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: Certification: The determination that an accredited laboratory has undergone training, proficiency testing, and quality assurance procedures for a specific diagnostic method. Note that these definitions are used differently by different groups. These are for the purpose of this discussion and are simply working definitions.Note that these definitions are used differently by different groups. These are for the purpose of this discussion and are simply working definitions.

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 NPPLAP is for agents of regulatory concern relative to PPQ�s safeguarding mission. It has nothing to do with ASTA or NSHS. NPPLAP is for agents of regulatory concern relative to PPQ�s safeguarding mission. It has nothing to do with ASTA or NSHS.

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. NPPLAP is for agents of regulatory concern relative to PPQ�s safeguarding mission. It has nothing to do with ASTA or NSHS. NPPLAP is for agents of regulatory concern relative to PPQ�s safeguarding mission. It has nothing to do with ASTA or 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 Planning Committee workshop was held on 21-22 Sept. in Raleigh. There were 29 participants, representing PPQ-CPHST, PDMP, PHP, and (for both regions), the WR. Also from USDA were reps. from NVSL, ARS and CSREES. Also in attendance were representatives from several NPDN labs and state Departments of Ag., The accomplishments of the committee are in red on this screen. A report of this meeting will be release soon.Planning Committee workshop was held on 21-22 Sept. in Raleigh. There were 29 participants, representing PPQ-CPHST, PDMP, PHP, and (for both regions), the WR. Also from USDA were reps. from NVSL, ARS and CSREES. Also in attendance were representatives from several NPDN labs and state Departments of Ag., The accomplishments of the committee are in red on this screen. A report of this meeting will be release soon.

10. 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 Development of the NPPLAP: Planning Committee workshop was held on 21-22 Sept. in Raleigh. There were 29 participants, representing PPQ-CPHST, PDMP, PHP, and (for both regions), the WR. Also from USDA were reps. from NVSL, ARS and CSREES. Also in attendance were representatives from several NPDN labs and state Departments of Ag., The accomplishments of the committee are in red on this screen. A report of this meeting will be release soon.Planning Committee workshop was held on 21-22 Sept. in Raleigh. There were 29 participants, representing PPQ-CPHST, PDMP, PHP, and (for both regions), the WR. Also from USDA were reps. from NVSL, ARS and CSREES. Also in attendance were representatives from several NPDN labs and state Departments of Ag., The accomplishments of the committee are in red on this screen. A report of this meeting will be release soon.

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. Regulatory � Federal CPHST (NSPL and/or NPGBL Director) PHP (NIS) PDMP ER/WR VS Regulatory � State NPB NASDA or State DA�s NPPLAP Steering Committee (proposed) Although the specific people to serve on the committee were not named, it was generally agreed that the people present at this workshop represent most of the groups mentioned above. Therefore, the committee could be a subset of this workshop/planning committee, and would be small enough to make timely decisions to continue the formation of the program. This is a potential list and is not final.Although the specific people to serve on the committee were not named, it was generally agreed that the people present at this workshop represent most of the groups mentioned above. Therefore, the committee could be a subset of this workshop/planning committee, and would be small enough to make timely decisions to continue the formation of the program. This is a potential list and is not final.

15. Technical panels may be initiated from a number of sources. Technical panels may be initiated from a number of sources.

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. National coordinator position is dependent on the �07 request remaining intact.National coordinator position is dependent on the �07 request remaining intact.

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

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 (con�t) 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

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