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 offer? What do public environmental labs offer? • What informatics issues plague them? – Environmental health LIMS E i t l h lth LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability • It is possible (a real ‐ world example)! Analysis, Answers, Action
Outline Outline • What do public environmental labs offer? What do public environmental labs offer? • What informatics issues plague them? – Environmental health LIMS E i t l h lth LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability • It is possible (a real ‐ world example)! Analysis, Answers, Action
“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
Public Environmental Health Laboratories Public Environmental Health Laboratories • Homeland security (clinical & non ‐ clinical) Homeland security (clinical & non clinical) • Drinking water compliance • Environmental assessment i l • Waste water treatment • Solid waste testing • And much more! And much more! Analysis, Answers, Action NEMC 2011 6
Outline Outline • What do public environmental labs offer? What do public environmental labs offer? • What informatics issues plague them? – Environmental health LIMS E i t l h lth LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability • It is possible (a real ‐ world example)! Analysis, Answers, Action
Why is informatics relevant now? Why is informatics relevant now? Hint: Buried in paper? . . .and p p Everyone wants your data.. Now! Analysis, Answers, Action 8
Public Health Laboratory Interoperability Project b l
Goal: Develop & implement an electronic data flow directly from environmental laboratories to multiple state and federal agencies 10
NEMC 2011 11
Outline Outline • What do public environmental labs offer? What do public environmental labs offer? • What informatics issues plague them? – Environmental health LIMS E i t l h lth LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability • It is possible (a real ‐ world example)! Analysis, Answers, Action
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
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
Environmental Laboratory Laboratory Testing GFAAS α , β , γ Detection Systems CVAF GC Samples I n ICP GC-MS D t Data Out O t NEMC 2011 15 ICP-MS Automated Colorimetric
Outline Outline • What do public environmental labs offer? What do public environmental labs offer? • What informatics issues plague them? – Environmental health LIMS E i t l h lth LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability • It is possible (a real ‐ world example)! Analysis, Answers, Action
Environmental Laboratory Reporting Environmental Laboratory Reporting EPA State PH Depts FDA City PH Depts Patients CDC PH Labs Practitioners Hospitals Hospitals Commercial orgs Other Labs First Emergency Ops PH Field Teams Responders Centers
Need a single, nationally ‐ standardized lab reporting d d d l b format. format. Multiple data exchange templates compromise commercial production compromise commercial production of tools to produce electronic messaging messaging. 19
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 interoperability project (PHLIP) ‐ 22 states, CDC ‐ CCID & b l ( ) CDC ‐ NCPHI working collaboratively Analysis, Answers, Action
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
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
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 LIMS capability rests at CDC bili CDC Analysis, Answers, Action NEMC 2011 23
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 • Includes significant QC data I l d i ifi t QC d t • Data is sent as an xml (accepts xls, SEDD, et al) Analysis, Answers, Action NEMC 2011 24
Pros and Cons for Each Pros and Cons for Each • LIMS costs LIMS costs • Data review • Centralization of data collection C li i f d ll i • 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
Outline Outline • What do public environmental labs offer? What do public environmental labs offer? • What informatics issues plague them? – Environmental health LIMS E i t l h lth LIMS – Environmental electronic data exchange – Quality control data – WebEDR as an approach to interoperability • It is possible (a real ‐ world example)! Analysis, Answers, Action
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 – Frequency F – Limits Analysis, Answers, Action 27
Lab Certification Assures Capability Lab Certification Assures Capability • Quality Assurance Plan Quality Assurance Plan • Method Detection Limit (MDL) studies • Initial Demonstration of Capability I i i l D i f C bili • Standard Operating Procedures • Annual Proficiency Testing • Training documentation • Training documentation • On ‐ site assessments every 2 ‐ 3 years Analysis, Answers, Action 28
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 methods? th d ? Analysis, Answers, Action 29
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 QCS Quality Control Sample Analysis, Answers, Action 30
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) • Human biomonitoring & environmental b l exposure assessment Analysis, Answers, Action NEMC 2011 31
Looking f forward to d our future our future..
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