 08E86, Office of the Director/Public Affairs Staff - 08E73, Office of Direct Service and Contracting Tribes - 08E17, Office of Environmental Health and Engineering - 10N14C, Office of Information Technology - 07E57B, Office of Resource Access and Partnerships - 10E85C, Office of Urban Indian Health Programs - 08E65C, U.S. Department of Health and Human Services, Exit Disclaimer: You Are Leaving www.ihs.gov, National Laboratory Professionals Council (NLPC), 120006456 v01 ID NOW COVID-19 CLSI More Packet, Shared templates - SOP, Training, and other implementation documents, Occupational Safety and Health Administration (OSHA), MMWR Good Laboratory Practices for CLIAWaived sites, 120004872 v04 ID NOW Performance Best Practices, Abbott ID NOW COVID19 Test Validation Form, COVID 19 Competency Assessment Mod High Complex, SCRSDS-0196 v4 Alere and ID NOW Positive and Negative Controls, SCRSDS-0275 v1 ID NOW COVID-19 Test Base SDS-US, TB000041 v1.0 Important Product Notice ID NOW COVID, Barcode Label COVID_19 QC Patients Results Log, ID NOW COVID-19 Technical Brief April 2020-Sample Type Labeling UpdateV2, SCRSDS-0274 v1 ID NOW COVID-19 Elution Buffer SDS-US. The tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Risk Assessment. Learn about career opportunities, search for positions and apply for a job. Rotate (twirl) swab shaft 3 times CLOCKWISE (to the right). 2 0 obj RALS LiNK - Abbott ID NOW COVID-19 | Abbott Point of Care Let us help you navigate your in-person or virtual visit to Mass General. At Physician's Immediate Care, same high confidence in accuracy of results. This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada. MoreCDC guidelinesfor COVID-19 can be found using the following links. Abbott - A Leader in Rapid Point-of-Care Diagnostics. 884 0 obj <>stream 21. (2003) Impact of the Rapid Diagnosis of Influenza on Physician Decision-Making and Patient Management in the Pediatric Emergency Department: Results of a Randomized, Prospective, Controlled Trial. Reliable test results depend on many factors, conformity to test design. 10/19/2020. Positive and Negative Control Swabs. POC:Piccolo Electrolyte Panel Reagent/QC Log: . We have remained at the forefront of medicine by fostering a culture of collaboration, pushing the boundaries of medical research, educating the brightest medical minds and maintaining an unwavering commitment to the diverse communities we serve. Competency must be verified by competent trainer, by performing the testing procedure outlined by Abbott. Specimen handling and collection training 7. ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. The ID NOW COVID-19 rapid test delivers high-quality molecular positive results in as little as 5 minutes, targeting the coronavirus (COVID-19) RdRp Gene. Copyright 2007-2023. How TO USE SOLUTION If surfaces are dirty, they should first be cleaned with detergent or soap and waterprior to disinfection with HALT solution. FACT SHEET FOR HEALTHCARE PROVIDERS - Food and Drug Administration Ensure your site has a valid CLIA ceritificate on file. Template log sheetscan be found under the Abbott IFU, Test Product Insert, CLSI folder >, Training of all users on the Abbott ID NOW analyzer using the 8 modules provided by Abbott, Competency of individuals need to be assessed using the appropriate requirements per your CLIA certificate, accrediting organizational requirements and/or local policyrequirements. Information for Laboratories Do not remove swab. ID NOW: THE FOREFRONT OF COVID-19 TESTING. Laboratory Biosafety ID NOW COVID-19 2.0. hb```b``Vb`e``fd@ A+&fZlU7. %PDF-1.5 Sites would need to ensure the following steps are completed prior to use of the Abbott ID NOW analyzer for patient testing of COVID-19: For diagnostic testing of specimens conducted outside of a BSL-2 laboratory, such as rapid respiratory testing performed at the point of care, use Standard Precautions to provide a barrier between the specimen and personnel during specimen manipulation. Title: Abbott ID Now Competency Assessment Effective date: 29/10/2022 Author: A. Bromley Checked by: M. Ribeiro Approved by: M. Ribeiro Page 1 of 1 Title: COPY Laboratory Requirements | COVID-19 - Laboratory Medicine *For Product Labeling documents, such as the Package Insert, Quick Reference Guide, SDS sheets and CLSI documents, please visit our e-IFU website. DOC COPY - Royal United Hospital PDF Abbott ID NOW - Training Procedure for Symptomatic Testing - Yukon Testing location should be reviewed to ensure minimal traffic for testing location, separate room if possible, location should be near asink and eyewashstation. REDUCING RISK BY DIAGNOSING WITH RELIABLE RAPID TEST. Peel off adhesive liner from the right edge of the test card. PPE training 6. PERC Health Canada COVID-19 - Full Text View - ClinicalTrials.gov (BLUE) and G3+ (BLUE) are now considered high complexity tests due to lack of FDA categorization. Contact Sales Technical Support Overview Benefits Helpful Documents Why is it important to make sure the patient ID band is replaced when a patient is transferred in from other facility? OVERVIEW; FINANCIALS; STOCK INFO; . PDF FACT SHEET: Implementation of Abbott ID NOW COVID-19 - APHL c. Send the completed POC Corrected Report Form to the lab. Competency Exam Initial Competency Semi-annual Competency Annual Competency (CY: _____) Follow up This exam is to be performed upon Initial Orientation & Training and Competency; twice in the first year of practice; and annually thereafter.

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abbott id now competency assessment

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abbott id now competency assessment

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