“Why do Environmental Health and Regulatory Programs ......EPA Methods Update Rule March 12, 2007...
Transcript of “Why do Environmental Health and Regulatory Programs ......EPA Methods Update Rule March 12, 2007...
““Why do Environmental Why do Environmental Health and Regulatory Health and Regulatory
Programs Ignore Laboratory Programs Ignore Laboratory QC data?QC data?””
Henry Leibovitz, Ph.D. Environmental QA/Lab Cert OfficerRI State Health Laboratories
Laboratory Data UsersLaboratory Data Users
Federal and State laws have created the reliance on laboratory testing to support environmental health, regulatory and monitoring programs.
CWA, SDWA, RCRA, CERCLA, Brownfields, CAA, etc.
Relying on Laboratory ResultsRelying on Laboratory Results
Federal, state and municipal Environmental Health and Regulatory Programs utilize laboratory test results to inform decisions affecting public health and the environment.
Environmental programs and utilities may use their own laboratories or contract the testing to laboratories that meet requirements specified in
methods.
Laboratory CertificationLaboratory Certification
Most federal, state and municipal environmental programs require support
laboratories to be certified by a recognized Accreditation Authority.
Quality Assurance and ControlQuality Assurance and Control
Environmental programs and laboratories each maintain and follow their own Quality Assurance Plans to
ensure mission and data quality objectives are met.
Programs Expect LaboratoriesPrograms Expect Laboratories
• Maintain certification and reliability• Follow approved methods• Meet method requirements including
quality controls• Produce accurate and precise data reports
Laboratory Quality AssuranceLaboratory Quality Assurance
Systematic process laboratories follow to produce reliable and reproducible
data.
Laboratory Quality ControlLaboratory Quality Control
Quality control samples are tested with environmental samples in the
laboratory to demonstrate testing is in control (accurate and precise.)
Laboratory Reports Include:Laboratory Reports Include:
• Sample test results (program required)
• QC test results (program discretion)
Lab Reports will include QC results at no extra cost to programs.
Reasons Laboratory QC Data Are Reasons Laboratory QC Data Are IgnoredIgnored
• Assumption - if laboratory is certified then no need to verify data.
• Most federal and state programs don’t require QC or sample data submittal.
• Data review not defined in program Quality Plans
• Programs choose not to use QC data
Laboratory Certification Laboratory Certification Assures CapabilityAssures Capability
• Quality Assurance Plan• Method Detection Limit (MDL) studies• Initial Demonstration of Capability• Standard Operating Procedures• Annual Proficiency Testing• Training Documentation• On-site assessments every 2-3 years
Laboratory Certification Laboratory Certification Does Not Assure AccountabilityDoes Not Assure Accountability
• Are sample testing Quality Controls met?• Are test results and reports reviewed?• Is compliance and monitoring data
acceptable?• Did the laboratory follow approved
methods?
Are Laboratory Results Acceptable Are Laboratory Results Acceptable --Who Decides ?Who Decides ?
• Laboratories decide data is acceptable for public health decision making.
• Programs forfeit this responsibility
EPA Methods Update RuleEPA Methods Update Rule
March 12, 2007 – 40 CFR Parts 122, 136, 141, 143, 430, 455 and 465
“This rule modifies the testing procedures approved for analysis and sampling under the Clean Water Act and Safe Drinking Water Act.”
EPA March 2007 Methods Update RuleEPA March 2007 Methods Update Rule
Most compliance methods require rejection of data that fail QC criteria.
EPA March 2007 Methods Update RuleEPA March 2007 Methods Update Rule
However, to do so when there is not opportunity for reanalysis, resamplingor corrective action may cause a violation of (compliance) reporting requirements.
EPA March 2007 Methods Update RuleEPA March 2007 Methods Update Rule
Regulatory authority should decide whether to reject or accept data that have failed QC specifications in the method, or when problems have occurred during sample collection.
Data Review, Verify or Validate?Data Review, Verify or Validate?
Environmental Programs may accept or reject sample results based on review, verification or validation of QC data results.
Data Quality Objectives (DQO)Data Quality Objectives (DQO)
Program Quality Plans
• Define how laboratory QC data will be used to meet DQO,
• Describe level of review necessary to determine if DQO are met.
EPA OIG Report on EPA OIG Report on Laboratory FraudLaboratory Fraud
• Real concerns about the reliability and quality of laboratory data
• Findings based on improper laboratory practices
• Failure of laboratory to follow method requirements
Unscrupulous LaboratoriesUnscrupulous Laboratories
• Fail to use approved methods• Fail to perform QA/QC testing • Fail to calibrate instruments properly• QA/QC testing “after the fact” to satisfy an
audit or data submission request
What to do about Improper What to do about Improper Laboratory Practices?Laboratory Practices?
• Addressed by data review and verification or validation
• Identify options and resources to assure the laboratories are certified and sample results are acceptable
Program Resources are LimitedProgram Resources are Limited
Many programs do not have the resources or the training necessary to review, verify or validate laboratory data.
Support using 3Support using 3--Way TiesWay Ties
Programs and laboratories rely on each other and on the Laboratory Certification Officer –Build ties between all three
““Solutions to Analytical Chemistry Problems Solutions to Analytical Chemistry Problems with Clean Water Act Methodswith Clean Water Act Methods””
((““Pumpkin BookPumpkin Book”” EPA 821EPA 821--RR--0707--002) 002) March 2007March 2007
Strongly recommends that the supporting QA/QC data be submitted
along with analytical results
EPA EPA ““Pumpkin BookPumpkin Book”” ––Principles of Data ReviewPrinciples of Data Review
Applicable to laboratory methods:• Drinking water methods (500 – series)• SW-846 methods (RCRA methods)• ASTM International Committee D19 (water
methods)• Standard Methods
Laboratory Accountability –Require QC Results in Reports
Problem with Retrieving QC Only Problem with Retrieving QC Only When Questions AriseWhen Questions Arise
• Programs rely upon laboratories to keep QA/QC records unless requested
• QA/QC data maybe components of analytical results for a variety of clients
• Resolving questions of compliance is time consuming and confusing for the program
Retrieving Data on RequestRetrieving Data on Request
Data provided by laboratories may have been compliant . . .
. . . if QC data becomes misplaced there is no way to prove the data was compliant.
Including QC Data in ReportIncluding QC Data in Report
• Quality of the data evaluated directly• Program decides to accept or reject data• Supporting data becomes property of
program• Programs can defend their decisions by
verifying supporting data
Laboratory Laboratory -- Program Accountability Program Accountability --Finding the ResourcesFinding the Resources
• Develop data review capability through training workshops
• Use laboratory and Certification Officer expertise as learning resource
• Utilize new electronic data review software to verify or validate electronic reporting
• Third Party Validation
Data Review Data Review -- What Level?What Level?
Programs must decide and define the level of data review they will require in in their Quality Plan prior to the onset of the project.
Programs should seek a predefined level Programs should seek a predefined level they can achieve with their resourcesthey can achieve with their resources
1. Review QC results only2. Review and verify QC and sample data3. Validate the entire calibration, QC and
sample data.
Random Data AuditsRandom Data Audits
Programs may randomly request entire data set including original QC, calibration and sample data for assessment.
Advantage – Laboratories must always be prepared for data validation by the program.
Standardized Laboratory QA/QC Standardized Laboratory QA/QC (reviewed by certification officer)(reviewed by certification officer)
• Method detection limit (MDL) and minimum level of quantitation
• Initial precision and recovery• Ongoing precision and recovery• Statements of data quality from the
laboratory
Standardized Laboratory QCStandardized Laboratory QC(determined by validation)(determined by validation)
• Purity and traceability of reference standards
• Number of calibration points• Linearity of calibration• Calibration verification
Standardized Laboratory QCStandardized Laboratory QC(reviewed by program)(reviewed by program)
• Analysis of blanks (Method Blank)• Recovery of analytes spiked into a
laboratory reagent blank (LFB, LCS)• Recovery of analytes spiked into the
sample matrix (MS, LFM)
Method Flexibility vs. DeviationsMethod Flexibility vs. Deviations
Data review must distinguish between program allowed flexibility and improper deviations in method implementation.
Method Flexibility vs. DeviationsMethod Flexibility vs. Deviations
For unanticipated situations or where there is ambiguity in the regulations or analytical methods, try working mutual solutions with accreditation or regulatory authority.
Three Way SupportThree Way Support
Environmental Programs
LaboratoryCertification
Laboratories
Improving CommunicationImproving Communication
Environmental Programs
Rarely communicate with laboratories
Establish analytical and reporting requirements
Lack access to laboratories
Laboratory Certification
Routinely communicatewith all laboratories
Communicate program analytical and reporting requirements
Access to all laboratories
Lab Certification Reinforces/Verifies
Lab Capability of MeetingProgram Requirements
Laboratories Provide
Verifiable Data
ProgramsEstablish Requirements, Verify Data Quality –
Approve or Reject Data
Program Support Through CommunicationProgram Support Through Communication
Overlapping ResponsibilityOverlapping Responsibility
Programs
LaboratoriesLaboratory Certification
DATA QUALITY
It Takes a Laboratory!It Takes a Laboratory!
Have you ever received QC data with your routine clinical laboratory test result?
It Takes a Laboratory!It Takes a Laboratory!
ClinicalRequires 1000 tests to determine the public health impact on 1000 people
It Takes a Laboratory!It Takes a Laboratory!
Environmental -ONE test to determine the public health impact to an
entire population!
Programs and laboratories together are engaged in the responsibility to protect public health.
Programs ultimately are responsible to make the decisions that impact it.
Laboratory accountability is necessary to protect public health and the environment against damages caused by the questions surrounding laboratory reliability and integrity that will always be a factor in making the correct decisions.
The final decision on accepting or rejecting laboratory results belongs to Environmental Programs.
Questions or Comments to:Questions or Comments to:
Henry Leibovitz, Ph.D.
RI State Health [email protected]
Thank you!