View source for LIMSpec for Cannabis Testing/Primary laboratory workflow/Reporting

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  ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-1]
  | style="background-color:white; vertical-align: text-top;" |'''6.1''' The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.4]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.4]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]
  | style="background-color:white; vertical-align: text-top;" |'''6.2''' The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (g) and (h)]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories F7.2]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-2]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2.1]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.2]<br />
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
  | style="background-color:white; vertical-align: text-top;" |'''6.3''' The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-2]
  | style="background-color:white; vertical-align: text-top;" |'''6.4''' The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., "less than X mg/L") when doing so would provide relevant information to the report recipient.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/91.25 7 CFR Part 91.25]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (c–e)]<br />
▪ [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.1]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.2–5]<br />
▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2A.7.8.1]<br />
▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-12 and -32]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-3]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 4.5.2]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.3]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.5.1]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.2.1]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.3.1]<br />
▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
▪ [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.43]
  | style="background-color:white; vertical-align: text-top;" |'''6.5''' The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/7/91.26 7 CFR Part 91.26–27]<br />▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-4]
  | style="background-color:white; vertical-align: text-top;" |'''6.6''' The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.10]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-5]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2]<br />
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.1]<br />
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)]<br />
▪ [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3]<br />
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.4]
  | style="background-color:white; vertical-align: text-top;" |'''6.7''' The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/331.5 7 CFR Part 331.5]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.5 9 CFR Part 121.5–6]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1110]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (a–b)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58.185]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/312.64 21 CFR Part 312.64]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/812.150 21 CFR Part 812.150]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/141.31 40 CFR Part 141.31]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/141.721 40 CFR Part 141.721]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/part-370/subpart-C 40 CFR Part 370 Subpart C]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/part-372/subpart-B 40 CFR Part 372 Subpart B]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/part-704 40 CFR Part 704]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/part-717/subpart-A 40 CFR Part 717 Subpart A]<br />
▪ [https://www.law.cornell.edu/cfr/text/40/720.40 40 CFR Part 720.40]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.5 42 CFR Part 73.5–6]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (d)]<br />
▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-7]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C13.3]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories E8]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories G17.1]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-7]<br />
▪ [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.1]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]<br />
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.3.2]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 4, 2.x]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 4, 1.x]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-6 and IR-6(1)]<br />
▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]<br />
▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (throughout)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.4]
  | style="background-color:white; vertical-align: text-top;" |'''6.8''' The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/91.28 7 CFR Part 91.28]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1154 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58 Sec. 58.185 (c)]<br />
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.10.9]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.9–10]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.4]<br />
▪ [https://ichgcp.net/ ICH GCP 4.9.3]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.8]<br />
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]<br />
▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)]
  | style="background-color:white; vertical-align: text-top;" |'''6.9''' The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec
  | style="background-color:white; vertical-align: text-top;" |'''6.10''' The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec
  | style="background-color:white; vertical-align: text-top;" |'''6.11''' The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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