The 25th anniversary of the modernization of the United States veterinary diagnostic laboratory system

Background

The Animal Health Safeguarding Review

The Animal Health Safeguarding Review ¹ (hereafter, Review) was the vision of leaders at USDA APHIS, the United States Animal Health Association (USAHA), and AAVLD who recognized and collectively decided to act on perceived threats to animal and human health, even before the historic events of 2001 occurred. An independent group was sought to conduct the Review, and it was managed via a cooperative agreement between the USDA APHIS and the National Association of State Departments of Agriculture (NASDA) Research Foundation. The work of the review occurred in 2000 and 2001, starting even before the accelerating crises of the time. The final report was published in October 2001 ( Fig. 1 ). The purpose of the Review was to evaluate the current programs for ensuring U.S. animal health, which was considered a national, military, and food security issue. The report would furnish an analysis of the current situation and make recommendations for the future.

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Figure 1.

Cover of Animal Health Safeguarding Review, October 2001.

The Review was written against the backdrop of the European FMD crisis, but subsequent events would make it even more urgent to improve preparedness. Overnight, the terrorist attacks of 2001 Sep 11 changed security and safety dynamics around the world. Risk analyses rapidly expanded beyond that of direct human safety to include vital infrastructures such as power, utilities, transportation, food safety, and food production/security.

In addition, pathogenic organisms regularly detected within our laboratories were found to be of interest to bioterrorists. This became obvious when, within weeks of 9/11, letters containing powder with viable anthrax spores were mailed to Senator Tom Daschle (South Dakota), Speaker of the U.S. House of Representatives, and Senator Tom Leahy (Vermont). A total of 22 individuals were sickened by anthrax-laced letters, and 5 were fatally infected. This event directly impacted safety management within our VDLs, revealing an imminent need for higher levels of laboratory personnel biosafety and pathogen containment and security.

Four committees were created to conduct the work of the Review, with several AAVLD leaders engaged in each committee. The committees included:

The 46 animal health experts assembled for the Review included veterinarians, industry leaders, state and federal agency leaders and regulatory officials, diagnosticians, researchers, and producers. AAVLD members serving on the Review included: Richard Breitmeyer, Sharon Hietala, Don Lein, Bruce Akey, David Zeman, Alex Ardans, Mo Salman, and Linda Logan.

The committees reviewed documents, analyzed data, held meetings with pertinent stakeholders, and conducted on-site visits and interviews at state and federal laboratory facilities. Some teams visited the borders and observed interdiction facilities and procedures (such as the Miami International Airport and the Canadian border at Pembina, ND). The Review report was published and released in October 2001. The following recommendations and needs are direct quotes from the Review.

MOU between AAVLD and USDA NVSL

After years of discussion, debate, and deliberation, and shortly following the publication of the Review, an historic agreement was finally reached between the federal diagnostic laboratories managed by the USDA APHIS-VS NVSL and the AAVLD, which represented the state veterinary diagnostic laboratories. The first Memorandum of Understanding ⁴ (MOU; APHIS agreement 02-9419-577-MU; Fig. 2 ) was signed on 2001 Nov 3, by AAVLD President David Zeman and NVSL Interim Director Beverly Schmitt. Shortly after, USDA APHIS-VS Deputy Administrator Alfonso Torres signed the document. The document clearly stated the purpose, background, objectives, and responsibilities of each party, and defined joint management roles. In short, it created an unprecedented state/federal partnership between AAVLD and the USDA APHIS-VS NVSL. The partners were charged with the task of developing an effective national strategy to create and maintain a system to ensure quality animal health diagnostic services.

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Figure 2.

The first MOU between AAVLD and USDA NVSL, November 2001.

Here are some key concepts directly quoted from the MOU, ⁴ as signed in the original 2001 document:

The MOU was a strategic necessity that removed much of the prior ambiguity regarding the working relationship between the state and federal laboratories. It clearly declared the need for partnering so that our global trade partners could have confidence in our national herd and flock health status. Each partner accepted roles that were necessary for a successful animal health diagnostic system in a nation of our size and complexity. The state laboratories brought access to animal diagnostic caseload across the nation, established relationships with veterinary practitioners, animal producers, and owners, and provided testing capacity along with cutting-edge technologies from university research affiliations. The federal laboratories brought statutory authority, coordination, and subject matter expertise, as well as working relationships with state and federal regulatory agencies.

The MOU utilized many recommendations from the Review ¹ and was one of the earliest action items from that landmark document. The MOU mandate to utilize AAVLD-accredited laboratories to establish an “animal health diagnostic system” in partnership with NVSL ultimately led to the establishment of the NAHLN in 2002. NAHLN not only fulfilled the MOU’s appeal for state lab participation in official FAD testing, but also ensured these labs have a continued role in testing for national animal program diseases and other high-consequence animal diseases.

After both partners signed the MOU in the fall of 2001, incoming President Pat Blanchard began implementation efforts, working alongside the new NVSL Director, Randall Levings. The following Joint USAHA/AAVLD Government Relations Committee meeting in Washington, DC, March 2002, was important for promoting the goals of the MOU. It was at this meeting that a group of AAVLD leaders met to write the first one-page legislative informational document describing and proposing the establishment of a new network, the NAHLN. Volunteers working on that original promotional document ( Fig. 3 ) were: Don Lein, Bruce Akey, Alex Ardans, Terry McElwain, and David Zeman. The document described the rationale and financial resources needed to establish such a network. It proposed $70M for startup funds: USD 20M for NVSL and USD 50M for the state labs (~1M per state laboratory). Ongoing annual operational costs were estimated at USD 22M per year. Upon completion, the NAHLN proposal document was shared with USDA leaders and widely distributed across Capitol Hill in 2002, officially launching the campaign to establish and fund the NAHLN.

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Figure 3.

The first AAVLD General Relations Committee legislative informational document (“white paper”) advocating for funding of the NAHLN, March 2002. https://www.aphis.usda.gov/sites/default/files/aavld_nahln_white_paper_2002march.pdf

The first federal support for the effort came quickly, with the passing of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The goal of the act was to strengthen our national defenses against biological threats, including threats to the food supply. Potential bioterrorism against our nation’s food-producing flocks and herds was a significant concern at the time.

Additional support toward the development of the NAHLN came from the direction of President George W. Bush when, on 2004 Jan 30, he signed the Homeland Security Presidential Directive 9 (HSPD-9). The USDA, Department of Homeland Security (DHS), and HHS were assigned responsibilities to establish policies and actions that would protect the nation’s food systems against potential terrorism, natural threats, or accidental introductions of foreign diseases associated with the growing international trade in agricultural products (including trading and transport of animals and animal products). VDLs working in coordination clearly were going to be necessary for success. HSPD-9 led to significant funding for the NAHLN. HSPD-9 also led to the establishment of the FDA Food Emergency Response Network. During that time, AAVLD leaders met with allies from USAHA and animal producers each year to promote the development of the NAHLN. Those efforts included regularly updating the original AAVLD NAHLN advocacy document, refining its mission, and seeking funds to improve animal health diagnostic laboratory infrastructure and operational needs. In 2006, USDA Administrator Ron DeHaven presented Terry McElwain and Willie Reed with the APHIS Administrator’s Award for their role in the early implementation years of the NAHLN.

AAVLD leaders and allies simultaneously advocated for the need to modernize NVSL facilities, including the labs at Ames and Plum Island, to secure their indispensable role as reference laboratories and coordinators of the new laboratory network. USDA leaders gave guidance on making these laboratories world-class and physically secure and biosecure facilities. USDA could not directly advocate for funding, so AAVLD, USAHA, and agricultural producer groups stepped in to garner support, promoting the urgent need for funding these federal laboratory improvements.

The original MOU of 2001 was launched through the efforts of several AAVLD leaders of the time, including Don Lein, Bruce Akey, Alex Ardans, Leon Thacker, Art Bickford, David Zeman, and Doris Miller. After its launch, the MOU goals were nurtured and refined by subsequent AAVLD leaders, including Pat Blanchard, Terry McElwain, and Willie Reed. From the start, USDA leaders were highly supportive of the goals of the MOU, and those early leaders included Bill Buisch, Beverly Schmitt, Alfonso Torres, Randall Levings, Elizabeth Lautner, Bobby Accord, Bill Wagner, John Clifford, Ron DeHaven, and Barb Martin. Subsequent leaders of both MOU partners have now worked for 25 y to sustain the goals of the MOU and improve key aspects of the system, making it one of the most effective state/federal partnerships of our time.

Since the signing of the original MOU on 2001 Nov 3, the document has been updated and renewed heartily by leaders of both AAVLD and USDA:

Modernization of the AAVLD laboratory accreditation standard

Larry Morehouse published a historic review of AAVLD in the June 1994 AAVLD Newsletter. ⁵ The first exploratory organizational meeting for the now AAVLD was in 1957, during the American Veterinary Medical Association (AVMA) meeting in Cleveland, OH. A core group of 32 diagnosticians (representing 19 states, Hawaii, Canada) and the USDA decided to name the organization the Conference of Veterinary Laboratory Diagnosticians and established its purpose and goals. As stated in Dr. Morehouse’s review: “All individuals present expressed the opinion that much closer organization and cooperation between laboratories offering diagnostic services throughout the country was needed.” That key concept of cooperation (working together to improve our diagnostic services; sharing best methods, procedures, and practices) has remained a core tenet and secret to our success over the decades.

About a decade later, in 1968, AAVLD President Vaugh Seaton of Iowa State University announced that a voluntary laboratory accreditation program was soon to be launched. He noted, “We do not yet have a final plan in mind as to how all the details can be carried out but real progress has been made and I believe we can very soon embark on a voluntary laboratory certification program.”

In 1969 that ongoing concept of cooperatively sharing best methods, procedures, and practices culminated in the writing of the historic first veterinary diagnostic laboratory accreditation standard of the AAVLD (to our knowledge, the world’s oldest comprehensive VDL accreditation standard). The AAVLD Accreditation Committee prepared to receive applications for the new standard and developed procedures to determine accreditation status for labs that were voluntarily applying. In 1970, the first applications were received from 8 VDLs. After on-site audits, 3 were accredited: the South Dakota State University ADRDL (Brookings, SD), the Iowa State University VDL (Ames, IA), and the Kentucky Department of Agriculture VDL (Hopkinsville, KY); 3 other laboratories were provisionally accredited: Indiana/Purdue University ADDL (West Lafayette, IN), the University of Missouri VMDL (Columbia, MO), and the University of Connecticut VMDL (Storrs, CT). Now, decades later, 70 accredited laboratories exist across the United States and Canada (includes branch laboratories).

The AAVLD laboratory accreditation standard proved to be a key mechanism for diagnostic laboratories, enabling them to work cooperatively, adopt best practices, and produce uniform animal test results across the continent. The combined test results from state laboratories formed the national herd and flock health status, which directly impacted trade negotiations. Getting these standards right was highly important, as the global trading of agricultural products expanded. In 1972, regarding the voluntary AAVLD accreditation program, AAVLD President Ken Keahey of Michigan State University stated, “We believe that accreditation of laboratories will be essential, in the years to come, to enable standardization of techniques, interpretations, nomenclature, reporting systems and animal disease surveillance.” This prediction certainly came true; in the decades to follow, laboratories across our nation and Canada continue to voluntarily maintain the quality rigor required to be an accredited AAVLD veterinary diagnostic laboratory.

However, in a world where the international trading of animals and animal products is ever-growing, international recognition of our VDL accreditation program quickly became an issue for consideration. AAVLD, with one of the world’s oldest, most comprehensive, and rigorous accreditation programs, was largely unfamiliar to those outside of North America. No defined world standard was available at that time. The OIE was studying the matter, as was AAVLD. In fact, AAVLD had been considering options a full year before 2001. In July 2000, President Akey reported to the board of directors that one of the goals established at the recent 2000 AAVLD Strategic Planning Meeting was to:

“Gain recognition of AAVLD accreditation as a viable internationally acceptable quality-based process for accreditation in order to ensure acceptance of work performed in AAVLD laboratories.”

At the 2000 Annual Meeting in Hershey, PA, Program Chair David Zeman arranged a panel of experts for our turn-of-the-century plenary session: Expectations of AAVLD Laboratories in the Next Century. Topics and participants included:

The 2000 AAVLD House of Delegates passed the following resolution at the same meeting: “The Accreditation Committee shall investigate the feasibility of utilizing ISO 17025 as part of the accreditation of AALVD Labs and the feasibility of utilizing an appropriate accreditor to assist with accreditation responsibilities for AAVLD under AAVLD/NVSL advisement.” ISO 17025 was the international standard for testing and calibration laboratories. It could be universally applied to VDL accreditation with some modifications.

In response to the resolution, Accreditation Committee Chair Leon Thacker and David Zeman registered for and completed a one-week auditor training with The American Association for Laboratory Accreditation (A2LA) in the spring of 2001, giving them greater familiarity with the ISO 17025 standard. Members of the Accreditation Committee agreed to write a feasibility white paper regarding the possible transition of our accreditation standard, making it compatible with both OIE expectations and the ISO 17025 standard. That paper was intended to be ready for board consideration at the 2001 annual meeting. Also in 2001, while attending the WAVLD meeting in Europe, AAVLD President David Zeman and President-Elect Pat Blanchard met with OIE leaders (Jim Pearson) and Great Britain laboratory leaders to discuss accreditation standards and how Europe was utilizing the ISO 17025 standard in their laboratories.

Taken together, the Review, ¹ the events of 9/11, and the UK FMD outbreak of 2001, encouraged AAVLD leaders to both hasten and make final decisions regarding possible transformations of the accreditation program. The AAVLD/NVSL MOU signed that year specifically recognized the importance of gaining international recognition of our accreditation process. AAVLD leaders needed analytical guidance from the Accreditation Committee (at the time chaired by Leon Thacker) to make some decisions. The draft white paper was presented to the AAVLD Board at the annual meeting in November 2001. In February 2002, AAVLD accreditation leaders released the final version of that key white paper: AAVLD Laboratory Accreditation Program—Current and Future Perspectives; authored by McElwain et al. ³ ( Fig. 4 ). The paper summarized the rationale for incorporating the recommended OIE Standard (based on ISO 17025) into the AAVLD VDL accreditation standard. The authors recommended that AAVLD continue to directly manage the program as before through the AAVLD Accreditation Committee (vs. transferring the process to a private third-party accreditor). The authors noted that such plans, if adopted, would fulfill OIE expectations, advance the goals of the MOU, and allow AAVLD to continue to advance our discipline, drawing on a tradition of interlaboratory cooperation and self-improvement. A direct quote from the white paper ³ follows:

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Figure 4.

Title page of the Accreditation White Paper, written to explain the decision to rewrite the AAVLD standard, February 2002.

“The time is at hand for the AAVLD accreditation program to adopt internationally recognized standards for measuring veterinary diagnostic laboratory competence to perform prompt, accurate, and reliable testing for animal diseases and disorders. It is anticipated that the outcome of alterations to the AAVLD accreditation program will incorporate those standards that will provide authority for international recognition while maintaining the flexibility to accommodate the varying needs, testing requests, financial means, and administrative structures present in veterinary diagnostic laboratories associated with the AAVLD. As a first step, the Accreditation Committee recommends incorporation of OIE standards into the AAVLD Essential Requirements and accreditation process. This will require changes in the standards for accreditation, the site visit, and laboratory operation. It is the intention of the Accreditation Committee that these changes will be incorporated promptly, openly and with guidance from the organization so that all laboratories will have the opportunity to respond as necessary.”

At the February 2002 AAVLD Executive Board meeting, the board unanimously approved the recommendations from the Accreditation Committee as stated in the white paper.

The adoption of the new standard was a heavy lift for AAVLD and our associated laboratories. In addition to a complete rewrite of the old standard to better align with OIE international expectations, the new standard required significant retraining and increased human resources to make the Accreditation Committee fully operational. Laboratory auditors needed to be re-trained for auditing under the new standard. Laboratories needed to re-write their quality manuals and comply with higher expectations for documentation to show compliance.

Once the decision had been made, the first AAVLD ISO Assessor Training Workshop was promptly held in June 2002. Twenty-nine attendees were trained by ISO expert consultant Ken Stoub. The first laboratories were accredited under the new standard in 2005. It was a very busy time for the Accreditation Committee, which diligently managed these changes with excellent results. Now, 25 y later, the progress in advancing our discipline through the new accreditation standard ( Fig. 5 ) is quite evident, proven by our stakeholders’ high confidence in the thousands of test results produced daily across the accredited laboratory system. By transforming our accreditation standard, we have achieved greater international recognition and significantly expanded opportunities for state laboratories to participate in FAD testing—thanks to the MOU and the hard work and cooperation of veterinary diagnosticians committed to advancing our field.

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Figure 5.

AAVLD Accreditation Standard, 2023. https://aavldac.qualtraxcloud.com/Showdocument.aspx?ID=1137

Closing comments and appreciation

Our manuscript is written primarily from the perspective of veterinary laboratory diagnosticians that have been engaged for many decades with the mission of AAVLD. The efforts of allied organizations, especially USAHA and USDA, are not meant to be diminished, given that these entities played essential roles in the transformation described.

The rapid changes following the launch of these 3 major initiatives in 2001 were remarkable. Major events of that time certainly accelerated the transition (the UK FMD outbreak, 9/11, and the anthrax letters). The nation was in a mood to solve problems, and state and federal legislators were anxious to hear solutions and apply funds where necessary. Creating an effective state and federal veterinary diagnostic laboratory partnership just made sense. The AAVLD/NVSL partnership blended the capacity muscle of the state laboratory system with the authority and coordination power of the federal laboratory system.

Since then, state and federal governments have spent billions of dollars to build or remodel animal health diagnostic and research laboratories, and operational budgets have been expanded to meet the needs of our stakeholders. These facilities combined are the most extensive and competent animal health laboratory network in the world, including:

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Figure 6.

Map of AAVLD-accredited laboratories, 2026.

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Figure 7.

Map of NAHLN laboratories, 2026. https://www.aphis.usda.gov/labs/nahln/approved-labs.

To all veterinary laboratory diagnosticians, thank you for your dedicated service and Happy 25th Anniversary of the modernization of the U.S. veterinary diagnostic laboratory system!

In appreciation of all those who safeguard animal and human health

Several individuals—from both before and after 2001—are mentioned in this review, causing us to historically reminisce and celebrate the 25th anniversary of major changes in our U.S. animal health diagnostic laboratory system. We focused on AAVLD people involved with these changes ( Fig. 8 ). We regret if we have inadvertently omitted key players. Their exclusion in no way diminishes our appreciation of all leaders and members of the AAVLD, USDA, and USAHA, who long before and after these initial events, planted the seeds for progressive change and/or nurtured the growth of the system. These organizations have been and still are filled with dedicated professionals devoted to public service. Their work has alleviated animal suffering, kept food animal herds and flocks healthy as we aid producers in feeding the nation and the world, and are vital for protecting public health. That is good and noble work, and all involved have our utmost respect and appreciation for advancing our discipline.

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Figure 8.

AAVLD leaders and Accreditation Committee members, circa 2002. Left to right, standing: Sharon Heitala, Dave Korcal, Grant Maxie, Richard Mock, Ron Lewis, David Zeman, Willie Reed, Frank Galy, Alex Ardans, Bill Johnson, Pat Lukens; left to right, sitting: Bev Byrum, Ron Wilson, Helen Acland, Doris Miller, Leon Thacker, Terry McElwain, Barb Powers.