Maintaining Ethics in the Laboratory - Cloud Object ... · Maintaining Ethics in the Laboratory ... – A failure to report errors from the technologist ... Code of Ethics

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INTRODUCTION

Your Faculty

Maintaining Ethics in the Laboratory

Your FacultyRonald B. Lepoff, MD

Clinical Laboratory DirectorUniversity of Colorado Hospital Clinical

Laboratory

AcknowledgementsDavid C. Hoak, MD

L b t M di l Di t

Click NEXT to continue

Laboratory Medical DirectorInCyte Pathology

Kristin MarriottDirector of Support Services

APP-UniPath, LLCFor their peer review contributions

Case study INTRODUCTION

• At Greenview General Hospital, controversy has arisen over several HIV tests that went out with potentially inaccurate results.

• What caused these inaccurate results?

– A failure to properly run controls


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Case study

• When it was discovered, the Lab director was held

INTRODUCTION

,accountable.

• The inspection process also suffered criticism though it would have been impossible to know the QC values were altered previously.

– This incident was one of many factors that contributed to CAP deciding to perform unannounced inspections.


unannounced inspections.

Case study

• What factors contributed to this?

INTRODUCTION

– Laboratory management created an atmosphere not conducive to reporting errors

– Low budget can lead to insufficient staffing

– Insufficient training of lab workers


– A failure to report errors from the technologist to the director and director to hospital management

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Ethics matter

• They are the basis of one’s professional integrity.

Why?

INTRODUCTION

y p g y

• In the laboratory, focusing on proper patient care first, leads to proper staff care, and ultimately the betterment of the organization as a whole.

• We derive our expectations for the team and individual based on our initial performance expectations. Similarly, we maintain ethical behavior in the laboratory.


behavior in the laboratory.

Objectives

• Determine ethical responsibilities to patients staff laboratory

INTRODUCTION

Determine ethical responsibilities to patients, staff, laboratory, hospital, industry and other organizations

• Identify management responsibilities in terms of employee rights, non-discrimination, and reporting sexual harassment

• Apply a framework for ethical decision making


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Definition

Ethics

INTRODUCTION

EthicsEthics are the principles or tenets that determine our behavior.

Code of EthicsConveys organizational values a commitment to standards


Conveys organizational values, a commitment to standards, and communicates a set of ideals.

From the topETHICAL

RESPONSIBILITY

Patients Patients receive accurate results

Staff

Lab

The staff precisely follows

procedures

The new SOP follows national

regulatory standards


OrganizationOrganization management

edits the operating manual

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Responsibility to Patients

ETHICALRESPONSIBILITY

Do the right testfor the right reasonson the right patientat the right time


Responsibility to Patients

• Balance competing interests when appropriate li it d


resources are limited

– Maintain quality results

• Have enough staff to handle incoming work

• Time constraints

– Attempting rapid test turnover without


p g pcompromising patient safety

• Patients must be made aware of their legal privacy rights by being reassured of the confidentiality of their private information.

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Responsibility to Staff


• Provide staff with training, manuals, equipment, software and technology to ensure data integrity and safety.

• Provide formal training to new staff about ethics and data integrity as part of orientation.

– Offer periodic refresher sessions on ethical


Offer periodic refresher sessions on ethical behavior and data integrity

Responsibility to Staff


• Health Insurance Portability and Accountability Act (HIPAA)

– All staff must be trained on procedures that ensure patient confidentiality

• Foster a climate for staff that looks for and reports system errors


system errors

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Staff Entitlements

• not to be discriminated against on the basis of their

Your staff are entitled

EMPLOYEE RIGHTS

grace, national origin, gender, pregnancy, religious beliefs, disability or age (marital status or sexual orientation).

• to a workplace free from harassment .

• to be paid at least the minimum wage and according to legal guidelines


Staff Entitlements

• to a safe workplace.

Your staff are entitled

EMPLOYEE RIGHTS

p

• to take leave to care for their own or a family member's serious illness, or following the birth or adoption of a child.

• to privacy in personal matters.


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Responsibility to the Laboratory

M i t f lit t t (QMS)


• Maintenance of quality management system (QMS) ensuring data integrity

– Setting up a QMS leads to continual performance improvement activities in the laboratory

– Perform regular internal audits of your laboratory


– Follow through to ensure corrective actions are taken

• Maintain legally required documentation

Responsibility to Your OrganizationServing your hospital, industry, or other organizations


• Do not enter into agreements that impair or interfere with your free use of medical knowledge and judgment.

– Disclose any possible conflicts of interest

• For example, a laboratory director who also offers consulting for a chemical

l


analyzer company.

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Responsibility to Your OrganizationServing your hospital, industry, or other organizations


• Participate in continuing education programs.

– In-service programs

– Support your staff to continue their education

• Attend meetings, seminars (ASCP annual meeting, USCAP annual meeting, etc.)


g, )

Knowledge Check

Mary recently joined a laboratory as a second job. The lab prohibits being a consultant for any medical device manufacturers. However, her first job is being a contractor for a chemical analyzer vendor What


A. Order chemical analyzers at discount from her vendor.B. Ask for her staff’s opinion on the quality of the chemical analyzer.C. Immediately resign from her contractor position with the vendor.D. None of the above

first job is being a contractor for a chemical analyzer vendor. What should Mary do in this situation?


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Ethical Management

d ti i t i d i ti ti j b

Be mindful of employee rights when

EMPLOYEE RIGHTS

• conducting interviews and investigating job applicants without invading their privacy

• it is appropriate to pay overtime and compensatory time.

• you handle employee leave and illness.


Ethical Management

d t dd l d t ff ti

Be mindful of employee rights when

EMPLOYEE RIGHTS

• you need to address employee conduct affecting safety, such as when one employee harasses or threatens another employee.

• you manage performance and discipline or dismiss employees


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Knowledge Check

Jane is currently interviewing for a new phlebotomist position. Which of the following questions is NOT ethically appropriate to ask in a job interview? (Select all that apply)

EMPLOYEE RIGHTS

A. Where have you worked previously as a phlebotomist?B. Are you planning on having more children?C. How did you receive your disability?D. What does your spouse do for a living?

interview? (Select all that apply)


Non-discrimination LawsClick each button to learn more. Click Next when you are done

LAWS

are done.


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Title VII of the Civil Rights Act of 1964

• “Prohibits discrimination by covered employers on the basis of race, color, religion, sex,

The highlights:

LAWS

y p y , , g , ,or national origin.”5

• Applies to and covers an employer "who has fifteen (15) or more employees for each working day in each of twenty or more calendar weeks in the current or preceding calendar year.“5

• Also prohibits “discrimination against an individual because of his or her association with another individual of a particular race, color, religion, sex, or national origin.“5


Age Discrimination in Employment Act of 1975

• Prohibits

The highlights:

LAWS

– “Discrimination in hiring, promotions, wages, or termination of employment and layoffs.”7

– “Statements or specifications in job notices or advertisements of age preference and limitations.”7

– “Denial of benefits to older employees. An employer may reduce benefits based on age only if th t f idi th d d b fit t


if the cost of providing the reduced benefits to older workers is the same as the cost of providing full benefits to younger workers.”7

– Mandatory retirement

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Rehabilitation Act of 1973

• Section 504 states that "no qualified individual with a disability in the United States shall be excluded from, denied the benefits of, or be subjected to discrimination under" any

The highlights:

LAWS

, , j yprogram or activity that either receives Federal financial assistance or is conducted by any Executive agency.

• Section 508 establishes requirements for electronic and information technology developed, maintained, procured, or used by the Federal government. Section 508 requires Federal electronic and information technology to be accessible to people with disabilities, including employees and members of the public.

– For example, a system that provides output only in visual format may not be accessible to people with visual impairments and a system that provides output


accessible to people with visual impairments and a system that provides output only in audio format may not be accessible to people who are deaf or hard of hearing. Some individuals with disabilities may need accessibility-related software or peripheral devices in order to use systems that comply with Section 508. This is only applicable if a reasonable accommodation is possible.

Americans with Disabilities Act (ADA)of 1990

• Prohibits discrimination towards disabled individuals.

The highlights:

LAWS

• Disability is defined by the ADA as "...a physical or mental impairment that substantially limits a major life activity." 9

– “The determination of whether any particular condition is considered a disability is made on a case by case basis.” 9

• Certain specific conditions are excluded as disabilities, such as “current substance abuse and visual impairment that is correctable by prescription lenses.” 9


• Disabilities may include, by the ADA definition: “inability to care for oneself, performing manual tasks, problems seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, and working.” 9

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Equal Pay Act of 1963

• “Employers may not pay lower wages to

The highlights:

LAWS

p y y p y gemployees of one gender than it pays to employees of the other gender for the same work.“6

• “Employees within the same establishment for equal work at jobs that require equal skill, effort and responsibility, and that are performed under similar working conditions should be compensated equally.”6a


Represented employees

• State Law

Do your staff belong to a union?

UNIONS

– NY• Service Employees International

Union(SEIU)

– CA


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Ethical Decision Making

FRAMEWORKS

Recognize the ethical

issue

Gather the facts

Evaluate alternative actions

Make a decision and test it

Act and reflect on

the outcome


Scenario FRAMEWORKS

It’s that dreaded time of year again. You are being asked to make budget cuts.

– Which of these options is ethically appropriate?

A. Outsource reference testing at a lower cost

B Cut non essential Staff


B. Cut non-essential Staff

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Scenario

You realized you can’t cut staff without lowering the quality of your lab’s output. What else can you sacrifice without affecting patient care and having

FRAMEWORKS

sacrifice without affecting patient care and having an immediate effect on your bottom line?

– Which of these options is ethically appropriate?

A. Measure the cost of your tests and outsource the costly esoteric ones

B. Discontinue some of your testing i


servicesC. Limit travel funds used for technical

service specialists to travel with company sales personnel to visit customers

D. A and C

Case Study

• Japan Nuclear Fuel Conversion Co (JCO)

FRAMEWORKS

p ( )

• Financial troubles means JCO has less staff on board

– Not all staff members came from same divisionand didn’t get special training

– They ignored procedures and equipment due to a lack of proper training


a lack of proper training

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Case Study

• The men had good intentions to support their

FRAMEWORKS

g ppcompany by being more “efficient”

• Japan Science and Technology Agency said the entire system and process had “no possibility of criticality accident occurrence due to malfunction and other failures.”11

– Bypassing some of the approved procedure was done formally by the manufacturing and


was done formally by the manufacturing and quality assurance divisions but NOT the safety management division and JSTA was never informed.

Case Study FRAMEWORKS

• Nuclear criticality was achieved

• 2 of the 3 men died

• 6 billion yen or ~$60 million in damages

• JCO’s license was revoked


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Best Practices

SUMMARY

SUMMARY

• Ethical decisions start with patient care

• Train staff

• Quality Management System

– Maintain proper documentation


• Patient Confidentiality as mandated by HIPAA

References

1. Ethics Glossary. Ethics Resource Center. Available athttp://www.ethics.org/resource/ethics-glossary. Accessed December 18, 2012.

2. A Framework for Ethical Decision Making. Santa Clara University. Available athttp://www scu edu/ethics/practicing/decision/framework html Accessedhttp://www.scu.edu/ethics/practicing/decision/framework.html. Accessed December 18, 2012.

3. Baron, D.N. Ethical issues and clinical pathology. Journal of Clinical Pathology. 1993: 46:385-387. Available athttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC501241/?page=1. December 17, 2012.

4. Thomas, T. Got Ethics? May 3, 2012. Lab Manager Magazine. Available at http://www.labmanager.com/?articles.view/articleNo/7487/title/Got-Ethics-/. Accessed December 18, 2012.

5 US EEOC Titl VII f th Ci il Ri ht A t f 1964 U S E l E l t O t it


5. US EEOC. Title VII of the Civil Rights Act of 1964. U.S. Equal Employment Opportunity Commission. 1964. Available at http://www.eeoc.gov/laws/statutes/titlevii.cfm. Accessed April 10, 2013

6. US EEOC. The Equal Pay Act of 1963. U.S. Equal Employment Opportunity Commission. 1963. Available at http://www.eeoc.gov/laws/statutes/epa.cfm. Accessed April 10, 2013

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References

7. US DOL. Age Discrimination Act of 1975. U.S. Department of Labor. 1975. Available at http://www.dol.gov/oasam/regs/statutes/age_act.htm. Accessed April 10, 2013

8. US DOJ. A Guide to Disability Rights Laws. U.S. Department of Justice. July 2009. Available at http://www ada gov/cguide htm#anchor65610 Accessed April 10Available at http://www.ada.gov/cguide.htm#anchor65610. Accessed April 10, 2013

9. US DOJ. AMERICANS WITH DISABILITIES ACT OF 1990, AS AMENDED. U.S. Department of Justice. June 15, 2009. Available at http://www.ada.gov/pubs/adastatute08.htm. Accessed April 10, 2013

10. Casey SM. The atomic chef, and other true tales of design, technology, and human error. Aegean Pub Co; 2006.

11. US NRC. NRC Review of the Tokai-Mura Criticality Accident. U.S. Nuclear Regulatory Commission. April 2000. Available at http://www.nrc.gov/reading-rm/doc-

ll ti / i i / /2000/ 2000 0085/ tt h t1 df A d


collections/commission/secys/2000/secy2000-0085/attachment1.pdf. Accessed May 24, 2013

You have successful completed the online learning course:

Maintaining Ethics in the LaboratoryCredit is awarded upon successful completion of the post-test.

Congratulations Completion Requirements

Access the post-test by exiting the course and returning to the course content page.

Click the link Post-Test to take the exam. You must score 80% in three attempts for credit to be awarded.

Interested in applying Lab Leadership best practices on the job?

Please download from your Lab Management Tool Kit the performance s pport tools pro ided to help appl


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Please join the lab leadership best practices discussion at the Lab Management University online Leadership Communities of Practice.


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Think about it

If you build that foundation, both the moral and the ethical foundation, as well as the business foundation and the experience foundation

CONCLUSION

foundation, and the experience foundation, then the building won't crumble.

-Henry Kravis

Documents

Maintaining Ethics in the Laboratory - Cloud Object ... · Maintaining Ethics in the Laboratory ... – A failure to report errors from the technologist ... Code of Ethics