6/2010 APHL Meeting 1

Discussions with LIMS Vendors to Improve Environmental/Chemical

LIMSImplementation, Data Exchange,

and Interoperability

Through the Efforts of APHL Committees

AgendaThis meeting is meant to be a round

table informal discussion IntroductionsBrief discussion about the current

state of Public Environmental Electronic Data Deliverables (EDD)

Barriers to EDD DevelopmentNew ERLN Requirements DocumentGeneral Discussion

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OBSERVATION: Data Exchange and Interoperability in the

Environmental Health/Environmental Laboratory arena is not keeping up with Clinical e.g.

reportable diseases.The reasons are many.

There is a need to develop a road map to improve Environmental Health/Environmental

Laboratory capabilities in this area.LIMS VENDORS ARE A VERY CRITICAL

COMPONENT

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There are many obstacles: Resources Staff Appropriate $ from the programs that

require services Public/private partnering LIMS systems and appropriate IT supportEnvironmental Labs also need

Incentives to Deliver New Electronic Messages

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Less Obvious, but still Critical: Conflicting/Multiple

Networks/Messages ExistLRN (Laboratory Response Network –BT and CT), FERN (Food Emergency Response Network), NAHLN (National Animal Health Lab Network), ERLN(Environmental Lab Response Network), NPDN (National Plant Diagnostic Network), CDX (Chemical Data Exchange)

Even within Single Agencies there can be Multiple Networks and Data FormatsAs an example: EPA hosts the following networks: CDX,

EPA Portal, EXES, Business Intelligence (BI)

The desired technical implementation of the data standard has been any of the following data formats:–SCRIBE, eDWR, SDWIS, SEDD, ERLN

(including WLA)

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This Old Slide is Still very Relevant:

In the case of the tainted hamburger:•If it’s the Ketchup, Mayo, Bun send the data to FDA•If it’s the Hamburger or Lettuce send the data to USDA•Did someone eat it? Test it at the Public Health Lab and report to CDC/State EPI-Biological or Chemical?•Was the Food Contaminated due to Environmental Concerns: Send the Data to the EPA- which Section of EPA?We Must Find a Common Set of LaboratoryData for these Submittals.

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The ICLN (Integrated Consortium of Laboratory Networks) Is Aware of Data Exchange problems for the data generator and data consumer:1.) There is a difficulty to share electronic data beyond the direct client/requester relationship.2.) Environmental Labs spent significant time creating the data deliverable, sometimes as much time as the testing.

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The existence of multiple data exchange templates has compromised commercial production of tools to produce electronic messaging.

The acceptance of a single nationally standardized lab reporting format will greatly serve the community of developers of Laboratory Information Management Systems (LIMS).

This is a HUGE CHALLENGE.A solution is not simple and we

NEED all the Partners at the Table

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Reporting Quality Control Data has become a major stumbling point. Increasingly, Electronic Data Deliverables (EDD’s) require significant, raw, quality control data. The lack of ability by many state labs to reproduce this data electronically has been a sore point for EPA and reason for EPA to use the private sector. Many states can only export flat files, often lacking QC data. They instead rely on a broad based Certification/accreditation of the laboratory as a substitute for QC data.

PUBLIC TRUST HAS BEEN JUSTIFICATION

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Reporting this Raw Analytical Data of Targets and QC Samples as Collected

in the Analytical Sequence is One Way to Satisfy Reviewer Concerns

about AccountabilityMEASUREMENT QUALITY OBJECTIVES

INCLUDE:–Completeness–Sequence–Frequency–Limits

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Quality Control Data is collected with each batch of samples in an analytical run, the Analytical Sequence. Examples include:

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

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This may seem contorted, but if a single Data Standard is to be adopted, should it be the most robust?

Comprehensive electronic messages contain more information which may be more easily translated from one to the other, but also can better represent more complex and diverse analyses.

One can always make a EDD less robust from a more robust EDD, but not visa versa.

It is more effort initially to create the more robust EDD in a LIMS……..

Once created however vendors and programmers can work together in agreement of code and utility.

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APHL’s Policy An Interoperable and Integrated Federal

Data Exchange Network for Environmental Data

Given the extreme diversity in laboratory information management systems and the various formats and reporting requirements of response agencies, the creation of a “standard” to address analytical reporting of environmental samples is a critical need.

Data Elements

Laboratory Generated Data-Results and Measurement Quality Objectives

Meta Data or Auxiliary Data that relates information about the sample and is necessary to support our public health mission

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? Question ?With regard to electronic delivery of lab results, some of the ships have sailed, and others are ready to leave. We're hoping to find a way for LIMS to provide Interoperable Environmental Electronic Deliverables. Can new LIMS strategies contribute without trying to recall those who are already underway?

An Example of a Modern Data Exchange Template

The recently developed ERLN Report Format and associated WebEDR tools provides modern approach for electronic data exchange.

To some this is SEDD 6.0, more flexible and usable in stages.

Unlike current versions of SEDD a flat file transition is offered as well as a data exchange portal for data review, both to the lab and the client.

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Contact Information

????

?Thanks for your attention on a Complex Topic

Jack Krueger, krueger@fairpoint.net

49 Nells Hill Road Liberty, Maine 04949

207-845-2482- Land Line

207-322-6297- Cell Line