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

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

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

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

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

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

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)

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

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

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

Quality Assurance New lab section established December 2017 Oversees all matters related to ISO 17025 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

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

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

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

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

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?

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

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

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

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 17025 standard. ALACC requirements should be available late summer.