LII:LIMSpec/Primary Laboratory Workflow

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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
42 CFR Part 493.1241
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
ASTM E1492-11 4.1.1.6
ASTM E1578-18 C-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
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.
ASTM E1578-18 C-1-4
USDA Sampling Procedures for PDP 6.4.1.1.3
1.5 The system should permit metadata like lot number, client demographics, sampling point, random selection process used, and industry-specific items 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 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
ASTM E1578-18 C-1-8
EPA 815-R-05-004 Chap. IV, Sec. 6 and 8
EPA 815-R-05-004 Chap. VI, Sec. 8
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
OECD GLP Principles 6.1
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 sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
ASTM E1578-18 C-1-9
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.
ASTM E1578-18 C-1-11 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 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
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
USDA Sample Processing and Analysis Procedures for PDP 5.1.11
USDA Sampling Procedures for PDP 6.4.1.2.5
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
EPA ERLN Laboratory Requirements 4.4.7
EPA QA/G-5 2.2.3
OECD GLP Principles 6.1

1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.
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.

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
EPA ERLN Laboratory Requirements 4.4.13
EPA ERLN Laboratory Requirements 4.11.8
USDA Sample Processing and Analysis Procedures for PDP 5.1.3–7
USDA Sampling Procedures for PDP 6.4.1.1.9

1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
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
42 CFR Part 73.11
42 CFR Part 73.17
42 CFR Part 493.1274
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
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

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.

2. Sample management

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-2-1
EPA ERLN Laboratory Requirements 4.11.14
2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
ASTM E1578-18 C-2-2
EPA ERLN Laboratory Requirements 4.11.14
2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.
ASTM E1578-18 C-2-3
EPA ERLN Laboratory Requirements 4.11.14
2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
ASTM E1578-18 C-2-4
EPA ERLN Laboratory Requirements 4.11.14
2.4 The system shall require the recording of a standard and reagent's first opening date.
ASTM E1578-18 C-2-5
EPA ERLN Laboratory Requirements 4.11.14
2.5 The system shall allow only active standards and reagents to be shown as available for use.
ASTM E1578-18 C-2-6
EPA ERLN Laboratory Requirements 4.11.14
2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
ASTM E1578-18 C-2-7 2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample 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 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

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

21 CFR Part 211.84
21 CFR Part 211.166–7
21 CFR Part 211.194 (e)
21 CFR Part 212.40 (c)
21 CFR Part 212.61
21 CFR Part 212.70 (e)
21 CFR Part 225.58
21 CFR Part 226.58
21 CFR Part 606.65 (c)
21 CFR Part 606.151
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
USDA Administrative Procedures for the PDP 8.5
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 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, compatibility testing, identity testing, proficiency testing, and service-event-related testing.

3. Core laboratory testing and experiments

Regulation, Specification, or Guidance Requirement

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
ISO 15189:2012 5.3.2.7

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
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 2018 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 211.194
21 CFR Part 212.60 (g)
21 CFR Part 606.160
ASTM E1578-18 C-3-14
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
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.

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
EPA ERLN Laboratory Requirements 4.9.11
EPA QA/G-5 2.4.1
ISO 15189:2012 5.5.1.4

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
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

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
CJIS Security Policy 5.4.1.1
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Commission Directive 2003/94/EC Article 9.2
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9

4.3 The system shall accurately maintain a full audit trail for modified results.

21 CFR Part 211.68 (b)
ABFT Accreditation Manual Sec. E-28–29
[AIHA-LAP Policies 2018 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
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
ISO 15189:2012 5.7.1
ISO/IEC 17025:2017 7.8.1.1
USDA Data and Instrumentation for PDP 10

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
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
ISO 15189:2012 5.9.2

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.

5. Sample, experiment, and study approval and verification

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-5-1
USDA Sample Processing and Analysis Procedures for PDP 5.9–10
5.1 The system shall accurately record details of a sample's final disposition.
AIHA-LAP Policies 2018 2A.7.7.2
ASTM E1578-18 C-5-2
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" and "rejected," 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)
ASTM E1578-18 C-6-2
EPA ERLN Laboratory Requirements 4.11.4
EPA QA/G-5 2.4.2
6.3 The system shall alert users in advance to cases when the 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.

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 2018 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
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.
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.
ASTM E1578-18 C-6-5
ISO 15189:2012 5.8.1
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, 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 58.185
21 CFR Part 312.64
21 CFR Part 812.150
21 CFR Part 812.200
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
ASTM E1578-18 C-6-7
CJIS Security Policy 5.3.1
EPA ERLN Laboratory Requirements 4.12–15
EPA QA/G-5 2.3.2
NIST 800-53, Rev. 4, IR-6 and IR-6(1)
OECD GLP Principles 9.1
USDA Administrative Procedures for the PDP (throughout)

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, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.

21 CFR Part 58 Sec. 58.185 (c)
AAVLD Requirements for an AVMDL Sec. 5.10.9–10
ISO/IEC 17025:2017 7.8.8
OECD GLP Principles 9.1

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.