1. 2007/2008 SWGDRUG ACCOMPLISHMENTS Drug Enforcement Administration Office of Forensic Sciences sponsored by the National Institute of Standards and Technology and the

2. SWGDRUG Scientific Working Group for the Analysis of Seized Drugs

3. CORE COMMITTEE DEA – Nelson Santos (Chair) Secretariat – Scott Oulton (non-voting) Secretariat – Scott Oulton (non-voting) FBI - Eileen Waninger FBI - Eileen Waninger ASCLD – Garth Glassburg ASCLD – Garth Glassburg NIST - Susan Ballou NIST - Susan Ballou ASTM and NEAFS- Jack Mario ASTM and NEAFS- Jack Mario Educator – Dr. Chris Tindall Educator – Dr. Chris Tindall Educator – Dr. Suzanne Bell

4. CORE COMMITTEE CAC & NWAFS - Jerry Massetti CAC & NWAFS - Jerry Massetti MAFS - Richard Paulas MAFS - Richard Paulas MAAFS - Linda Jackson MAAFS - Linda Jackson SAFS – Christian Matchett SAFS – Christian Matchett Toxicology – Dr. Robert Powers Toxicology – Dr. Robert Powers

5. CORE COMMITTEE Canada - Richard Laing Canada - Richard Laing Japan – Mr. Osamu Ohtsuru Japan – Mr. Osamu Ohtsuru United Kingdom - Dr. Sylvia Burns United Kingdom - Dr. Sylvia Burns Australia - Catherine Quinn Australia - Catherine Quinn Germany - Dr. Udo Zerell Germany - Dr. Udo Zerell ENFSI - Dr. Michael Bovens ENFSI - Dr. Michael Bovens UNODC - Dr. Iphigenia Naidis UNODC - Dr. Iphigenia Naidis

6. APPROVED RECOMMENDATIONS (Since 1997) Code of Professional Practice Code of Professional Practice Education & Training Education & Training Methods of Analysis Methods of Analysis Drug Identification Drug Identification Sampling Seized Drugs For Qualitative Analysis Sampling Seized Drugs For Qualitative Analysis Quality Assurance Quality Assurance General Practices General Practices Method Validation Method Validation Uncertainty Uncertainty Annex Annex Code of Professional Practice: Examples Code of Professional Practice: Examples Glossary of Terms and Definitions Glossary of Terms and Definitions

7. WHY UNCERTAINTY? Forensic community was asking for guidance. Forensic community was asking for guidance. Accrediting bodies are establishing measures of assessing conformity with ISO. Accrediting bodies are establishing measures of assessing conformity with ISO. User requirements (Threshold Amounts) User requirements (Threshold Amounts) Legal requirements Legal requirements Transparency (nothing to hide) Transparency (nothing to hide) Potential Exculpatory Information Potential Exculpatory Information

8. Development of an Uncertainty Document The core committee voted in January 2008 to release the draft uncertainty document for public comment. The core committee voted in January 2008 to release the draft uncertainty document for public comment. Posted on the website since February 2008 Posted on the website since February 2008 A SWGDRUG meeting was held July 21-23, 2008 in New Orleans, LA. A SWGDRUG meeting was held July 21-23, 2008 in New Orleans, LA. Comments were addressed and the core committee voted to adopt the document on July 22, 2008. Comments were addressed and the core committee voted to adopt the document on July 22, 2008. The document should be posted on the website by the end of ??? 2008. The document should be posted on the website by the end of ??? 2008.

9. SWGDRUG’S GOALS IN ADDRESSING UNCERTAINTY There is a wealth of information that already exists on uncertainty. We had no intentions of repeating existing information. There is a wealth of information that already exists on uncertainty. We had no intentions of repeating existing information. Our Goal was to tailor the recommendations to answer specific seized-drug-analysis-uncertainty questions, and do so before others did. Our Goal was to tailor the recommendations to answer specific seized-drug-analysis-uncertainty questions, and do so before others did. Provide Guidance To Accrediting Bodies and To Laboratories in meeting their responsibilities. Provide Guidance To Accrediting Bodies and To Laboratories in meeting their responsibilities. Uncertainty is associated with both qualitative and quantitative procedures. Uncertainty is associated with both qualitative and quantitative procedures. Consider user requirements and address uncertainty through training, procedures, and documentation. Consider user requirements and address uncertainty through training, procedures, and documentation.

10. SWGDRUG’S GOALS IN ADDRESSING UNCERTAINTY SWGDRUG’S GOALS IN ADDRESSING UNCERTAINTY Raise Awareness Raise Awareness Uncertainty is not doubt, it provides assurance that results and conclusions are fit for purpose. Uncertainty is not doubt, it provides assurance that results and conclusions are fit for purpose. Other Benefits Other Benefits Provide enhanced confidence through increased understanding of results. Provide enhanced confidence through increased understanding of results. Provide mechanism to express reliability of results. Provide mechanism to express reliability of results.

11. HOW? Two Primary Sections Two Primary Sections Qualitative Determinations Qualitative Determinations Quantitative Determinations Quantitative Determinations Purity Purity Weights Weights

12. QUALITATIVE DETERMINATIONS Individual methods have limitations and, consequently, uncertainty. Individual methods have limitations and, consequently, uncertainty. Understanding limitations allows analysts to build an appropriate analytical scheme to correctly identify drugs or chemicals. “It is expected that an appropriate qualitative analytical scheme will result in, effectively, no uncertainty in reported identifications.” Understanding limitations allows analysts to build an appropriate analytical scheme to correctly identify drugs or chemicals. “It is expected that an appropriate qualitative analytical scheme will result in, effectively, no uncertainty in reported identifications.” Use Part III B Methods of Analysis/Drug Identification, e.g., IR and microcrystalline test positive for cocaine – effectively NO uncertainty. Use Part III B Methods of Analysis/Drug Identification, e.g., IR and microcrystalline test positive for cocaine – effectively NO uncertainty.

13. QUALITATIVE DETERMINATIONS Relevant limitations of an analytical scheme should be documented and may need to be in report. For example, Relevant limitations of an analytical scheme should be documented and may need to be in report. For example, Marquis test positive for methamphetamine – could be methamphetamine or other similarly structured compound. Marquis test positive for methamphetamine – could be methamphetamine or other similarly structured compound. MS test positive for ephedrine – could be ephedrine or pseudoephedrine. MS test positive for ephedrine – could be ephedrine or pseudoephedrine.

14. QUANTITATIVE DETERMINATIONS Uncertainty is defined as “an estimate attached to a test result which characterizes the range of values within which the true value is asserted to lie.” (ISO 3534-1: 1993) Uncertainty is defined as “an estimate attached to a test result which characterizes the range of values within which the true value is asserted to lie.” (ISO 3534-1: 1993) Very precise calculations of measurement uncertainty is not always required. Very precise calculations of measurement uncertainty is not always required.

15. QUANTITATIVE DETERMINATIONS Primary numerical values reported in the analysis of seized drugs are Primary numerical values reported in the analysis of seized drugs are Weight and Purity Weight and Purity Where a value is critical, an appropriate measurement uncertainty determination shall be applied. Illustrations of “critical” include, Where a value is critical, an appropriate measurement uncertainty determination shall be applied. Illustrations of “critical” include, where weight is close to a statutory threshold where weight is close to a statutory threshold where purity of drug affects sentencing. where purity of drug affects sentencing.

16. UNCERTAINTY OF WEIGHT DETERMINATIONS Uncertainty of a reported value is dependant on the weighing process. Factors include, Uncertainty of a reported value is dependant on the weighing process. Factors include, Single item versus multiple items (# of weighing operations) Single item versus multiple items (# of weighing operations) Tare function as separate weighing operation Tare function as separate weighing operation Extrapolation of population weight from limited sampling of multiple items Extrapolation of population weight from limited sampling of multiple items Incomplete recovery of material from packaging Incomplete recovery of material from packaging Balance selection (e.g., readability, capacity) Balance selection (e.g., readability, capacity) Balance operation (e.g., sample placement, environmental conditions) Balance operation (e.g., sample placement, environmental conditions)

17. UNCERTAINTY OF PURITY DETERMINATIONS Sources of uncertainty for purity determination include, Sources of uncertainty for purity determination include, Sampling plan (e.g., handling of multiple items) Sampling plan (e.g., handling of multiple items) Sample homogeneity Sample homogeneity Analytical method Analytical method Sample preparation (e.g., size, matrix effects, solubility) Sample preparation (e.g., size, matrix effects, solubility) Analytical technique Analytical technique Reference material (e.g., purity of standard) Reference material (e.g., purity of standard) Equipment and instrumentation performance (e.g., glassware, pipetters, balances, chromatographs) Equipment and instrumentation performance (e.g., glassware, pipetters, balances, chromatographs) Concentration of analyte Concentration of analyte Environmental conditions Environmental conditions

18. GENERAL CONSIDERATIONS FOR ASSESSING UNCERTAINTY IN PURITY DETERMINATIONS Analytical Error Analytical Error Address both systematic and random error through method validation and quality assurance. Address both systematic and random error through method validation and quality assurance. Sampling Error Sampling Error Pay particular attention to the sampling process as it is often the largest contributor to measurement uncertainty of the test result. Pay particular attention to the sampling process as it is often the largest contributor to measurement uncertainty of the test result. Where appropriate, confidence levels (e.g., 95%) shall be selected based on considerations relevant to the analytical context. Where appropriate, confidence levels (e.g., 95%) shall be selected based on considerations relevant to the analytical context. Record uncertainty information in validation documents or case records. Record uncertainty information in validation documents or case records.

19. SPECIFIC APPROACHES: I. UNCERTAINTY BUDGET All sources of error are separately identified and tabulated. All sources of error are separately identified and tabulated. Assign values to each error source using Assign values to each error source using Empirical data Empirical data Validation process, Historical performance data, Control chart data, proficiency tests Validation process, Historical performance data, Control chart data, proficiency tests Published data Published data Combination of empirical and published data. Combination of empirical and published data. Can exclude insignificant sources. Can exclude insignificant sources. Calculate combined and expanded uncertainty using significant values for procedure. Calculate combined and expanded uncertainty using significant values for procedure.

20. II. NON-BUDGET OR EMPERICAL APPROACH Example 1: Use data from replicate analyses from a validated method with an appropriate sampling plan. Example 1: Use data from replicate analyses from a validated method with an appropriate sampling plan. Sources of uncertainty that are separately assessed in the budget method are collectively assessed by experimental measurements. Sources of uncertainty that are separately assessed in the budget method are collectively assessed by experimental measurements. Example 2: Use two standard deviations (2σ) of test method results from reproducibility data from validation studies. Example 2: Use two standard deviations (2σ) of test method results from reproducibility data from validation studies. Provides an approximation of the measurement uncertainty for non-critical values. Provides an approximation of the measurement uncertainty for non-critical values.

21. WHEN TO REPORT? Reporting of measurement uncertainty Reporting of measurement uncertainty Uncertainty shall be documented but may not need to be reported. Uncertainty shall be documented but may not need to be reported. It should be reported when result impacts user. It should be reported when result impacts user. Whether reported or not, analysts shall be cognizant of the uncertainty associated with their results—Most important point of all! Whether reported or not, analysts shall be cognizant of the uncertainty associated with their results—Most important point of all!

22. REPORTING Factors to consider when reporting include: Factors to consider when reporting include: Jurisdictional Jurisdictional Prevailing statutory requirement Prevailing statutory requirement Relevant governing body (agency) requirements Relevant governing body (agency) requirements User requests User requests Potential exculpatory value Potential exculpatory value Analytical Analytical Qualitative results where limitations are known (e.g., inability to differentiate isomers) Qualitative results where limitations are known (e.g., inability to differentiate isomers) Quantitative measurements where a value is critical (e.g., weight or purity level close to statutory threshold) Quantitative measurements where a value is critical (e.g., weight or purity level close to statutory threshold) Laboratory accreditation requirements Laboratory accreditation requirements

23. REPORTING EXAMPLES Qualitative: Qualitative: Contains Ephedrine or Pseudoephedrine. Item tested: 5.2 grams net Contains Ephedrine or Pseudoephedrine. Item tested: 5.2 grams net Visual examination determined that the physical characteristics are consistent with a Schedule IV pharmaceutical preparation containing Diazepam. There was no apparent tampering of the dosage unit and no further tests are being conducted. Visual examination determined that the physical characteristics are consistent with a Schedule IV pharmaceutical preparation containing Diazepam. There was no apparent tampering of the dosage unit and no further tests are being conducted. Contains cocaine (salt form not determined) Contains cocaine (salt form not determined)

24. REPORTING EXAMPLES Quantitative: Quantitative: Positive for cocaine in the sample tested Net weight of total sample: 5.23 grams ± 0.03 grams Quantitation: 54.7% ± 2.8% Positive for cocaine in the sample tested Net weight of total sample: 5.23 grams ± 0.03 grams Quantitation: 54.7% ± 2.8% Sample tested positive for cocaine Net weight: 5.23 grams Purity: 54.7% Confidence Range: ± 2.8%* Calculated net weight of drug: 2.8 grams of cocaine *Confidence range refers to a 95% confidence level Sample tested positive for cocaine Net weight: 5.23 grams Purity: 54.7% Confidence Range: ± 2.8%* Calculated net weight of drug: 2.8 grams of cocaine *Confidence range refers to a 95% confidence level

25. TRAINING “Individuals responsible for determining, evaluating and documenting uncertainty shall be capable of demonstrating familiarity with foundational concepts and principles of estimating uncertainty. “Individuals responsible for determining, evaluating and documenting uncertainty shall be capable of demonstrating familiarity with foundational concepts and principles of estimating uncertainty. General metrology (terminology, symbols, etc.) General metrology (terminology, symbols, etc.) Concepts of random and systematic error, accuracy, precision, propagation of error, etc. Concepts of random and systematic error, accuracy, precision, propagation of error, etc. Reporting conventions (sig. figs, truncating, rounding) Reporting conventions (sig. figs, truncating, rounding) Basis statistics (i.e., confidence interval, probability, etc) Basis statistics (i.e., confidence interval, probability, etc) Analysts shall be capable of explaining their laboratory’s procedures for evaluating uncertainty of qualitative and quantitative analyses.” Analysts shall be capable of explaining their laboratory’s procedures for evaluating uncertainty of qualitative and quantitative analyses.” A helpful list of references is provided. A helpful list of references is provided.

26. SUPPLEMENTAL DOCUMENTS TO FOLLOW Summing weights from individual exhibits Summing weights from individual exhibits Expression of sampling uncertainty based on confidence interval using multiple samplings Expression of sampling uncertainty based on confidence interval using multiple samplings Uncertainty budget example Uncertainty budget example

27. May All Your Uncertainties Be Small Ones Visit Us At www.swgdrug.org