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The National Plant Protection Laboratory Accreditation Program NPPLAP

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Certification: The determination that an accredited ... Purpose: accredit NPDN, SDA., private & commercial labs. United States Department of Agriculture ... – PowerPoint PPT presentation

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Title: 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

2
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.

3
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

4
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.

5
Program objectives
  • Ensure highest quality performance using
    validated methods
  • Lab-to-lab consistency
  • Lab-to-lab reproducibility

6
Program objectives
  • Increase national laboratory capacity,
    capabilities, and quality
  • Rapid accurate detection
  • Rapid response reduced impact

7
Essential Elements
  • Adequate facilities, instrumentation and
    equipment
  • Personnel Training program
  • Quality Management Program
  • Sample control, sample integrity
  • Records management
  • Approved analytical methods

8
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

9
Development of the NPPLAP
  • Planning committee established (21-22 Sept.,
    2005)
  • Wide stakeholder support
  • Input from NPDN, State and APHIS diagnosticians
    and technical experts

10
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

11
Outcomes of NPPLAP planning
  • Strategy for technical development, deployment
    and industry involvement
  • Continued stakeholder input
  • Transparent process
  • Continued and coordinated funding

12
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

13
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
  • NPDN Professional Societies APS, ESA,
    ASMUSDA-ARS
  • USDA-CSREES-Natl Prog. Staff, and NRI Ag. Expt.
    Stations
  • University Extension
  • At Large
  • - additional technical resources e.g. USDA-OGC
  • - International (CSL, CFIA, Australia)
  • - NAPPO, EPPO, IPPC??

14
DRAFT 10/05
NPPLAP Administrative Structure
Reagents has components that cross over between
NPPLAP and NPGBL.
15
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
16
Needs for NPPLAP
  • Increased staffing and infrastructure
  • Methods development
  • Methods validation
  • Training
  • Proficiency test panel
  • development and deployment
  • Quality management
  • IT

17
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.

18
The P. ramorum Provisional Approval
Program Lessons Learned
19
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
20
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

21
Provisional Approval Program Phytophthora
ramorum
  • 2) Inspection team is sent to laboratory
  • headed by APHIS CPHST
  • often includes scientist from NVSL or ARS

22
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
23
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

24
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

25
The National Plant Protection Laboratory
Accreditation Program (NPPLAP)
Questions or Comments
  • Phil Berger
  • USDA, APHIS, CPHST
  • Jim Stack
  • Kansas State University
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