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| Regulation, Specification, or Guidance
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Requirement
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42 CFR Part 493.1241
APHL 2019 LIS Project Management Guidebook
ASTM E1578-18 C-1-1
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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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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
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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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45 CFR Part 162.410
CJIS Security Policy 5.6.1
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1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.
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42 CFR Part 493.1241
ASTM E1578-18 C-1-3
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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.
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7 CFR Part 91.19
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
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1.5 The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number) to be included during registration.
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| ASTM E1578-18 C-1-5
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1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
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| ASTM E1578-18 C-1-6
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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.
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| ASTM E1578-18 C-1-7
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1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.
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7 CFR Part 91.19
7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 58.105 (c)
21 CFR Part 58.195
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
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
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1.9 The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
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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
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1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.
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| ASTM E1578-18 C-1-10
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1.11 The system should support the creation of user-definable default sample registration preferences and/or input screens.
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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
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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.
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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</ref>
WHO Technical Report Series, #986, Annex 2, 17.11
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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.
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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)
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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.
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ASTM E1578-18 C-1-14
EPA ERLN Laboratory Requirements 4.4.6
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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.
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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
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
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1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
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A2LA C211 5.7
ASTM E1578-18 C-1-16
EPA QA/G-5 2.2.2 and 2.2.3
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1.17 The system should provide a means to document sample preparation activities for a given sample.
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7 CFR Part 331.11
7 CFR Part 331.17
9 CFR Part 121.11
9 CFR Part 121.17
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
PFP Human and Animal Food Testing Laboratories Best Practices Manual
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)
WADA International Standard for Laboratories (ISL) (throughout)
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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.
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7 CFR Part 331.16
9 CFR Part 121.16
42 CFR Part 73.16
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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.
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ACMG Technical Standards for Clinical Genetics Laboratories G1.1
APHL 2019 LIS Project Management Guidebook
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1.20 The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.
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