In Support of California Adoption of the TNI Standard
By Allison Mackenzie
“ELAP does not have a relevant accreditation standard…” and “…these deficiencies have cost the program credibility among key constituencies” (Phelps, Adelson, Arms, Miller, &
These were some of the stark conclusions of a panel of five laboratory accreditation experts from across the United States after their external examination of the existing California Environmental Laboratory Accreditation Program (CA ELAP). Their conclusion was that not only does California need a robust accreditation standard, but adoption in a timely fashion is of critical importance as hundreds of labs across the state and the country test and report thousands of pieces of analytical data—data that is vital to the protection of the public health and preservation of the environment—to California agencies daily. This paper will explore the key reasons why CA ELAP should adopt The NELAC Institute (TNI) Standard. Simply stated, the TNI Standard is the most comprehensive, practical, and economically viable option available to CA ELAP.
To begin, it is important to understand the basic purpose of accreditation. According to the website of the California State Water Resources Control Board (SWRCB), “ELAP-accredited laboratories have demonstrated capability to analyze environmental samples using approved methods” (ELAP, 2016). The purpose of a quality systems based laboratory standard is to ensure the competency of a laboratory to produce data of known and documented quality. All labs—public and private— produce data for decision making purposes affecting public health and safety and therefore must be held to the same standard, regardless of lab size. Labs perform compliance testing that is vital to the future of environmental sustainability and human health (Morgan, 2015; See also Appendix B). It is precisely because State agencies use this analytical data to monitor and make decisions regarding the environment and public health that ELAP “provides evaluation and accreditation on environmental testing laboratories to ensure the quality of analytical data [produced]” (ELAP, 2016). With ELAP’s purpose defined, we can assume that CA ELAP agrees with Parr’s (2010) following statement on data quality:
Data of known and documented quality is critical for end users of environmental measurement data and government agencies to make accurate, reliable and cost-effective decisions to protect the public health and the environment.
Focusing an accreditation system on methods alone is insufficient to ensure quality and consistency. As Parr (2010; See also Appendix C) continues to explain:
An important factor in improving the quality of environmental data and ensuring that the data are adequate for the intended purpose, is a consistent, stringent, comprehensive and yet practical accreditation program to ensure the competency of all environmental testing laboratories and related sampling and measurement organizations in the United States.
With this understanding of the basic purpose of accreditation under CA ELAP and the need for a quality system based laboratory standard to ensure data quality, this paper proposes that CA ELAP should adopt the TNI Standard because it is the most comprehensive, practical, and economically viable option available to CA ELAP.
Sitting on the edge of the Pacific Rim and boasting the world’s 8th largest economy, California is a global leader in agriculture, education, industry, manufacturing and technology (Sisney, Garosi, 2015). Interstate and international commerce depend on mutual recognition of standards and in fact, California’s trade and commerce extend across all fifty states and into countries around the world.
The TNI Standard employs the International Organization for Standardization (ISO) 17025, a quality systems document recognized nationally and internationally for the conformity assessment of testing laboratories. ISO standards, including ISO 17025, are used around the globe and are requisite in many nations, including the European Union (EU) countries and in Asia, (ISO, 2014).
With ISO 17025 as the foundation, the TNI laboratory standard adds requirements, specifications, and clarifications unique to the environmental field and necessary to assure a consistent approach to quality and establish the foundation for data comparability between labs. At the present time, the TNI Standard is recognized in over twenty five (25) states across the United States and has full reciprocity in twenty three (23) states. Twelve (12) states are qualified as TNI Assessment Bodies (AB) and TNI has been adopted by several states as the only acceptable accreditation standard across all regulatory programs, (Morgan, 2015; See also Appendix B). Founded in 1998 as the National Laboratory Accreditation Council and the National Laboratory Accreditation Program (NELAC & NELAP), the TNI Standard is well established and widely recognized (Parr, 2010; See also Appendix C).
Perhaps the most important feature of the TNI Standard is that it is a consensus-based standard which has been developed over twenty years with input and comment from hundreds of laboratory and regulatory professionals at the federal, state, and local levels. Countless hours of time have been devoted by experts with proficiency in all areas of environmental testing—from microbiology and chemistry to whole effluent toxicity and radiological testing—to create the TNI Standard. Hundreds of professionals gather twice each year at TNI conferences to discuss, clarify, recommend, and ultimately adopt improvements to the Standard with input having been derived from multiple committees working throughout the year. Collaboration and technical knowledge is the power of TNI, resulting in recognition of the TNI Standard as an American National Standard by the American National Standards Institute (ANSI).
Founded in 1918, ANSI’s mission is “To enhance both the global competitiveness of U. S. business and the U. S. quality of life by promoting…consensus standards and conformity assessment systems” (ANSI, 2016). In addition to creating guidelines and standards that impact energy, agriculture, construction, etc., a key activity of ANSI is to evaluate the competence of organizations that determine conformity assessment. ANSI recognition of TNI and the Standard adds credibility and further wide-spread recognition.
TNI is a comprehensive standard because it includes more than one aspect of accreditation. TNI has established standards for laboratory Performance Testing (PT) and for the providers of PTs. It outlines the requirements necessary for conformity in production, distribution, and evaluation of PTs and the generation and interpretation of PT results. Additionally, TNI addresses the quality systems necessary for an organization or program that provides accreditation under the Standard—the conformity of the AB. The AB’s must also adopt quality systems and practices to maintain consistency and demonstrate competence, and to ensure objectivity in assessment.
The TNI Standard has also shown scalability and applicability to a wide variety of laboratories. Large laboratories with more than 75 staff, specialty laboratories such as whole effluent toxicity and microbiology laboratories, and small laboratories with only one or two employees have all successfully implemented and benefited from the TNI Standard (Morgan, 2009). TNI and the lab professionals engaged in the continuous evaluation and improvement of the Standard have demonstrated a commitment to quality and sensitivity to the limited resources of small labs. In fact, many of the resources available through TNI, the working committees, and at the annual meetings are a direct reflection of this commitment. These resources include templates for Quality Assurance Manuals and Standard Operating Procedures (SOPs) and training webinars on implementation.
Adoption of the TNI Standard in California is the most practical option offering the quickest and most efficient implementation. The Standard is already well established and would not require the resources that would be necessary to create a California laboratory accreditation standard from scratch. At the onset, it took more than ten years to complete and adopt the first TNI Standard and more than five years is spent just to update the existing Standard.
In Wisconsin, a state that opted to take elements of existing standards and customize them, the process of creating and adopting a standard took six years (Sotomayor, 2015; See also Appendix D). Even using the regulatory framework developed more than six years ago in California as a starting point, agreement and consensus would take time and create delays. Given the constraints of the Bagley-Keene Act—and the strongly held opinions of members of ELTAC, the regulated community, and the regulatory agencies—collaboration would be both contentious and costly.
Adoption of the TNI Standard would enable ELAP and environmental laboratory managers to spend valuable time learning and applying the Standard and refining their existing laboratory systems and processes to meet the new criteria. Training and orientation of laboratory personnel could also begin sooner rather than waiting for new program development, approval and implementation. Additionally, the drafting, review and adoption of new regulations can begin in a more time efficient manner.
Data suggests TNI Standard adoption and implementation would improve data quality and defensibility across numerous regulatory programs: drinking water, recycled water, wastewater, and solid waste. According to a 2009 NELAP survey with 553 respondents from 42 states and six countries, 85% of the labs surveyed believed that implementation of NELAP had improved the quality and defensibility of the data they produced. 294 of the respondents were labs with 10 or fewer staff members and 17.5% (97) were small labs with less than three employees. Further, 476 out of 553 labs felt that NELAP improves employee quality awareness (Morgan, 2009). Implementing a standard that benefits both the data consumers and data producers is exceptionally practical.
Accreditation consistency is enhanced by the TNI Standard because ABs and labs must follow the same quality systems based program. Not only are the expectations of the accredited labs more clearly defined, but the AB must also meet clearly defined expectations. Therefore, in addition to serving the needs of State agencies by ensuring data quality and defensibility, the Standard also serves the needs of labs by ensuring the AB follows a specific set of rules and it offers a means of reconciling differences of perception through a formal standard interpretation request process.
Development of a customized California laboratory accreditation standard would be costly and fiscally irresponsible. According to conservative estimates, each year that the ELTAC and ELAP spend working to create a standard will cost the state of California, public agencies, and commercial laboratories somewhere between $200,000 and $500,000 (Appendix A). Even three years spent to accomplish the initiative could have a potential price tag of $1.5 Million. Arguably, that money is better invested in implementation and training instead of recreating the proverbial wheel.
A common misconception is that TNI places an undue financial burden on labs based on size. As previously discussed, there has been considerable effort made to streamline TNI requirements and to minimize the cost of implementation to small laboratories. All laboratories should be capable of the same level of quality, documentation, and technical ability. Indeed, all laboratory data—especially data used for regulatory compliance—must be of known quality and integrity. Size of population served should not have a bearing on the quality and reliability of the lab or the lab’s test results. Organizations and agencies unwilling or incapable of investing the time to meet a minimum level of regulatory conformity and quality should not be generating data critical to protection of the public health and the environment.
Finally, the TNI Standard provides the State of California and the laboratory community with resources that they would otherwise lack. The power of TNI rests in collaboration with environmental professionals across the United States, with direct access through TNI to the top experts in the environmental field and at regulatory agencies, and with the myriad resources developed by those professionals over the course of the existence of the national laboratory accreditation efforts. Without a doubt, the TNI Standard is the most economically viable option that is fiscally responsible to the water rate payer and to the California taxpayer.
In conclusion, if the intention of CA ELAP is to best serve its stakeholders—laboratories, State agencies, regulators, and the general public—adopting the TNI Standard is the answer. The TNI Standard is comprehensive in scope, service, and expertise. Its ISO 17025 and consensus-based foundation give the Standard wide-spread recognition, support, and applicability. The Standard is well-established and has proven benefits, making it the most practical choice in terms of manageable and effective implementation. Furthermore, adopting the TNI Standard is the most cost-effective solution for the State, as it can invest in implementation and training rather than the development of a new, untested program. In addition, the Standard will help ensure all labs operate at the appropriate level of quality—a level that is consistent with the quality of protection to which the public and environment are entitled. In short, the Standard is the best option for California which is why CA ELAP should adopt the TNI Standard.
ANSI (2016). ANSI Mission. Retrieved from http://www.ansi.org/about_ansi/overview.
ELAP, 2016. California State Water Resources Control Board website information on the Division of Drinking Water Environmental Laboratory Accreditation Program. Retrieved from http://www.waterboards.ca.gov/drinking_water/certlic/labs/index.shtml.
ISO (2014). Using and referencing ISO and IEC standards to support public policy. Retrieved from http://www.iso.org/sites/policy/documents.
Morgan, J. (2009). NELAP survey conducted Nov. 7th to Dec. 20th, 2008. Powerpoint presentation, 2009 National Environmental Monitoring Conference, San Antonio, TX.
Morgan, J. (2015). ACIL Laboratory Accreditation Perspective. Powerpoint presentation, Expert Review Panel Meeting, March, 2015, Costa Mesa, CA. Retrieved from http://sccwrp.org/elap.
Parr, J. (2010). History and future of laboratory accreditation. Presented at WEFTEC in 2008 and updated in 2010.
Phelps, L., Adelson, J., Arms, S., Miller, M., Speis, D. (2015). Expert Review Panel Final Report, October, 2015, Costa Mesa, CA. Retrieved from http://sccwrp.org/elap.
Sisney, J., Garosi, J. (2015). 2014 GDP: California Ranks 7th or 8th in the world. Retrieved from http://www.lao.ca.gov/LAOEconTax/Article/Detail/90.
Sotomayor, A. (2015). Hybrid accreditation standards: Wisconsin’s laboratory accreditation. Powerpoint presentation, Expert Review Panel meeting, August, 2015, Sacramento, CA.
This white paper was prepared for the May 11th meeting of the Environmental Laboratory Technical Advisory Committee (ELTAC) to CA ELAP.