erln operational framework epa quality management conference presented by: sean kolb schatzi...
TRANSCRIPT
ERLN OPERATIONAL FRAMEWORK
EPA Quality Management Conference
Presented By: Sean Kolb
Schatzi Fitz-James and Terry Smith, OEM
Sean Kolb and Lisa Modigliani, CSC
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 capability5
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 project’s 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 ERLN’s quality system’s 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 ERLN’s 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 defensible8
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 9
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. 11
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 project’s 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
Phone: (202) 564-2521
Terry Smith Michele Burgess Marissa Mullins
Lead Chemical Liaison Lead Biology Liaison Biologist
[email protected] [email protected] [email protected]
202-564-2908 202-564-8006 202-564-5848
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