Difference between revisions of "Template:LIMSpec/Sample management"
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! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14] | ||
| style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents. | | style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents. | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14] | ||
| style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents. | | style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents. | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14] | ||
| style="background-color:white;" |'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value. | | style="background-color:white;" |'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value. | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14] | ||
| style="background-color:white;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date. | | style="background-color:white;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date. | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14] | ||
| style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use. | | style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use. | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-6]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14] | ||
| style="background-color:white;" |'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel. | | style="background-color:white;" |'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel. | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-7] | ||
| style="background-color:white;" |'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status. | | style="background-color:white;" |'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status. | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2] | ||
| style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology. | | style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology. | ||
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[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br /> | [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br /> | [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br /> | ||
[https://www.astm.org/ | [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.2.1]<br /> | ||
[https://www.astm.org/ | [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-9]<br /> | ||
| style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample inventory amounts and status. | [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual] | ||
| style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample or specimen inventory amounts and status. | |||
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| style="padding:5px; width:500px;" |[ | | style="padding:5px; width:500px;" |[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<br />[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-10] | ||
| style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents. | | style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents. | ||
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[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br /> | [https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br /> | [https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br /> | ||
[https://www.astm.org/ | [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.9]<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 C6.2]<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 C10–12]<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.astm.org/e1578-18.html ASTM E1578-18 C-2-11]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br /> | ||
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf | [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | ||
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<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,M1 1.1)]<br /> | |||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br /> | ||
[https://www.who.int/medicines/ | [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2]<br /> | ||
[https:// | [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h]<br /> | ||
| style="background-color:white;" |'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing. | [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.7]<br /> | ||
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 12.1]<br /> | |||
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br /> | |||
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25] | |||
| style="background-color:white;" |'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing. | |||
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