ETHICS IN LABORATORY

1
ETHICS IN LABORATORY
2
WHAT IS ETHICS

• PRINCIPLES
• MORAL
• BELIEFS
• MORAL VALUES
• A set of principles of right conduct

3
PROFESSIONALISM

• Trust worthy, Competent, Respectful, Act with
  Integrity, Considerate, Empathetic, Courteous,
  Dependable

4
PROFESSIONALISM

• CO-OPERATIVE, COMMITTED, APPROACHABLE,
  TRUSTWORTHY, SUPPORTIVE, RESPECTFUL, ACCOUNTABLE

5
PROFESSIONALISM

• A SPECIFIC STYLE OF BEHAVIOUR IN THE WORK PLACE
• VALUES AND PROFESSIONAL ROLES EXHIBITED IN OUR
  BEHAVIOUR
• RESPECT FOR SELF AND OTHERS
• MATURE RESPOSIBILITY
• PROBLEM SOLVING

6
PROFESSIONALISM

• THEY HAVE ATTITUDE AND CONFLICT VALUE
• SELF RESPECT
• ACCEPT PERSONAL RESPONSIBILITY
• RESPECT FOR OTHERS
• RESPECT THE EXPERIENCE

7
UNPROFESSIONALISM

• NOT CONFIRMING TO THE STANDARDS OF A PROFESSION
  OR UNPROFESSIONAL BEHAVIOUR

8
MEDICAL ETHICS

• AUTONOMY
• BENEFICENCE
• NONMALEFICENCE Acting without malice towards
  patient
• JUSTICE
• TRUTHFULNESS AND HONESTY
• DIGNITY
• HELSINKI DECLARATION

9
HISTORY OF ETHICS

• MEDICAL ETHICS HAS BEEN PREVALENT SINCE 13TH
  CENTURY
• IT WAS GIVEN ANTIQUE VALUE .
• IT IS A FIELD OF APPLIED ETHICS ,THE STUDY OF
  MORAL VALUES AND JUDGEMENT AS APPLIED TO
  MEDICINE.
• ARE DOCTORS TODAY FOLLOWING ESTABLISHED
  PRINCIPLES OF MEDICAL ETHICS?

10
HISTORY OF ETHICS IN LABORATORY

• REVIEW INDICATES 1975 AMERICAN ASSOCIATION FOR
  CLINICAL CHEMISTRY ISSUED GUIDELINES TO ETHICS
  GOVERNING THE CONDUCT OF CLINICAL CHEMISTRY
• CONGRESS DISCUSSION CONTINUED FOR SEVERAL YEARS
  1978, 1981 - BUT IT WAS ACCEPTED ONLY ON MAY
  29,1990

11
DO WE NEED A SENSE OF ETHICS ?

• HELPS TO DEVELOP AND UNDERSTAND THE IMAGE IN
  OURSELF AS PROFESSIONALS
• LABORATORY PRFESSIONALS ARE PHYSICIANS,
  SCIENTISTS, OR BOTH
• PROFESSIONAL ETHICS GIVES VOICE TO THE MORAL BOND
  THAT LINKS PROFESSION, THE INDIVIDUALS IT SERVES
• IT STRENGHENS THE SENSE OF ETHICAL
  RESPSONSIBLITY.

12
WE NEED ETHICS

• WE SERVE THE SOCIETY AS WHOLE
• WE HAVE AN IMPACT ON THE INTEREST AND WELL BEING
  OF THE INDIVIDUALS
• WE PLAY AN IMPORTANT ROLE IN PUBLIC INTEREST AND
  THE COMMON GOOD WITH ETHICAL STANDARDS
• ETHICS IS THE KEY ELEMENT IN THE PUBLIC TRUST IN
  THE PROFESSION.

13
ETHICS

• LABORATORY EXAMINATION IN
• PHYSIOLOGY (MUSCLE, NERVE, BLOOD, URINE)
• PATHOLOGY
• TWO TYPES OF EXAMINATION
• CLINICAL EXAMINATION
• PATHOLOGICAL EXAMINATION
• ETHICS IS IMPORTANT FOR BOTH TYPES OF EXAMINATION
  

14
LABORATORY ETHICSExamination of patient

• Keywords
• Laboratory Test
• General Test
• System Examination
• Diagnosis
• Interpretation

15
LABORATORY ETHICSExamination of patient

• Examination Process
• pre-analytic
• analytic
• post-analytic phases

16
LABORATORY ETHICSExamination of patient

• The pre-analytic phase
• 1) deciding to organize the examination
•  2) informing the patient and gaining consent
•  3) ordering the examination and preparing the
  patient
• 4) collecting the specimen

17
LABORATORY ETHICSExamination of patient

• The analytic phase consists of
• preparing the sample
• storing the sample
• analysing the results
• verifying the results

18
LABORATORY ETHICSExamination of patient

• The post-analytic phase
• reporting the results
• interpreting the results
• informing the patient or relatives of the
  meaning of the results
• applying the results to patient care
•  

19
LABORATORY ETHICSExamination of patient

• CONFIDENTIALITY
• COUNSELLING
• JUSTIFICATION
• PROBLOEMS IN CONNECTION WITH DISCLOSURE OF TRUE
  CAUSE OF DEATH
• EXPERT TESTIMONY IN GENETIC AND AUTOPSY

20
Laboratory Quality Assurance

• Autonomous bodies like CMC Vellore
• Internal quality assurance
• External quality assurance Biorad control
• National Accreditation Board of Laboratories

21
What The Data User Can Do

• Adopt Best Practices for the Detection and
  Deterrence of Laboratory Fraud
• Utilize Contractual Agreements
• Adopt QAPP, SAMP, DQO and SOP
• Consider Third-Party Experts

22
Quality Assurance/Quality Control Requirements in
the Laboratory Contract

• Prior to awarding a contract, the laboratory
  QA/QC requirements should be evaluated
• Provides insight into the laboratorys ability to
  comply with contract and method specific
  requirements

23
Laboratory Selection and Use of Phased Audits

• Two-phase audit and check system is a method for
  oversight of laboratory operations.
• The process includes a pre-award on-site audit
  and follow-up audit

24
Monitoring Laboratory Performance Using Follow-up
Audits

• Verify the adequacy and maintenance of
  instrumentation
• Continuity of personnel meeting experience
  requirements
• Acceptable performance of analytical and QC
  procedures

25
Performance Evaluation Samples

• PES are used to assess routine performance levels
  of laboratories
• General QA oversight of laboratories should
  include PES program
• Use of PES sends a message to a laboratory that
  the client is serious about performance of the
  laboratory

26
Split-Sample Analyses

• Useful tool in detecting and deterring data
  quality problems
• Measure inter laboratory performance on sample
  matrices relevant to a program (drinking water,
  waste water, etc)
• Existence of split-samples can be divulged to
  primary laboratory or not

27
Laboratory Performance Histories

• Performance histories are shared among utilities,
  regulatory agencies, government project managers,
  etc
• Certain third-party consultants maintain
  performance histories of laboratories

28
Ethical Conduct

• Laboratories should have a company ethics policy
  read and signed by all employees
• Training should be provided to staff
• Specific method performed by the laboratory
  should be written and maintained
• Laboratory management must provide adequate
  resources and assign sufficient authority to
  supervisors

29
What The Laboratory Can Do

• Ethics References
• Ethics Policy or Statement
• Employee Ethics Agreements
• Ethics Communication
• Ethics Program Management
• Ethics Procedures
• Zero Tolerance Policy
• Ethics Assistance and Reporting Mechanism
• Compliance Plan A plan to ensure compliance of
  ethics policy
• Ethics Training
• Compliance Audits To check if ethics policy is
  adhered to

30
Potential Laboratory Fraud and the Data User

• Fraudulent activities are being performed by
  laboratories
• Protect your program(s) by planning or
  reassessing your needs
• Utilize best practices whenever possible to meet
  your analytical requirements

31
Ethics in laboratory

• IT IS URINE AND STOOL FOR YOU .. BUT IT IS
  BREAD AND BUTTER FOR US