aphl ethics then and now [read-only] environmental... · ethics: then and now ... agencies to...

9/22/2017

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Analysis. Answers. Action. www.aphl.org

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Environmental Laboratory Ethics: Then and Now

Dorothy Love – Eurofins Environment Testing

Larry Penfold – TestAmerica Laboratories, Inc.

Analysis. Answers. Action. www.aphl.org2

SPEAKER DISCLOSUREAPHL 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.”


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.

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Topics

• Ethical and Data Integrity Issues – past and present in our industry

• Why Ethics Matter

• Proper procedures

• Detection and Prevention

• Responsibilities

• Actions


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


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”

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Development of Laboratory Ethics Over the Last 50 Years


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


4 Eras of Data Processing, Analytical Chemistry & Laboratory Ethics

Pre-Digital1960 and earlier

1960–1980 Early Digital

1980 -1995 Digital Explosion

1995 –Today Full Digital Integration with Social Media

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Pre-Digital Data Processing Tools

Mechanical calculators for adding numbers

Slide rules for multiplying and dividing


Environmental Instrument Output On Strip Chart Recorders

Peaks measured with a ruler

All peaks manually integrated!


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 typicallyprovince of physicists

• No ethics training, little awareness

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Early Digital Era in Routine

Analytical Chemistry

1960-1980


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


IBM 1401 8k core memory & 2 Mb hard disk

Hollerith cards used to load program & data for every computer run

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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 typicallyprovince of physicists

• No ethics training, little awareness


Era of Digital Explosion

in Analytical Chemistry and

Ethics Awareness

1980-1995


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

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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


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


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

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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


Era of Full Digital Integration

and Social Media

1995 - Today


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

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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….


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


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

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The More Things Change, The More They Stay The Same


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


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?

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Importance of ethical behavior• Decisions we make as chemists and

environmental professionals affect the environment and lives of others, including our families and friends

• Your personal reputation and reputation of your company depend on it

• The penalties for misconduct for you and your organization can be substantial


Importance of ethical behavior

• Clients submit laboratory data to government agencies to fulfill their legal obligations. Actions are taken based on this data.

• Clients demand laboratories with a solid reputation for accurate results produced in a compliant manner.


Foundation of Ethics

• Personnel– Management

– Employees

• Documentation – Policies

– Procedures

• Training

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Personnel Responsibilities

Everyone is Responsible for Ensuring Ethics in our Work!!

Every employee is responsible for working in an ethical manner and ensuring the integrity of the data that we produce.

Every employee is responsible to report ethical or data integrity concerns.

.


Personnel ResponsibilitiesEvery employee is expected to adhere to the highest professional and ethical standards. Each employee must commit to honest and ethical practices in daily actions.

No one will intentionally improperly manipulate or falsify activities, procedures, or records in any way.

Even if directions are given by management and you feel it is not ethical you have the responsibility to report it.


Personnel Responsibilities

Management is responsible for ensuring a work environment where employees are free from retaliation and feel supported and open to communicate concerns.

Management is responsible to perform thorough investigations into concerns and take immediate action when necessary.

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Priorities

• Ethical performance and Data Integrity MUST supersede any other objectives of your operations.

• Because we have many critical requirements, sometimes it can be challenging to meet them all. We can never allow pressures to meet schedule, budget, or client demands to cause us to modify adherence to our approved procedures.


Priorities

• Don’t over pressure staff on deadlines, make sure they aren’t pressured to cheat. Let them know that Quality and reliability of the data comes first

• Let the staff know that if they need help – ask for it! You can find a way to help them out.

• QC is used to determine sample, equipment, or method issues, not necessarily how good the staff is – qualification of data is often necessary

• What ever the problem, it is not worth losing your job or going to jail!


Priorities• Communication is critical. Notify your supervisor

or QA if you feel there are conflicting expectations or undue pressure. Discussion with the client can often resolve these conflicts.

• There is often a fine line between criminal activity, a violation of methods or regulations, or a legitimate exercise of professional judgment and discretion. FRAUD = INTENT

• The difference may just be in documentation of the event or situation. (… Otherwise the data reviewer will likely use their imagination.)

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Improper Practices• A scientifically unsound or technically unjustified

omission, manipulation, or alteration of procedures or data that bypasses the required quality control parameters, making the results appear acceptable

• Any alteration of data such that the data are unauthentic or untrue representations of the test performed

• Fraud is essentially the INTENT to deceive. An improper practice is not fraudulent unless it is found to be intentional


Prohibited Lab Activities Dry labbing – Fabricating results without physically

performing the testing

Time travel – recording an incorrect date or time to make it appear that a process occurred at a different time than it had; not documenting in real time; backdating; future dating; altering electronic time stamps

Failure to follow SOPs – not performing steps in the proper order; taking shortcuts

Cherry picking – Selectively excluding data without scientific justification

Changing observed measurements (weights, volume, readings) in order to get desired results


Prohibited Lab Activities (cont.) Unwarranted manipulation of samples or analytical

conditions

• Unjustified dilution of samples

• Manipulating tuning data to “make it pass”

• Changing instrument conditions between standards and samples

• Processing PTs differently than routine samples

• Forcing data to meet criteria, removing operational codes (“m” flags), improper background subtraction or baseline setting, turning off/disabling audit/tracking functions of software

Failure to record all trials for an analysis or test

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Prohibited Lab Activities (cont.) Misrepresenting or misreporting QC samples

• Representing QCs as extracted or digested when it has not been done

• Substituting previous passing runs/calibrations for non-compliant runs/calibrations

• Not preparing QCs in the same manner as samples

• Tampering with QCs, e.g., over- or under-spiking

• Avoid corrective action or instrument maintenance by continually repeating analysis until calibration or QC meets requirements.

• Deleting or not recording failed QC data to conceal failures


Prohibited Lab Activities (cont.) Overwriting files or deleting/destroying records (written

or electronic). If there is failing QC, and you reanalyze, create a new file and not overwrite the existing one. For hard copies, line out the data not used and keep on file.


Manual IntegrationThere are situations where it is appropriate to manually integrate data, i.e. incorrect baselines, co-eluting peaks. In these situations there are strict requirements for documentation and justification.• Manual changes to integration are often the subject of

regulatory scrutiny because they can be used to alter results.

• Any analyst controlled changes to automatic instrument readings must be fully documented. Original results may not be over written and full justification for the change must be provided.

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Manual Integration (cont.)Once Upon A Time…

Before computers, all peaks were manually integrated

It was part of a chemist’s job

Then computers introduced automated integration, it is now faster and easier to process analyses

Manual integrations are still an important part of an analytical chemist’s job!


Ensuring Data Integrity

Do not intentionally: • report data values that are not the actual values;

• report other than the actual dates, times, sample or QC identifications, or method citations of data analyses;

• misrepresent another individual's work;

• misrepresent data values that do not meet established QC criteria, and if they are reported, do include all appropriate notes and/or qualifiers.


Ensuring Data IntegritySignatures

• Every employee bears responsibility for the validation and accuracy of his or her documentation. – Your signature on a record confirms that the action

taken to generate the information/data and the documentation are accurate, authentic and that all proper procedures were followed.

– This is true for hand signed records as well as ones where an e-signature is attached through your login or with a signature stamp.

– No one else is permitted to sign another person’s name or use their stamp or login.

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Ensuring Data IntegrityFollow Policies and Procedures

• All laboratory processes, both technical and support, are to be detailed in written work instructions (i.e. SOPs)

• The instructions must match with the referenced methods or regulatory protocols. These references include technical methods but also can provide direction over other laboratory processes including, but not limited to, report content, client communication, sample identification.

• All steps must be followed as written! If there is a need to deviate, it must be approved by management and QA and may also require client approval.


Ensuring Data IntegrityDocumentation

• All documentation must be made real time, as it occurs and be recorded by the employee performing that task. Do not measure out all sample aliquots and then wait to record the amount at the end of your sample set. Do not sign, enter dates/times in advance of any activity.

• Be sure all entries are legible. Take time to write clearly.

• If corrections or edits are needed, follow appropriate error correction procedures. These must include a single line cross out, the date the change is made and identification of the employee making the change. Reason for the change must also be recorded.


Ensuring Data IntegrityDocumentation (cont.)

• All records must be maintained. Record your data and observations on controlled forms, in controlled logs. Do not jot notes on paper towels, post-its, or scrap paper.

• All documentation must be in permanent ink. Note: Gel pens are not permanent.

• The original data and documentation must be archived for a defined period of time. Scanned copies can be archived electronically and identified as the true record but you must have a system to ensure the accuracy of the scanned archived record.

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Ensuring Data IntegrityMistakes

• Mistakes happen. What happens next can be the difference between an error and fraud.

• Clearly document what happened. If there is a missing piece of information, or if it “seems like” there was a wrong step taken in a process we cannot guess at what the information should have been or whether or not the right step occurred.

• Consult your supervisor and/or QA for guidance. The work may be able to be repeated and if it can’t discussion may be needed with a client.


Ensuring Data Integrity

Mistakes

• Never try to cover up a mistake.

• Errors are unintentional. Covering it up becomes Fraud – a deliberate act to mislead about the truth.


Ensuring Data IntegrityDocumentation is not just for Analysts…• Field samplers, Couriers, Sample receipt: Anyone

handling sample transfers between the client and the laboratory must document this on the Chain of Custody at the time it occurs.

• All employees: Your time records must accurately reflect the times that you are working.

• Computer and facilities staff: Documentation of computer programming, hardware changes, work on equipment or other system maintenance must be documented as directed at your site. Follow change control procedures.

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Confidentiality

Any potential conflicts of interest must be reported to management. These conflicts could bring our integrity and intentions into question.

– A conflict of interest occurs when an employee is in a position to influence business decisions that result in personal gain for the employee, a friend, or a relative.

– Employees should avoid any relationship with individuals or organizations that might affect their independence or judgment


Confidentiality

Most projects that can be very sensitive for the client, have legal ramifications, and are not intended for release to the general public.

• You need to ensure confidentiality. Do not disclose the following to anyone outside of the company:– Client identity

– Client projects

– Proprietary client information (i.e. client methods)

– Analysis results

– Pending projects and proposals


ConfidentialityMany business practices are proprietary. These may include:

– Computer programs and codes

– New method research

– SOPs

– Assessment reports

– Corrective action reports

– Personnel records

– Facility floor plans

These should have restricted accessibility and specific approval processes if the information is requested externally.

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ConfidentialitySocial Media

If your company has a Facebook page, LinkedIn account, etc. Pictures and content posted on these pages are approved through company management and marketing staff. These may be shared on an employee’s personal page, in fact this is encouraged to help spread the word.

However…

Employees should be restricted from posting their own photos taken inside the facilities to their own social media accounts.

Employees must be restricted from posting their own information about clients, workload, etc. through their social media accounts.


Computer SecurityYou are responsible for everything recorded and processed under your login• Do not give out your password

• Not to IT

• Not to your friend or backup

• Do not write it on a note and stick it to your computer

• Log off or lock your computer when unattended

• All software and hardware must be managed by IT

• If you suspect your computer/device has been compromised, notify your supervisor and IT immediately.


Prevention and Detection

An Ethics program protects everyone who is living & working up to their ethics commitment

A well-run laboratory with a strong, thorough Ethics and Data Integrity Program will periodically find potential data problems

Sporadic findings prove the system is working

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Detection Strategies• Independent and proactive QA staff

• Internal quality systems audits and proficiency testing

• Data review

• Independent data audits

• Training – Both ethics and job specific training

• Written Procedures and Policies

• Good documentation and record keeping practices.

• Monitoring corrective actions.

• Clearly defined stop-work authority for all staff

• Defined mechanisms for reporting unethical behavior


Incident Reporting

• Employees who know of, or witness any violation of business, quality or data integrity policies are required to report the activity. Employees who fail to report known violations of business, quality, or data integrity policy will be subject to disciplinary action.

• No retribution for reporting wrongdoing. However, the reporting of a wrongdoing does not absolve you if you participated in the wrong doing.

• Any employee found to have retaliated or in anyway punished another employee for reporting a violation will be subject to discipline, up to and including termination.


Incident Reporting

Every employee should feel empowered to address an ethics or integrity issue directly with the employee when they see something adverse occur. Let them know that what they are doing is improper. You can give them the benefit of the doubt that it was an honest mistake.

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Incident ReportingIf it obviously is not a mistake or misunderstanding, or you are not comfortable doing this, then Go Where You Are Comfortable

• Supervisor

• QA Manager

• Laboratory Manager

• Human Resources Manager

• Or, Anonymous Reporting.....

JUST TELL SOMEONE!!!


InvestigationsAny employee who is involved in an investigation needs to hold the information in strict confidentiality. Do not discuss it with anyone outside of the company unless instructed to do so by senior management (i.e. discussions with legal counsel).


InvestigationsCommunication/discussion on the issues should be held in person or by phone. Keep hand written notes. Electronic (i.e. email) documentation should be kept to a minimum and only used if absolutely necessary. Any required emails with legal counsel need to specify “Privileged Attorney-Client Communication” in the subject line.

Do not discuss investigations with clients, media, friends, or family.

External communications should be directed by senior management.

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Questions ?

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