ERLN OPERATIONAL FRAMEWORK

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ERLN OPERATIONAL FRAMEWORK

• EPA Quality Management Conference
• Presented By Sean Kolb
• Schatzi Fitz-James and Terry Smith, OEM
• Sean Kolb and Lisa Modigliani, CSC

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ERLN OPERATIONAL FRAMEWORK

• ERLN Program Overview
• Operational Framework Requirements
• Quality System Design
• Internal
• External
• Sample Management
• Analytical Services System
• Data Reporting Requirements

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PURPOSE

• Environmental Response Laboratory Network (ERLN)
• Provide known laboratory capabilities,
  capacities, and quality data in a scalable,
  systematic, and coordinated response to
  environmental emergencies.

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ERLN PROGRAM OFFICE

• The Homeland Security Laboratory Response Center
  (HSLRC), within the EPA Office of Solid Waste and
  Emergency Response, Office of Emergency
  Management, is responsible for the development,
  deployment, maintenance, and management of the
  ERLN
• HSLRC responsibilities include oversight of
• manage ERLN daily operations
• implement the ERLNs external quality system
• access to ERLN laboratories
• monitor method and laboratory performance

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WHAT DOES THE ERLN PROVIDE?

• An all-hazards/all environmental media
  laboratory network to address preparedness,
  response, remediated, and recovery resulting from
  acts of terrorism or other environmental
  emergencies
• Day-to-day support that can seamlessly support
  incidents of any scale
• A network of laboratories with a known quality
• Provides support to the response community
• Limited biological capability

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CHALLENGES

• ERLN must be able to provide
• A wide variety of laboratory analytical
  capabilities
• Analytical capabilities for a wide variety of
  environmental matrices including drinking water,
  surface water, soil, air, surfaces (wipes), plant
  and animal tissue, waste, oil and debris
• Analytical capabilities to support a wide variety
  of capacity needs
• Analytical capabilities to support a wide variety
  of data needs
• In order to meet these challenges, the ERLN has
  established an operational framework.

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OPERATIONAL FRAMEWORK

• Establishes laboratory reliability, capability,
  capacity, and quality by implementing the
  following laboratory requirements
• A comprehensive quality system, based on
  industry-accepted standards, designed to ensure
  that ERLN data meet their intended use.
• A stable sample management system designed to
  maintain the integrity of samples at the
  laboratory.
• An analytical services system designed to
  identify the laboratories best able to meet a
  projects analytical, capacity, and data needs.
• A data reporting requirement designed to provide
  consistent, reliable data of known and documented
  quality to its ERLN customers.

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QUALITY SYSTEM DESIGN

• The ERLNs quality systems flexibility enables
  it to address various analytical services while
  maintaining the integrity of the data used to
  make major decisions regarding public health and
  environmental welfare.
• The ERLNs quality system is designed to
• Ensure that ERLN laboratory analytical
  measurement systems are maintained in an
  acceptable state of stability and reproducibility
• Detect problems through data assessment and
  establish corrective action procedures that keep
  the analytical process reliable
• Document all aspects of the measurement process
  to improve inter-laboratory data comparison
• To provide data that are technically sound and
  legally defensible

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INTERNAL QUALITY SYSTEM

• ERLN laboratories will be responsible for
  managing the quality aspect of its laboratory
  operations in a systematic and organized manner,
  also referred to as the internal framework.
• The laboratory internal framework consists of
  the establishment and maintenance of a documented
  quality system. The framework should include
  the following components
• Planning
• Implementing
• Assessing work performed
• QA/QC activities necessary to endure integrity of
  the data they generate

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EXTERNAL QUALITY SYSTEM

• EPA will manage the External Quality System.
  This system will monitor the processes followed
  and data generated by each ERLN laboratory.
• Features of an External Quality System include
• Third party laboratory accreditation
• Proficiency testing
• On-site laboratory evaluations
• Data assessments
• Electronic instrumentation data audits

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SAMPLE MANAGEMENT SYSTEM (SMS)

• A stable SMS is critical to maintain the
  integrity of samples within a laboratory.
• ERLN laboratories must establish and maintain a
  SMS that ensures
• Traceability of samples while in possession of
  the laboratory
• Custody of samples while in possession of the
  laboratory
• The integrity of sample identity while in
  possession of the laboratory
• Sample-related activities (i.e., sample receipt,
  storage, preparation, analysis, and disposal) are
  recorded on documents or in other formats
• All laboratory records for each sample received
  by the laboratory are accounted for when the
  project is completed
• All laboratory records directly related to
  samples are assembled and delivered or made
  available upon request to the data user
  upon request.

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CUSTODY OF SAMPLES

• Sample custody is when a sample is
• in the possession of an individual or
• in the view of an individual after being in
  his/her possession or
• locked in a secure area by an individual after
  being in his/her possession or
• in a designated secure area that is only
  accessible by authorized personnel.
• All ERLN samples are to be received and
  maintained under Chain of Custody (COC).
• To aid in this process, laboratories can employ a
  variety of tools as part of the SMS.

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ANALYTICAL SERVICES SYSTEM

• The Analytical Services System is based on the
  framework of the Incident Command System.
• This system is designed so support personnel can
  fill one or multiple roles during a response,
  depending on the scale of the incident
• The Analytical Services System is composed of
  four phases
• Initiation
• Planning
• Execution
• Closing ERLN Laboratory Services

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PHASES OF THE ANALYTICAL SERVICES SYSTEM
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DATA REPORTING REQUIREMENTS

• ERLN data reporting business processes,
  specifications and formats are designed to
  support the various ERLN projects data needs by
  enabling laboratories to provide data submissions
  with rapid turnarounds, while having sufficient
  data to support decisions made for each project.
• ERLN data are reported in both electronic and
  hardcopy format.
• Electronic data in computer-readable and PDF are
  required for each ERLN data submission, while
  hardcopy submissions are optional.

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TYPES OF DATA SUBMISSIONS

• ERLN data submissions are separated into three
  types
• Type One
• Type One Transitional
• Type Two
• Type Three
• The data submission type is determined by the
  data user for each individual project. These
  types correlate to the data required to support
  decisions made for the various intended uses of
  response personnel.

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ERLN OPERATIONAL FRAMEWORK

• ERLN Program Overview
• Operational Framework Requirements
• Quality System Design
• Internal
• External
• Sample Management
• Analytical Services System
• Data Reporting Requirements

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POINTS OF CONTACT HSLRC TEAM

• EPA Office of Emergency Management (5104A)
• 1200 Pennsylvania Avenue, N.W.
• Washington, DC 20460
• Schatzi Fitz-James, HSLRC Team
• fitz-james.schatzi_at_epa.gov
• Phone [phone]
• Terry Smith Michele
  Burgess Marissa Mullins
• Lead Chemical Liaison Lead Biology
  Liaison Biologist
• smith.terry_at_epa.gov 
  burgess.michele_at_epa.gov  mullins.marissa_at_epa
  .gov
• 202-564-2908 202-564-8006
  202-564-5848