Difference between revisions of "Template:LIMSpec for Cannabis Testing/Sample and experiment registration"
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! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ||
|- | |- | ||
! style="color:brown; background-color:#ffffee; width: | ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />▪ [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="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; vertical-align: text-top;" |'''1.1''' The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[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 58.105 (c)]<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/21/211.101 21 CFR Part 211.101]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/606.120 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/21/606.121 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/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/29/1910.1030 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/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.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.astm.org/ | ▪ [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.6]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br /> | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-2]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br /> | ▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br /> | ||
[https://eur-lex.europa.eu/ | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br /> | ||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11] | ▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 15]<br /> | ||
| style="background-color:white;" |'''1.2''' The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate/matrix) sample labels, with barcode support. | ▪ [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; vertical-align: text-top;" |'''1.2''' The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate/matrix) sample labels, with barcode support.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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 U.S. Department of Food and Agriculture unique cultivator identifier 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. | | style="background-color:white; vertical-align: text-top;" |'''1.3''' The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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="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; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''1.5''' The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration. | ▪ [https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<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/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; vertical-align: text-top;" |'''1.5''' The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-5] | ||
| style="background-color:white;" |'''1.6''' The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols—with configurable measurement units and substrates/matrices—while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter. | | style="background-color:white; vertical-align: text-top;" |'''1.6''' The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols—with configurable measurement units and substrates/matrices—while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-6] | ||
| style="background-color:white;" |'''1.7''' The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type. | | style="background-color:white; vertical-align: text-top;" |'''1.7''' The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-7] | ||
| style="background-color:white;" |'''1.8''' The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples. | | style="background-color:white; vertical-align: text-top;" |'''1.8''' The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding:5px;;" | | ||
[https://www.law.cornell.edu/cfr/text/7/ | ▪ [https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/ | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/ | ▪ [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/ | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/ | ▪ [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/ | ▪ [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.195]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/21/part-129 21 CFR Part 129.80 (g)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/21/211.170 21 CFR Part 211.170]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (d)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/ | ▪ [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br /> | ||
[https://www. | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br /> | ||
[https://www. | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> | ||
[ | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1242 42 CFR Part 493.1242]<br /> | ||
[https://www. | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (f)]<br /> | ||
[https:// | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br /> | ||
[https:// | ▪ [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. | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.7.1.2]<br /> | ||
[https://www. | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br /> | ||
[https://www. | ▪ [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. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-8]<br /> | ||
[https:// | ▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br /> | ||
[https:// | ▪ [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://www. | ▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1000PUE.txt EPA 815-R-05-004 Supplement 1]<br /> | ||
[https://www. | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br /> | ||
[https:// | ▪ [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.iso.org/standard/66912.html ISO/IEC 17025:2017 7.3.3]<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; vertical-align: text-top;" |'''1.9''' The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| 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. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-9]<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 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; vertical-align: text-top;" |'''1.10''' The system should allow for the addition of observations and descriptions to registered samples in the form of free text.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-10] | ||
| style="background-color:white;" |'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens—including associated measurement units and any other regulation-mandated attributes—based upon the various cannabis substrates/matrices and derivative products tested, as well as the sample source location and/or laboratory location. | | style="background-color:white; vertical-align: text-top;" |'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens—including associated measurement units and any other regulation-mandated attributes—based upon the various cannabis substrates/matrices and derivative products tested, as well as the sample source location and/or laboratory location.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''1.12''' The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample/batch/lot ID, laboratory sample/batch/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes. | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br /> | ||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-11]<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)]<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] | |||
| style="background-color:white; vertical-align: text-top;" |'''1.12''' The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample/batch/lot ID, laboratory sample/batch/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[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/part-1 21 CFR Part 1.1152 (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/21/58.107 21 CFR Part 58.107 (c)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br /> | ||
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.2]<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.astm.org/ | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual D-3]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br /> | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-12]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.11]<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 4.4.10]<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://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.11]<br /> | ||
[https://eur-lex.europa.eu/ | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10]<br /> | ||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]<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.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.11]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]<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.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]<br /> | ||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11] | ▪ [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 /> | ||
| 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. | ▪ [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]</br> | |||
▪ [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11] | |||
| style="background-color:white; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[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/21/58.107 21 CFR Part 58.107 (d)]<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/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.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-13]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.7]<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.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<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 /> | ||
| style="background-color:white;" |'''1.14''' The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception. | ▪ [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; vertical-align: text-top;" |'''1.14''' The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| 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. | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br /> | ||
▪ [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; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.3]<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 C3.3]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.3]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.5]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.6]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.2]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.13]<br /> | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-15]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.8]<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.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.3–7]<br /> | ▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.9] | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.13]<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.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.8]<br /> | ||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.3]<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 5.8.7.2)]<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 Sampling Procedures for PDP 6.4.1.1.9]<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] | |||
| style="background-color:white; vertical-align: text-top;" |'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''1.17''' The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc. | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br /> | ||
▪ [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] | |||
| style="background-color:white; vertical-align: text-top;" |'''1.17''' The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[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 331.11]<br /> | ||
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.17]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/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/9/121.11 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/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/21/part-1 21 CFR Part 1.1149]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<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/42/493.1274 42 CFR Part 493.1274]<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://www.astm.org/ | ▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br /> | ||
[https:// | ▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.8]<br /> | ||
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 12]<br /> | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D-9–10]<br /> | ||
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Appendix A]<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.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.3–5]<br /> | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-17]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13]<br /> | ▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.5]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.8–9]<br /> | ▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 12]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3] | ▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Appendix A]<br /> | ||
| 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. | ▪ [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://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10(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://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.6.2]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2]<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,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; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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 such as cannabis, 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 shipping information. | | style="background-color:white; vertical-align: text-top;" |'''1.19''' In the case of regulated samples such as cannabis, 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 shipping information.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |||
| 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 shipper sample/batch/lot ID, laboratory sample/batch/lot ID, customer, and more.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
|} | |} | ||
|} | |} |