1. Sally Flowers, NDA Laboratory Administrator
Accreditation Maintenance at the Nebraska Department of Agriculture Laboratory
Sally Flowers, NDA Laboratory Administrator

2. Location and Building 3703 South 14th Street, Lincoln
State Laboratory Building
Nebraska Department
of Agriculture
of Health & Human
Services
DHHS: EPA water testing methods (public, private wells), BSL3 lab
Food, Residue Accredited since Nov 2015; up for renewal next week; Feed Lab

3. Mission of the NDA Laboratory
Support the activities of NDA by providing accurate, timely testing of samples
Most of our data support NDA regulatory programs.
Food Safety & Consumer Protection
Dairy & Food
Residue
Animal & Plant Health Protection
Feed, Fertilizer, and Agricultural Lime
Ensure public health and economic well-being of Nebraska citizens

4. Partnerships and programs
FSIS FERN (microbiology)
FDA FERN (chemistry)
4-way MOA for Emergency Response
Nebraska Department of Agriculture
Nebraska Department of Health and Human Services Public Health Environmental Laboratory
University of Nebraska Medical Center – Nebraska Public Health Laboratory
University of Nebraska-Lincoln Veterinary Diagnostic Laboratory
Nebraska National Guard 72nd Civil Support Team (FERN)
FSMA Implementation
MFRPS Cooperative Agreement
AFRPS Cooperative Agreement
Produce Safety

5. Laboratory Sections and Personnel
19 FTEs
Three Laboratory Sections
Food, Dairy, and Residue
Food: 3 Chemists
Residue: 3 Chemists
Dairy: 2 Laboratory Scientists
Feed, Fertilizer, and Agricultural Lime
5 Chemists
Quality Assurance
1 Chemist
Each section has a supervisor

6. Food Microiology Food Microbiology scope methods Other methods
L. monocytogenes, E. coli O157:H7, Salmonella spp.
Screening and confirmation
Other methods
Allergens, toxins, mycotoxins
AOAC, FERN, FDA BAM, USDA MLG
Foodborne outbreak investigations
FDA Excellence in Collaboration Award
Ensure personnel up to date on FERN micro methods

7. Recent Foodborne Investigations
August 2017: Taco bar at a wedding (B. cereus, C. perfringens detected)
December 2016: Raw milk, powdered formula (E. coli O157:H7 - not detected)
November 2016: Prepared salads from a Thanksgiving buffet (B. cereus detected)
June 2016: Enchiladas and chorizo from a food truck (S. Heidelberg detected - food and patients)
April 2016: Cucumbers from a grocery chain, six state outbreak (Salmonella - not detected)
January 2016: Flour from a pizza restaurant, multi-state (E. coli O157:H7 – not detected)

8. Dairy Testing Grade A milk and milk products processed in Nebraska
Guided by FDA Pasteurized Milk Ordinance (PMO) and National Conference of Interstate Milk Shippers (NCIMS)
All personnel must be FDA-certified to perform dairy testing.
Added water, fat, moisture
Standard Plate Count, coliforms
Alkaline phosphatase
Drug residues
Somatic cell count
Kathy is LEO; Jeanene does Soil Lab duties

9. Residue Chemistry Food Chemistry Methods (mostly FERN)
Platforms (poisons, residues, heavy metals, toxins)
GC-MS
LC-MS
ICP-MS
ELISA
HPLC
Tasked with food adulteration, food defense, and food tampering
Occasional work performed for Nebraska State Patrol, local law enforcement
GC-MS for NSP forensic samples
IC Chromatograph – also available

10. Feed, Fertilizer, and Agricultural Lime Laboratory
Support labeling claims
Macro and micronutrients
Feed, fertilizer, and lime
Analyses
HPLC (UV, Fluorescent detectors)
ICP-OES
Proximal analysis
PCR, microscopy (BSE)
Surveillance
Prohibited materials in cattle feed
Salmonella in pet foods
Antibiotics in animal feed
Mycotoxin in corn (AFRPS) and wheat
Mostly chemistry; Vitamins, too

11. Quality Assurance New lab section established December 2017
Oversees all matters related to ISO accreditation
Food, Dairy, and Residue Laboratory
Feed, Fertilizer, and Agricultural Lime Laboratory
Document control
Internal audits
Training on administrative level documents
Help us remain compliant

12. Management Reorganization
2015
Food and Residue were separate lab sections.
Each section had its own QA Manager.
Accreditation funded by two different grants.
Accreditation earned November 2015
2017
Feed, Fertilizer and Agricultural Lime Laboratory
Sought accreditation under a third grant
Lab Supervisor was also the full-time QA Manager
Merged Food, Dairy, and Residue into one section
Created Quality Assurance lab section
Completed reorganization in January 2018

13. Lincoln-based ISO 17025 workgroup
ISO 17025:2017 issued last November
All accredited labs adopt by November 30, 2020
Our members include testing and calibration laboratories:
State government
Commercial
Academic
Opportunities to collaborate
Identified local accredited labs
Share resources, ask questions
Split costs to bring training courses to Lincoln
2017 std – lab defined as testing, calib, and/or sampling lab

14. NDA Laboratory plan for migration
Attend training
FSMA cooperative agreements
Association of Public Health Laboratories resources
Trainers invited to Lincoln
Already 90% compliant with the 2017 standard
Keep Quality Manual
Keep Quality Managers
Keep our SOPs
Add what we’re missing
Renumber sections to match 2017 standard

15. Things we’ve learned ISO 17025:2017 is less prescriptive
Focus is on outcomes and processes rather than procedures
Quality Manual is no longer required.
No longer required to have:
Job descriptions
Quality Manager
Top management
Technical Management
Quality policy statement and policy references
Master list of documents
Disclaimer – not an assessor or part of any accrediting body – been to a handful of trainings on 2017 changes

16. Things we’ve learned No longer need these SOPs:
Document control
Corrective action
Preventive action
Control of records
Internal audit
Management Review
Measurement Uncertainty
But, you still have to do it
Lab determines frequency (planned intervals)
Before removing: ask if it affects your competency, consistency, or impartiality
Labs have had since 2005 to get good at doing these things so CASCO expects us to carry on
If this goes away, would its absence have a negative effect on quality?

17. Things we’ve learned
Process: “set of interrelated or interacting activities that use inputs to deliver an intended result” ISO 9001:2015
Processes
Sources of inputs
Inputs
Activities
Outputs
Output receivers
Process might be made up of several procedures.
Plan, Do, Check, Act – then repeat

18. Things we’ve learned New Clauses renumbered to match CASCO numbering
Lab definition now includes testing, calibration, and sampling
Risk assessment and risk management
Notes now give examples and background (many were removed or became requirements)
Competence, impartiality, and consistency
Recipe for customer confidence
Monitor service providers (calibration, reference materials, etc.)
“Subcontractors” are now “external service providers” or “resources”
Three-legged stool.
Tech competence of personnel; take a hard look at your lab – lack of conflict? Can you tell if you’re being impartial? Do you have favorites? Want to be consistently good, not consistently bad

19. Things we’ve learned More new requirements
Demonstrate competence of personnel
Old way: qualifications and monitoring
Qualification = college degree
Competence = Show you can perform the method
Complaint system
Lab gathers info the validate complaint
Lab acknowledges receipt of complaint
Complaints reviewed by third party
Lab notifies customer at end of complaint

20. Things we’ve learned More new requirements
LIMS
no longer need Master List of documents
If managed off-site or by external provider, lab ensures that LIMS complies with ISO requirements
Show that you can retrieve data
Management Review
Inputs to MR shall be recorded
Outputs of MR shall be recorded
Confidentiality
Lab notifies customer if test results are subject to release to a third party.
Laws trump ISO standard.
ALACC requirements should be available late summer.