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Gregory M. Zarus Agency for Toxic Substances and Disease Registry
Data Quality Gregory M. Zarus Agency for Toxic Substances and Disease Registry
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Are you in the fog when it comes to sampling data?
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Does looking at lab data make you want to see an eye doctor?
ND j B i N E R D QL DL SQL MDL IDL Q 91 Does looking at lab data make you want to see an eye doctor?
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I want to fix that… I want to help you to become exposure detectives
I want to fix that… I want to help you to become exposure detectives. I want you to… get the data quality you need better interpret the data you get
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What I’ll give you A decoder list for lab and field data
A list of things to look for when collecting or looking at field data A list of things to look for when looking at lab data
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Why EI is different We are not the FDA: we’re not looking at the potential food supply and making judgment weather or not it should be eaten. We are not the EPA: we’re not looking at the pollution in the environment and seeing if it poses a potential risk. We are ATSDR: we’re looking for what the people are being exposed to.
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Once upon a time.. I went to collect land crabs to evaluate exposures….. using an efficient trap.
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and caught a lot of crabs.
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But this is the size that the locals ate…
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Because the people used home-made traps that
limited the size of the crab caught.
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Moral of the story Collect the right samples
to make the right exposure call.
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So what did I do with the big crabs?
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Visualize … A health call needs to be made about whether local crabs are safe to eat.
You get lab data on crabs and fish and you have to make the health call. An exposure detective needs to review the sampling plan before collection (to ensure appropriate data is collected for the call). An exposure detective who is given the data post facto needs to ask the right questions (to prevent false conclusions).
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A good exposure detective has to check if the data is good enough for evaluating exposures.
You can be an exposure detective by doing 3 things.
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Three things you need to do (The ARQ Method)
1. Check if there is adequate data to evaluate public health impact. (A) 2. Assess if the sampling plan represents the exposures. (R) 3. Understand standard quality assurance and control procedures. (Q)
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Data Adequacy Is there enough data to make a health impact call?
Have samples been collected… …in the right areas (on- and off-site)? …with the right media? …or analyzed for the right contaminants? …in a manner to evaluate exposure?
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Data Adequacy Have samples been collected in the appropriate areas on-site?
With likely contamination Where occupational exposures are possible With public access Where contaminants may or may not be migrating
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Data Adequacy Have samples been collected in the appropriate areas off-site?
…where the public can be exposed …of current or past contaminant off-site migration …with sensitive populations …during the right times
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Data Adequacy Have samples been collected in the appropriate media?
Ambient air Indoor air Biota Indoor dust Sediment Outdoor PM Surface water Groundwater Surface soil Subsurface soil Soil gas
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Data Adequacy Have samples been collected/analyzed for appropriate contaminants?
Site processes and history Contaminant break-down products Sample preparation, collection, preservation, and analysis method(s) Look for:
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Representativeness of Sampling
SAMPLING PLANS should include: Purpose and objectives Type(s) of media to be sampled Location and number of samples Sampling equipment and method description Quality Assurance and Quality Control (QA/QC) Analytic method Limitations
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Representativeness of Sampling (continued)
SAMPLING REPORTS should include or reference The sampling plan Reason for changes in the field (if) Times/dates of sampling and analysis Analytic data summary and raw data Evaluation of field and laboratory QA/QC
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Representativeness of Sampling (continued)
The PURPOSE AND OBJECTIVES of the sampling plan will influence: Sampling approach Analytic approach QA/QC requirements If results represent “worst case,” typical, etc. levels of contaminants
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Representativeness of Sampling (continued)
The sampling, analysis, and QA/QC will influence: Detection limits Specificity/interferences Reproducibility
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Representativeness of Sampling –Sampling Approach (continued)
Air sampling Real-time Time-weighted Grab/instantaneous Combination Soil sampling Discrete Composite
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Representativeness of Sampling (continued)
Biota Whole fish Edible portion only
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Representativeness of Sampling Analysis
Air sampling Screening Field analysis NIOSH & EPA methods NOTE: Agency sampling method agency analytical method!!! Soil sampling Screening NIOSH, EPA Biota FDA, USDA, EPA Contaminant vs. metabolite Modified method……
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Quality Assurance/Quality Control QA/QC
Were samples -contaminated in the field? -stored/preserved properly? -analyzed within an appropriate time frame? -analyzed appropriately by the lab?
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QA/QC QA/QC Sampling QA/QC Field, lot, or trip blank Chain of custody
Field duplicate or split samples (blind) Field spike samples Sample preservation, storage, and transport
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QA/QC (continued) Laboratory QA/QC: Chain of custody Holding time
Matrix spikes, matrix spike duplicates (recoveries are good) Lab blank Duplicate injections Instrument calibration and sample dilution
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QA/QC (continued) Field sampling meets requirements
No contaminants in field, trip, or lot blank Chain of custody held Samples received in good condition at lab
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QA/QC (continued) Analyses meet requirements if
No contaminants in lab blank Chain of custody held Matrix spikes are within method-specified percent recovery range Field duplicate samples show similar results (air is not the same)
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QA/QC (continued) Analyses meet requirements if
Samples are extracted/analyzed within holding time Contaminant concentrations within calibration range of instrument
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Common QA/QC Terms (a gift to you for decoding lab data)
Detection Limits Instrument (IDL) Method (MDL) Contract required (CRDL) Sample quantitation limit (SQL) Instrument – Lowest amount of substance that can be detected by the instrument.; does not consider any other effects such as sample handling, matrix, preparation. Method – Takes into account the reagents, sample matrix, and preparation steps applied to a sample in specific analytical methods. CRDL – Are not necessarily the lowest detectable levels achievable, but rather are levels that a CLP laboratory would routinely and reliably detect and quantitate in a variety of sample matrices. SQL – Takes into account sample characteristics, sample preparation, and analytical preparation (dilution, use of a smaller aliquot) which would affect the quantitation limit. Your key
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Common QA/QC Terms (continued)
Data qualifiers U- analyzed for but not detected (ND) J - value is estimated (j) B - found in blank as well as sample E - concentration exceeds calibration range of instrument Instrument – Lowest amount of substance that can be detected by the instrument.; does not consider any other effects such as sample handling, matrix, preparation. Method – Takes into account the reagents, sample matrix, and preparation steps applied to a sample in specific analytical methods. CRDL – Are not necessarily the lowest detectable levels achievable, but rather are levels that a CLP laboratory would routinely and reliably detect and quantitate in a variety of sample matrices. SQL – Takes into account sample characteristics, sample preparation, and analytical preparation (dilution, use of a smaller aliquot) which would affect the quantitation limit. Your key
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Common QA/QC Terms (continued)
Data qualifiers D – identified in an analysis at a secondary dilution factor N - spiked sample recovery not within control limits R – data not usable, rejected i – interferant: conflicting results reported by instrument due to another compound 91 – if following a concentration is a “Q value” and indicates that the sample was a 91% match to the instrument’s library spectra Instrument – Lowest amount of substance that can be detected by the instrument.; does not consider any other effects such as sample handling, matrix, preparation. Method – Takes into account the reagents, sample matrix, and preparation steps applied to a sample in specific analytical methods. CRDL – Are not necessarily the lowest detectable levels achievable, but rather are levels that a CLP laboratory would routinely and reliably detect and quantitate in a variety of sample matrices. SQL – Takes into account sample characteristics, sample preparation, and analytical preparation (dilution, use of a smaller aliquot) which would affect the quantitation limit. Your key
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Common QA/QC Terms (continued)
Data qualifiers H – EPA data qualifier indicating high bias L – EPA data qualifier indicating low bias K – EPA data qualifier representing an unknown bias Q – EPA data qualifier indicating that the result is estimated because the concentration is below the CRQLs T – indicates that the value was summed from other constituents by software. Result was not present in original laboratory results CC – sample identification number indicating that a duplicate sample was also collected at this location and this data was not present in the original lab results. Only conservative results were selected to be presented. Instrument – Lowest amount of substance that can be detected by the instrument.; does not consider any other effects such as sample handling, matrix, preparation. Method – Takes into account the reagents, sample matrix, and preparation steps applied to a sample in specific analytical methods. CRDL – Are not necessarily the lowest detectable levels achievable, but rather are levels that a CLP laboratory would routinely and reliably detect and quantitate in a variety of sample matrices. SQL – Takes into account sample characteristics, sample preparation, and analytical preparation (dilution, use of a smaller aliquot) which would affect the quantitation limit. Your key
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R U SQL i ND N E B D QL DL MDL IDL Q 91
Remember this? R U SQL i ND N E B D QL DL MDL IDL Q 91 Now you know what it means
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So what does this crab data tell you?
Lead 240 Mercury U Zinc 2400 B Sodium 59000 Arsenic 400 Calcium 5800 Chromium 5.5 j DL = 10 ppm
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Where to look for the QA/QC data… the Data Summary Report
Compiled by the laboratory Contains Narrative Glossary Data summary Data sheets Support information
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Failure to Meet QA/QC Criteria
Disclaimer Acknowledge Use of possibly unreliable data Possibility of an inaccurate conclusion
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QA/QC Sampling Terms Data qualifiers for field sampling
QA1 = screening (monitoring instrument or sampling with little QA) QA2 = screening + a little proof (monitoring/sampling with blanks, spikes, and duplicates) QA3 = screening + a lot of proof (QA2 + splits, checks, and more duplicates) Instrument – Lowest amount of substance that can be detected by the instrument.; does not consider any other effects such as sample handling, matrix, preparation. Method – Takes into account the reagents, sample matrix, and preparation steps applied to a sample in specific analytical methods. CRDL – Are not necessarily the lowest detectable levels achievable, but rather are levels that a CLP laboratory would routinely and reliably detect and quantitate in a variety of sample matrices. SQL – Takes into account sample characteristics, sample preparation, and analytical preparation (dilution, use of a smaller aliquot) which would affect the quantitation limit. Your key
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Frequent Mistakes with Quality Issues
Misuse of field screening data QA1, QA2, QA3 Concluding that a health concern does/does not exist on the basis of Incomplete data (A) Data that are not representative (R) Poor quality data due to improper sample collection or analysis (Q)
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What makes Adequate, Representative, and Quality Samples?
Do samples represent actual conditions? (R) Are data available for critical sampling points? (A&R) Are the quantity and quality of the data adequate to draw conclusions about those most likely to be exposed? (Q)
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Critical Samples Source (ARQ) Environmental media (A&R)
Time periods (A&R) Exposure point (R) Transport ID (R) Background (RQ)
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Sources of Error Sampling design
Sampling methodology and sample handling procedures Sample heterogeneity Analytical procedures
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A Detective Must Evaluate
Health data requirements Field data quality Laboratory data quality Media-specific considerations
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Do you feel qualified to be a detective? Did you to learn…
How to get the data quality you need? How to interpret the data you get? ARQ
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That’s all folks! Credits Z ® Productions no rights reserved
Lynn Wilder’s HA QA course 2001 Brim Hall EI 2002 NYC 9-11 Response 2001 Vieques EI 2001 Indian Wells EI 2001 Salisbury EI 2001 Rubbertown EI 2000 WTI Strike Response 2000 Z’s X-mas 2000 Jared Burchette 2000 Clarkston EI 2000 Trinity NC DENR 1995 Warner Bros 1972 Z ® Productions no rights reserved
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