LII:LIMSpec/Primary Laboratory Workflow

Note: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample/specimen receipt and sampling procedures, to analysis, review, and reporting.

1. Sample and experiment registration

Regulation, Specification, or Guidance Requirement 21 CFR Part 1.1149 42 CFR Part 493.1241 APHL 2019 LIS Project Management Guidebook ASTM E1578-18 C-1-1 1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection. 21 CFR Part 58.105 (c) 21 CFR Part 211.84 21 CFR Part 211.101 21 CFR Part 226.80 21 CFR Part 606.120 (b) 21 CFR Part 606.121 (c–i) 21 CFR Part 606.140 (c) 29 CFR Part 1910.1030 (g) 29 CFR Part 1910.1096 (e1-6) 42 CFR Part 493.1232 ABFT Accreditation Manual Sec. D APHL 2019 LIS Project Management Guidebook ASTM E1492-11 4.1.1.6 ASTM E1578-18 C-1-2 CLSI QMS22 2.2.1.2 EPA ERLN Laboratory Requirements 3.2.2 EPA QA/G-5 2.2.3 E.U. Commission Directive 2003/94/EC Article 15 OECD GLP Principles 6.1 TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6) USDA Sampling Procedures for PDP 6.4.1.2.6 WHO Technical Report Series, #986, Annex 2, 17.11 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. 45 CFR Part 162.410 CJIS Security Policy 5.6.1 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. 42 CFR Part 493.1241 ASTM E1578-18 C-1-3 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. 7 CFR Part 91.19 21 CFR Part 1.1152 (a–b) 40 CFR Part 262.18 ACMG Technical Standards for Clinical Genetics Laboratories C2.1 APHL 2019 LIS Project Management Guidebook ASTM E1578-18 C-1-4 USDA Sampling Procedures for PDP 6.4.1.1.3 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 or U.S. Customs and Border Protection number) to be included during registration. ASTM E1578-18 C-1-5 1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests. ASTM E1578-18 C-1-6 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. ASTM E1578-18 C-1-7 1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples. 7 CFR Part 91.19 7 CFR Part 331.17 9 CFR Part 121.17 21 CFR Part 1.1149 21 CFR Part 1.1152 (a–b) 21 CFR Part 1.1152 (d) 21 CFR Part 58.105 (c) 21 CFR Part 58.195 21 CFR Part 129.80 (g) 21 CFR Part 211.84 21 CFR Part 211.170 21 CFR Part 211.194 21 CFR Part 312.57 (d) 40 CFR Part 141.33 42 CFR Part 73.17 42 CFR Part 493.1105 42 CFR Part 493.1241 42 CFR Part 493.1242 42 CFR Part 493.1274 (f) 42 CFR Part 493.1283 AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.2–3 AAVLD Requirements for an AVMDL Sec. 5.7.1.2 ABFT Accreditation Manual Sec. D ACMG Technical Standards for Clinical Genetics Laboratories C2 ASTM E1578-18 C-1-8 CLSI QMS22 2.2.1.3 EPA 815-R-05-004 Chap. IV, Sec. 6 and 8 EPA 815-R-05-004 Chap. VI, Sec. 8 EPA 815-R-05-004 Supplement 1 EPA ERLN Laboratory Requirements 3.2 EPA ERLN Laboratory Requirements 4.4.10–11 EPA ERLN Laboratory Requirements 4.7.1–6 EPA QA/G-5 2.2.2 and 2.2.3 E.U. Commission Directive 2003/94/EC Article 11.4 ISO 15189:2012 5.7.2 ISO/IEC 17025:2017 7.3.3 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards OECD GLP Principles 6.1 PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6) USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13 USDA Sampling Procedures for PDP 5.1 WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21 1.9 The system shall be able to define the collection and sampling 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), sampling methods used, safety concerns, and retention period. ASTM E1578-18 C-1-9 ACMG Technical Standards for Clinical Genetics Laboratories G1.4 CLSI QMS22 2.2.1.3 EPA ERLN Laboratory Requirements 3.2.1 EPA ERLN Laboratory Requirements 4.4.5 1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text. ASTM E1578-18 C-1-10 1.11 The system should support the creation of user-definable default sample registration preferences and/or input screens. 21 CFR Part 1.1149 ASTM E1578-18 C-1-11 PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7) WADA International Standard for Laboratories (ISL) 5.3.2 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. 21 CFR Part 1.1152 (d) 21 CFR Part 58.107 (c) 21 CFR Part 211.194 42 CFR Part 493.1241 42 CFR Part 493.1274 42 CFR Part 493.1283 AAVLD Requirements for an AVMDL Sec. 5.8.2 ABFT Accreditation Manual D-3 ASTM E1578-18 C-1-12 CAP Laboratory Accreditation Manual EPA ERLN Laboratory Requirements 3.2.2 EPA ERLN Laboratory Requirements 4.1.11 EPA ERLN Laboratory Requirements 4.4.10 EPA QA/G-5 2.2.3 E.U. Commission Directive 2003/94/EC Article 15 ISO/IEC 17025:2017 7.4.2 OECD GLP Principles 6.2 PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5) USDA Sample Processing and Analysis Procedures for PDP 5.1.11 USDA Sampling Procedures for PDP 6.4.1.2.5 WADA International Standard for Laboratories (ISL) 5.3.2 WHO Technical Report Series, #986, Annex 2, 17.11 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. 7 CFR Part 331.17 9 CFR Part 121.17 21 CFR Part 58.107 (d) 21 CFR Part 211.194 42 CFR Part 73.17 ASTM E1578-18 C-1-13 CAP Laboratory Accreditation Manual CLSI QMS22 2.2.1.3 EPA ERLN Laboratory Requirements 4.4.7 EPA QA/G-5 2.2.3 OECD GLP Principles 6.1 TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3) 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. 21 CFR Part 1.1149 ASTM E1578-18 C-1-14 EPA ERLN Laboratory Requirements 4.4.6 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. ACMG Technical Standards for Clinical Genetics Laboratories C3.3 AAVLD Requirements for an AVMDL Sec. 5.8.3 ASTM E1492-11 4.1.1.5 ASTM E1492-11 4.1.6 ASTM E1492-11 4.3.3.2 ASTM E1578-18 C-1-15 CAP Laboratory Accreditation Manual CLSI QMS22 2.2.1.3 EPA ERLN Laboratory Requirements 4.4.13 EPA ERLN Laboratory Requirements 4.11.8 ISO/IEC 17025:2017 7.4.3 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2) USDA Sample Processing and Analysis Procedures for PDP 5.1.3–7 USDA Sampling Procedures for PDP 6.4.1.1.9 WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1 1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample. 21 CFR Part 1.1149 A2LA C211 5.7 ASTM E1578-18 C-1-16 EPA QA/G-5 2.2.2 and 2.2.3 1.17 The system should provide a means to document sample preparation activities for a given sample. 7 CFR Part 331.11 7 CFR Part 331.17 9 CFR Part 121.11 9 CFR Part 121.17 21 CFR Part 1.1149 21 CFR Part 1.1152 (d) 42 CFR Part 73.11 42 CFR Part 73.17 42 CFR Part 493.1274 A2LA C223 4.13 A2LA C223 5.8 ABFT Accreditation Manual Sec. D-9–10 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1 ASTM E1492-11 (throughout) ASTM E1578-18 C-1-17 CLSI QMS22 2.2.3.5 EPA 815-R-05-004 Chap. III, Sec. 12 EPA 815-R-05-004 Appendix A EPA ERLN Laboratory Requirements 3.2.3–5 EPA ERLN Laboratory Requirements 4.1.13 EPA ERLN Laboratory Requirements 4.4.8–9 EPA QA/G-5 2.2.3 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1 GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2 GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3 NIST 800-53, Rev. 5, AU-10(3) PFP Human and Animal Food Testing Laboratories Best Practices Manual SQF FSC 9, Food Manufacturing, Part B, 2.6.2 SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2 TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8) WADA International Standard for Laboratories (ISL) (throughout) 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. 7 CFR Part 331.16 9 CFR Part 121.16 42 CFR Part 73.16 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. ACMG Technical Standards for Clinical Genetics Laboratories G1.1 APHL 2019 LIS Project Management Guidebook 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.

2. Sample management

Regulation, Specification, or Guidance Requirement ASTM E1578-18 C-2-1 EPA ERLN Laboratory Requirements 4.11.14 SQF FSC 9, Food Manufacturing, Part B, 2.6.2 SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2 2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents. ASTM E1578-18 C-2-2 EPA ERLN Laboratory Requirements 4.11.14 2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents. ASTM E1578-18 C-2-3 EPA ERLN Laboratory Requirements 4.11.14 2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value. ASTM E1578-18 C-2-4 EPA ERLN Laboratory Requirements 4.11.14 2.4 The system shall require the recording of a standard and reagent's first opening date. ASTM E1578-18 C-2-5 EPA ERLN Laboratory Requirements 4.11.14 2.5 The system shall allow only active standards and reagents to be shown as available for use. ASTM E1578-18 C-2-6 EPA ERLN Laboratory Requirements 4.11.14 2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel. ASTM E1578-18 C-2-7 2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status. ASTM E1578-18 C-2-8 EPA ERLN Laboratory Requirements 3.2 ISO/IEC 17025:2017 7.4.2 2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology. 7 CFR Part 331.17 9 CFR Part 121.17 21 CFR Part 211.84 42 CFR Part 73.17 ASTM E1492-11 4.2.1 ASTM E1578-18 C-2-9 CAP Laboratory Accreditation Manual 2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status. 21 CFR Part 1.1152 (d) A2LA C211 5.4 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1 ASTM E1578-18 C-2-10 2.10 The system shall be able to link test methods and specifications to standards and reagents. 21 CFR Part 1.1138 21 CFR Part 1.1150 21 CFR Part 1.1153 (c) 21 CFR Part 111.315 21 CFR Part 129.80 (g) 21 CFR Part 211.84 21 CFR Part 211.166–7 21 CFR Part 211.194 (e) 21 CFR Part 212.40 (c) 21 CFR Part 212.61 21 CFR Part 212.70 (e) 21 CFR Part 225.58 21 CFR Part 226.58 21 CFR Part 606.65 (c) 21 CFR Part 606.151 A2LA C223 5.9 ACMG Technical Standards for Clinical Genetics Laboratories C6.2 ACMG Technical Standards for Clinical Genetics Laboratories C10–12 CAP Laboratory Accreditation Manual ASTM E1578-18 C-2-11 EPA ERLN Laboratory Requirements 3.1.2.1 EPA ERLN Laboratory Requirements 4.3.2 EPA ERLN Laboratory Requirements 4.11.3.2 EPA QA/G-5 2.2.5 ISO/IEC 17025:2017 7.7.2 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards NYSDOH ELAP Medical Marijuana Microbiology Guidance PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1) USDA Administrative Procedures for the PDP 8.5 USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2 USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h WADA International Standard for Laboratories (ISL) 5.3.7 WHO Technical Report Series, #961, Annex 13, 12.1 WHO Technical Report Series, #986, Annex 2, 17.7 WHO Technical Report Series, #986, Annex 2, 17.22–25 2.11 The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing. FDA Q1A(R2) 2.12 The system should allow authorized users to create projects and research studies in the system—including, e.g., stability studies—and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.

3. Core laboratory testing and experiments

Regulation, Specification, or Guidance Requirement 21 CFR Part 111.315 21 CFR Part 211.84 (d) ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1 ASTM E1578-18 C-3-1 CLSI QMS22 2.2.2.1 ISO 15189:2012 5.3.2.7 WADA International Standard for Laboratories (ISL) 5.2.7 3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use. 21 CFR Part 211.84 (e) 42 CFR Part 493.1252 (d) ASTM E1578-18 C-3-2 WADA International Standard for Laboratories (ISL) 5.2.7 3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments. 42 CFR Part 493.1252 (d) ASTM E1578-18 C-3-3 3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing. ASTM E1578-18 C-3-4 3.4 The system shall be able to check physical, control, and specification limits for an instrument sample. ASTM E1578-18 C-3-6 3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test. ASTM E1578-18 C-3-7 3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet. ASTM E1578-18 C-3-8 3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes. ASTM E1578-18 C-3-9 3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest. ASTM E1578-18 C-3-10 3.9 The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results. AIHA-LAP Policies 2022 2A.7.8.2 ASTM E1578-18 C-3-11 3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results. ASTM E1578-18 C-3-12 3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions. 42 CFR Part 493.1241 ASTM E1578-18 C-3-13 EPA ERLN Laboratory Requirements 4.9.11 3.12 The system should effectively alert users upon entry of out-of-specification test results. 21 CFR Part 1.1150 21 CFR Part 1.1152 (a–b) 21 CFR Part 1.1152 (d) 21 CFR Part 1.1153 (c) 21 CFR Part 106.100 (c–f) 21 CFR Part 111.110 21 CFR Part 111.325 21 CFR Part 112.161 21 CFR Part 114.100 (a) 21 CFR Part 129.80 (g) 21 CFR Part 211.194 21 CFR Part 212.60 (g) 21 CFR Part 507.202 21 CFR Part 606.160 ACMG Technical Standards for Clinical Genetics Laboratories G16.1 A2LA C223 5.10 ASTM E1578-18 C-3-14 BRC GSFS, Issue 8, 5.6.1.2 BRC GSFS, Issue 8, 9.3.1 BRC GSFS, Issue 8, 9.3.5 CLSI QMS22 2.1.2 CLSI QMS22 2.2.2.1 EPA ERLN Laboratory Requirements 3.1.2.3–4 EPA ERLN Laboratory Requirements 3.2 EPA ERLN Laboratory Requirements 4.3.4 EPA ERLN Laboratory Requirements 4.8.1–4 EPA ERLN Laboratory Requirements 4.11.16 E.U. Commission Reg. No. 852/2004 Annex I, Section II.4.i E.U. Commission Reg. No. 852/2004 Annex I, Section III.8.d E.U. Commission Reg. No. 852/2004 Annex I, Section III.9.c IFS Food 7, Part 2, 4.18.3 IFS PACsecure 2, Part 2, 4.18.3 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards PFP Human and Animal Food Testing Laboratories Best Practices Manual SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6 SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6 USDA Data and Instrumentation for PDP 5.4.2 USDA Data and Instrumentation for PDP 8.1.3 WHO Technical Report Series, #986, Annex 2, 15.8 3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes. WADA International Standard for Laboratories (ISL) 1.2 3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.

4. Results review and verification

Regulation, Specification, or Guidance Requirement 21 CFR Part 211.68 (b) 42 CFR Part 493.1241 ASTM E1578-18 C-4-1 BRC GSFS, Issue 8, 5.6.2.4 CAP Laboratory Accreditation Manual CLSI QMS22 2.2.1.2 EPA ERLN Laboratory Requirements 4.9.11 EPA QA/G-5 2.4.1 ISO 15189:2012 5.5.1.4 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards WHO Technical Report Series, #996, Annex 5, Appendix 1 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded. ASTM E1578-18 C-4-2 CLSI AUTO15 1.2 EPA ERLN Laboratory Requirements 4.9.2 EPA ERLN Laboratory Requirements 4.9.11 EPA QA/G-5 2.4.1 ISO 15189:2012 5.9.2 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards 4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests. 21 CFR Part 211.68 21 CFR Part 211.100 21 CFR Part 211.160 (a) 21 CFR Part 211.188 21 CFR Part 211.194 45 CFR Part 170.315 (d) ASTM E1578-18 C-4-3 CAP Laboratory Accreditation Manual CJIS Security Policy 5.4.1.1 CLSI QMS22 2.2.2.2 EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7 E.U. Commission Directive 2003/94/EC Article 9.2 ICH GCP 4.9.0 and 4.9.3 TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3) WADA International Standard for Laboratories (ISL) 5.2.3.5 WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9 WHO Technical Report Series, #996, Annex 5, 4.12 4.3 The system shall accurately maintain a full audit trail for modified results. 21 CFR Part 1.1152 (c) 21 CFR Part 111.110 21 CFR Part 211.68 (b) A2LA C211 5.9.1 A2LA C223 4.13 ABFT Accreditation Manual Sec. E-28–29 ACMG Technical Standards for Clinical Genetics Laboratories G15.1 AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4–5 ASTM E1578-18 C-4-4 BRC GSFS, Issue 8, 5.6.2.4 CAP Laboratory Accreditation Manual CLSI QMS22 2.2.2.2 EPA ERLN Laboratory Requirements 3.2.6 EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11 EPA ERLN Laboratory Requirements 4.11.4 EPA QA/G-5 2.2.10 EPA QA/G-5 2.4.1 E.U. Annex 11-6 IFS Food 7, Part 2, 5.6.4 IFS PACsecure 2, Part 2, 5.6.4 ISO 15189:2012 5.7.1 ISO/IEC 17025:2017 6.2.6 ISO/IEC 17025:2017 7.7.1 ISO/IEC 17025:2017 7.8.1.1 NIST 800-53, Rev. 5, AU-10(3) NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards PFP Human and Animal Food Testing Laboratories Best Practices Manual USDA Data and Instrumentation for PDP 10 WADA International Standard for Laboratories (ISL) 5.3.8.1 WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1 4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release. ASTM E1578-18 C-4-5 BRC GSFS, Issue 8, 5.6.2.4 BRC GSFS, Issue 8, 5.6.2.5 EPA ERLN Laboratory Requirements 4.9.11 EPA QA/G-5 2.2.10 EPA QA/G-5 2.4.1 E.U. Annex 11-6 IFS Food 7, Part 2, 5.6.4 IFS PACsecure 2, Part 2, 5.6.4 ISO 15189:2012 5.9.2 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards WHO Technical Report Series, #996, Annex 5, Appendix 1 4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results. ASTM E1578-18 C-4-6 EPA QA/G-5 2.2.10 EPA QA/G-5 2.4.1 E.U. Annex 11-6 4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits. CAP Laboratory Accreditation Manual CLSI AUTO15 4.0 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards 4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.

5. Sample, experiment, and study approval and verification

Regulation, Specification, or Guidance Requirement ASTM E1578-18 C-5-1 CAP Laboratory Accreditation Manual CLSI QMS22 2.2.3.5 USDA Sample Processing and Analysis Procedures for PDP 5.9–10 WADA International Standard for Laboratories (ISL) 5.3.12.1 5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc. AIHA-LAP Policies 2022 2A.7.7.2 ASTM E1578-18 C-5-2 CLSI QMS22 2.2.2.2 EMA Guidance on Good Manufacturing Practice and Good Distribution Practice WHO Technical Report Series, #996, Annex 5, 4.12 5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports. 21 CFR Part 211.160 (b) ASTM E1578-18 C-5-3 EPA 815-R-05-004 Chap. IV, Sec. 6.1 5.3 The system should provide appropriate functions for specific sample statuses like "approved," "rejected," and "cancelled," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.

6. Reporting

Regulation, Specification, or Guidance Requirement ASTM E1578-18 C-6-1 6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested. EPA ERLN Laboratory Requirements 3.4 EPA ERLN Laboratory Requirements 4.1.4 EPA ERLN Laboratory Requirements 4.12–15 6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes. 42 CFR Part 493.1291 (g) and (h) ACMG Technical Standards for Clinical Genetics Laboratories F7.2 ASTM E1578-18 C-6-2 CLSI QMS22 2.1.2.1 EPA ERLN Laboratory Requirements 4.11.4 EPA QA/G-5 2.4.2 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards 6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements. ABFT Accreditation Manual Sec. G-2 6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., "less than X mg/L") when doing so would provide relevant information to the report recipient. 7 CFR Part 91.25 21 CFR Part 1.1152 (d) 40 CFR Part 141.33 42 CFR Part 493.1291 (c–e) AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2 AAVLD Requirements for an AVMDL Sec. 5.4.2.1 AAVLD Requirements for an AVMDL Sec. 5.10.2–5 AIHA-LAP Policies 2022 2A.7.8.1 ABFT Accreditation Manual Sec. E-12 and -32 ASTM E1578-18 C-6-3 EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8 EPA 815-R-05-004 Chap. VI, Sec. 8 ISO 15189:2012 4.5.2 ISO 15189:2012 5.8.3 ISO/IEC 17025:2017 7.5.1 ISO/IEC 17025:2017 7.8.1.1 ISO/IEC 17025:2017 7.8.2.1 ISO/IEC 17025:2017 7.8.3.1 PFP Human and Animal Food Testing Laboratories Best Practices Manual USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d WHO Technical Report Series, #986, Annex 2, 15.43 6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates. 7 CFR Part 91.26–27 21 CFR Part 1.1152 (d) ASTM E1578-18 C-6-4 6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel. A2LA C211 5.10 ASTM E1578-18 C-6-5 BRC GSFS, Issue 8, 5.6.1.2 BRC GSFS, Issue 8, 9.3.5 CLSI QMS22 2.2.3 ISO 15189:2012 5.8.1 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10) USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3 WADA International Standard for Laboratories (ISL) 5.3.8.4 6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance. 7 CFR Part 331.5 9 CFR Part 121.5–6 21 CFR Part 1.1110 21 CFR Part 1.1152 (a–b) 21 CFR Part 58.185 21 CFR Part 312.64 21 CFR Part 812.150 40 CFR Part 141.31 40 CFR Part 141.721 40 CFR Part 370 Subpart C 40 CFR Part 372 Subpart B 40 CFR Part 704 40 CFR Part 717 Subpart A 40 CFR Part 720.40 42 CFR Part 73.5–6 42 CFR Part 493.43 (d) ABFT Accreditation Manual Sec. E-7 ACMG Technical Standards for Clinical Genetics Laboratories C13.3 ACMG Technical Standards for Clinical Genetics Laboratories E8 ACMG Technical Standards for Clinical Genetics Laboratories G17.1 ASTM E1578-18 C-6-7 CAP Laboratory Accreditation Manual CJIS Security Policy 5.3.1 EPA ERLN Laboratory Requirements 4.12–15 EPA QA/G-5 2.3.2 IFS Food 7, Part 4, 2.x IFS PACsecure 2, Part 4, 1.x NIST 800-53, Rev. 5, IR-6 and IR-6(1) OECD GLP Principles 9.1 PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (throughout) USDA Administrative Procedures for the PDP (throughout) WADA International Standard for Laboratories (ISL) 5.3.8.4 6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports. 7 CFR Part 91.28 21 CFR Part 1.1154 (c) 21 CFR Part 58 Sec. 58.185 (c) A2LA C211 5.10.9 AAVLD Requirements for an AVMDL Sec. 5.10.9–10 CLSI QMS22 2.2.3.4 ICH GCP 4.9.3 ISO/IEC 17025:2017 7.8.8 NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards OECD GLP Principles 9.1 PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9) 6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.