The National Plant Protection Laboratory Accreditation Program NPPLAP

1
The National Plant Protection Laboratory
Accreditation Program(NPPLAP)

• Phil Berger
• USDA, APHIS, CPHST
• Jim Stack
• Kansas State University

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Definitions

• Accreditation The determination that a
  laboratory is capable of performing competent
  diagnoses.

• Certification The determination that an
  accredited laboratory has undergone training,
  proficiency testing, and quality assurance
  procedures for a specific diagnostic method.

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Why an accreditation program?

• Enhanced response and management of outbreaks
• plant diseases and pests
• increased speed and reliability of diagnosis
• Purpose accredit NPDN, SDA., private
  commercial labs

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Why an accreditation program?

• Pathogens or pests of regulatory concern.
• Defined standards for facilities, equipment,
  personnel training, sample tracking, and methods.
• Not intended to replace or supplement NSHS.

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Program objectives

• Ensure highest quality performance using
  validated methods
• Lab-to-lab consistency
• Lab-to-lab reproducibility

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Program objectives

• Increase national laboratory capacity,
  capabilities, and quality
• Rapid accurate detection
• Rapid response reduced impact

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Essential Elements

• Adequate facilities, instrumentation and
  equipment
• Personnel Training program
• Quality Management Program
• Sample control, sample integrity
• Records management
• Approved analytical methods

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Essential Elements

• Methods development, methods validation
• Good laboratory practices/ISO accreditation
• Facilities and records audits random on-site
  review
• Proficiency testing program
• Program parallel with NAHLN/VS system

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Development of the NPPLAP

• Planning committee established (21-22 Sept.,
  2005)
• Wide stakeholder support
• Input from NPDN, State and APHIS diagnosticians
  and technical experts

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Development of the NPPLAP

• Consensus reached
• Organizational structure and staffing discussed
• Roles of NPDN, LGUs, SDA, private labs discussed
• Technology transfer plan proposed
• Formation of Steering Committee
• Size, representation, credentials decided
• Standardized definitions discussed
• Certified reference materials discussed

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Outcomes of NPPLAP planning

• Strategy for technical development, deployment
  and industry involvement
• Continued stakeholder input
• Transparent process
• Continued and coordinated funding

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Outcomes of NPPLAP planning

• Streamlined methods development and validation
• Role and function of technical working groups
  established
• Stakeholder buy-in
• Potentially Actionable Suspect (PAS) sample
  policy developed

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NPPLAP Steering Committee (proposed)

• Regulatory Federal
• CPHST (NSPL and/or NPGBL Director)
• PHP (NIS)
• PDMP
• ER/WR
• VS
• Regulatory State
• NPB
• NASDA or State DAs

• Non-Regulatory
• NPDNProfessional Societies APS, ESA,
  ASMUSDA-ARS
• USDA-CSREES-Natl Prog. Staff, and NRIAg. Expt.
  Stations
• University Extension
• At Large
• - additional technical resources e.g. USDA-OGC
• - International (CSL, CFIA, Australia)
• - NAPPO, EPPO, IPPC??

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DRAFT 10/05
NPPLAP Administrative Structure
Reagents has components that cross over between
NPPLAP and NPGBL.
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DRAFT 10/05
Regulatory Input
Stakeholders
Communications Interactions
NPPLAP National Coordinator APHIS, PPQ
Steering Committee
Technical Panels
CPHST HQ National Programs
NPPLAP QA Manager
NPGBL
QA Coordinator
NPDN
USDA Labs POEs Insp. Stat.
CPHST QA Manager
State Dept. Ag. Ag. Exp. Stat.
SOPs
SOPs
PT Delivery, Training and Reagents
PPQ Methods, Validation Test Development
Inspections Audits
Revalidation Dossier Review
Document Flow
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Needs for NPPLAP

• Increased staffing and infrastructure
• Methods development
• Methods validation
• Training
• Proficiency test panel
• development and deployment
• Quality management
• IT

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Time Frame

• Planning committee meeting Sept. 2005
• Funding increase in APHIS 2007 budget
• 5-6M to establish
• (2.5M in PPQ 07 request)
• 2-3M to maintain
• National Coordinator within 3-6 mos.
• First laboratories accredited within 18 mos.

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The P. ramorum Provisional Approval
Program Lessons Learned
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Case Study Provisional Approval Program for
Phytophthora ramorum

• Laboratory infrastructure guidelines
• Implement laboratory inspection policies and
  procedures
• Develop and deploy proficiency test panels
• Modeled after NAHLN system, and is comparable to
  other existing programs

Phytophthora ramorum infection on tanoak
Proficiency panels generated and tested at the
NPGBL
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Provisional Approval Program Phytophthora
ramorum

• Provisional approval guidelines
• infrastructure (physical layout, HVAC)
• sample processing and flow
• instrumentation (types, maintenance
  calibration)
• personnel training and experience (hands-on
  training in Beltsville required)
• Labs provide documentation to APHIS

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Provisional Approval Program Phytophthora
ramorum

• 2) Inspection team is sent to laboratory
• headed by APHIS CPHST
• often includes scientist from NVSL or ARS

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P. ramorum provisional approval (cont)

• Inspection report sent to lab along with
  checklist
• Lab corrects any deficiencies
• Blind proficiency test panel sent to lab
• results analyzed by APHIS
• APHIS scientists must also pass test
• If lab passes, provisional approval is granted
• If lab does not pass, corrective measures taken
  and a new panel is provided

PCR results of a Proficiency panel
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Provisionally Approved Labs

• 6 labs provisionally approved as of 9/20/05
• Oregon State Univ.
• OR Dept. of Ag.
• WA Dept. of Ag.
• CDFA
• Univ. of Tenn.
• Univ. of Florida NPDN
• USDA-AMS (Gastonia, NC) PPQ surge capacity lab.
• 15 additional labs in various stages of process

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What does provisional approval mean in terms of
regulatory action?

• USDA will accept negative results
• Potentially actionable suspect (PAS) samples
  Policy to define which positive samples require
  confirmatory testing (e.g., new hosts,
  environmental finds, etc.)
• At present, all positives need federal
  confirmation

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The National Plant Protection Laboratory
Accreditation Program(NPPLAP)
Questions or Comments

• Phil Berger
• USDA, APHIS, CPHST
• Jim Stack
• Kansas State University