October 2 5, 2012 NAHLN Concept Paper Page 1 of 6 

## United States Department of Agriculture Animal and Plant Health Inspection Service

and National Institute of Food and Agriculture

A Proposal for a Revised Structure of the National Animal Health Laboratory Network

(NAHLN)

October 2012October 2 5, 2012 NAHLN Concept Paper Page 2 of 6



### Executive Summary

The National Animal Health L aboratory Network (NAHLN) is a nationally coordinated network and partnership of F ederal , S tate , and university

- associated animal health laboratories. NAHLN laboratories provide animal health diagnostic testing to detect biological threats to the nation’s food animals, thus protecting animal health, public health, and the nation's food supply

. This paper : 1. D efin es the NAHLN laboratory membership structure; 2

. Recogni zes NAHLN oversight b y the U

. S

. Department of Agriculture (USD A) ; 3. Id entifies the role of the NAHLN Coordinating Council ; 4

. Id entifies the N ational Veterinary Service Laboratories (NVSL) a s the ref erence laboratories for the NAHLN ; and , 5

. Affirms the opportunity for each S tate to have a NAHLN laboratory as long as S tate laboratories meet defined minimum criteria.
These actions will allow the NAHLN to achieve its original surveillance and response goals and expand its capability and capacity for detecting emerging and zoonotic disease to protect animal health, public health , and the nation’s food supply

. Moreover, c odification of USDA oversight of the NAHLN , the existence of a NAHLN charter , and the outline of the network structure will give the NAHLN the flexibility to respond to future national animal health testing needs . The NAHLN will gain this flexibility through clearer designation of network members’ roles and responsibilities , and through the ability to more easil y expand or contract NAHLN testing capabilities and capacities. Other elements, such as the actual NAHLN charter and the specific requirements for each level of laboratory participation, will be referenced in program standards and will allow the NAHLN to respon d to the changing needs of animal agriculture. 

### Introduction
The NAHLN is the result of mutual recognition by members of the Ameri can Association of Veterinary Laboratory Diagnosticians (AAVLD) and F ederal officials that a nationall y coordinated network of animal health diagnostic laboratories is essential to protecting animal health, public health , and the nation's food supply from foreign animal and emerging diseases. In 2002, the USDA established a partnership with S tate and university

associated animal health diagnostic laboratories , with funding derived from appropriations authorized under Public Law 107

- 38 ( Emergency

Supplemental Appropriations Act for Recovery from and Response to Terrorist Att acks on the United States , codified at 50 U.S.C 414) to leverage and unite existing F ederal and S tate animal health diagnostic resources. Funding continues through c ongressional appropriations to the USDA , and substantial support from S tate governments. Originall y composed of 12 laboratories, the NAH LN has grown to include 12 C ore, 28 Member, and 9 Contract laboratories. Core laboratories are regionally distributed and capable of testing large numbers of samples that originate from food animal species

. Member laboratories are more widel y disseminated than C ore laboratories , and facilitate greater geographic coverage. Contract laboratories provide diagnostic testing for specific disease agents. In addition, a small number of adjunct laboratories , such as Fo od Safety and Inspection Service (FSIS) laboratories,October 2 5 , 2012 NAHLN Concept Paper Page 3 of 6

contribute to NAHLN efforts by providing a specific but needed diagnostic capability

. The NAHLN is overseen and administered by the USDA , with operational oversight provided through the Animal and Plant Health Inspection Service (APHIS). Initiall y, a s teering c ommittee composed of staff from S tate and university

- associated animal health laboratories, additional representatives from the AAV LD, a S tate veterinarian, and USDA staff was formed to provide input to NAHLN leadership

. The steering c ommittee was dis continued in 2009 , and a NAHLN C oordinating C ouncil was established to represent S tate regulatory and laboratory

partners rather than professional or other organizations

. The Coordinating Council is composed of USDA representatives, S tate animal health officials , and S tate employee representatives of NAHLN laboratories

. USDA established and approved a charter for the NAHLN Coordinating Council. This charter d efines F ederal oversight of the NAHLN and the roles and responsibilities of USDA agencies , the NAHLN Executive Committee, and the NAHLN Coordinating Council

. The structure of the network was not changed. 

### Proposed Changes
Recent feedback from a wide variety of stakeholders indicate s that the NAHLN structure need s to change to fully meet original surveillance and response goals , and to expand detection of emerging and zoonotic diseases. While the current NAHLN structure of C ore, M ember, and C ontract l aboratories has served the stakeholders well , the changes proposed in this paper ensure that the NAHLN continues to meet current and future needs. F ounding principles that guided NAHLN development in preceding ye ars remain intact

. For each participating laboratory , these are : a. Operat e within a quality management system that meets AAVLD , I SO 17025 , or equivalent requirements ; b. E stablish and maintain competency of laboratory

personnel ; c. U se s tandardized protocols, reference materials, and equipment ; d. P articipate in communications and reporting s ys tem s established by the NAHLN ; e. Us e f acilities with biosafety

/biosecurity levels requisite for testing performed ; and f. Evaluate preparedness (identify and prioritize gaps) through scenario testing.
The NAHLN structure described below is intended to ensure continuation of the founding principles while addressing changes necessary

to allow for needed flexibility and added capacity to more completely

address the current gaps in the nation ’ s surveillance , detection, and response capability

. 

### Proposed NAHLN Structure

**Governance :**  The proposed NAHLN structure preserves its current oversight, leadership, administrative structure, and roles and responsibilities as outlined in the USDA

- approved NAHLN charter (appended)

. Specifically , the USDA will provide F ederal oversight w ith APHI S being responsible for operational aspects of the NAHLN

. An Executive Committee composed of USDA staff will continue to review and implement the NAHLN s trategic and operational plans. The Coordinating Council , composed of USDA staff, S tate employee representatives of NAHLN laboratories , an d S tate animal healthOctober 2 5 , 2012 NAHLN Concept Paper Page 4 of 6

officials , will continue to provide a forum to discuss the NAHLN’s current and future needs.
**P articipation:**  Under the proposed structure, e ach S tate can sponsor a publicly

funded NAHLN laboratory

. However, participating laboratories must have sufficient laboratory

- generated income, S tate resources , or other public funds to qualify for their level of participation (see below)

. Having S tate

- based NAHLN laboratories allows for proximity to and linkages with producers and veterinarians critical to earl y detection of foreign animal and emerging diseases. Qualifying
requirements are tiered, and based on current understanding s of the needs of the overall network (see below) . To maintain a NAHLN designation, qualifying laboratories will undergo annual review s to demonstrate adherence to established NAHLN policies and procedures. **Laboratory designation s**  **:** Participating lab oratori es will be designated as Level s 1, 2, 3 , A ffiliate , or S pecialty laboratories

. Level 1, 2, and 3 l aboratories are publicl yfunded S tate and university

- associated animal health diagnostic laboratories

. Affiliated l aboratories are public ly

- funded laboratories that may occasionally p erform NAHLN

- related testing , and currently include the FSIS , the National Wildlife Health Center (NWHC) , and the Department of Defense, F ort Sam Houston laboratories

. Specialty l aboratories are private or commercial enterprises that provide diagnostic capabilities that do not exist at needed capacities within the NAHLN

. T o participate in the NAHLN, specialty l aboratories must have a written , USDA

approved plan that demonstrates the ability to avoid conflicts of interest in the testing they perform. USDA will have responsibility for decisions regarding laboratory membership and tier designations in the NAHLN , with input on criteria from the NAHLN Coordinating Council and other NAHLN s takeholders . All NAHLN laboratories are subject to an annual accountability

review with the designation of Level 1 laboratories reassessed at least every 5 years
. The principal difference between Level 1 and Level 2 laboratories is that L evel 1 laboratories must meet each defined criteri on , whereas Level 2 laboratories must only meet a subset of Level 1 criteria and have the option of meeting others as resources permit . Level 3 , A ffiliate , and S pecialty l aboratories need not be accredited , but will be required to have a USDA

- approv ed quality

management system. Affiliate and S pecialty l aboratories must also e stablish operational relationships with a designated NAHLN l aboratory and with the State animal h ealth o fficial for the S tate in which the laboratory is located

. **Level 1 L aboratories**  **:** Similar to current C ore laboratories, L evel 1 l aboratories will have the capacity

to perform test s on large numbers of samples that originate from U.S

farmed food animals. Unlike the current C ore laboratories , the number and identity of L evel 1 laboratories may change by adding or removing laboratories depending on national need and available funding

. The decision to modify the number or location of Level 1 l aboratories will be based on (1) overall national need , (2) population density

of the food animals of interest , (3 ) geographic location , (4) testing capabilities, (5) personnel expertise, (6) facilities and other infrastructure , and (7) level of S tate support.October 2 5 , 2012 NAHLN Concept Paper Page 5 of 6

T o be classified as a L evel 1 NAHLN l aboratory , a laboratory must:

a. M aintain capacity

to provide surge testing for disease agents of interest ; b. A s requested b y the USDA , participate in surveillance testing ; c. B e full y accredited by AAVLD , IS O 17025 , or by

another accrediting bo dy with equivalent standard s ; d. P erform all work within a quality management system under the direction of a quality

manager ; e. H ave staff members trained and proficiency

tested in diseases of interest ; f. P ossess a functional laboratory information management system (LIMS) ; g. H ave the capability

to electronicall y send diagnostic test results to APHI S databases ; h. Report test results within timeframes indicated in NAHLN standard operating procedures ; i. Help further develop the NAHLN IT system ; j. A s requested by the USDA , help other laboratories develop and implement IT capabilities to permit them to communicate testing results with NAHLN ; k. P rovide and maintain biosafety level 3 laboratory space adequate for work performed ; l. P ossess ongoing S tate funding adequate to maintain equipment and laboratory space used for NAHLN purposes ; m. A s requested by the USDA , send staf f members to other laboratories or field operation centers during emergency situations ; n. A s requested by the USDA , provide training for NAHLN test procedures ; o. A ccept samples that originate from other S tates affected by

disease outbreaks, especiall y those from Level 2 laboratories ; p. A ssist with NAHL

N test development and validation ; q. P articipate in NAHL

N

- related activities (e.g. subcommittee and working group activities, develop ment of training programs, scenario testing exercises, AAVLD/USAHA NAHLN Joint Committee, etc.) ; r. A s requested by the USDA , p articipate in auditing NAHLN or prospective NAHLN laboratories ; s. H ave an acceptable periodic review conducted under the oversight of USDA.
**Level 2 L**  **aboratories:** Similar to current M ember l aboratories , L evel 2 l aboratories provide greater geographic coverage and consequentl y more rapid disease detection. T o be classified as a Level 2 NAHLN Laboratory , a laboratory

must meet most of the requirements outlined above for Level 1 Laboratories , except that Level 2 Laboratories :

a. Are no t required to maintain capacity to provide for surge testing ; b. M ay be provisionally

accredited by AAVLD or b y another accrediting body to World Organization for Animal health ( OIE ) standards, ISO 17025, or equivalent standards; c. P erform all work within a quality management system under the direction of a quality

manager ;
H ave no requirement for biosafety level 3 laboratory

space; and d. In reference to items i

– q (except k

– the biosafety requirement), participate as resources allow.
**Level 3 Laboratories :**  These laboratories participate primarily in surveillanceOctober 2 5 , 2012 NAHLN Concept Paper Page 6 of 6

activities. T o be classified as a Level 3 NAHLN l aboratory , a laboratory must :

a. A s requested b y the USDA , p articipate in surveillance testing ; b. W ork under a NAHLN

- approved quality management system overseen b y a quality manager ; c. H ave staff members trained and proficiency

tested in diseases of interest ; d. H ave a functional LIMS ; e. Report test results within timeframes indicated in NAHLN standard operating procedures.
**Affiliate L aboratories:**  These are public ly

funded laboratories that may occasionall y perform NAHLN

- related testing. To be classified as a NAHLN A ffiliate l aboratory , a laboratory must meet the requirements of a Level 3 l aboratory , plus :

a. E stablish a memorandum of understanding with the USDA that defines the role and relationship of the laboratory

within the NAHLN; and b. E stablish operational relationships with a designated NAHLN l aboratory and with the State animal h ealth o fficial of the S tate in which the laboratory is located

. **Specialty Laboratories :**  These are private laboratories that have a specific , but needed , capability as determined by the USDA with input from the Coordinating Council. T o be classified as a NAHLN S pecialty l aboratory , a laboratory must meet the requirement s of a Level 3 laboratory , plus :

a. E stablish operational relationships with a designated NAHLN l aboratory and with the State animal h ealth o fficial of the S tate in which the laboratory is located ; and b. H ave a written, USDA

- approved plan that demonstrates the ability to avoid conflicts of interest in the testing they

perform.
**Reference Laborator ies**  **:** The NAHLN Reference l aboratories are the NVSL. In fulfilling this role, NVSL personnel provide : (1) oversight on testing and reporting procedures ; (2) assay

development, validation, and deplo ym ent ; (3) proficiency test s ; (4) reference materials ; and (5) procedure training. 

### Summary The proposed revisions to the structure of the NAHLN and codification of USDA oversight, the existence of a NAHLN charter, and the outline of the network structure will give the NAHLN flexibility to respond to future national animal health testing needs . The proposed changes clarify the roles and responsibilities of network members and provide the ability to more easi ly expand or contract NAHLN testing capabilities and capacities. Having the actual NAHLN charter and the specific requirements for each level of participation referenced in program standards but not codified allows the NAHLN to respond readil y to the changing needs of animal agriculture. The proposed changes will allow the NAHLN to achieve its original surveillance and response goals and to expand detection of emerging and zoonotic diseases to protect animal and public health a s well as the nation's food suppl y.