New Analytical Excellence, Inc. - NELAC Institutenelac-institute.org/docs/eds/id112/Print Copy-final... · 2012. 11. 12. · Ethics Training for the ... Addressing Ethical Dilemmas

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Analytical Excellence, Inc.Analytical Excellence, Inc.

Q li SQ li SQuality SystemsQuality Systems

Compliance Mgmt.Compliance Mgmt.

ProfitabilityProfitability

AEX@ix netcom comAEX@ix netcom [email protected]@ix.netcom.com(407) 331(407) 331--5040 (voice)5040 (voice)(407) 331(407) 331--4025 (fax)4025 (fax)

812 Point Pleasant Place, Altamonte Springs, FL 32701

Ethics Training for the Ethics Training for the

Workshop Excellence

Environmental ProfessionalEnvironmental Professional

Addressing Ethical Dilemmas and Installing a “Culture of Integrity”

A Presentation by:A Presentation by:

Jack Farrell, Analytical Excellence, Inc.Jack Farrell, Analytical Excellence, Inc.

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WelcomeWelcome

This is the This is the fourthfourth in our series of Quality in our series of Quality A d A di i iA d A di i iAssurance and Accreditation topicsAssurance and Accreditation topics

Continue to explore topics for understanding Continue to explore topics for understanding the various the various Management System elementsManagement System elements

The TNI EL 2009 StandardThe TNI EL 2009 Standard The TNI EL 2009 StandardThe TNI EL 2009 Standard

And suggestions on implementing them effectivelyAnd suggestions on implementing them effectively

Thank you for your support and participationThank you for your support and participation

IntroductionIntroduction

This is a partnership between Analytical This is a partnership between Analytical E ll I (AEX) d Th NELACE ll I (AEX) d Th NELACExcellence, Inc. (AEX) and The NELAC Excellence, Inc. (AEX) and The NELAC Institute (TNI)Institute (TNI) Primary Trainer: Jack Farrell Primary Trainer: Jack Farrell –– AEXAEX

Workshop Development and PresenterWorkshop Development and Presenter

Host: Ilona Taunton Host: Ilona Taunton –– TNI Training CoordinatorTNI Training Coordinator Organization and Webex AdministratorOrganization and Webex Administrator

Training Support: Patty Snyder Training Support: Patty Snyder –– AEXAEX

Workshop MaterialsWorkshop Materials

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Disclaimer & ConfidentialityDisclaimer & Confidentiality

The materials presented in this workshop are for The materials presented in this workshop are for llyour use only.your use only.

You are free and encouraged to use them internally You are free and encouraged to use them internally within your company or organization.within your company or organization.

The materials are not for external use or distribution The materials are not for external use or distribution without written permission from AEX.without written permission from AEX.

If you have any questions, please contact Jack If you have any questions, please contact Jack Farrell or Patty Snyder.Farrell or Patty Snyder.

Thank you for your consideration. Thank you for your consideration.

Continuous ImprovementContinuous Improvement

All of us continue to explore improvement, and All of us continue to explore improvement, and h bi b l fh bi b l fthese webinars can be elements of your these webinars can be elements of your OnOn--going training efforts for management, QA, going training efforts for management, QA,

supervisors and analysts, andsupervisors and analysts, and

Continuous improvement and preventive action Continuous improvement and preventive action programsprograms

Your participation and feedback are a very Your participation and feedback are a very important part of OUR continuous important part of OUR continuous improvement processes.improvement processes.

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Meeting Meeting MechanicsMechanics

Meeting Mechanics …Meeting Mechanics …

All phone lines are muted when you All phone lines are muted when you join the call There will be Q&Ajoin the call There will be Q&Ajoin the call. There will be Q&A join the call. There will be Q&A sections in this training. If you want sections in this training. If you want to speak to speak –– click on the hand. The click on the hand. The hand will come up next to your name, hand will come up next to your name, and this alerts the trainer you want to and this alerts the trainer you want to speak. Your phone will be unspeak. Your phone will be un--muted muted (red x is removed) when it is your (red x is removed) when it is your turn to speak. turn to speak.

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Use the feedback button if you want to alert the Use the feedback button if you want to alert the trainer that the subject matter is going too fasttrainer that the subject matter is going too fasttrainer that the subject matter is going too fast trainer that the subject matter is going too fast or too slow. or too slow.

You can also type your questions or comments You can also type your questions or comments into the dialogue box, and the instructor will try into the dialogue box, and the instructor will try to answer your questions or present your to answer your questions or present your y q p yy q p ycomments.comments.

About midway through the workshop we will About midway through the workshop we will take a 10 minute break take a 10 minute break –– keep the lines open!keep the lines open!


The trainer will have poll questions The trainer will have poll questions during the webinar to test yourduring the webinar to test yourduring the webinar to test your during the webinar to test your knowledge of the material and gain knowledge of the material and gain some feedback and opinions. You some feedback and opinions. You will see the poll pop up … answer will see the poll pop up … answer the questions … and then submit the questions … and then submit your responses. The result your responses. The result summary will be presented and the summary will be presented and the answers reviewed.answers reviewed.

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When the webinar ends, a TNI Course Survey When the webinar ends, a TNI Course Survey will pop up You can select your answers typewill pop up You can select your answers typewill pop up. You can select your answers, type will pop up. You can select your answers, type responses and then click submit. responses and then click submit.

Learning ObjectivesLearning Objectives

At the end of this workshop, you should …At the end of this workshop, you should …U d d h TNI 2009 EL S d d dU d d h TNI 2009 EL S d d d Understand the TNI 2009 EL Standard contents and Understand the TNI 2009 EL Standard contents and requirements for ethics training.requirements for ethics training.

Be familiar with some of the components of effective Be familiar with some of the components of effective ethics training and proper scientific decision making.ethics training and proper scientific decision making.

Be able to discuss the definitions of key terms, causes Be able to discuss the definitions of key terms, causes f i b h i d l f i ifif i b h i d l f i ifiof improper behavior and examples of poor scientific of improper behavior and examples of poor scientific

decision making.decision making.

Be able to discuss and evaluate what your organization Be able to discuss and evaluate what your organization should consider in developing an ethics training should consider in developing an ethics training program.program.

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What this workshop is and is notWhat this workshop is and is not

This workshop does not discuss how to develop This workshop does not discuss how to develop d i l D I i Pd i l D I i Pand implement a Data Integrity Programand implement a Data Integrity Program

That is next month’s workshopThat is next month’s workshop

It does touch on several components of a DI It does touch on several components of a DI programprogram

It focuses primarily on two components of a DI It focuses primarily on two components of a DI p y pp y pprogram, that of proper scientific decision program, that of proper scientific decision making and ethical conductmaking and ethical conduct

AGENDAAGENDA

The TNI 2009 EL Standard and requirements The TNI 2009 EL Standard and requirements

Ethical conduct and proper scientific decision Ethical conduct and proper scientific decision makingmaking

Values, morals and ethics in laboratoriesValues, morals and ethics in laboratories

Definitions of key terms and root causes of Definitions of key terms and root causes of i b h ii b h iimproper behavior improper behavior

Examples of poor scientific decision makingExamples of poor scientific decision making

Developing an ethics training programDeveloping an ethics training program

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What I hope to explore and accomplish ….

Sh i f i d iShare some information and experiences.Give you one perspective.Provide some ideas and challenges.Provide some simple common sense tools. Get you thinking. This can be a very hard and

confusing topic for some to digestconfusing topic for some to digest.Provide a “language” to facilitate dilemma resolution.

I must apologize …

… you folks have been brought here on false pretenses!!!!

I can’t teach you ethics …

It’s like Army Intelligenceor being legally drunk

or slightly pregnant!!

But I will present some topics to explore…

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Why Be Ethical?Why Be Ethical?

Aren’t we all ethical and moral Aren’t we all ethical and moral folks folks l d ???l d ???already???already???

Let’s get something straight …

We are not here because you are not ethical or moral folks …

We are not here because you are not professionals …

We are not here to change your personal deep seated morals or Personal Values …

We are here to discuss the business climate, working environments, pressures to shortcut and how to avoid ‘pitfalls’

that have trapped other public and private laboratory organizations.

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The Institute for Global EthicsThe Institute for Global Ethics

R h th M Kidd & A i tR h th M Kidd & A i t Rushworth M. Kidder & AssociatesRushworth M. Kidder & Associates

Founded in 1990 in Camden, MaineFounded in 1990 in Camden, Maine We will not survive the twentyWe will not survive the twenty--first first

century with the ethics of the twentieth century with the ethics of the twentieth century. century.

The Institute for Global EthicsThe Institute for Global Ethics

Can be purchased from theInstitute for Global Ethics (IGE)

www. globalethics.org

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Why Be Ethical?• We won’t survive the 21st century with 20th

hi T h l L !century ethics - Technology Leverage!

• Ethics, Quality and Leadership will be even more important in the future!

• To respond to customer demands!

• A l i thi l j d t b• A lapse in ethical judgment can be a career ending move.

• To the extent that we do not self regulate, we will be regulated by the external!

Why Be Ethical?

• Practicing Ethical Fitness is a way of life. • Ethics training is not an inoculation, it’s a

continual process of communication.

• Ethics training will not provide a magic

tanswer or a guarantee.

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... because no matter what else you do, profits, marketshare, niche products ...

a laboratory or field sampling organization lives and dies by its integrity and reputation--

without it there is no survival!!!

Chernobyl Disaster – Reactor Number 4

Ramifications of Unethical Behavior

y

Fifteen Minutes at Bath Iron Works

Walkerton, Ontario Drinking Water Supply

An ethical lapse (even for one brief moment) can be a Career Ending Move (CEM).

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Walkerton, OntarioWalkerton, Ontario

May 2000

A small farming communityA small farming community

Population of 5,000+Population of 5,000+

A freak rain storm and floodingA freak rain storm and flooding

Contaminated a PUC well with manureContaminated a PUC well with manure

May 2000

Contaminated a PUC well with manureContaminated a PUC well with manure

Victoria Day holiday was right around the cornerVictoria Day holiday was right around the corner

Call attention to a tragic set of practicesCall attention to a tragic set of practices

Walkerton, OntarioWalkerton, Ontario

…So disturbing were the events in this small Ontario farming town last spring, they might have leapt from the f g p g y g p fpages of a Stephen King novel. One by one, hundreds of people began suffering nausea, blinding headaches, agonizing stomach cramps and bloody diarrhea. …

…Bad lab results, sick children, and several calls from health officials left the town’s utility manager with a growing sense of uneasegrowing sense of unease …

…Falsifying testing samples and records of chlorine levelsin the town’s water was a time honored practice for over two decades …

www.cbc.ca/news/indepth/walkerton/inquiry

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How can this possibly happen?How can this possibly happen?

Didn’t believe in chlorinationDidn’t believe in chlorination

PUC l i d iPUC l i d i PUC personnel inept and incompetentPUC personnel inept and incompetent

Falsified lab results (Falsified lab results (dirty little secret)dirty little secret)

Felt that he (Koebel) could handle the problemFelt that he (Koebel) could handle the problem

Did not want to raise an alarmDid not want to raise an alarm

Didn’t want to interfere with Victoria DayDidn’t want to interfere with Victoria Dayyy

Insufficient required reporting due to cost cuttingInsufficient required reporting due to cost cutting

The Tragic ResultThe Tragic Result

Seven deathsSeven deaths 2300+ taken sick2300+ taken sick 2300+ taken sick2300+ taken sick 2 year long investigation2 year long investigation Big economic costsBig economic costs

$4$4--5 K per household5 K per household $5+ Million in legal fees$5+ Million in legal fees $64.5 Million business loss$64.5 Million business loss$$ Overall cost $155 MillionOverall cost $155 Million

And what about the social and psychological impact?

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The Facts of the Matter

Al ll i l li dAlmost all environmental compliance and management decisions are based on

measurement data.

Credible measurements of defined known li i i l kiquality are critical to making accurate cost -

effective decisions by regulators and industry in protecting our environment and the public.

The Facts of the MatterLaboratories are coming under tremendous scrutiny by investigators for improper practices and noncomplianceinvestigators for improper practices and noncompliance.

Improper or inappropriate practices do occur in a number of private and government laboratories.

Exactly what is inappropriate and what is a mistake isvery complicated and confusing.

Laboratory managers, owners and directors are being held accountable financially and legally for what happens in the laboratory.

Ignorance is not bliss or an acceptable defense.

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Challenges to your reputation may come from internal sources or external sources.

f lifrom clients... but I can't be out of compliance... it’s only a little bit - can't you round it?... I'll take my business elsewhere

from employees... if QC fails, I have to repeat it... get it out now!g... sure we can do that... I'll miss my son's ball game

Do you encourage a culture of “shortcuts”?

A thumbnail list of examples ...

... the FBI laboratory (questionable practices)

... in academic research (falsified research data)

... the environmental laboratory industry(falsified data, jail terms, failed businesses)

... the OJ trials ( l l b d h i b )(a total laboratory and chemist embarrassment)

... the clinical laboratory industry(medicare fraud and improper billing practices)

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Ethics Data IntegrityEthics Data IntegrityEthics, Data Integrity Ethics, Data Integrity and the TNI Standardand the TNI Standard

2009 TNI EL Standard2009 TNI EL Standard

Incorporation of ISO LanguageIncorporation of ISO Language

MM NN i l d di l d d Many Many NotesNotes are now included.are now included.

Notes provide clarification of the text, examples and guidance. Notes provide clarification of the text, examples and guidance.

“They do not contain requirements and do not form an integral part of “They do not contain requirements and do not form an integral part of this Standard.”this Standard.”

17025 language reproduced faithfully.17025 language reproduced faithfully.

Shown in italics.Shown in italics.

Underlining in the following slides referencing theUnderlining in the following slides referencing the

2009 TNI Standard added for emphasis.2009 TNI Standard added for emphasis.

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2009 TNI EL Standard2009 TNI EL StandardVolume 1 Module 2Volume 1 Module 2

ManagementManagement -- Additional RequirementsAdditional Requirements -- Section 4.2.8.1Section 4.2.8.1Management Management Additional Requirements Additional Requirements Section 4.2.8.1 Section 4.2.8.1

The laboratory shall establish and maintain a documented data The laboratory shall establish and maintain a documented data integrity system. integrity system.

There are four (4) required elements within a data integrity system. There are four (4) required elements within a data integrity system. These are These are

11) d i i i i) d i i i i11) data integrity training) data integrity training, ,

2) signed data integrity documentation for all laboratory employees, 2) signed data integrity documentation for all laboratory employees,

3) in3) in--depth, periodic monitoring of data integrity, and depth, periodic monitoring of data integrity, and

4) data integrity procedure documentation. 4) data integrity procedure documentation.

The data integrity procedures shall be signed and dated by top The data integrity procedures shall be signed and dated by top management. management.

2009 TNI EL Standard2009 TNI EL StandardVolume 1 Module 2

Data Integrity TrainingData Integrity Training Section 5 2 7Section 5 2 7Data Integrity TrainingData Integrity Training –– Section 5.2.7Section 5.2.7

Data integrity training shall be provided as Data integrity training shall be provided as a formal part of new a formal part of new employee orientationemployee orientation and shall also be provided on an and shall also be provided on an annual basis for annual basis for all current employeesall current employees. .

Employees are required to Employees are required to understand that any infractionsunderstand that any infractions of the of the laboratory data integrity procedures shall result in a detailedlaboratory data integrity procedures shall result in a detailedlaboratory data integrity procedures shall result in a detailed laboratory data integrity procedures shall result in a detailed investigation that could lead investigation that could lead to very serious consequencesto very serious consequences including including {*but not limited to} {*but not limited to} immediate termination, debarment or civil/criminal immediate termination, debarment or civil/criminal prosecution. prosecution.

* Not in Standard* Not in Standard

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Data Integrity TrainingData Integrity Training –– Section 5.2.7 (cont.)Section 5.2.7 (cont.)Data Integrity Training Data Integrity Training Section 5.2.7 (cont.)Section 5.2.7 (cont.)

The initial data integrity training and the annual refresher training shall The initial data integrity training and the annual refresher training shall have a have a signature attendance sheet or other form of documentationsignature attendance sheet or other form of documentation that that demonstrates all staff have demonstrates all staff have participated and understandparticipated and understand their their obligations related to data integrity.obligations related to data integrity.

Data integrity training requires emphasis on the importance of Data integrity training requires emphasis on the importance of proper proper g y g q p pg y g q p p p pp pwritten narrationwritten narration on the part of the analyst with respect to those cases on the part of the analyst with respect to those cases where analytical data may be useful, but are in one sense or another where analytical data may be useful, but are in one sense or another partially deficient. partially deficient.


Data Integrity TrainingData Integrity Training –– Section 5.2.7 (cont.)Section 5.2.7 (cont.)Data Integrity Training Data Integrity Training Section 5.2.7 (cont.)Section 5.2.7 (cont.)

At a minimum, the following topics and activities shall be included:At a minimum, the following topics and activities shall be included:

a)a) organizational missionorganizational mission and its relationship to the critical need for and its relationship to the critical need for honesty honesty and and full disclosure in all analytical reporting, how and when to report data integrity full disclosure in all analytical reporting, how and when to report data integrity issues, and record keeping;issues, and record keeping;

b)b) tr inin in l din di i n r rdin lltr inin in l din di i n r rdin ll d t int rit pr d rd t int rit pr d rb)b) training, including discussion regarding all training, including discussion regarding all data integrity proceduresdata integrity procedures; ;

c)c) data integrity training data integrity training documentationdocumentation; ;

d)d) inin--depth data monitoringdepth data monitoring and data integrity procedure documentation; and and data integrity procedure documentation; and

e)e) specific examples of breachesspecific examples of breaches of ethical behavior such as improper data of ethical behavior such as improper data manipulations, adjustments of instrument time clocks, and inappropriate manipulations, adjustments of instrument time clocks, and inappropriate changes in concentrations of standards.changes in concentrations of standards.

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Data Integrity Training Data Integrity Training –– Section 5.2.7 (cont.)Section 5.2.7 (cont.)

The data integrity procedures may also include written ethics The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees.program training, and any external resources available to employees.

2009 TNI EL Standard2009 TNI EL Standard

SummarySummary

The wording may have changed.The wording may have changed. The format and organization may have changed.The format and organization may have changed. The requirements may have been clarified.The requirements may have been clarified.

…but the intent and requirements have…but the intent and requirements haveessentially stayed the same…essentially stayed the same…

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Why Ethics Training?Why Ethics Training?

In June 1999 the OIG releasedIn June 1999 the OIG released a report entitled

Laboratory Fraud: Deterrence and Detection

indicates that ethics training was one ofindicates that ethics training was one of the primary training remedies for

laboratory fraud.

www.epa.gov/oig/reports

“Laboratory Fraud: “Laboratory Fraud: Deterrence and Detection”Deterrence and Detection”

Having employees that understand the difference between a mistake and improper behavior and that are trained to make “ethic[al] decisions” is one of the best prevention strategies. A strong reinforcedp g gethics training program is one of the key cornerstones to an effective “total ethical process”.

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Assuring Ethical Practices & Decision Makingg

-:- The Total Ethical Process -:-

A System of Shared ValuesA System of Shared Values

Proper ethical and scientific decisionstarts with a system of wellstarts with a system of well communicated and understood Shared Values as the basis for analyzing and resolving ethical dilemma.

Does your organization have well definedValues?

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Defining EthicsDefining Ethics

Ethics is one of the hardest “Words” Ethics is one of the hardest “Words” d fi d d d b l ’ !d fi d d d b l ’ !to define and understand…but let’s try!to define and understand…but let’s try!

Defining EthicsDefining Ethics

Derives from the Greek word Derives from the Greek word ethosethos, meaning , meaning “custom”, “usage”, or “character”.“custom”, “usage”, or “character”.

The science of moral duty (The science of moral duty (Webster’s New Webster’s New InternationalInternational, 1924)., 1924).

More broadly, the science of the ideal human More broadly, the science of the ideal human character.character.

A body of knowledge about morals.A body of knowledge about morals.

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Defining MoralDefining Moral

Derives from the Latin word Derives from the Latin word mos mos or or morismorisi h bi f lifi h bi f lifmeaning manner, custom, habit, way of life, or meaning manner, custom, habit, way of life, or

conduct.conduct.

Pertaining to man’s natural sense of what is right Pertaining to man’s natural sense of what is right and proper (and proper (Webster’sWebster’s, 1924)., 1924).

That which is good or right such as a goodThat which is good or right such as a good That which is good or right, such as a good That which is good or right, such as a good person or right action (person or right action (ThirouxThiroux, 1986)., 1986).

Defining ValueDefining Value Derives from the French word Derives from the French word valoirvaloir meaning to meaning to

be of worthbe of worthbe of worth.be of worth. That which is worthy of esteem for its own sake, That which is worthy of esteem for its own sake,

that which has intrinsic worth (that which has intrinsic worth (Oxford English Oxford English DictionaryDictionary).).

A principle, standard, or quality regarded as A principle, standard, or quality regarded as h hil d i bl (h hil d i bl (W b ’ N Ri idW b ’ N Ri idworthwhile or desirable (worthwhile or desirable (Webster’s New Riverside Webster’s New Riverside

University Dictionary, 1984).University Dictionary, 1984).

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Defining EthicsDefining EthicsJohn Fletcher MoultonJohn Fletcher Moulton

positive law

manners

• Obedience to the Unenforceable

free choice

So, what is ethics ...So, what is ethics ...

A manner, custom, habit, way of life, or conduct that A manner, custom, habit, way of life, or conduct that emphasizes a person’s natural sense of right and properemphasizes a person’s natural sense of right and properemphasizes a person s natural sense of right and proper emphasizes a person s natural sense of right and proper based on based on currentcurrent community standards.community standards.

A process by which an individual can rationally and A process by which an individual can rationally and logically decide what is right in a given situation.logically decide what is right in a given situation.

It’s how you live your life.It’s how you live your life.

I ’ h MAMA h !!!I ’ h MAMA h !!! It’s what your MAMA taught you!!!It’s what your MAMA taught you!!!

It’s what you do when no one is looking!!!It’s what you do when no one is looking!!!

Can you accept and live up to these definitions?

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A CautionA Caution Opinion and decision making are influenced by Opinion and decision making are influenced by

what your community thinks….what your community thinks….y yy y

Care must be taken not to be overly influenced Care must be taken not to be overly influenced by public opinion or to rationalize decision by public opinion or to rationalize decision making making Well, it really is not that importantWell, it really is not that important

It is only a small changeIt is only a small change It is only a small changeIt is only a small change

Others have done it…Others have done it…

Turnaround time is really important over qualityTurnaround time is really important over quality

ExamplesExamples

Codes of Ethics

Greater than 95% of corporations have Greater than 95% of corporations have implemented a code of ethicsimplemented a code of ethicsimplemented a code of ethicsimplemented a code of ethics Most organizations in your community have codes Most organizations in your community have codes

of ethics or statements of organizational valuesof ethics or statements of organizational values Look around the next time you go out!!!Look around the next time you go out!!!

BanksBanks Fast Food RestaurantsFast Food Restaurants BanksBanks

ChurchesChurches

SchoolsSchools

Fast Food RestaurantsFast Food Restaurants

Government BuildingsGovernment Buildings

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Code of EthicsCode of Ethics

Not a MissionNot a MissionNot a Mission Not a Mission StatementStatement

Not a Strategic Not a Strategic PlanPlan

Not a MottoNot a Motto Not a MottoNot a Motto

A Statement of Shared Values

Codes of Ethics ExamplesCodes of Ethics Examples

dd Ten CommandmentsTen Commandments

Boy Scout Law Boy Scout Law ((A scout is ….)A scout is ….)

West Point Honor CodeWest Point Honor Code((A cadet does not lie, cheat or steal or tolerate that in others)A cadet does not lie, cheat or steal or tolerate that in others)

S i t f Q lit A i th U SS i t f Q lit A i th U S Society of Quality Assurance in the U.S.Society of Quality Assurance in the U.S.

ACIL Code of EthicsACIL Code of Ethics

Lancaster Laboratories Statement of ValuesLancaster Laboratories Statement of Values

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Up ‘N Smoke Club, Inc. Ethics Codified

As a membership organization, we will provide an alternative environment that recognizes, respects and embraces the responsible use and enjoyment of cigars by our members. To that end, we pledge: Honesty & Responsibility

To provide accurate information on the ingredients, quality and origins of our cigars and beverages.

To offer professional services to our members.

To offer humidors which are safe, dry and environmentally controlled.

Compassion

To post accurate and up-to-date information on the results of current research relative to cigar smoking.

To provide a safe, supportive and friendly atmosphere consistent with

the heritage and tradition of a cigar aficionado.

To furnish state-of-the-art air quality environmental systems to insure the smoking ambiance.

Fairness & Tolerance

To insist upon behavior by our professional staff and members which is “proper” and respectful of each person’s individual preferences.

To tolerate no behavior or conduct which is abusive or rude.

To operate our business in accordance with all applicable local, state

and federal laws, and while on the premises, expect our members and guests to do the same.

Foremost, we are stewards of cigar smoking – for all time!

Ethical Value WordsEthical Value Words

Trust Honor Integrity* DedicatedTrust Honor Integrity Dedicated

Truth Love Considerate Accurate

Quality* Caring Kindness Responsible

Capable Respectful Competent Concerned

Fairness Profits*** Trustworthy Kind

Unity Honesty Tolerate Courageous

Tolerance Freedom Responsive Consistent

Respect Empathy Logical Etc….

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W k h pW k h pWorkshopWorkshop

Build a Code of EthicsBuild a Code of EthicsA Suggested Organizational ActivityA Suggested Organizational ActivityA Suggested Organizational ActivityA Suggested Organizational Activity

The Ground Rules

We have a brand new laboratory building. Over the front entrance

Choose 5-7 ethical value words

y g fis a stone arch, where we are going to carve 5 words for the worldto see … These Values will be seen by our employees, clients, families every day. These are the words to live by.

Write a statement of shared values Underline your value words Share your statement of shared values

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For the most part, decisions are made based on an individual’s background education training and cultural make up These differences

The Facts of the Matter

Laboratory organizations are comprised of a wide variety of differing human resources, all with … different cultural backgrounds different economic backgrounds different educational backgrounds

background, education, training and cultural make up. These differences or similarities manifest themselves into a person’s value system.

different educational backgrounds different levels of training different religious backgrounds different home and family backgrounds

This can result in decisions made based on different and sometimes opposing value systems.

Assuring Ethical Practices & Decision Makingg

-:- Improper, Unethical & Illegal Practices -:-

Causes, Ramifications & AnalysisCauses, Ramifications & Analysis

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What is this thing “Fraud”?What is this thing “Fraud”?

“Fraud” is a legal term. In our industry, it is usually i d i h b i i f “f l l i ” hassociated with submission of “false claims” to the

government. It boils down in its simplest form as:

Not doing what your contract or method or certification or warranty that you signed or agreed to, said you would do!And then charging money as if you were compliant.g g y f y p

Essentially, you are cheating the person that is paying your company for services.

What is this thing “Fraud”?What is this thing “Fraud”?

The circumstances surrounding events, requirements,The circumstances surrounding events, requirements,what was agreed to, intent vs. mistake -- Make this anything but a simple issue.

The absolute best thing to do is concentrate on performing properanalysis in the laboratory, following SOPs and the publishedprocedures and documenting events when out of controlprocedures, and documenting events when out of control.

If you do your part, to the best of your ability, then the rest will take care of itself.

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Improper BehaviorsImproper Behaviors

“Improper behavior” is a Jack Farrell term that applies more to theImproper behavior is a Jack Farrell term that applies more to thelaboratory operation and doesn’t depend on a legal infraction.

Improper behaviors can lead to or be the basis for allegations of FRAUD.

Actions may be considered improper -- if samples that areActions may be considered improper if samples that areprocessed and released from the laboratory, ordinarily wouldhave needed to be reanalyzed, resampled or reprocessed due

to failed control parameters or other requirements, and manipulation is done without solid technical justification and

proper documentation.

Let’s be real clear ...

Intentionally bypassing QC requirements or reporting unauthentic data or

making untrue claims is wrong!!!!

A person(s) or company(s) that is convicted of these crimes, after fair and equitable due process,

must be punished to the fullest extent of the law.

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“Laboratory Fraud: “Laboratory Fraud: Deterrence and Detection”Deterrence and Detection”

Laboratory fraud has been defined by the Agency as “the y y g ydeliberate falsification of analytical and quality assurance results, where failed method and contractual requirements are made to appear acceptable”. There are a number of laboratory practices which may constitute fraud.

‘ Fabricating data‘ Misrepresenting quality control samples‘ Calibrating equipment using other than accepted procedures‘ Modifying samples to alter characteristics‘ Manipulating analytical results‘ Substituting samples, files, or data‘ Falsifying records of analytical equipment readings

Right vs. WrongRight vs. Wrong

Three Ways to be WrongViolation of Law

Departure from TruthpDeviation from Moral Rectitude

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Right vs. WrongRight vs. Wrong

Test for Right vs. WrongLegal Test

Stench TestFront-Page Test

Mom Test

So, how do I make a decision?So, how do I make a decision?

Wh t d th SOP ?Wh t d th SOP ? What does the SOP say? What does the SOP say? (These are very important documents!)(These are very important documents!)

What does the method say? (What does the method say? (Can I get any guidance?)Can I get any guidance?) Are there any special customer requirements?Are there any special customer requirements? Am I being consistent with my standards, QC and samples?Am I being consistent with my standards, QC and samples? Is there solid technical justification for passing this through?Is there solid technical justification for passing this through? Does it feel right? Does it feel right?

((Now is the time to get some advice and direction.)Now is the time to get some advice and direction.) Have I properly documented my decision to a requirement?Have I properly documented my decision to a requirement?

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Categories of Improper PracticesCategories of Improper Practices

Fabricating data (inventing test data or QC)g ( g Q ) Reporting results without performing tests - Dry sink Blanks - broken vials that reappear later Inserting calibration numbers – page 3 insertions Copying and renaming data file “McDonald’s” samples

Misrepresenting quality control samples Misrepresenting quality control samples QC fortification - surrogates, calibrations, spiking Surrogate failures without flagging or notification LCS failures without any flagging or notification Subtracting blank values from results


Calibrating equipment using other than accepted g q p g pprocedures Dropping calibration points - run 10 pick 5 Weighting of calibration curves – multiple low level

standards – selective Using low level calibration where little or no response

is available “Samples first – Standards later”

Modifying samples to alter characteristics Diluting samples - with sawdust

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Manipulating analytical resultsp g y Time travel - holding times, calibration cycles Non-technically sound manual integrations Eliminating blank contamination values

Substituting samples, files, or data Altering file header information – sample names,

d t /ti t tidate/time, concentration Copying and renaming data file Adding spectra together from different files Use of pencil to record sample and lab data


Falsifying records of analytical equipment readingsy g y q p g Non-technically sound manual integrations Adding temperature readings days later Adding balance readings later Changing recoveries of QC results – duplicates in TDS

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Ramifications of Unethical BehaviorRamifications of Unethical Behavior

The risk to business is tremendous even if it’s onlyThe risk to business is tremendous, even if it s only one employee or one test.

ConfusionConfusion

Morale DisruptionMorale Disruption

Business LossBusiness Loss

FinesFines

DebarmentDebarment

InvestigationInvestigation

SuspensionSuspension

gg

Close of BusinessClose of Business

Ramifications of Unethical BehaviorRamifications of Unethical Behavior

What are the effects on customers, employees,

Loss of ReputationLoss of Reputation

Loss of BusinessLoss of Business

Loss of EmploymentLoss of Employment

Loss of FamilyLoss of Family

managers and families by being scrutinized in an investigation?

Loss of MoneyLoss of Money Loss of FreedomLoss of Freedom

Accusation of Unethical Behavior can be a Career Ending Event

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What potentially causes improper actions to occur or to go undetected?

A Root Cause AnalysisA Root Cause Analysis

Potential Causes of Improper Actions

Survey says ...

Lack of solid foundations in laboratory sciences,Word of mouth (serial) training,Myriad of changing requirements and requests,Shifting priorities,Competitive pressures,Inability of customers to understand data needs,Buying based solely on cost,Perfection versus "usable" dataPerfection versus usable data,Lack of experienced and trained supervisors,Insufficient or uneven enforcement,Ineffective accreditations or certification programs,Conflict of "science" versus regulatory chemistry,

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Potential Causes of Improper Actions

Survey says (more) ...

Unclear expectations from customers and regulators,Methods interpretation - everybody's got one, two or three!,Inconsistent contracting and procurement practices,Prescriptive analysis (cookbook) versus process control,Poor quality assurance practices,High turnover of staff,Lack of performance standards,Lack of management focus, training, and experience,g g pDependence on a few "key" staff, andLOUSY Business Sense.

Potential Root CausesThis all boils down to ...

A l k f d dA lack of documented systems,A lack of established training and proficiency programs,Inconsistent documentation procedures and records keeping requirements,No real schooling or foundation in practical laboratory sciences,A severe lack of seasoned, experienced, and trained pmanagement, andInconsistent requirements and buying procedures.

Training -:- Documented Systems -:- Management

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What are Inappropriate orImproper Practices?p p

Practices that are not technically sound, andPractices used to bypass required quality control parameters, andPractices that make control results go from outside to ginside limits, andPractices that result in some sort of gain or benefit to the laboratory.

All others are defined as “questionable or sloppy” work practices.

Now, let’s look at some realNow, let s look at some real examples from the files of

our Rogues Gallery

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An Effective EthicsAn Effective EthicsAn Effective Ethics An Effective Ethics Training ProgramTraining ProgramHow do I establish ethics training How do I establish ethics training

in my organizationin my organization

Objectives of An Effective Ethics Program

• Create Awareness• Create Awareness

• Develop a Statement of Shared Values

• Implement an Ethical Fitness Training Program

• Publish an Ethics Policy

• Obtain Commitment and Buy-in of Staff

• Communicate Regularly about Ethical Decision Making

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Ethics Training ProgramsMost ethics training talks about ...g

Contracts & requirementsMethods & complianceConflicts of interestGovernment contracting (FAR)C li iCompany policiesLegal issues& maybe some discussion of right vs. wrong stuff

Ethics Training Programs

Thi i d b tThis is very good, but ...

It really doesn't emphasize the basics-or-

provide the skills for the analyst toprovide the skills for the analyst to effectively resolve ethical dilemmas

-&-it's usually all talk and no real interaction!

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Ethics Training Programs

An effective training program mustAn effective training program must -

Provide a foundation in thinking -a language for discussion and communicationBe based on Values - moral basis for decision makingBe specific to address the issues at hand -use real examples that have occurred or are of concernProvide skills and toolsBe very interactive, not "preaching"Provide opportunities to practiceFit into your everyday life

Training ConsiderationsTraining Considerations

Read the StandardRead the Standard

Lots of training programs and resources on the Lots of training programs and resources on the internetinternet State of New York ELABState of New York ELAB

Detection and Prevention Detection and Prevention –– EPA ProgramEPA Program

Regional laboratory organizationsRegional laboratory organizations Regional laboratory organizationsRegional laboratory organizations

Institute for Global EthicsInstitute for Global Ethics

Joesph’sJoesph’s Six Pillars of DecisionSix Pillars of Decision

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Training ConsiderationsTraining Considerations

Frequency of TrainingFrequency of Training It is up to you but at least every 12 monthsIt is up to you but at least every 12 months

Small bits quarterly or monthly reinforces Small bits quarterly or monthly reinforces management support and awarenessmanagement support and awareness

Length of TrainingLength of Training It is entirely up to youIt is entirely up to you (2 hours to 12 hours(2 hours to 12 hours))It is entirely up to you It is entirely up to you (2 hours to 12 hours(2 hours to 12 hours))

Monthly, quarterly or annuallyMonthly, quarterly or annually

Establish a firm foundation and then reinforceEstablish a firm foundation and then reinforce

Use “issues” for additional training opportunitiesUse “issues” for additional training opportunities

Potential Topics for InclusionPotential Topics for Inclusion

Organizational Values and MissionOrganizational Values and Mission

Definition of ethics and improper behaviorsDefinition of ethics and improper behaviors

Management and employee responsibilitiesManagement and employee responsibilities

Laboratory or field practice vulnerabilitiesLaboratory or field practice vulnerabilities

Examples of improper practicesExamples of improper practices

Data Integrity policies and proceduresData Integrity policies and procedures

Ramifications of unethical behaviorRamifications of unethical behavior

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Potential Topics for InclusionPotential Topics for Inclusion

Symptoms and root causeSymptoms and root cause

Reporting expectations Reporting expectations –– confidential reportingconfidential reporting

Zero Tolerance policyZero Tolerance policy

Use of narratives and qualifiersUse of narratives and qualifiers

Who to go to for help or questionsWho to go to for help or questions

Commitment to ethical and proper scientific Commitment to ethical and proper scientific decision makingdecision making

SummarySummary

Ethical practices and training are critical to a Ethical practices and training are critical to a f lf lsuccessful management systemsuccessful management system

It takes work It takes work –– it is not an inoculationit is not an inoculation

Reinforce the trainingReinforce the training

Use examples and problem solving techniquesUse examples and problem solving techniques

Don’t be afraid of communicationDon’t be afraid of communication

Don’t preach Don’t preach -- interactinteract

Lots of resources on the internet and public and Lots of resources on the internet and public and private organizationsprivate organizations

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SummarySummary

Ethics training is one component of a data Ethics training is one component of a data i ii iintegrity programintegrity program

There is no one way to present this informationThere is no one way to present this information

Customize to meet your operation requirementsCustomize to meet your operation requirements

More often is better than less oftenMore often is better than less often

Problem solving is a good tool for training; Problem solving is a good tool for training; come up with your own examplescome up with your own examples

The world and news have lots of examples for The world and news have lots of examples for discussiondiscussion

A Final Word of Warning ...

It can't happen in my laboratory!

I don't do federal work!

My lab and my people are too good!

Data from my laboratory is always good!Data from my laboratory is always good!

"Prevention" beats "damage control" every single time!

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Th k YTh k YThank YouThank You

HAVE HAVE A GREAT DAY!A GREAT DAY!

Documents

New Analytical Excellence, Inc. - NELAC Institutenelac-institute.org/docs/eds/id112/Print Copy-final... · 2012. 11. 12. · Ethics Training for the ... Addressing Ethical Dilemmas