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Includes a legal and compliance disclaimer, guidance on editing customizable sections, and accountability requirements for drafting, review, approval, signatures, and change history. Provides a structured Table of Contents covering method principles, intended use, limitations, general policies, quality assurance and control, patient testing workflow, result interpretation, troubleshooting, software/connectivity, advanced tools, maintenance, calibration, cleaning, and analyzer self-check/auto adjustment.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/cobas-sars-cov-2-influenza-ab-policies-and-procedures-manual/164480/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/cobas-sars-cov-2-influenza-ab-policies-and-procedures-manual/164480.png","ImageObject",442,249,{"name":88,"@type":89},"Aurelia","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-19","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":73},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of this policies and procedures manual template?","Question",{"text":108,"@type":109},"It provides sample policies and procedures to help develop a comprehensive manual for using the cobas® Liat® System in a facility.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Who is responsible for composing, maintaining, and approving the procedures?",{"text":113,"@type":109},"The responsibility lies with the specified department staff position, and the Director must approve, sign, and date the manual when placed in use and annually thereafter.",{"name":115,"@type":106,"acceptedAnswer":116},"What areas are covered for quality assurance and testing operations?",{"text":117,"@type":109},"The template includes quality assurance, quality control testing (including external quality control and general quality control policies), patient testing steps, and guidance for viewing/interpreting results and troubleshooting.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},164480,1788154006,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":73,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":125,"read_time":20},1099514068365,"https://ap-avatar.wpscdn.com/avatar/10000253d8d9f28188e?_k=1776742907772140068","Sample Template\nfor cobas® SARS-CoV-2 & Influenza A/B\nPolicies and Procedures Manual\nFor use with the cobas® Liat® System\nDisclaimer\nThe content of this document is intended only as a guide to assist you in developing a comprehensive policies and procedures manual. This is an optional auxiliary tool. It reflects the current reagent package inserts and instrument operator’s manual for the product at the time of publication. Additional cobas® Liat® System usage information, which resides in bulletins, updated manuals/package inserts or any other valid labeling source, may not be present.\nRoche Diagnostics makes no representation or warranty that by utilizing the information contained in these procedures, a facility will be in compliance with all applicable laws or regulations. Compliance with applicable laws or regulations remains solely the responsibility of the individual facility.\nUpdates, review, and approval of procedures for all laboratory tests, as well as supplementing them with any other information necessary to perform a valid test, is the responsibility of the facility’s program director or his/her designee. It is his/her responsibility to revise the procedure used in the facility when procedure changes are announced by Roche Diagnostics, or when there is a change in laws, regulations or their interpretations. Roche Diagnostics hereby disclaims all liability for any facility's compliance with any laws or regulations.\nIf you have any questions regarding the content of this document, please contact your local representative or call the Roche Support Network Customer Support Center cobas Liat hotline at 1-800-800-5973.\nIntroduction\nRoche Diagnostics is pleased to offer this tool to assist you in developing your policies and procedures manual for the use of the cobas Liat System in your facility. This guide contains sample policies and procedures for use with the cobas Liat System and is intended only as a guide. It is important that you edit and make updates as may be required by your internal policies and changes in policies or related laws or regulations or their interpretation. This is a working document that is in general compliance with CLIA Title 42; Chapter IV, Subchapter K, Part 493; cfr.493-1251 requirements for policies and procedures manuals.\nAll text in this template is editable to reflect information specific to your facility and preferences. You will find blank spaces___ and \u003Cgray italicized text> throughout this document. These are provided to alert you to areas that you will commonly want to customize and to provide examples of text for you to consider. You will need to delete or adjust the font of the \u003Cgray italicized text> after you have customized your entries.\ncobas SARS-CoV-2 & Influenza A/B\nPolicies and Procedures Manual\nPolicy: It is the responsibility of the \u003Center the department and title of the staff position(s)> to compose and maintain the cobas SARS-CoV-2 & Influenza A/B cobas Liat System Policies and Procedures Manual. It must be approved, signed and dated by \u003CEnter the title of the Director the program in your facility> when it is placed in use and then reviewed and approved annually throughout the use of the test system. If a new Director assumes this responsibility, the procedures must be re-approved, signed and dated by the new Director. Changes to this manual, or discontinuation of the test system must be approved, signed and dated by the Director including the date of change or discontinuation. A copy of the manual with change history is maintained throughout the use of the test system and for at least \u003Center the number of years you wish to retain this manual> years after it has been discontinued.\nInitial approval date: _____________ Date test discontinued: ______________\nSignature:_____________________________\nSignature:_________________________\nPrinted Name:__________________________\nPrinted Name:_____________________\n\u000f\n\u0003Table of Contents\n\u0013 TOC \\o \"1-2\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc7","cbCaisRJAJLUs2Vf","https://ap.wps.com/l/cbCaisRJAJLUs2Vf","docx",113073,39,"English","# Principle of the Method\n# Intended Use Policy\n# Limitations of the Method\n# General Policies\n# Policies\n# Quality Assurance\n# Quality Control Testing\n## General Quality Control Policies\n## External Quality Control Testing Procedure\n## Add Lot Procedure\n# Patient Testing\n## Patient Sample Collection\n## Patient Test Procedure\n# Viewing and Interpreting Results\n# Troubleshooting Error Messages or Unexpected Results\n# Software/Connectivity\n# Advanced Tools\n# System Maintenance and Calibration\n# Cleaning the Analyzer\n# Analyzer Self-Check\n# Analyzer Auto Adjustment\n# Product Ordering and Replacement Information\n# Analyzer","[{\"question\":\"What is the purpose of this policies and procedures manual template?\",\"answer\":\"It provides sample policies and procedures to help develop a comprehensive manual for using the cobas® Liat® System in a facility.\"},{\"question\":\"Who is responsible for composing, maintaining, and approving the procedures?\",\"answer\":\"The responsibility lies with the specified department staff position, and the Director must approve, sign, and date the manual when placed in use and annually thereafter.\"},{\"question\":\"What areas are covered for quality assurance and testing operations?\",\"answer\":\"The template includes quality assurance, quality control testing (including external quality control and general quality control policies), patient testing steps, and guidance for viewing/interpreting results and troubleshooting.\"}]","cobas® SARS-CoV-2 & Influenza A/B - Policies and Procedures Manual | DOCX"]