Standardizing Electronic Data Deliverables:Public Health Laboratory - - PowerPoint PPT Presentation

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Standardizing Electronic Data Deliverables:Public Health Laboratory - - PowerPoint PPT Presentation

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Standardizing Electronic Data Deliverables:Public Health Laboratory Emergency Response Laboratory Emergency Response Jack Krueger Jack Krueger Informatics Consultant for APHL NEMC 2011 1 Outline Outline What do public environmental labs

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Standardizing Electronic Data Deliverables:Public Health Laboratory Emergency Response Laboratory Emergency Response

Jack Krueger Jack Krueger Informatics Consultant for APHL

NEMC 2011 1

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Outline Outline

  • What do public environmental labs offer?

What do public environmental labs offer?

  • What informatics issues plague them?

E i t l h lth LIMS – Environmental health LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability

  • It is possible (a real‐world example)!

Analysis, Answers, Action

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Outline Outline

  • What do public environmental labs offer?

What do public environmental labs offer?

  • What informatics issues plague them?

E i t l h lth LIMS – Environmental health LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability

  • It is possible (a real‐world example)!

Analysis, Answers, Action

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“The state PHL is the only lab with the culture & the mentality of emergency response. y g y p We’re [the only] emergency responders from the lab perspective.” perspective.

Peter Shult, PhD Director, Communicable Disease Division and Emergency Laboratory Response Wisconsin State Laboratory of Hygiene

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Public Environmental Health Laboratories Public Environmental Health Laboratories

  • Homeland security (clinical & non‐clinical)

Homeland security (clinical & non clinical)

  • Drinking water compliance

i l

  • Environmental assessment
  • Waste water treatment
  • Solid waste testing
  • And much more!

And much more!

Analysis, Answers, Action

NEMC 2011 6

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Outline Outline

  • What do public environmental labs offer?

What do public environmental labs offer?

  • What informatics issues plague them?

E i t l h lth LIMS – Environmental health LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability

  • It is possible (a real‐world example)!

Analysis, Answers, Action

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Why is informatics relevant now? Why is informatics relevant now?

Hint: Buried in paper? . . .and

Analysis, Answers, Action

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p p Everyone wants your data.. Now!

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Public Health Laboratory b l Interoperability Project

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Goal:

Develop & implement an electronic data flow directly from environmental laboratories to multiple state and federal agencies

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NEMC 2011 11

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Outline Outline

  • What do public environmental labs offer?

What do public environmental labs offer?

  • What informatics issues plague them?

E i t l h lth LIMS – Environmental health LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability

  • It is possible (a real‐world example)!

Analysis, Answers, Action

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Successful LIMS “See” Down the Road

  • Support collection of pure measurements
  • Measurements stem directly from instruments
  • Data is based upon standards

p

  • Are normalized
  • Have machine‐to‐machine connectivity

Have machine to machine connectivity

  • Include quality control data
  • Are not matrix dependent
  • Are not matrix‐dependent
  • Look at how data is collected, not reported

Analysis, Answers, Action

NEMC 2011 13

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Two Types of Business Cases for LIMS Two Types of Business Cases for LIMS 1 Local needs to manage your

  • 1. Local needs to manage your

laboratory

  • 2. A national need for LIMS integration

Analysis, Answers, Action

NEMC 2011 14

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Environmental Laboratory

GFAAS α, β, γ Detection Systems

Laboratory Testing

CVAF GC

Samples I n

ICP GC-MS

D t O t

ICP-MS Automated Colorimetric

Data Out

NEMC 2011 15

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Outline Outline

  • What do public environmental labs offer?

What do public environmental labs offer?

  • What informatics issues plague them?

E i t l h lth LIMS – Environmental health LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability

  • It is possible (a real‐world example)!

Analysis, Answers, Action

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Environmental Laboratory Reporting Environmental Laboratory Reporting

City PH Depts EPA State PH Depts

FDA

Patients CDC Practitioners PH Labs Hospitals Commercial orgs Hospitals PH Field Teams Emergency Ops Centers First Responders Other Labs

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Need a single, nationally‐ d d d l b standardized lab reporting format. format.

Multiple data exchange templates compromise commercial production compromise commercial production

  • f tools to produce electronic

messaging messaging.

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PHLs Putting their House in Order

  • Increasing data exchange capacity & expertise
  • Taking control of their vocabularies‐
  • Reviewing and tracking pertinent federal

g g p standards development

  • Working with LIMS vendors‐

– Defining the best solutions to meet data exchange

  • Participating in the Public Health Laboratory

b l ( ) interoperability project (PHLIP)‐ 22 states, CDC‐CCID &

CDC‐NCPHI working collaboratively

Analysis, Answers, Action

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Components of this Goal

  • Tools to extract data from LIMS and

Tools to extract data from LIMS and export it to a laboratory network

  • Connectivity of environmental

laboratories including private & public laboratories, including private & public

Analysis, Answers, Action

NEMC 2011 21

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Points of Confusion Points of Confusion

  • Minimum data sets vs comprehensive

Minimum data sets vs. comprehensive minimum data element sets

  • Intra agency interoperability
  • Intra‐agency interoperability
  • Inter‐agency interoperability
  • Laboratory generated data‐results &

measurement quality objectives measurement quality objectives

  • Meta‐data or auxiliary data

Analysis, Answers, Action

NEMC 2011 22

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Interoperability Model 1: CDC LRN‐C Interoperability Model 1: CDC LRN C

  • All laboratories use the SAME:

–method, instruments, software, QC samples analytical sequence training samples, analytical sequence, training, results spreadsheet, and secure messaging service service

  • Don’t need a LIMS, as comprehensive

LIMS bili CDC LIMS capability rests at CDC

Analysis, Answers, Action

NEMC 2011 23

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Interoperability Model 2: EPA ERLN Interoperability Model 2: EPA ERLN

  • A robust data exchange template:

A robust data exchange template:

– Not matrix dependent Not method dependent – Not method dependent – Uses common analytical data

I l d i ifi t QC d t

  • Includes significant QC data
  • Data is sent as an xml (accepts xls, SEDD, et al)

Analysis, Answers, Action

NEMC 2011 24

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Pros and Cons for Each Pros and Cons for Each

  • LIMS costs

LIMS costs

  • Data review

C li i f d ll i

  • Centralization of data collection
  • Need for consistency across laboratory
  • Surge capability
  • APHL favors the EPA ERLN model

APHL favors the EPA ERLN model.

Analysis, Answers, Action

NEMC 2011 25

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Outline Outline

  • What do public environmental labs offer?

What do public environmental labs offer?

  • What informatics issues plague them?

E i t l h lth LIMS – Environmental health LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability

  • It is possible (a real‐world example)!

Analysis, Answers, Action

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Assuring Accountability Assuring Accountability

  • Certification assures capability

Certification assures capability

  • Reporting raw data (including QC) assures

accountability accountability

  • Measurement Quality Objectives include:

–Completeness –Completeness –Sequence F –Frequency –Limits

Analysis, Answers, Action

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Lab Certification Assures Capability Lab Certification Assures Capability

  • Quality Assurance Plan

Quality Assurance Plan

  • Method Detection Limit (MDL) studies

I i i l D i f C bili

  • Initial Demonstration of Capability
  • Standard Operating Procedures
  • Annual Proficiency Testing
  • Training documentation
  • Training documentation
  • On‐site assessments every 2‐3 years

Analysis, Answers, Action

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Certification Doesn’t Assure Accountability Certification Doesn t Assure Accountability

  • Are sample testing Quality Controls met?
  • Are sample testing Quality Controls met?
  • Are test results and reports reviewed?
  • Is compliance and monitoring data

acceptable? acceptable?

  • Did the laboratory follow approved

th d ? methods?

Analysis, Answers, Action

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Quality Control Data Quality Control Data

  • Collected w/ each sample batch in an analytical run

p y

  • Examples include:

– Blank CCB Continuing Cal Blank – CCB‐Continuing Cal. Blank – CCC‐Continuing Cal. Check – LRB‐Lab Reagent Blank – LFB‐Lab Fortified Blank or Laboratory Control Sample (LCS)‐ a Key QC Sample – MS‐Matrix Spike – MSD‐ Matrix Spike Dup – SD‐Sample Duplicate – QCS‐Quality Control Sample

Analysis, Answers, Action

QCS Quality Control Sample

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Quality Control Data not Limited to EPA Quality Control Data not Limited to EPA

  • CDC’s LRN‐C will include (limited) QA/QC

CDC s LRN C will include (limited) QA/QC data

  • Air Force Center for Environmental
  • Air Force Center for Environmental

Excellence (Environmental Resources Program Information Management Program Information Management System) b l

  • Human biomonitoring & environmental

exposure assessment

Analysis, Answers, Action

NEMC 2011 31

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Looking f d forward to

  • ur future
  • ur future..
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What is the ERLN What is the ERLN

E i t l R Environmental Response Laboratory Network Laboratory Network

Analysis, Answers, Action

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APHL recommends that EDDs be based upon EPA’s ERLN Type upon EPA s ERLN Type 1t and Type 2 data yp exchange template

NEMC 2011 34

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What’s in a Name?

A pig by any other name….

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Outline Outline

  • What do public environmental labs offer?

What do public environmental labs offer?

  • What informatics issues plague them?

E i t l h lth LIMS – Environmental health LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability

  • It is possible (a real‐world example)!

Analysis, Answers, Action

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APHL recommends APHL recommends that interoperability that interoperability be based upon the be based upo t e ERLN WebEDR

NEMC 2011 37

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Wh t i W bEDR? What is WebEDR?

A free, web‐based system that f t t d d t l ti performs automated data evaluation

  • n ERLN Electronic Data Deliverables

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WebEDR WebEDR

  • Uses tests derived from the National Functional

Guidelines (NFGs) for data evaluation and review.

  • Uses a Data Exchange Template (DET) and XML Data

Type Definitions (DTD) to exchange laboratory Type Definitions (DTD) to exchange laboratory measurements

  • Uses method‐defined limits to measure data.

P f t d di d l ti f th ll lit

  • Performs standardized evaluation of the overall quality
  • f data.
  • Provides reviewers with tools to measure data against

g different quality objectives.

  • Capable of processing multiple EDDs

Analysis, Answers, Action

NEMC 2011 39

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Outline Outline

  • What do public environmental labs offer?

What do public environmental labs offer?

  • What informatics issues plague them?

E i t l h lth LIMS – Environmental health LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability

  • It is possible (a real‐world example)!

Analysis, Answers, Action

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Recent Uranium Exercise Recent Uranium Exercise

  • Data was:

– Successfully collected from multiple laboratories – Evaluated at a central site for data quality, and Evaluated at a central site for data quality, and – Processed as if all came from a single laboratory.

Analysis, Answers, Action

NEMC 2011 41

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Laboratories Reporting

Laboratory Type Number Participating Used EXCEL EDD Used XML EDD p g

State 4 3 1 State 4 3 1 DOE 4 3 1 Commercial 11 5 6

NEMC 2011 42

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Parameter Test Type Data Quality Indicator Method Blank Frequency Completeness Method Blank Frequency Completeness Duplicate Relative Percent Difference Limit Precision/Accuracy/Bias Percent Difference Duplicate Frequency Frequency Completeness Analyzed Time Limit Limit Representativeness/Comp leteness/Accuracy/Bias L b C l F C l Laboratory Control Sample (LCS) Frequency Completeness LCS Spike Percent Limit Accuracy/Bias/Precision LCS Spike Percent Recovery Limit Limit Accuracy/Bias/Precision Sample Properly Limit Representativeness,

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Sample Properly Received Limit Representativeness, Accuracy/Bias Target Completeness Completeness Completeness

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Other ERLN Exercises

Date Exercise # of Labs Particpants Date Exercise # of Labs Particpants May 2011 2011 Region 3 CWA Throughput 1 (1) EPA April 2011 2011 EPA Radiological PT Study 19 (4) State (11) Commerical April 2011 2011 EPA Radiological PT Study 19 (11) Commerical (4) DOE March 2011 2011 PHILIS Deployment Sanford 1 (1) EPA March 2011 Gassification, FL 1 (1) EPA November 2010 2010 Fall CWA Study 4 (2) EPA (2) State ( ) August 2010 2010 Full‐scale Exercise (Region 9,10) 16 (2) EPA (16) State/Local (4) Commercial (4) Commercial August 2010 Joint Confidence Building Exercise (Cyanide) 10 (8) EPA (2) State

NEMC 2011 44

July 2010 2010 Spring CWA Study 8 (7) EPA (2) State

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Contact Information Contact Information

Thanks for your attention Jack Krueger, krueger@fairpoint.net krueger@fairpoint.net 49 Nells Hill Road Liberty, Maine 04949 207‐845‐2482‐ Land Line 207‐322‐6297‐ Cell Line

NEMC 2011 45

207 322 6297 Cell Line