Attachment 1 - Performance Work Statement.pdf

National Animal Health Laboratory Network (NAHLN) Indefinite Delivery, Indefinite Quantity (IDIQ) Performance Work Statement

Diagnostic Testing by NAHLN-approved Laboratories

A. BACKGROUND

Establish an Indefinite Delivery, Indefinite Quantity contract with NAHLN-approved laboratories to reimburse for diagnostic testing services. The NAHLN is a cooperative effort between two USDA agencies the Animal and Plant Health Inspection Service (APHIS) and the National Institute of Food and Agriculture (NIFA), and the American Association of Veterinary Laboratory Diagnosticians (AAVLD). It is a multi-faceted network comprised of laboratories that focus on NAHLN-scope diseases, using common testing methods and software platforms to process diagnostic requests and share information.

At the Federal level, the U.S. Department of Agriculture’s (USDA) National Veterinary Services Laboratories (NVSL) serves as the national veterinary diagnostic reference and confirmatory laboratory. NVSL coordinates activities, participates in methods validation, and provides training, proficiency testing, assistance, materials, and prototypes for diagnostic tests.

B. SCOPE OF WORK

The laboratories in the NAHLN perform diagnostic tests for endemic animal diseases of high consequence as well as for foreign animal diseases. These laboratories also participate in the development of new assay methodologies.

Networking these resources provides an extensive infrastructure of facilities, equipment, and personnel that are geographically accessible no matter where disease strikes. The laboratories have the capability and capacity to conduct nationwide testing for the early detection of an animal disease outbreak as well as test large numbers of samples rapidly during an outbreak and to demonstrate freedom from disease after eradication.

Key elements of the NAHLN system include:

Increased and more flexible capacity for laboratory support of routine and emergency animal disease diagnosis, including bioterrorism events;

Standardized, rapid diagnostic techniques used at State, Regional, and National levels;

Secure communication, alert, and reporting systems;

Modern equipment and experienced personnel;

National training, proficiency testing, and quality assurance;

Facilities that meet biocontainment and physical security requirements;

Regional and National animal health emergency training exercises (scenario tests) to test and evaluate the communication and reporting protocols of the network.

Description of Services

The Contractor must provide a price schedule for diagnostic services, based on their disease approvals (Attachment 1 Diagnostic Services Price List). The pricing must include all costs necessary including, but not limited to, general and administrative costs, profit, labor, materials, safety equipment, facilities, licenses, and special permits required for the identified diagnostic services in accordance with local, State and Federal regulations as well as NVSL and participating laboratory standard operating procedures (SOPs).

The Contractor will be responsible for performing the respective diagnostic service, as directed by the contracting officer, on appropriate samples and follow quality assurance policies and procedures and test result reporting as set forth by the NVSL. All samples that test as presumptive positive or inconclusive will be submitted to NVSL for confirmatory testing as required in the current version of the respective NVSL testing SOPs, relevant guidance documents, procedure manuals, or Code of Federal Regulations (CFR) references. Consult the NAHLN website, https://www.aphis.usda.gov/labs/nahln/approved-labs/nahln-document-list, for a listing of SOPs, forms, procedure manuals, or CFR references required for successful performance.

Within 14 calendar days after award, the Contractor must provide and maintain a dedicated general mailbox email address for all correspondence related to the contract, task orders, and invoicing. This mailbox must be monitored regularly to ensure timely receipt and response to Government communications.

C. CONTRACTOR QUALIFICATIONS

The Contractor must:

Provide accessible, timely, accurate, and consistent animal disease laboratory services nationwide;

Provide laboratory data to meet epidemiological and disease reporting needs as outlined in standard operating procedures, procedure manuals, Code of Federal Regulations (CFR) or as set forth by the NVSL;

Maintain the capacity and capability to provide laboratory services in support of responses to foreign animal disease outbreaks or other adverse animal health events; and

Focus on diseases of livestock (exotic, zoonotic, and emerging diseases), while including diseases of non-livestock species.

Approved laboratories must meet the requirements for membership in the NAHLN. Membership evaluation criteria for NAHLN approved laboratories are outlined in the Agreement for Participation in the National Animal Health Laboratory Network (NAHLN). Agreements are completed on a biennial basis, and the requirements are specific to the assigned laboratory level.

The NAHLN website, noted above, contains a current listing of NAHLN approved laboratories as well as information on joining the NAHLN.

D. QUALITY ASSURANCE

The Contractor may be involved in testing for early detection of foreign animal disease, surge testing during an outbreak, and testing samples during the outbreak recovery phase. As such, there must be a high degree of confidence in the quality of the laboratories and associated test results.

All approved NAHLN laboratories must have an implemented Quality System consistent with ISO 17025 standards. This can be demonstrated through accreditation, by AAVLD or by another accrediting body to the ISO 17025 standard. If a NAHLN laboratory is not accredited, it must be willing to participate in regular site visits and must be approved by APHIS-VS. Each NAHLN laboratory, regardless of type of accreditation or accreditation status, must agree to provide documentation concerning accreditation and implementation of AAVLD or ISO 17025 Quality System requirements, including scope, and must agree to NAHLN compliance audits and/or site visits upon request. In addition, all NAHLN laboratories must have their auditors document on the NAHLN Standard verification form at the time of any regularly scheduled external audit that elements of the appropriate standards important to NAHLN (NAHLN Standard) are being met.

The NAHLN Program Office must be contacted if there is any change in accreditation status.

E. GOVERNMENT CONTACTS

The Contracting Officer (CO) is the point of contact for clarifying contract issues or changes. At the time of award, the CO will designate a Contracting Officer’s Representative (COR) in a separate letter. The COR is the main point of contact for daily operations and administrative issues and is responsible for monitoring performance as written in the contract.

The NAHLN Coordinator also serves as a Government Point of Contact for operational and administrative matters. The Contractor must direct all operational and administrative communications to both the COR and the NAHLN Coordinator at NAHLN.Coordinators@usda.gov.

The Government NAHLN billing contact email, monitored by the COR, is NAHLN@usda.gov.

In no event will any understanding, agreement, modification, change order, or other matter deviating from the contract terms be effective or binding upon the Government unless advance authorization is received from the CO and proper contractual documents are executed prior to performing the work.

The COR shall promptly inform the CO of any recommended modifications or any actions or inactions by the contractor or the Government that could affect compliance with contract performance requirements or completion times.

F. PERIOD OF PERFORMANCE

This IDIQ is effective from date of issuance through 5 years.

Diagnostic Testing by NAHLN-approved Laboratories

G. INDIVIDUALS AUTHORIZED TO PLACE ORDERS

The following individuals and/or organizational components are authorized to place delivery orders:

Delivery orders may only be placed by warranted contracting personnel (Contracting Officers).

IDIQ Ceiling

Total cumulative value of delivery orders issued under this IDIQ shall not exceed $25 million.

H. TASK ORDERS

Task orders will identify the specific diagnostic tests authorized for performance and define the period during which those tests may be conducted. The Contractor and the Contracting Officer’s Representative (COR) are jointly responsible for monitoring all services performed. Services performed must be within the authorized scope and not exceed the allocated funding. The contractor is responsible for performing the acceptable testing within the task order constraints of the period of performance and funding limits. Any services performed outside the scope of the task order or in excess of the authorized funding will be considered unauthorized and will not be reimbursed by the Government.

The pricing for tests is determined and fixed based on the date of task order issuance. Applicable prices must correspond to the ordering period in effect at the time of issuance, as set forth in Attachment 1 – Diagnostic Services Price List. Prices will not be adjusted based on the timing of service performance or completion.

I. DELIVERY TICKETS

All test results shall be reported as outlined in the respective standard operating procedure, procedure manual, CFR reference, or as set forth by the respective APHIS program. Frequency of reporting is subject to increase as determined by the respective APHIS program. Test result data will be used to confirm services rendered before related invoices are approved for payment.

J. INVOICES

Invoices should be submitted by email monthly to NAHLN@usda.gov and NAHLN.Coordinators@usda.gov. A separate invoice is required for each task order.

Each invoice must include:

IDIQ contract number

IDIQ Task Order number

FAD number (Required for FAD Task Order Funds)

Testing number for services rendered

Sample ID/Accession Number

Quantity and Unit Price

Date of Each Test Performed

Contractors must submit invoices to NAHLN, with supporting documentation attached, within 30 days of completion of services provided as required. The COR will review the supporting documents before approving invoices. If supporting documentation is not provided the COR will contact the contractor to request complete documentation.

Once the invoices have been reconciled with corresponding test results, they will be entered in the system used by USDA, Invoice Processing Platform (IPP), for electronic submission and tracking of purchase orders, invoices, and payment information to its suppliers of goods and services: Enroll at https://ipp.gov. The IPP is a government-wide secure web-based invoice processing service offered free of charge to government agencies and their suppliers by the U.S.

Department of Treasury’s Financial Management Service (FMS).

Upon contract award, you will receive a notification of your one-time enrollment requirement in an automatic invoice payment notification system available through IPP. This one-time enrollment in IPP means that you will receive a series of e-mails from Treasury services.

Noncompliance of terms and conditions outlined in this performance work statement will be reported to the Contracting Officer and may result in remedial action or possible termination of the contract.