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It provides guidance for developing documents/forms for each section of the plan, covering audit purpose and goals, audit scope across laboratory processes and testing, key activities to be audited in preanalytical, analytical, and postanalytical phases, relevant reference requirements, and auditor qualifications, responsibilities, training, and continuing education.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/aphl-laboratory-internal-audit-plan-may-2017/657477/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/aphl-laboratory-internal-audit-plan-may-2017/657477.png","ImageObject",300,407,{"name":92,"@type":93},"fresh2021","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-10-26",true,{"@type":102,"interactionType":103,"userInteractionCount":8},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the purpose of the APHL Laboratory Internal Audit Plan?","Question",{"text":112,"@type":113},"It describes the audit purpose and goals, including ensuring compliance with internal policies and regulatory requirements, providing management assurance, supporting training for accreditation standards, improving processes, and verifying quality management system requirements and documentation.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What does the audit scope cover?",{"text":117,"@type":113},"The scope covers establishing appropriate test procedures, equipment, controls, and calibration methods, ensuring proper ordering of laboratory tests, efficient procurement of test samples, producing accurate results, timely dissemination of test information, and using qualified laboratory personnel.",{"name":119,"@type":110,"acceptedAnswer":120},"Which laboratory activities are included in the audit?",{"text":121,"@type":113},"Auditable activities include preanalytical, analytical, and postanalytical processes, such as temperature and sample receipt reviews, nonconforming events and corrected reports, analytical reviews of instrument runs and logs, quality control and calibration activities, and defined result release and report preparation procedures.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},657477,1792980654,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":8,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":129,"read_time":41},962093912154,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","Laboratory  \nInternal Audit Plan  \nMAY 2017  \nAcknowledgements  \nThe following APHL workgroup members contributed to this document:  \nCharlene Thomas, BS, MT(ASCP), manager, microbiologist, Alabama Bureau of Clinical Laboratories (workgroup lead) Lauren Farnsworth, MS, QA & Safety Program manager, Colorado Department of Public Health & Environment Steve Gradus, PhD, D(ABMM), CLIA director, City of Milwaukee Health Department  \nSheri Hearn, MPH, Quality Management officer, Oregon State Public Health Laboratory  \nLorelei Kurimski, MS, director, Office of Organizational Development, State Hygienic Laboratory at the University of Iowa Deborah Severson, BS MT(ASCP), director of Laboratory Services, Fairfax County Health Department Laboratory Bertina Su, MPH, senior specialist, Quality Systems, Association of Public Health Laboratories  \nAPHL Laboratory Internal Audit Plan | 2  \nAPHL Internal Laboratory Audit Plan  \nA laboratory audit program is critical to ensuring the institution meets applicable requirements. Follow the guidelines below to develop appropriate documents/forms/statements for each heading of your internal audit plan. Add more headings as necessary.  \n\n| Purpose | This section should describe the purpose of the internal audit including any defined goals. For example:\u003Cbr>• To determine overall compliance with internal policy or regulatory requirements in preparation for an external audit\u003Cbr>• To conduct a follow-up internal audit in response to a complaint, poor external inspection or a nonconforming event\u003Cbr>• To ensure a new method is compliant with regulatory requirements\u003Cbr>• To provide assurance to management that the management system is implemented as intended\u003Cbr>• To serve training purposes, learn the requirements of accreditation bodies (standards)\u003Cbr>• To improve processes\u003Cbr>• To verify compliance with the requirements of the quality management system, including analytical methods, SOPs, the quality manual, ethics policies, data integrity, internal laboratory policies, and regulatory requirements such as AIHA-LAP, LLC, CLIA and TNI\u003Cbr>• To compile the appropriate documentation to include:\u003Cbr>• Auditor reviews of corrective actions\u003Cbr>• Auditee/section response if necessary\u003Cbr>• Final report reviewed by management\u003Cbr>• Follow-up if needed |\n| --- | --- |\n| Scope | This section should describe the range of the audit. For example:\u003Cbr>• Ensuring that appropriate test procedures, equipment, controls, calibrations methods are established\u003Cbr>• Ensuring that appropriate laboratory tests are ordered\u003Cbr>• Procuring test samples in an efficient and timely manner\u003Cbr>• Producing accurate laboratory test results\u003Cbr>• Disseminating laboratory test information to clients/providers in a timely manner\u003Cbr>• Utilizing qualified laboratory personnel |\n\nAPHL Laboratory Internal Audit Plan | 3  \n| Activities to Be Audited | This section should define the activities to be audited. For example: |  |\n| --- | --- | --- |\n|  | • Preanalytical Review of:\u003Cbr>• Temperature logs\u003Cbr>• Sample receipt logs\u003Cbr>• Sample rejection logs\u003Cbr>• Sample quality logs Policies and procedures for:\u003Cbr>• Sample or patient identification verification\u003Cbr>• Sample collection, handling, and transportation\u003Cbr>• Sample receipt, preparation, and storage\u003Cbr>• Sample acceptance and rejection criteria\u003Cbr>• Chain of custody\u003Cbr>• Data entry and review\u003Cbr>• Postanalytical Review of:\u003Cbr>• Non-conforming events/corrective actions\u003Cbr>▫ Report completeness\u003Cbr>▫ Turn-around-time\u003Cbr>▫ Corrected reports Policies and procedures for:\u003Cbr>• Result release\u003Cbr>• Report preparation and delivery\u003Cbr>• Sample archiving and management\u003Cbr>• Sample storage and disposal requirements\u003Cbr>• Demographic and results corrections (corrected reports) | • Analytical Review of:\u003Cbr>• Temperature logs\u003Cbr>• Review of instrument runs\u003Cbr>• Reagent and standard logs\u003Cbr>• Instrument/equipment maintenance logs\u003Cbr>• Proficiency tests\u003Cbr>• Failed runs\u003Cbr>Policies and procedures for:\u003Cbr>• Testing and examinat","cbCaigbsA3H4dlJO","https://ap.wps.com/l/cbCaigbsA3H4dlJO","pdf",240260,12,"English","# Purpose\n# Scope\n# Activities to Be Audited\n## Preanalytical Review\n## Postanalytical Review\n## Analytical Review\n# Reference Requirements\n# Assigned Auditors(s)","[{\"question\":\"What is the purpose of the APHL Laboratory Internal Audit Plan?\",\"answer\":\"It describes the audit purpose and goals, including ensuring compliance with internal policies and regulatory requirements, providing management assurance, supporting training for accreditation standards, improving processes, and verifying quality management system requirements and documentation.\"},{\"question\":\"What does the audit scope cover?\",\"answer\":\"The scope covers establishing appropriate test procedures, equipment, controls, and calibration methods, ensuring proper ordering of laboratory tests, efficient procurement of test samples, producing accurate results, timely dissemination of test information, and using qualified laboratory personnel.\"},{\"question\":\"Which laboratory activities are included in the audit?\",\"answer\":\"Auditable activities include preanalytical, analytical, and postanalytical processes, such as temperature and sample receipt reviews, nonconforming events and corrected reports, analytical reviews of instrument runs and logs, quality control and calibration activities, and defined result release and report preparation procedures.\"}]","APHL Laboratory Internal Audit Plan - May 2017 | PDF"]