[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-165486-en":3,"doc-seo-165486-105":30,"detail-sidebar-cat-1-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":4,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":29},165486,962075114101,"Seraphina","https://ap-avatar.wpscdn.com/avatar/e000253a75eb197efd?x-image-process=image/resize,m_fixed,w_180,h_180&k=1780044092746381165",1,158,"General","cobas Cdiff Policies and Procedures Manual - for use with the cobas Liat System","Sample template for developing a comprehensive cobas Cdiff policies and procedures manual for use with the cobas Liat System. The manual framework includes guidance and editable sections, blank placeholders, and editable gray italic text to customize facility-specific information. It emphasizes responsibilities for composing, maintaining, reviewing, and annually approving procedures, including director sign-off, change history retention, and re-approval when leadership changes. Sections outline key policy areas such as intended use, procedural limits, quality assurance, quality control testing, patient testing workflow, troubleshooting, and system maintenance.","Sample Template for\ncobas® Cdiff Policies 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 Cdiff\nPolicies and Procedures Manual Approval\nPolicy: It is the responsibility of the \u003Center the department and title of the staff position(s)> to compose and maintain the cobas Cdiff Policies and Procedures Manual for use with the cobas Liat System. 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 \"_Toc94179822\" \u0014Principles of the Pro","cbCaijMaaIZE9IU9","https://ap.wps.com/l/cbCaijMaaIZE9IU9","docx",110071,35,"English","en",105,"# Principles of the Procedure\n# Intended Use Policy\n# Procedural Limitations\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## Specimen transfer into cobas PCR Media\n## Patient Test Procedure\n## Viewing and Interpreting Results\n## Troubleshooting Error Messages or Unexpected Results\n## Suggested Re-Test Procedure\n## Software/Connectivity\n## Advanced Tools\n## System Maintenance and Calibration\n## Cleaning the Analyzer\n## Analyzer Self-Check\n## Analyzer Auto Adjustment","[{\"question\":\"What is the purpose of this COBAS Cdiff Policies and Procedures manual template?\",\"answer\":\"It provides a sample framework to help facilities develop a comprehensive policies and procedures manual for use with the cobas Liat System. The template is intended as an editable guide and must be customized to match facility policies and applicable requirements.\"},{\"question\":\"Who is responsible for composing and maintaining the policies and procedures manual?\",\"answer\":\"The manual assigns responsibility to a designated department and staff position. It must be approved, signed, and dated by the facility program director (or designee) when placed in use and reviewed and approved annually.\"},{\"question\":\"How should facilities handle updates, changes, and discontinuation of the test system?\",\"answer\":\"When Roche Diagnostics announces procedure changes or when laws, regulations, or interpretations change, the facility must revise the procedures accordingly. Changes to the manual and any discontinuation of the test system must be approved, signed, and dated by the director, with a maintained copy including change history.\"}]","cobas Cdiff Policies and Procedures Manual - for use with the cobas Liat System | DOCX",1788172463,12,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":86,"head_meta":88,"extra_data":90,"updated_unix":28},"cobas-cdiff-policies-and-procedures-manual-for-use-with-the-cobas-liat-system","",{"@graph":36,"@context":85},[37,54,68],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/template/","Template",2,{"item":49,"name":13,"@type":43,"position":50},"https://docshare.wps.com/template/general/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/cobas-cdiff-policies-and-procedures-manual-for-use-with-the-cobas-liat-system/165486/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":62,"encodingFormat":61,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-08-31",true,{"@type":65,"interactionType":66,"userInteractionCount":4},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71,77,81],{"name":72,"@type":73,"acceptedAnswer":74},"What is the purpose of this COBAS Cdiff Policies and Procedures manual template?","Question",{"text":75,"@type":76},"It provides a sample framework to help facilities develop a comprehensive policies and procedures manual for use with the cobas Liat System. The template is intended as an editable guide and must be customized to match facility policies and applicable requirements.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"Who is responsible for composing and maintaining the policies and procedures manual?",{"text":80,"@type":76},"The manual assigns responsibility to a designated department and staff position. It must be approved, signed, and dated by the facility program director (or designee) when placed in use and reviewed and approved annually.",{"name":82,"@type":73,"acceptedAnswer":83},"How should facilities handle updates, changes, and discontinuation of the test system?",{"text":84,"@type":76},"When Roche Diagnostics announces procedure changes or when laws, regulations, or interpretations change, the facility must revise the procedures accordingly. 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