Environmental Laboratory Ethics: Then and Now Dorothy Love - PDF document

9/22/2017 Analysis. Answers. Action. www.aphl.org Environmental Laboratory Ethics: Then and Now Dorothy Love – Eurofins Environment Testing Larry Penfold – TestAmerica Laboratories, Inc. 1 SPEAKER DISCLOSURE APHL adheres to established standards regarding industry support of continuing education for healthcare professionals. The following disclosures of personal financial relationships with commercial interests within the last 12 months as relative to this presentation have been made by the speaker(s): “All speakers in this session have nothing to disclose.” 2 Analysis. Answers. Action. www.aphl.org Objectives • Every year there are new reports of fraud, ethics violations, and/or data integrity issues in our industry. • It is critical that every employee understand industry expectations and requirements in regard to Ethics and Data Integrity and the procedures necessary to ensure the integrity of our work and for reporting any concerns. 3 Analysis. Answers. Action. www.aphl.org 1

9/22/2017 Topics • Ethical and Data Integrity Issues – past and present in our industry • Why Ethics Matter • Proper procedures • Detection and Prevention • Responsibilities • Actions 4 Analysis. Answers. Action. www.aphl.org Why Have Ethics Training? Most lab workers have high ethical standards, but current and past information shows: • Data integrity lapses can and do occur, even with highly trained scientific staff • Applicable to government and commercial labs • Not limited to environmental labs • Frequency of cases investigated continues to increase Ramifications of ethical lapses can have far reaching consequences 5 Analysis. Answers. Action. www.aphl.org Data Integrity Training Expected At Modern Laboratories • ISO/IEC 17025, Section 4.1.5 d), labs must “have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment, or operational integrity” • 2009 TNI (NELAC) Standard, Section 5.2.7 • “Data integrity training shall be provided as a formal part of new employee orientation and shall also be provided on an annual basis” 6 Analysis. Answers. Action. www.aphl.org 2

9/22/2017 Development of Laboratory Ethics Over the Last 50 Years 7 Analysis. Answers. Action. www.aphl.org Ethics Concerns Driven By Changes in Laboratory Data Processing • Progress in data processing technology affected all aspects of analytical chemistry - Power of analytical instrumentation: - Analyst control of data - QC processed with samples - Nature of reports & deliverables - Frequency & depth of validation - Awareness of ethics concerns 8 Analysis. Answers. Action. www.aphl.org 4 Eras of Data Processing, Analytical Chemistry & Laboratory Ethics 1995 –Today Full Digital Integration with Social Media 1980 -1995 Digital Explosion 1960–1980 Early Digital Pre-Digital 1960 and earlier 9 Analysis. Answers. Action. www.aphl.org 3

9/22/2017 Pre-Digital Data Processing Tools Mechanical calculators for adding numbers Slide rules for multiplying and dividing 10 Analysis. Answers. Action. www.aphl.org Environmental Instrument Output On Strip Chart Recorders Peaks measured with a ruler All peaks manually integrated! 11 Analysis. Answers. Action. www.aphl.org Analytical Laboratory QC and Reports in Pre-Digital Era • Calibration, negative controls (blanks), positive controls (matrix spikes, tracers…), but QC results generally not reported • Reports often simple description of testing performed and a table of analytical results • Uncertainty of measurement typically province of physicists • No ethics training, little awareness 12 Analysis. Answers. Action. www.aphl.org 4

9/22/2017 Early Digital Era in Routine Analytical Chemistry 1960-1980 13 Analysis. Answers. Action. www.aphl.org Key Events During Early Digital Era • 1970 U.S. EPA formed • 1974-1975 Xerox PARC, Microsoft formed • 1978 EPA’s first manual for the certification of laboratories analyzing drinking water, establishing minimum QC, which started a program of laboratory compliance audits 14 Analysis. Answers. Action. www.aphl.org IBM 1401 8k core memory & 2 Mb hard disk Hollerith cards used to load program & data for every computer run 15 Analysis. Answers. Action. www.aphl.org 5

9/22/2017 Analytical Laboratory QC and Reports in Early Digital Era….Same as before • Calibration, negative controls (blanks), positive controls (matrix spikes, tracers…), generally not reported • Reports often simple description of testing performed and a table of analytical results • Uncertainty of measurement typically province of physicists • No ethics training, little awareness 16 Analysis. Answers. Action. www.aphl.org Era of Digital Explosion in Analytical Chemistry and Ethics Awareness 1980-1995 17 Analysis. Answers. Action. www.aphl.org Key Events in Era of Digital Explosion • December 1980 EPA Superfund program and Contract Laboratory Program (CLP) • August 1981 IBM releases first consumer personal computer 18 Analysis. Answers. Action. www.aphl.org 6

9/22/2017 Importance of PC Revolution • Distributed data processing • PCs connected directly to analytical instruments, but not yet integrated to a single network • Pro: Much wider range of QC included and results easily calculated • Con: Increased ability of analyst to modify data after collection 19 Analysis. Answers. Action. www.aphl.org Importance of CLP Program for Environmental Lab Ethics • EPA CLP Statements of Work define detailed calibration and QC requirements • EPA PT program and qualification audits • EPA National Functional Guidelines (NFG) defines detailed data validation requirements • Labs supply reports, QC forms, plus extensive raw data packages for validation 20 Analysis. Answers. Action. www.aphl.org Growing Awareness of Data Integrity and Ethics Concerns • By the end of the 1980s, widely recognized to be a serious problem affecting a significant number of labs • A menagerie of data integrity problems found: time travelling, improper mass spectrometer tuning, peak shaving, file switching, juicing standards, and more 21 Analysis. Answers. Action. www.aphl.org 7

9/22/2017 Watershed Moment • Prompted by a multi-million dollar laboratory fraud issue, EPA Region 9’s laboratory program was audited by the EPA Office of the Inspector General (OIG) which in turn launched nation- wide investigation • September 27, 1995 EPA OIG investigations report to DoD, EPA and Congress 22 Analysis. Answers. Action. www.aphl.org Era of Full Digital Integration and Social Media 1995 - Today 23 Analysis. Answers. Action. www.aphl.org Key Events – National Programs 1999 The National Environmental Laboratory Accreditation Conference (NELAC), defines ethics and data integrity requirements and training standards 2006 OIG issues report describing best practice assessment and evaluation processes, and provides advice to improve laboratory integrity 24 Analysis. Answers. Action. www.aphl.org 8

9/22/2017 Modern Digital Trends Truly integrated data processing networks – Nearly all analytical instruments connected to company-wide intranet – LIMS capturing virtually all raw data – Expert systems data review tools • Not just QC results, but also • Validity of elution order • Appropriate ions in GC/MS spectra…. 25 Analysis. Answers. Action. www.aphl.org Result of More Sophisticated Automated Data Review Some types of data integrity problems that used to be among biggest concerns in 1980s and 1990s are seldom encountered, such as –Inappropriate mass tuning –Time travelling 26 Analysis. Answers. Action. www.aphl.org Social Media Has Introduced New Ethics Concerns • Cell phones and social media – Extensive computer memory – Cameras everywhere – Internet connectivity • Labs now encounter new ethical concerns: – Photos posted on-line compromising client confidentiality – Data security issues 27 Analysis. Answers. Action. www.aphl.org 9

9/22/2017 The More Things Change, The More They Stay The Same 28 Analysis. Answers. Action. www.aphl.org Fundamental Lab Ethics Issues Remain the Same • Where expert systems can’t or teams of expert validators don’t check, familiar bad practices continue to crop up, e.g., – Improper manual integrations – File switching – Juicing • Rigorous ethics programs within each laboratory are more important than ever 29 Analysis. Answers. Action. www.aphl.org Importance of ethical behavior • In addition to fines and business closures, people convicted of fraud involving laboratory data can be debarred from working in the laboratory business and the worst offenders can be jailed. • Data is used to make decisions that affect the public health. – Is water fit to drink? – How clean is the environment where we live and play? – Are products safe and effective? 30 Analysis. Answers. Action. www.aphl.org 10