TRACEABILITY IN TOXICITY TESTING

1. TRACEABILITY IN TOXICITY TESTING Beth Thompson September 20, 2011

2. TRACEABILITY • COMPLETENESS OF THE INFORMATION REGARDING EVERY STEP IN A PROCESS • DOCUMENTATION OF RECORDED INFORMATION’S HISTORY • GENERATE REPRODUCABLE AND/OR DEFENDABLE DATA SHEALY CONSULTING, LLC

3. ANALYTICAL TRACEABILITY • SAMPLE TRACKING • STANDARD AND REAGENT RECORDS • EQUIPMENT IDENTIFICATION AND RECORDS • ANALYST TRAINING SHEALY CONSULTING, LLC

4. TOXICITY TRACEABILITY • SAMPLE TRACKING • STANDARD AND REAGENT RECORDS • EQUIPMENT IDENTIFICATION AND RECORDS • ENVIRONMENTAL FACTORS • ANALYST TRAINING • UNQUANTIFIED BIOLOGICAL EFFECT SHEALY CONSULTING, LLC

5. EQUIPMENT RECORDS http://cfb.unh.edu/cfbkey/html/Organisms/CCladocera/FDaphnidae/GCeriodaphnia/Ceriodaphnia_dubia/C_dubia_fb_05_600x600.jpg Used with permission. SHEALY CONSULTING, LLC

6. OVERALL CULTURE HEALTH DETAILED REPRODUCTION AND MORTALITY RECORDS ARE MAINTAINED FOR CULTURES. SHEALY CONSULTING, LLC

7. BROOD BOARD TRACKING: BB #52 SHEALY CONSULTING, LLC

8. BROOD BOARD TRACKING: BB #52 SHEALY CONSULTING, LLC

9. BROOD BOARD TRACKING: BB #52 SHEALY CONSULTING, LLC

10. BROOD BOARD TRACKING: BB #52 SHEALY CONSULTING, LLC

11. BROOD BOARD TRACKING: BB #52 SHEALY CONSULTING, LLC

12. NEONATE DOCUMENTATION: • Identify the brood board from which they came • Identify the ‘mom’ from which they came • Have records proving that the ‘mom’ is a female deemed valid for use in testing • Identify the time period in which they were born • Have records that the neonates were fed properly prior to use in testing • Have the original female preserved at the lab SHEALY CONSULTING, LLC

13. OVERALL CULTURE HEALTH MONTHLY REFERENCE TOXICANT TESTING IS PERFORMED WITH A KNOWN TOXICANT TO DETERMINE TRENDS IN CULTURE HEALTH. EVERY TOXICITY TEST REPORT SHOULD IDENTIFY THE MOST RECENT REFERENCE TOXICANT TEST. SHEALY CONSULTING, LLC

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15. INDIVIDUAL TEST ORGANISM HEALTH BLOCKING PROCEDURE ENSURES THAT ONE REPLICATE IN EACH TEST TREATMENT GETS NEONATES FROM THE SAME MOM. SHOULD HAVE DOCUMENTATION OF BLOCKING PROCEDURE. SHEALY CONSULTING, LLC

16. BLOCKING PROCEDURE Each source cup contains a brood on neonates from one female. One neonate is transferred from each source cup to the test cups lined-up above it. SHEALY CONSULTING, LLC

17. ENVIRONMENTAL CONDITIONS CHECK DOCUMENTATION FOR: • RANDOMIZATION OF TEST BOARD TEST CUPS ARE RANDOMIZED ON BOARDS SO THAT ONE TREATMENT DOES NOT BENEFIT FROM VARIATION IN LIGHT OR TEMPERATURE. TRACE THE TEST BOARD # OR LOOK AT THE LAB’S PROCEDURE FOR RANDOMIZATION. SHEALY CONSULTING, LLC

18. ENVIRONMENTAL CONDITIONS CHECK DOCUMENTATION FOR: • RANDOMIZATION OF TEST BOARD • INCUBATOR ID INCUBATOR LIGHT INTENSITY, PHOTOPERIOD, AND TEMPERATURE ARE MONITORED AND DOCUMENTED AS REQUIRED. SHEALY CONSULTING, LLC

19. ENVIRONMENTAL CONDITIONS CHECK DOCUMENTATION FOR: • RANDOMIZATION OF TEST BOARD • INCUBATOR ID • FOOD SOURCE ID / FEEDING REGIME ALL FOOD SOURCES SHOULD BE PRE-TESTED. THERE MUST BE TRACEABLE RECORDS FOR CONSTITUENTS USED TO PREPARE FOOD. ANALYTICAL REQUIREMENTS ARE NOT AS HELPFUL, BUT ARE REQUIRED. SHEALY CONSULTING, LLC

20. ENVIRONMENTAL CONDITIONS CHECK DOCUMENTATION FOR: • RANDOMIZATION OF TEST BOARD • INCUBATOR ID • FOOD SOURCE ID / FEEDING REGIME • WATER BATCH ID WATER BATCHES SHOULD BE PRE-TESTED. THERE MUST BE TRACEABLE RECORDS FOR CHEMICALS USED TO PREPARE WATER. WATER CHEMISTRY MUST BE DOCUMENTED. SHEALY CONSULTING, LLC

21. ENVIRONMENTAL CONDITIONS CHECK DOCUMENTATION FOR: • RANDOMIZATION OF TEST BOARD • INCUBATOR ID • FOOD SOURCE ID / FEEDING REGIME • WATER BATCH ID • TEST DILUTION PREPARATION D.O. CAN NOT BE SUPERSATURATED. MUST AERATE SAMPLES WITH SUPERSATURATION AFTER HEATING FROM 40C TO 250C. AERATION MUST BE DOCUMENTED. SHEALY CONSULTING, LLC

22. ANALYST TRAINING • IDOC’S ALL ANALYSTS MUST COMPLETE AN INITIAL DEMONSTRATION OF CAPABILITY (IDOC) PRIOR TO CONDUCTING TESTS INDEPENDENTLY. SHEALY CONSULTING, LLC

23. ANALYST TRAINING • IDOC’S • CDOC’S ALL ANALYSTS MUST COMPLETE A YEARLY CONTINUING DEMONSTRATION OF CAPABILITY (CDOC) FOR EACH TEST METHOD. A BLIND SAMPLE IS PREFERABLE TO ROUTINE REFERENCE TOXICANTS. SHEALY CONSULTING, LLC

24. ANALYST TRAINING • IDOC’S • CDOC’S • COUNTING PROFICIENCY COUNTING PROFICIENCY TESTS MAY BE USED TO DETERMINE VARIABILITY IN COUNTING TECHNIQUES AND THE ABILITY OF AN ANALYST TO ADEQUATELY SEE THE NEONATES. SHEALY CONSULTING, LLC

25. ANALYST TRAINING • IDOC’S • CDOC’S • COUNTING PROFICIENCY ANALYSTS ARE PROVIDED MAGNIFYING GLASSES TO MAKE SURE ALL NEONATES ARE COUNTED. ESPECIALLY ANALYSTS OVER 40! SHEALY CONSULTING, LLC

26. LAB PROFICIENCY TESTING YEARLY DMR/QA STUDIES ARE CONDUCTED ON BLIND SAMPLES FROM AN EPA-APPROVED VENDOR. SHEALY CONSULTING, LLC

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28. FINAL QC REVIEW EACH TEST UNDERGOES A DOCUMENTED FINAL QC REVIEW TO ENSURE THAT ALL TEST CONDITIONS WERE MET AND THAT THE TEST RESULTS GENERATED FROM THE DATA ARE REASONABLE. LABS MUST HAVE NON-CONFORMITIES DOCUMENTED IN A NON-CONFORMANCE MEMO. SHEALY CONSULTING, LLC

29. QUESTIONS? SHEALY CONSULTING, LLC