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| ===Methodology===
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| At its core, this LIMSpec—which has seen several iterations over the years—is rooted in [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics''. The latest version was released in 2018, which includes an updated Laboratory Informatics Functional Requirements checklist in the appendix. That list of requirements "covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide." It goes on to state that the checklist "is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system," though it is certainly "not meant to be exhaustive."
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| This LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, this should definitely be considered a work in progress, with more to be added with additional public and private comment on missing sources.
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| That said, this third revision (2022) taps into more than 100 resources, including the following:
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| {| | | {| |
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width="80%" | | {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" |
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| | colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|'''Table 1.''' Regulations, standards, guidance, and other documents guiding LIMSpec development. <sup>*</sup> indicates added, updated, or revised for 2022 update. | | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| |
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance | | ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Familiar Name and/or Responsible Entity | | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement |
| |- | | |- |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301] | | | 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:10px; background-color:white;" |Office of Personnel Management > Civil Service Regulations > Programs for Specific Positions and Examinations (Miscellaneous) > Information Security Responsibilities for Employees who Manage or Use Federal Information Systems > Information systems security awareness training program
| | | 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. |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/7/part-91 7 CFR Part 91]<sup>*</sup>
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| | style="padding:10px; background-color:white;" |Agricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture > Commodity Laboratory Testing Programs > Services and General Information
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331]
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| | style="padding:10px; background-color:white;" |Animal and Plant Health Inspection Service, Department of Agriculture > Possession, Use, and Transfer of Select Agents and Toxins
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/9/part-2 9 CFR Part 2]<sup>*</sup>
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| | style="padding:10px; background-color:white;" |Animal and Plant Health Inspection Service, Department of Agriculture > Animal Welfare > Regulations
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121]
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| | style="padding:10px; background-color:white;" |Animal and Plant Health Inspection Service, Department of Agriculture > Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors > Possession, Use, and Transfer of Select Agents and Toxins
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| |-
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/10/part-20 10 CFR Part 20]<sup>*</sup>
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| | style="padding:10px; background-color:white;" |Nuclear Regulatory Commission > Standards for Protection Against Radiation | |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/10/part-30 10 CFR Part 30]<sup>*</sup>
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| | style="padding:10px; background-color:white;" |Nuclear Regulatory Commission > Rules of General Applicability to Domestic Licensing of Byproduct Material
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| |- | | |- |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-7 21 CFR Part 7] | | | style="padding:5px; width:350px;" | |
| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > General > Enforcement Policy
| | [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 /> |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-11 21 CFR Part 11]
| | [https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br /> |
| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > General > Electronic Records; Electronic Signatures
| | [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 /> |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-58 21 CFR Part 58]
| | [https://www.law.cornell.edu/cfr/text/21/606.121 21 CFR Part 606.121 (c–i)]<br /> |
| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > General > Good Laboratory Practice for Nonclinical Laboratory Studies
| | [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 /> |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-211 21 CFR Part 211]
| | [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e1-6)]<br /> |
| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Finished Pharmaceuticals
| | [https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br /> |
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| | [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br /> |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-212 21 CFR Part 212]
| | [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br /> |
| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Positron Emission Tomography Drugs
| | [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.6]<br /> |
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| | [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-2]<br /> |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-225 21 CFR Part 225]
| | [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br /> |
| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Medicated Feeds
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br /> |
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| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br /> |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-226 21 CFR Part 226]
| | [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 /> |
| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Type A Medicated Articles
| | [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 /> |
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| | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br /> |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-312 21 CFR Part 312]
| | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11] |
| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Drugs for Human Use > Investigational New Drug Application
| | | 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. |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606]
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| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Biologics > Current Good Manufacturing Practice for Blood and Blood Components
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-810 21 CFR Part 810]
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| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Medical Devices > Medical Device Recall Authority
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812]
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| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Medical Devices > Investigational Device Exemptions
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/21/part-820 21 CFR Part 820]
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| | style="padding:10px; background-color:white;" |Food and Drug Administration, Department of Health and Human Services > Medical Devices > Quality System Regulation
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]
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| | style="padding:10px; background-color:white;" |Occupational Safety and Health Standards > Hazardous Materials > Hazardous waste operations and emergency response
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134]
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| | style="padding:10px; background-color:white;" |Occupational Safety and Health Standards > Personal Protective Equipment > Respiratory protection
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030]
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| | style="padding:10px; background-color:white;" |Occupational Safety and Health Standards > Toxic and Hazardous Substances > Bloodborne pathogens
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| |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096]
| |
| | style="padding:10px; background-color:white;" |Occupational Safety and Health Standards > Toxic and Hazardous Substances > Ionizing radiation
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| |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200]
| |
| | style="padding:10px; background-color:white;" |Occupational Safety and Health Standards > Toxic and Hazardous Substances > Hazard communication
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450]
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| | style="padding:10px; background-color:white;" |Occupational Safety and Health Standards > Toxic and Hazardous Substances > Occupational exposure to hazardous chemicals in laboratories
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-3 40 CFR Part 3]
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| | style="padding:10px; background-color:white;" |Environmental Protection Agency > General > Cross-media Electronic Reporting
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-60 40 CFR Part 60]
| |
| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Air Programs > Standards of Performance for New Stationary Sources
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-62 40 CFR Part 62]
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| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Air Programs > Approval and Promulgation of State Plans for Designated Facilities and Pollutants
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-63 40 CFR Part 63]
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| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Air Programs > National Emission Standards for Hazardous Air Pollutants for Source Categories
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-141 40 CFR Part 141]
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| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Water Programs > National Primary Drinking Water Regulations
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-262 40 CFR Part 262]<sup>*</sup>
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| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Solid Wastes > Standards Applicable to Generators of Hazardous Waste
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-370 40 CFR Part 370]
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| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Hazardous Chemical Reporting: Community Right-to-know
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-372 40 CFR Part 372]
| |
| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Toxic Chemical Release Reporting: Community Right-to-know
| |
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| |
| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-704 40 CFR Part 704]
| |
| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Toxic Substances Control Act > Reporting and Recordkeeping Requirements
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-717 40 CFR Part 717]
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| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Toxic Substances Control Act > Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/40/part-720 40 CFR Part 720]
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| | style="padding:10px; background-color:white;" |Environmental Protection Agency > Toxic Substances Control Act > Premanufacture Notification
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73]
| |
| | style="padding:10px; background-color:white;" |Public Health Service, Department of Health and Human Services > Quarantine, Inspection, Licensing > Select Agents and Toxins
| |
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/part-93 42 CFR Part 93]<sup>*</sup>
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| | style="padding:10px; background-color:white;" |Public Health Service, Department of Health and Human Services > Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities > Public Health Service Policies on Research Misconduct
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/part-493 42 CFR Part 493]
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| | style="padding:10px; background-color:white;" |Centers for Medicare & Medicaid Services, Department of Health and Human Services > Standards and Certification > Laboratory Requirements
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/45/part-160 45 CFR Part 160]
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| | style="padding:10px; background-color:white;" |Department of Health and Human Services > Administrative Data Standards and Related Requirements > General Administrative Requirements
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/45/part-162 45 CFR Part 162]
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| | style="padding:10px; background-color:white;" |Department of Health and Human Services > Administrative Data Standards and Related Requirements > Administrative Requirements
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164]
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| | style="padding:10px; background-color:white;" |Department of Health and Human Services > Administrative Data Standards and Related Requirements > Security and Privacy
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| | style="padding:10px; width:350px;" |[https://www.law.cornell.edu/cfr/text/45/part-170 45 CFR Part 170]
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| | style="padding:10px; background-color:white;" |Department of Health and Human Services > Health Information Technology > Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology
| |
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| |
| | style="padding:10px; width:350px;" |[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211, Specific Checklist, Combined ISO/IEC 17025 and Veterinary Laboratory Accreditation Program]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |American Association for Laboratory Accreditation
| |
| |-
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| | style="padding:10px; width:350px;" |[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223, Specific Checklist, Forensic Examination Accreditation Program-Testing]<sup>*</sup>
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| | style="padding:10px; background-color:white;" |American Association for Laboratory Accreditation
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories]
| |
| | style="padding:10px; background-color:white;" |Association of American Feed Control Officials
| |
| |-
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| | style="padding:10px; width:350px;" |[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL]
| |
| | style="padding:10px; background-color:white;" |American Association of Veterinary Laboratory Diagnosticians
| |
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| | style="padding:10px; width:350px;" |[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual]
| |
| | style="padding:10px; background-color:white;" |American Board of Forensic Toxicology
| |
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| | style="padding:10px; 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]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |American College of Medical Genetics and Genomics
| |
| |-
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| | style="padding:10px; width:350px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2022]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |American Industrial Hygiene Association Laboratory Accreditation Programs
| |
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| | style="padding:10px; width:350px;" |[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Association of Public Health Laboratories
| |
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| |
| | style="padding:10px; width:350px;" |[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]
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| | style="padding:10px; background-color:white;" |American Society of Crime Laboratory Directors/Laboratory Accreditation Board; note that ASCLD/LAB merged with ANAB (ANSI National Accreditation Board) in 2016, and their requirements for Forensic Service Provider Accreditation are not made public. As such, this serves as a proxy for ANAB.
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| |
| | style="padding:10px; width:350px;" |[https://www.astm.org/e1188-11r17.html ASTM E1188-11]
| |
| | style="padding:10px; background-color:white;" |ASTM E1188-11(2017) ''Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator''
| |
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| |
| | style="padding:10px; width:350px;" |[https://www.astm.org/e1459-13r18.html ASTM E1459-13]
| |
| | style="padding:10px; background-color:white;" |ASTM E1459-13(2018) ''Standard Guide for Physical Evidence Labeling and Related Documentation''
| |
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| |
| | style="padding:10px; width:350px;" |[https://www.astm.org/e1492-11r17.html ASTM E1492-11]
| |
| | style="padding:10px; background-color:white;" |ASTM E1492-11(2017) ''Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18]
| |
| | style="padding:10px; background-color:white;" |ASTM E1578-18 ''Standard Guide for Laboratory Informatics''
| |
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| |
| | style="padding:10px; width:350px;" |[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |College of American Pathologists
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |U.S. Centers for Disease Control and Prevention
| |
| |-
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| | style="padding:10px; width:350px;" |[https://www.cdc.gov/phin/tools/phinms/index.html CDC PHIN Messaging System]
| |
| | style="padding:10px; background-color:white;" |U.S. Centers for Disease Control and Prevention
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy]
| |
| | style="padding:10px; background-color:white;" |Federal Bureau of Investigation, Criminal Justice Information Services
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://clsi.org/standards/products/automation-and-informatics/documents/auto15/ CLSI AUTO15]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Clinical and Laboratory Standards Institute
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://clsi.org/standards/products/automation-and-informatics/documents/auto16/ CLSI AUTO16]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Clinical and Laboratory Standards Institute
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Clinical and Laboratory Standards Institute
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://denix.osd.mil/edqw/documents/documents/gen-data-validation-rev1/ DoD General Data Validation Guidelines]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |U.S. Department of Defense
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11]
| |
| | style="padding:10px; background-color:white;" |European Union, European Commission
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC]
| |
| | style="padding:10px; background-color:white;" |European Union, European Commission
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on good manufacturing practice and good distribution practice]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |E.U. European Medicines Agency
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.epa.gov/dwlabcert/laboratory-certification-manual-drinking-water EPA 815-R-05-004 + supplements]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |U.S. Environmental Protection Agency
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.epa.gov/emergency-response/environmental-response-laboratory-network-erln-laboratory-requirements EPA ERLN Laboratory Requirements v1.6]
| |
| | style="padding:10px; background-color:white;" |U.S. Environmental Protection Agency, Environmental Response Laboratory Network
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.epa.gov/geospatial/epa-metadata-technical-specification EPA Metadata Technical Specification]
| |
| | style="padding:10px; background-color:white;" |U.S. Environmental Protection Agency
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5]
| |
| | style="padding:10px; background-color:white;" |U.S. Environmental Protection Agency Guidance for Quality Assurance Project Plans
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://nepis.epa.gov/Exe/ZyPDF.cgi/P100WP4J.PDF?Dockey=P100WP4J.PDF EPA SEDD Specification and Data Element Dictionary v5.2]
| |
| | style="padding:10px; background-color:white;" |U.S. Environmental Protection Agency Staged Electronic Data Deliverable
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://orapartners.fda.gov/cs/groups/public/documents/document/b2hh/bmri/~edisp/rpohandbook.pdf FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |U.S. Food and Drug Administration
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (HACCP)]
| |
| | style="padding:10px; background-color:white;" |U.S. Food and Drug Administration
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.icar.org/Guidelines/15-Data-Exchange.pdf ICAR 15 Data Exchange]
| |
| | style="padding:10px; background-color:white;" |International Committee for Animal Recording
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://ichgcp.net/ ICH GCP]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |International Council for Harmonisation Good Clinical Practice
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.iso.org/standard/56115.html ISO 15189:2012]
| |
| | style="padding:10px; background-color:white;" |ISO 15189:2012 ''Medical laboratories — Requirements for quality and competence''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017]
| |
| | style="padding:10px; background-color:white;" |ISO/IEC 17025:2017 ''General requirements for the competence of testing and calibration laboratories''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.aphis.usda.gov/animal_health/nahln/downloads/MessagingQuickGuide.pdf NAHLN HL7 Messaging Quick User Guide]
| |
| | style="padding:10px; background-color:white;" |National Animal Health Laboratory Network
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://web.archive.org/web/20170509221853/https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/lab-info-services/nahln/ct_nahln_it NAHLN Information Technology System]
| |
| | style="padding:10px; background-color:white;" |National Animal Health Laboratory Network
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |New York State Department of Health Clinical Laboratory Evaluation Program
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |New York State Department of Health Environmental Laboratory Approval Program
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |National Institute of Standards and Technology
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles]
| |
| | style="padding:10px; background-color:white;" |Organisation for Economic Co-operation and Development Good Laboratory Practice
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi ONC United States Core Data for Interoperability (USCDI)]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Office of the National Coordinator for Health Information Technology
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020 OSHA 1910.1020]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Occupational Safety and Health Administration 1910.1020 - ''Access to employee exposure and medical records''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020 OSHA 1910.1200]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Occupational Safety and Health Administration 1910.1200 - ''Hazard Communication''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Occupational Safety and Health Administration 1910.1450 - ''Occupational exposure to hazardous chemicals in laboratories''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[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]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |Partnership for Food Protection
| |
| |-
| |
| | style="padding:10px; width:350px;" |[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]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |The NELAC Institute ''Management and Technical Requirements for Laboratories Performing Environmental Analysis'', Volume 1
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the Pesticide Data Program (PDP)]
| |
| | style="padding:10px; background-color:white;" |U.S. Department of Agriculture
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for Pesticide Data Program]
| |
| | style="padding:10px; background-color:white;" |U.S. Department of Agriculture
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |U.S. Department of Agriculture
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA Laboratory Approval Service (LAS) Laboratory Approval Program (LAP) Policies and Procedures]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |U.S. Department of Agriculture
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for Pesticide Data Program]
| |
| | style="padding:10px; background-color:white;" |U.S. Department of Agriculture
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for Pesticide Data Program]
| |
| | style="padding:10px; background-color:white;" |U.S. Department of Agriculture
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://venomcoding.org/ VeNom Coding Group terminology]
| |
| | style="padding:10px; background-color:white;" |Veterinary Nomenclature
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://vtsl.vetmed.vt.edu/ VTSL terminology]
| |
| | style="padding:10px; background-color:white;" |Veterinary Terminology Services Laboratory at Virginia-Maryland College of Veterinary Medicine
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://vichsec.org/en/guidelines/general VICH GL53]
| |
| | style="padding:10px; background-color:white;" |Veterinary International Conference on Harmonization GL53 ''Electronic Exchange of Documents: Electronic File Format''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL)]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |World Anti-Doping Agency
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-protection-privacy-and-personal WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI)]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |World Anti-Doping Agency
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |World Health Organization TRS, #961, Annex 13 ''Guidelines for preparing a laboratory information file''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2]
| |
| | style="padding:10px; background-color:white;" |World Health Organization TRS, #986, Annex 2 ''WHO good manufacturing practices for pharmaceutical products: main principles''
| |
| |-
| |
| | style="padding:10px; width:350px;" |[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5]<sup>*</sup>
| |
| | style="padding:10px; background-color:white;" |World Health Organization TRS, #996, Annex 5 ''Guidance on good data and record management practices''
| |
| |- | | |- |
| | | 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. |
| | |- |
| | | 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="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="padding:5px; width:350px;" | |
| | [https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<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;" |'''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. |
| | |- |
| | | style="padding:5px; width:350px;" |[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 analytical tests. |
| | |- |
| | | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-6] |
| | | 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="padding:5px; width:350px;" |[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 and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples. |
| | |- |
| | | style="padding:5px; width:350px;" | |
| | [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/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/21/211.170 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/42/493.1105 42 CFR Part 493.1105]<br /> |
| | [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> |
| | [https://www.law.cornell.edu/cfr/text/42/493.1242 42 CFR Part 493.1242]<br /> |
| | [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (f)]<br /> |
| | [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. |
| | |- |
| | | style="padding:5px; width:350px;" | |
| | [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;" |'''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="background-color:white;" |'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens. |
| | |- |
| | | style="padding:5px; width:350px;" |[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;" |'''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. |
| | |- |
| | | style="padding:5px; width:350px;" | |
| | [https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (c)]<br /> |
| | [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> |
| | [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> |
| | [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<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://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 4.4.13]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.8]<br /> |
| | [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> |
| | [https://www.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;" |'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample. |
| | |- |
| | | 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] |
| | | style="background-color:white;" |'''1.17''' The system should provide a means to document sample preparation activities for a given sample. |
| | |- |
| | | 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. |
| | |- |
| |} | | |} |
| |} | | |} |
|
| |
| Each requirement statement has at least one linked regulation, standard, or guidance item. In some cases, the standards covered are proprietary. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some sources have been intentionally omitted. For example, the AOAC International ''Official Methods of Analysis'' and ''Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals'' are both proprietary and more or less prohibitively expensive. In other cases, such as with the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public and thus can't be included.
| |
