TNI Offers Supports for California Laboratories after Adoption of a New Accreditation Program
Date Posted: 6-4-2020
May 15th, 2020, Weatherford, TX - On May 5, 2020 California's State Water Resources Control Board adopted a new set of regulations designed to modernize the California Environmental Laboratory Accreditation Program (ELAP). The NELAC Institute (TNI) congratulates the Water Board on their decision to require laboratories to use the TNI 2016 Standard, a nationally recognized standard that will improve laboratory data quality and performance and result in increased confidence in laboratory data. While some California laboratories are already operating under the requirements of the TNI Standard, the majority of the laboratories overseen by ELAP will need to undergo a transitionary process to ensure they comply with these new regulations. Beginning October 1st, 2020, laboratories will have a 3-year period to ensure they meet the TNI Standard requirements.
Depending on the type of laboratory technology they employ, many California laboratories may be required to use a "third-party assessment agency" or be accredited by one of TNI's NELAP Accreditation Bodies. A third-party assessment agency is a TNI-recognized Non-Governmental Accreditation Body (NGAB) that has a contract with California ELAP, or an accreditation body recognized by the Department of Defense. The table below lists all of the NELAP and TNI recognized Accreditation Bodies.
|Florida Department of Health
Illinois Environmental Protection Agency
Kansas Department of Health & Environment
Louisiana Department of Health
Louisiana Department of Environmental Quality
Minnesota Department of Health
New Hampshire Department of Environmental Services
New Jersey Department of Environmental Protection
New York State Department of Health
Oklahoma Department of Environmental Quality
Oregon Public Health Division
Pennsylvania Department of Environmental Protection
Texas Commission on Environmental Quality
Utah Department of Health
Virginia Department of General Services
|American Association for Laboratory Accreditation (A2LA)
ANSI National Accreditation Board (ANAB)
International Accreditation Service (IAS)
Perry Johnson Laboratory Accreditation, Inc. (PJLA)
* Only those NGABS that have a contract with California ELAP may be used.
TNI is also supporting California's efforts in a number of other ways.
TNI has a number of downloadable webcasts that are specific designed to help laboratories implement the 2016 standard, including:
- Corrective Action Process and Root Cause Analysis
- Internal Audits and Management Review
- Ethics Training for the Environmental Professional
- Establishing a Data Integrity Plan
- Defining Organizational Responsibilities
- Developing the Quality Manual as a Useful Management Tool
- Document and Document Control
- Records and Record Keeping
- Managing an Environmental Laboratory
- Method Selection, Validation and Demonstration of Capability
These and many other related courses can be found at: https://nelac-institute.org/content/eds-home.php
Small Laboratory Handbook
This document is intended to help explain the requirements of the 2016 Standard and to provide environmental laboratories, especially small laboratories, with clear, simple guidance on how to develop the policies and procedures that will allow them to become accredited to the TNI Standard. This handbook is NOT a substitute for reading and understanding the TNI Standard. https://nelac-institute.org/content/NELAP/howto.php
2016 Quality Manual Template
The 2016 TNI Quality Manual Template is a tool designed for laboratories to help prepare a Quality Manual in compliance with the 2016 TNI Standard. The prefabricated sections of the Quality Manual follow the ISO/IEC 17025 outline but are completely fluid so that you can put sections, examples, links or references anywhere. The Template includes helpful notes, examples and text that can be edited to match each laboratory's particular circumstances. It can be used by a laboratory to create a Quality Manual from scratch or ideas and sections can be used to update a current Quality Manual. https://nelac-institute.org/content/NELAP/howto.php
Quality Systems Checklist
TNI has published a Checklist to allow laboratories to do an internal gap analysis for the TNI 2016 Standard. This checklist may be downloaded online if you own a copy of the TNI Standard. This analysis will laboratories to see where they might need to add policies, procedures, or other documentation. https://nelac-institute.org/content/NELAP/qscheck2016-access.php
TNI has published three guidance documents on these specific topics.
- Proficiency Testing Reporting Limit (PTRL)
- Detection and Quantitation
- Instrument Calibration
Based on the successful pilot of a small program in California that occurred in 2019, on April 30, 2020, TNI launched a Mentor Program whose goal is to develop a laboratory mentoring program which considers various approaches such as one on one, conference calls, webinars and electronic bulletin boards. This program is expected to be implemented in the next 6-8 months.