Difference between revisions of "User:Shawndouglas/sandbox/sublevel8"

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Tag: Reverted
Tag: Reverted
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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:350px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-1]
   | 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;" |'''1.1''' The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
   | 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:350px;" |
   | 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]
[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />
   | style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
  |-  
[https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br />
   | 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]
[https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
   | 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.
[https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.121 21 CFR Part 606.121 (c–i)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.140 21 CFR Part 606.140 (c)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e1-6)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.6]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-2]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 15]<br />[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<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 5.8.6)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
   | style="background-color:white;" |'''1.2''' The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
  |-
   | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/45/162.410 45 CFR Part 162.410]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]
   | style="background-color:white;" |'''1.3''' The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.
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   | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-3]
   | 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;" |'''1.4''' The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.
   | 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:350px;" |
   | 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]
[https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br />
   | style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.
[https://www.law.cornell.edu/cfr/text/40/262.18 40 CFR Part 262.18]<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 C2.1]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.3]
   | style="background-color:white;" |'''1.5''' The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number) to be included during registration.
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   | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-5]
   | 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;" |'''1.6''' The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
   | 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:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-6]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-7]
   | style="background-color:white;" |'''1.7''' The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.
   | style="background-color:white;" |'''2.7''' The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.
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   | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-7]
   | 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;" |'''1.8''' The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.
   | style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.
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   | style="padding:5px; width:350px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br />
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.195]<br />
[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/21/211.170 21 CFR Part 211.170]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (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/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.2.1]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-9]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1242 42 CFR Part 493.1242]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (f)]<br />
   | style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.
[https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.2–3]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.7.1.2]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<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 C2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-8]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 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://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1000PUE.txt EPA 815-R-05-004 Supplement 1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10–11]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.7.1–6]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 11.4]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.2]<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 6.1]<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 5.8.6)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.1]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21]
   | style="background-color:white;" |'''1.9''' The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
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   | style="padding:5px; width:350px;" |
   | 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]
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-9]<br />
   | style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
[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 G1.4]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.5]
   | style="background-color:white;" |'''1.10''' The system should allow for the addition of observations and descriptions to registered samples in the form of free text.
  |-  
  |-  
   | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-10]
   | style="padding:5px; width:500px;" |
  | style="background-color:white;" |'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens.
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
|-
[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />
  | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-11]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)]<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.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<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 5.8.7)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2]
[https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (e)]<br />
  | style="background-color:white;" |'''1.12''' The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58]<br />
|-
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58]<br />
  | style="padding:5px; width:350px;" |
[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (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/21/211.194 21 CFR Part 211.194]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.9]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<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.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<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://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.2]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual D-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-12]<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.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.11]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 15]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]<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 5.8.5)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.11]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.5]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2]</ref>
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
  | style="background-color:white;" |'''1.13''' The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
|-
  | style="padding:5px; width:350px;" |
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-13]<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://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.7]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<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 5.8.3)]
  | style="background-color:white;" |'''1.14''' The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.
|-
  | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-14]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.6]
  | style="background-color:white;" |'''1.15''' The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
|-
  | style="padding:5px; width:350px;" |
[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 C3.3]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.3]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.5]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.6]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-15]<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://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<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 4.4.13]<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 4.11.8]<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/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
[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/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://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 5.8.7.2)]<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 Sample Processing and Analysis Procedures for PDP 5.1.3–7]<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 Sampling Procedures for PDP 6.4.1.1.9]<br />
[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://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1]
[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;" |'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
[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 />
  | style="padding:5px; width:350px;" |[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.7]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-16]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
  | style="background-color:white;" |'''1.17''' The system should provide a means to document sample preparation activities for a given sample.
[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, specimens, 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.
  | style="padding:5px; width:350px;" |
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.8]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D-9–10]<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 5.8.1.1]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 (throughout)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-17]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.5]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 12]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Appendix A]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.3–5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.8–9]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<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 5.8.7.5 and 5.8.8)]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) (throughout)]
  | style="background-color:white;" |'''1.18''' The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.
|-
  | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/7/331.16 7 CFR Part 331.16]<br />[https://www.law.cornell.edu/cfr/text/9/121.16 9 CFR Part 121.16]<br />[https://www.law.cornell.edu/cfr/text/42/73.16 42 CFR Part 73.16]
  | style="background-color:white;" |'''1.19''' In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.
|-
  | style="padding:5px; width:350px;" |[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 G1.1]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]
   | style="background-color:white;" |'''1.20''' The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.
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Revision as of 19:58, 15 August 2022

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-2-1
EPA ERLN Laboratory Requirements 4.11.14 		2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
ASTM E1578-18 C-2-2
EPA ERLN Laboratory Requirements 4.11.14 		2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.
ASTM E1578-18 C-2-3
EPA ERLN Laboratory Requirements 4.11.14 		2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
ASTM E1578-18 C-2-4
EPA ERLN Laboratory Requirements 4.11.14 		2.4 The system shall require the recording of a standard and reagent's first opening date.
ASTM E1578-18 C-2-5
EPA ERLN Laboratory Requirements 4.11.14 		2.5 The system shall allow only active standards and reagents to be shown as available for use.
ASTM E1578-18 C-2-6
EPA ERLN Laboratory Requirements 4.11.14 		2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
ASTM E1578-18 C-2-7 2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.
ASTM E1578-18 C-2-8
EPA ERLN Laboratory Requirements 3.2
ISO/IEC 17025:2017 7.4.2 		2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.

7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 211.84
42 CFR Part 73.17
ASTM E1492-11 4.2.1
ASTM E1578-18 C-2-9
CAP Laboratory Accreditation Manual

2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.
A2LA C211 5.4
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1
ASTM E1578-18 C-2-10 		2.10 The system shall be able to link test methods and specifications to standards and reagents.

21 CFR Part 211.84
21 CFR Part 211.166–7
21 CFR Part 211.194 (e)
21 CFR Part 212.40 (c)
21 CFR Part 212.61
21 CFR Part 212.70 (e)
21 CFR Part 225.58
21 CFR Part 226.58
21 CFR Part 606.65 (c)
21 CFR Part 606.151
A2LA C223 5.9
ACMG Technical Standards for Clinical Genetics Laboratories C6.2
ACMG Technical Standards for Clinical Genetics Laboratories C10–12
CAP Laboratory Accreditation Manual
ASTM E1578-18 C-2-11
EPA ERLN Laboratory Requirements 3.1.2.1
EPA ERLN Laboratory Requirements 4.3.2
EPA ERLN Laboratory Requirements 4.11.3.2
EPA QA/G-5 2.2.5
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
NYSDOH ELAP Medical Marijuana Microbiology Guidance
PFP Human and Animal Food Testing Laboratories Best Practices Manual
TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)
USDA Administrative Procedures for the PDP 8.5
USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h
WADA International Standard for Laboratories (ISL) 5.3.7
WHO Technical Report Series, #961, Annex 13, 12.1
WHO Technical Report Series, #986, Annex 2, 17.7
WHO Technical Report Series, #986, Annex 2, 17.22–25

2.11 The system shall allow samples, specimens, 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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