develop consensus standards for use by TNI's programs. This group has a support role in assisting other programs with activities such as guidance and standards interpretation.
fosters the generation of data of known and documented quality is through the National Environmental Laboratory Accreditation Program, or NELAP. The purpose of this program is to establish and implement a program for the accreditation of environmental laboratories.
is to establish and maintain a national PT program to support TNI’s National Environmental Laboratory Accreditation Program, and other activities.
Field Activities Program (NEFAP) Executive Committee is to establish and implement an accreditation program for field sampling and measurement organizations (FSMOs).
Audit Sample Program is to develop consensus standards for the manufacture and analysis of audit samples for source emission testing.
on a variety of topics of interest to the environmental measurement community. TNI also hosts two regularly scheduled meetings per year, typically in January and August. Both are a week long and involve open meetings of TNI committees as well as training courses and other special sessions.Standard Interpretations, Implementation Guidance, and Guidance Documents
TNI has established an avenue for resolution of questions submitted electronically on interpretation of the 2003 NELAC and 2009 and 2016 TNI Standards. The method for submittal is to complete an on-line form (available here). Use of this entry form ensures that a question is automatically accepted, cataloged and emailed to the NELAP Accreditation Council Chair, the LAS Executive Committee Chair and the TNI Program Administrator for review. A consensus of these three individuals shall determine who oversees the final disposition of the question. Timelines are defined for the NELAP Accreditation Council Chair and LAS Executive Committee Chair to ensure a timely response to the question. Publication of the consensus resolution is then made to the affected parties via email and on this page. These interpretations are organized by each Standard (2003, 2009, and 2016) and then by section number.
Some of the older interpretations are still applicable to the 2016 Standard; others are not. TNI has prepared a consolidated document with all interpretations that relate to Volume 1 of the 2016 standard.
Some SIR submissions are valid questions but do not meet the criteria to be a SIR. Those are being treated as clarification requests and are now addressed with answers termed “Implementation Guidance" that are posted below.
Three Guidance Documents relating to Proficiency Testing Reporting Limits, Instrument Calibration, and Limit of Detection and Limit of Quantitation have been developed to assist with implementation of the 2016 Standard.
Click here to subscribe.
|
|
|
|
|
| 475 | V1M1, Section 5.2 | PT Study Validity | 08/29/24 |
| 363 | V1M2, Section 4.3.1 and 4.3.2.2 | Laboratory Copy of TNI Standard | 10/13/20 |
| 433 | V1M2, Section 4.13.3 | Documentation of Lab Activities | 09/10/23 |
| 392 | V1M2, Section 5.5.8 | Calibration Labeling Requirements | 01/10/22 |
| 378 | V1M2, Section 5.5.13.1 | Calibration Frequency of Reference Thermometers | 01/10/22 |
| 401 | V1M2, Section 5.5.13.1 | Allowable microliter syringes | 12/15/21 |
| 453 | V1M2, Section 5.5.13.1 | Calibration of manual repeating pipettes | 09/17/23 |
| 465 | V1M2, Section 5.5.13.1 (e) | Verification of glass microliter syringes and Class A glassware | 01/05/24 |
| 321 | V1M2, Section 5.6.2.1 (f) | Technical manager education and experience for radon | 02/11/19 |
| 422 | V1M2, Section 5.6.4.2 | Consumable Materials for 'Technical Operations of the Laboratory' | 05/04/23 |
| 416 | V1M2, Section 5.6.4.2 (c) | Records for Standards, Reference Materials, and Reagent Preparation | 01/10/22 |
| 412 | V1M2, Section 5.6.4.2 (d) | Unique ID of Containers/Bottles | 09/10/23 |
| 340 | V1M4, Section 1.5.2.1.2 | MDL Requirements | 05/20/20 |
| 402 | V1M4, Section 1.5.2.1.2 and 1.5.2.2.2 (b) | Verification of DL and LOQ | 05/04/23 |
| 339 | V1M4, Section 1.6.1 (c) | Demonstration of Capability | 01/19/21 |
| 334 | V1M4, Section 1.6.3 | Demonstration of Capability Requirements | 01/19/21 |
| 396 | V1M4, Section 1.6.3 | Alternate Approaches to Ongoing Demonstration of Capability | 06/03/21 |
| 336 | V1M4, Section 1.6.3.2 | Demonstration of Capability - Use of Marginal Exceedance Limits | 01/19/21 |
| 437 | V1M4, Section 1.6.3.2 (c) | Ongoing Demonstration of Capability Requirements | 05/04/23 |
| 373 | V1M4, Section 1.7.1.1 | Negative Values of Relative Percent Error | 12/15/21 |
| 387 | V1M4, Section 1.7.1.1 | Instrumentation with Internal Calibrations | 12/15/21 |
| 389 | V1M4, Section 1.7.1.1 | Initial Calibration Second Source Verification of Surrogates or Internal Standards | 06/03/21 |
| 398 | V1M4, Section 1.7.1.1 | Minimum Number of Calibration Standards | 01/10/22 |
| 390 | V1M4, Section 1.7.1.1 (f) | Number of Standards Required for ISE Calibrations | 09/17/23 |
| 355 | V1M4, Section 1.7.1.1 (k) | Calibration Standard Requirements | 05/20/20 |
| 426 | V1M4, Section 1.7.3.2.2 (b) | Surrogates | 03/06/24 |
| 414 | V1M5, Section 1.6.4.2 (e) | Ongoing Demonstration of Capability Requirements | 07/29/22 |
| 331 | V1M5, Section 1.7.3.1 (a) | Checking Materials and Supplies | 12/11/19 |
| 406 | V1M5, Section 1.7.3.1 (b) | Media Performance Testing | 12/15/21 |
| 379 | V1M5, Section 1.7.3.3 | Variability/Reproducibility of Quanti-Tray | 10/13/20 |
| 471 | V1M5, Section 1.7.3.7.b.ii.a.4 | Autoclave Pressure Checks | 08/29/24 |
| 403 | V1M6, Section 1.7.2.1 | Radiation Measurement Batches (RMBs) | 07/29/22 |
| 441 | V1M6, Section 1.7.2.4 (b) | Using MD as a Measure of Precision | 05/04/23 |
| 399 | V1M6, Section 1.7.3.5 | Radiochemistry: Reporting Uncertainty | 12/15/21 |
| 477 | V2M1, Section 7.4.2 | AB Responsibility for Subcontracted Assessments | 07/25/24 |
|
|
|
|
|
| 266 | V1M1, Section 4.2.1 | Proficiency Testing, Methods and Technologies | 08/16/18 |
| 184 | V1M1, Section 4.2.1 | Analysis Date for PT Samples | 10/05/14 |
| 181 | V1M1, Section 4.2.1 (a) | Analysis Date for PT Samples | 03/13/14 |
| 185 | V1M1, Section 6.1 (b) and V1M2 8.2 (c) | Corrective Action Date for PTs | 10/05/14 |
| 194 | V1M1, Section 7.7.3; V2M3, Section 5.1 | Reassessment Requirements | 04/07/13 |
| 158 | V1M2, Section 4.1.7.2 and 5.2.6.1 (a) | Technical Director Requirements | 03/13/14 |
| 154 | V1M4, Section 4.2.8.4.r | Demonstration of Capability (DOC) | 04/07/13 |
| 308 | V1M2, Section 4.14.1 | Method Selection for Internal Audits | 01/16/18 |
| 296 | V1M2, Section 5.2.6.1 | Technical Manager Experience | 08/16/18 |
| 212 | V1M2, Section 5.2.6.1 (a) and (b) | Technical Director Experience | 04/07/14 |
| 302 | V1M2, Section 5.2.6.1 (c) | Technical Manager Education Requirements | 11/28/16 |
| 350 | V1M2, Section 5.2.6.2 (c) | Technical Manager Qualifications | 05/20/20 |
| 10005 | V1M2, Section 5.4.2 | Selection of Methods | 12/29/11 |
| 180 | V1M2, Section 5.4.2 | Selection of Methods | 10/05/14 |
| 270 | V1M2, Section 5.5.13.1 | Verification of Disposable Volumetric Dispensing Devices | 11/28/16 |
| 274 | V1M2, Section 5.5.13.1 | Checking Accuracy of Plasticware | 02/23/17 |
| 290 | V1M2, Section 5.5.13.1 (b) | Thermometer Correction Factors | 08/16/18 |
| 304 | V1M2, Section 5.5.13.1 (e) | Syringe Quarterly Checks | 08/16/18 |
| 232 | V1M2, Section 5.5.13.1 (e) | Accuracy Checks of Non-Class A Glassware | 01/16/18 |
| 206 | V1M2, Section 5.5.13.1 (b) | Calibration of Support Equipment | 10/05/14 |
| 192 | V1M2, Section 5.6.4.2 | Certificates of Analysis | 04/07/13 |
| 198 | V1M2, Section 5.6.4.2 | Documentation and Traceability of Consumables | 03/13/14 |
| 251 | V1M2, Section 5.6.4.2 (d) | Traceability of Reagents | 10/13/15 |
| 246 | V1M2, Section 5.8.5 (a) | Sample Container Identification | 06/11/19 |
| 204 | V1M4, Section 1.5.2.1 | Limit of Detection (LoD) Requirement | 02/10/14 |
| 148 | V1M4, Section 1.5.4 | Second Column Confirmation of PT Results | 03/13/14 |
| 297 | V1M4, Section 1.6.2 and 1.6.3 | Demonstration of Capability Requirements | 01/19/21 |
| 170 | V1M4, Section 1.6.2-1.6.3 | Demonstration of Capability for Work Cells | 03/13/14 |
| 199 | V1M4, Section 1.6.2.2 and 1.7.4.2 (b) | Marginal Exceedences and IDOCs | 03/13/14 |
| 277 | V1M4, Section 1.7.3.2.2 | LCS Requirements | 06/11/19 |
| 282 | V1M4, Section 1.7.3.2.3 and Note | LCS Requirements | 05/20/20 |
| 229 | V1M4, Section 1.7.3.2.3 | Matrix Spike in place of LCS | 06/11/19 |
| 161 | V1M4, Section 1.7.4.3 | Matrix Duplicate Precision | 02/10/14 |
| 285 | V1M5, Section 1.7.3.2 | Methods that Specify Colony Counts | 01/16/18 |
| 98 | V1M5, Section 1.7.3.5 (c) | Reagent Water | 10/13/15 |
| 138 | V1M4, Section 4.2.8.4 (r) | Microbiological Sample Handling | 04/07/13 |
| 214 | V1M6, Section 1.5.4 | Precision and Uncertainty | 10/14/13 |
| 215 | V1M6, Section 1.7.1 (a) | Calibration of Gamma Detectors | 01/07/14 |
| 305 | V2M1, Section 6.0 (ISO 17011:2004(E) 6.2.3) | Specific Scopes for Assessors | 01/16/18 |
| 165 | V2M1 (7.7.2-7.7.3) and V2M3 (6.13.2) | Reassessments and Surveillance Audits | 09/12/13 |
| 413 | V2M1, Section 8.2.1 | Secondary AB Reporting in LAMS | 07/29/22 |
| 200 | V2M1, V2M3: 8.2.1 (b) and 7 (b) | Key Personnel | 10/05/14 |
| 176 | V2M2 | PT for Biological Testing | 10/13/15 |
| 275 | V2M2, Section 4.1.1 (f) | Secondary AB Notification of Revocation of Lab Accreditation | 01/16/18 |
| 168 | V2M2, Section 6.3 | Multiple Preparation Methods for PTs | 10/05/14 |
| 216 | V2M3, Section 4.2.4 | Assessor Training Requirements | 02/10/14 |
|
|
|
|
| 2 | SCM FoPT (7/1/07); FoPT Table - NELAC Analyte 1935, Footnote 13 | 01/18/12 |
| 2 | FoPT Table - List of Analytes Requiring PTs | 10/16/17 |
| 2 | Proficiency Testing - evaluation of less than "<" results | 10/12/09 |
| 2.2.1, Appendix C.3 | PT Result Acceptability Below the PTRL | 07/26/11 |
| 2.5 | Requirements for Laboratory Testing of PT Study Samples | 07/26/11 |
| 2.6 | Evaluation of Proficiency Testing Results | 10/12/09 |
| 2.7.3.1 (d) | Supplemental PT Studies for Demonstating Corrective Action (PCB exception) | 10/12/09 |
| 5.4.2.6 | Data Integrity Procedures | 03/10/11 |
| 5.4.3.1 | Controlled Documents | 04/07/14 |
| 5.4.3.2.2 (b) | Frequency of Document Review | 01/25/09 |
| 5.4.5.4 | Subcontrator Lab Documentation | 11/08/12 |
| 5.4.9.1, 5.4.10.6 (b), 5.5.5.2.2.1 (d), 5.5.10.3.1 (a) | Initial Calibration Verification (ICV) Acceptance | 04/07/14 |
| 5.4.12 | Chain of Custody Requirements | 04/07/14 |
| 5.4.12.2.2 | Technical Records | 01/25/09 |
| 5.4.13.1 | Internal Audits | 03/29/12 |
| 5.5.2.6.c.3, 5.5.4.2.2.d, Chapter 5 Appendix C.1, Chapter 5 Appendix C.2 | Certification Statement for Demonstration of Capability | 07/26/11 |
| 5.5.2.6 (c) | Demonstration of Capability Requirements | 10/13/15 |
| 5.5.4.1.1 | Standard Operating Procedures (SOPs) | 01/25/09 |
| 5.5.4.2.2 | Demonstration of Capability | 01/25/09 |
| 5.5.4.2.2, Appendix A | Biological Tissue QC Matrix | 11/08/12 |
| 5.5.4.4; 5.5.4.5; Appendix C3.3 (b) | Non-standard methods / modification of methods | 02/22/09 |
| 5.5.4.6.1 | Estimation of Uncertainty of Measurement | 01/18/12 |
| 5.5.5.2.1 (b) | Calibration of NIST-traceable References | 04/07/14 |
| 5.5.5.2.2.1 (h) | Calibration Range for pH | 10/05/14 |
| 5.5.5.2.2.1 (d) | Definition of a second source standard | 02/22/09 |
| 5.5.5.2.2.1 (d) | Second Source Calibration Standards | 10/05/14 |
| 5.5.5.2.2.1 (d) | Initial Instrument Calibration (ICAL) - second source for surrogates | 10/26/09 |
| 5.5.5.5 | Electronic instrument maintenance records | 10/26/09 |
| 5.5.5.8 | Labeling of Calibrated Equipment | 04/16/12 |
| 5.5.5.10 | Instrument Calibration - CCVs | 01/25/09 |
| 5.5.5.10 | Initial Calibration Verification | 07/17/11 |
| 5.5.6.3.1 | Reference Standards | 03/12/12 |
| 5.5.6.4 | Certificate of Analysis for Reagents | 04/07/13 |
| 5.5.6.4 (c) | Documentation and Labeling of Standards, Reagents, and Reference Materials | 07/26/11 |
| 5.5.8.3.1 | Sample Receipt Protocols | 10/26/09 |
| 5.5.8.3.2 | Sample Acceptance Plan - communication frequency | 10/26/09 |
| 5.5.10 | Reporting Results | 07/26/11 |
| 5.5.10 | LOD and LOQ in Test Reports | 02/23/17 |
| 5.5.10.2 (i) | Test Reports - dry or wet weight notations | 01/25/09 |
| 5.5.10.2 | Identification of Test Method on Test Reports | 02/10/13 |
| Appendix B.2.1 and B.2.2 | RSD of verification analyses / QC check of assigned value | 10/26/09 |
| Appendix C.1 | Demonstration of Capability | 01/25/09 |
| Appendix C.1 (a), C.3.1, C.3.2 | Outside Source vs Secondary Source | 11/28/16 |
| Appendix C.1 (e) | Demonstration of Capability | 02/22/09 |
| Appendix.C.3.1 and C.3.2 | Limit of Quantitation (LOQ) Criteria | 09/22/14 |
| Appendix C.3.1 | Limit of Detection (LOD) | 04/07/13 |
| Appendix C.3.5 | Limit of Detection (LOD) / Limit of Quantitation (LOQ) | 02/10/13 |
| Appendix C.3.1 (b) | Limit of Detection (LOD) Verification | 07/26/11 |
| Appendix C.3.1 (b) | Limit of Detection (LOD) | 01/25/09 |
| Appendix C.3.2 | Limit of Quantitation (LOQ) | 03/12/12 |
| Appendix C.3.2 (c) | Confirmation of the Limit of Quantitation (LOQ) | 02/10/13 |
| Appendix D.1.1.1 (c) | Method Blank Composition | 11/28/16 |
| Appendix D.1.1.2.1 | Control Limits including Zero | 01/25/09 |
| Appendix D.1.1.2.1 (c) | Evaluation Criteria and Corrective Action | 09/18/12 |
| Appendix D.1.1.3.1 (c) | The laboratory does not include all target analytes in the matrix spike mixture over a 2-year period. | 01/25/09 |
| Appendix D.1.2.1 | MDL determination and the Method Update Rule (MUR) | 02/22/09 |
| Appendix D.1.2.1 (b) | Comparison of LOD with Blank | 10/14/13 |
| Appendix D.1.2.1 (c) | The laboratory must have established procedures to relate LOD with LOQ. | 01/25/09 |
| Appendix D.1.6 (a) | Constant and Consistent Test Conditions | 02/22/09 |
| Appendix D.2.8 (s) | Holding Time for Effluents | 03/12/12 |
| Appendix D.3.1 | Microbiological tests - positive sample verification | 10/26/09 |
| Appendix D.3.1.a.5 | Microbiology, Sterility Checks and Blanks | 04/09/12 |
| Appendix D.3.1(a)(2) | Microbiology, Sterility Checks and Blanks | 01/18/11 |
| Appendix D.3.8.b.2)iv) | Autoclave Maintenance | 03/29/12 |
| Appendix D.4.4c.3 | Radiation, Count Times of Background Measurements | 04/07/13 |
| Appendix E.3.2.1 / Chapter 2 2.6 | PT evaluations for microbiological data | 10/26/09 |
| Appendix F.2.1, F.2.2, F.3 | PT Requirements for WET Analysis | 07/26/11 |
Implementation Guidance documents are created to explain best practices for problem-solving or basic lab activities, typically but not always in response to questions submitted for interpretations which cannot be addressed adequately by that route. New IG documents are added over time, as topics for them are identified. Individuals that have questions about the applicability, scope, and use of this guidance may contact TNI at this link.
Implementation Guidance is available as a benefit to TNI Members only. You must be logged-in to view this content. If you are a TNI Member, click here to log in. For information about how to become a member, click here.
Disclaimer: This material represents the opinion of its authors. It is intended solely as guidance and does not include any mandatory requirements except where such requirements are referenced. This guidance does not establish expectations of being implemented universally, exclusively, in whole, or in part.
This guidance does not establish or affect legal rights or obligations and is not finally determinative of the issues it addresses. It does not create any rights enforceable by any party in litigation with TNI, its accreditation bodies, or affiliated institutions. Any decisions made by TNI regarding requirements addressed in this guidance will be made by applying the applicable standards, policies or procedures to the relevant facts.
Individuals that have questions about the applicability, scope, and use of this guidance may contact TNI at this link.
Guidance Documents
TNI Guidance on Instrument Calibration
TNI V1M1 2016 Standard Update Guidance on Proficiency Testing Reporting Limit (PTRL)
TNI V1M4 2016 Standard Update Guidance on Detection and Quantitation (rev. 9-23-2019)