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 Table of Contents  
REVIEW ARTICLE
Year : 2019  |  Volume : 14  |  Issue : 6  |  Page : 103-106

Bioethics in laboratory medicine


Department of Biochemistry, Jawaharlal Nehru Medical College, Sawangi (M), Wardha, Maharashtra, India

Date of Submission10-Dec-2019
Date of Acceptance28-Dec-2020
Date of Web Publication30-Sep-2020

Correspondence Address:
Dr. Ashish Anjankar
Department of Biochemistry, Jawaharlal Nehru Medical College, Sawangi (M), Wardha, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jdmimsu.jdmimsu_216_19

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  Abstract 


The medical laboratory professionals are answerable to the ethical codes of their profession. Patient's welfare is paramount in health-care ethics. This principle applies to laboratory medicine as well. The laboratory should treat all patients fairly and without discrimination. Ethics in laboratory medicine commences from the collection of information for proper recognition of patients and specimens. Ethical principles continue during specimen collection, performance of tests, and reporting of the results. Consent can be implied for most laboratory procedures when the patient produces him or herself at a laboratory with a request form and readily agrees to the routine collecting procedures. The laboratory shall always use test procedures, which meet the applicable standards. The results of laboratory examinations are confidential unless disclosure is authorized. The results will normally be reported to the requesting physician and may be reported to other parties with the patient's consent or as required by law. Ethical guidelines should also be followed during storage and retention of medical records. Test results must never be altered or corrected, except by properly authorized persons in accordance with established procedures. Facilities shall provide a suitable environment to prevent damage, deterioration, loss, or unauthorized access. Patients, profession and colleagues, and society are the three main groups toward which medical laboratories owe their responsibility. Ethics in laboratory medicine have to be practically followed as a moral responsibility of all the laboratory staff, rather than being recorded in an operating manual. This requires the medical laboratory professionals to realize their duties and have a conscientious attitude toward their work.

Keywords: Bioethics, laboratory medicine, laboratory professionals


How to cite this article:
Anjankar A, Kute P. Bioethics in laboratory medicine. J Datta Meghe Inst Med Sci Univ 2019;14, Suppl S2:103-6

How to cite this URL:
Anjankar A, Kute P. Bioethics in laboratory medicine. J Datta Meghe Inst Med Sci Univ [serial online] 2019 [cited 2022 Jan 17];14, Suppl S2:103-6. Available from: http://www.journaldmims.com/text.asp?2019/14/6/103/296816




  Introduction Top


Medical Ethics is a system of moral principles that apply values to the practice of clinical medicine and in scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice.

Bioethics in laboratory medicine

The duty of the medical doctors to their patients is to follow their professional skills ethically and to observe the laws of the community. The purpose is to ensure that the patient's trust in the medical profession is justified. Like other areas of medicine, laboratory medicine is also committed to adhere to high ethical standards. The patient's welfare is paramount in health-care ethics. This principle applies to laboratory medicine as well.

The medical laboratory professionals are answerable to the ethical codes of their profession. Patients, colleagues, and the society are the three main groups toward which medical laboratories owe their responsibility. “Ethical medical practice is the expected conduct of laboratory physicians” and that attempt to achieve high ethical standards is essential for medical excellence.[1] The underlying goal for laboratory physicians is to maintain professional integrity.

Why ethics in laboratory medicine is important?

Around 70% of medical diagnoses now bank on laboratory analysis.[2] This accentuates the crucial role that laboratory physicians play in patient care. The intermediary clinician, acting as the lawyer for the patient, needs to endorse to the same ethical framework, as the laboratory physician to ensure that investigation results are practiced in the patient's best interest.[3],[4] Verdicts about diagnosis, prognosis, and treatment are frequently based on the results and interpretations of laboratory tests. Inevitable harm may be caused by faulty tests.

Ethical issues in clinical laboratory range from the collection of information from a patient, collection of specimen, performance of the tests, sample stocking, storage protocol, and retention of records. There are several other areas of ethical concern related to clinical laboratory such as biomedical waste management and financial arrangements, which are not directly related to patients.

Guidelines have been developed on ethical issues related to laboratory medicine by several countries and professional organizations. For instance, the International Organization for Standardization (ISO) has created ISO 15189:2012 “Medical laboratories − Requirements for quality and competence.”[5] Many professional societies have defined codes of ethics for laboratory professionals.[6],[7],[8],[9],[10],[11] Although the importance of ethics in laboratory medicine is undisputed, there is volatility in education that is concentrated on ethics in the laboratory medicine.

Laboratory professionals face ethical dilemmas daily, but still, ethics does not receive the attention it deserves. A report by the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on ethics indicates that formal teaching of ethics is missing from many laboratory medicine training programs and that there is a recognized need for training programs for ethical considerations in laboratory medicine.[12]


  Description Top


Ethical issues in clinical laboratory range from the collection of information from a patient, collection of specimen, performance of the tests, sample stocking, storage protocol reporting of the results, and retention of records. There are several other areas of ethical concern related to clinical laboratories such as biomedical waste management and financial arrangements, which are not directly related to patients.

Collection of information

Ethics in laboratory medicine commences from the collection of information for proper recognition of patients and specimens. Sufficient information should be collected by the laboratory for the proper recognition of the patient and specimen. It is also for lawful purposes (billing purpose and safety of other patients), but irrelevant personal information should not be collected. The patient should be acquainted with the purpose for which the information is collected. [13,14].

Collection of specimen

Consent can be implied for most laboratory procedures when the patient produces him or herself at a laboratory with a request form and readily agrees to the routine collecting procedures, for example, venipuncture. Special procedures, including the more invasive procedures (bone marrow aspirations), will require a more comprehensive explanation, and in some cases, written consent. Counseling will be required for human immunodeficiency virus (HIV) testing and certain genetic testing. In emergency situations, consent might not be possible, and under these circumstances, it is sufficient to perform necessary procedures provided they are in the patient's best interest.

Laboratories performing HIV testing shall pursue the National AIDS Control Organization guidelines, which include pretest and posttest counseling. Certain genetic testing will require pretest counseling to ensure that the patient fully realizes the significance of the test result.[15],[16],[17]

Patient autonomy

The patient's right to refuse to be tested should be admired. However, in certain situations, patient's autonomy is not absolute. For instance, when the patient is unconscious, mentally ill, or under the influence of drugs, he/she may be presumed to be incapable to make a decision about their health. Children are generally not supposed to make decisions for them. When a patient is incompetent by a reason (age or mental state), consent may be given by a parent or other authorized person. Compulsory testing needs to be carried out in certain groups such as intravenous drug users and prisoners. In these exceptional cases, laboratory professionals have an accountability to consider the guidelines provided by the institution in which they practice, and they must weigh the risks of loss of a patient's autonomy versus the benefits of the testing.

Performance of tests

The laboratory shall always use test procedures, which meet the applicable standards. Besides meticulous reporting of laboratory results, the laboratory has an additional responsibility to ensure that the results are correctly interpreted and applied in the patient's best interest. In some situations, the laboratory should refuse to attempt a test rather than produce an unreliable result which could result in harm being done to the patient.

Good laboratory practice includes the refusal to analyze or report a result when there is evidence of deficiencies that may compromise the test result. All laboratory works must be carried out with a high level of skill and competence expected of the medical, scientific, and allied health professions.


  Reporting of Results Top


The results will normally be reported to the requesting clinician. The results may be reported to other parties with the patient's consent or as required by law. The laboratory should have written procedures detailing how various requests are to be handled.

The results of laboratory examinations are confidential unless disclosure is authorized, under special circumstances or by the law, for example:[18],[19]

  1. When referring a patient to a different hospital
  2. When a written requisition by the court or the police is given demanding the disclosure of the reports
  3. Under the Insurance Act, when a patient gives up his/her rights on taking the insurance, and the insurance company demands the reports of the patient
  4. When required under workmen compensation and consumer protection laws
  5. Disease registration of a notifiable disease
  6. Investigations of contagious diseases
  7. Vaccination studies
  8. Reporting of adverse drug reactions
  9. If a person is admitted to a government hospital during police or judicial custody, his/her health records should be disclosed under the Right to Information Act.


The laboratory is also answerable for taking all necessary precautions to ensure that the method of transmitting results to requesting clinicians and other authorized persons is secure and reliable. This applies whether the transmission is by courier, public post, or electronic means. Decisions concerning implied consent for the reporting of results to other practitioners involved (such as consultant practitioners to whom the patient has been referred) should be made carefully taking into account local customs.

The laboratory is also liable for ensuring that the turnaround time for results is acceptable, taking into account the type of test and the patient's condition. Urgent results should be reported as soon as they are available. Delays in reporting should be avoided. Erroneous results can lead to mismanagement. Ordering clinicians should be notified of errors as soon as they are identified, and test results should be corrected as soon as possible. The change should be marked on the report, and the incorrect result or results should be clearly identified as erroneous.

Competent professional's consultation regarding the selection and interpretation of the results is a part of medical laboratory service. The results of laboratory examination that have been detached from all patient identification may be used for purposes such as epidemiology, demography, or other statistical analyses.

Withholding of laboratory results because the patient has not paid should be avoided. A policy on the use of residual samples should be developed. Residual samples are often used without the patient's knowledge. There is a dilemma about patients' share in profits if financial gains are derived from leftover samples.

Storage and retention of medical records

All records should be neat and readable and stored such that they are easily retrievable. The results of tests must never be altered or corrected, except by legally certified persons in accordance with entrenched procedures. Facilities shall provide a proper environment to prevent destruction, devaluation, loss, or unapproved access. Records may be stored for convenient retention time as per the national, regional, or local legal regulations. Laboratories should develop their own protocols indicating retention time for various results, specimens, and slides. Test results should be physically available for ready authorized access. When medical records need to be destroyed, this should be carried out with minimal risk of inadvertent disclosure.

Access to medical records

Access should be available to clinician, patient, hospital staff, and other authorized individuals. The laboratory should develop protocols to deal with distinct requests considering local laws and customs. Identity of the person must be confirmed by the laboratory when a request to access the result is made by an authorized person. In exceptional circumstances, the prohibition of health information from individuals normally authorized to receive may be justified. An example of such a circumstance is when disclosure may be contrary to a patient's best interests.

Different methods may exist in the same laboratory for different tests. For example, a degree of certainty associated with the identity of an authorized person seeking an HIV test result may be much greater than that required of one asking for the results of a routine hemoglobin test. Laboratories should establish appropriate procedures for each situation.

Financial arrangements

Medical laboratories should not enter into financial arrangements with referring clinicians where those arrangements act as a stimulus for the referral of patients. It is desirable that private laboratory collection rooms should be completely separate and independent from the referring clinician's rooms. If this is not practicable, any financial arrangements must not include any component of encouragement. Laboratories should try to avoid situations that give rise to a conflict of interest and must be able to function with professional independence.

Conscientiousness of the laboratory personnel

  • The laboratory personnel must access his/her conduct and maintain professional integrity
  • The personnel must take great care in performing the test procedure and recording the results
  • The patient's sample must be carefully stored
  • No fabrication of the sample to be tested or the result should be done
  • While delegating tasks to the staff, great care has to be taken keeping in mind the importance of each patient's sample
  • Financial or personal interests should not supersede the patient's interest.


Research ethics

No sample should be used by the researcher without obtaining informed consent from the patient. The researcher should honestly report the data, materials, and methods used in the laboratory without fabricating any reports. It is the responsibility of the researcher to maintain the confidentiality of the patient's information obtained for the purpose of research.

Steps for implementation of ethical practices in a laboratory:

  • Standardization of all procedures
  • Safe environment including proper wiring and maintenance of all electrical appliances and diagnostic equipment
  • Ensuring the safety of the laboratory staff from health-care hazards by the administration
  • Automation including bar coding that decreases manual error
  • Different tiers of checking/monitoring system to detect the errors timely
  • Repeated training of the laboratory staff
  • Standardized operating procedures in different sections of the laboratory with the display of all instructions
  • Accountability of the technical staff and reporting doctors for the safe and lawful practice
  • Alleviating distracting elements such as mobile



  Conclusion Top


Medical errors usually occur when there is a failure to complete a planned action as it was intended or when an incorrect plan is being implemented. Ethics in laboratory medicine have to be practically followed as a moral responsibility of all the laboratory staff, rather than being recorded in an operating manual. This requires medical laboratory professionals to realize their duties and have a conscientious attitude toward their work. The principal virtues of compassion, discernment, trustworthiness, integrity, and conscientiousness must always be kept in mind by the laboratory physician for ethical practice.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Canadian Association of Pathologists. Canadian Association of Pathologists Professionalism and Ethics. Available from: http://cap-acp.org/professionalism_and_ethics.cfm. [Last accessed on 2009 Aug 05].  Back to cited text no. 1
    
2.
Lock RJ. Rational requesting or rationing testing? J Clin Pathol 2004;57:121-2.  Back to cited text no. 2
    
3.
Arora DR, Arora B. Ethics in laboratory medicine. Indian J Med Microbiol 2007;25:179-80.  Back to cited text no. 3
[PUBMED]  [Full text]  
4.
Burnett L, McQueen MJ, Jonsson JJ, Torricelli F, IFCC Taskforce on Ethics [137]. IFCC position paper: Report of the IFCC taskforce on ethics: Introduction and framework. Clin Chem Lab Med 2007;45:1098-104.  Back to cited text no. 4
    
5.
ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence. Available from: https://www.iso.org/obp/ui/#iso: std: iso: 15189:ed-3:v2:en. [Last accessed on 2016 Jan 09].  Back to cited text no. 5
    
6.
AACC Ethics Guidelines. American Association of Clinical Chemistry. Available from: https://www.aacc.org/about-aacc/governance/ethic-guidelines. [Last accessed on 2016 Jan 09].  Back to cited text no. 6
    
7.
American Society for Clinical Laboratory Science; Code of Ethics. 2016. Available from: http://www.ascls.org/about-us/code-of-ethics. [Last accessed on 2016 Jan 09].  Back to cited text no. 7
    
8.
College of American Pathologists Principles of Ethical and Professional Conduct. Available from: http://www.cap.org/web/oracle/webcenter/portalapp/pages/searchresults.jspx?searchTerms=cap%20principles%20ethical%20professional&_afrLoo. [Last accessed on 2016 Jan 04].  Back to cited text no. 8
    
9.
Pathology Australia Code of Ethics and Practice Guidelines. Available from: Http://www.pathologyaustralia.com.au/wp-content/uploads/2010/07/02_Pathology-Australia-Code-of-Ethics-and-Practice-Guidelines-November-2012.pdf. [Last Accessed on 2016 Jan 09].  Back to cited text no. 9
    
10.
Canadian Society for Medical Laboratory Science (SCMLS). Available from: http://www.csmls.org/About-Us/Who-We-Serve/Code-of-Conduct.aspx. [Last Accessed on 2016 Jan 09].  Back to cited text no. 10
    
11.
College of Pathologists Pakistan. Ethics for Pathologists. Available from: http://www.healthwayslabs.net/docs/ethics.pdf. [Last Accessed on 2016 Jan 09].  Back to cited text no. 11
    
12.
Bruns DE, Burtis CA, Gronowski AM, McQueen MJ, Newman A, Jonsson JJ, et al. Variability of ethics education in laboratory medicine training programs: Results of an international survey. Clin Chim Acta 2015;442:115-8.  Back to cited text no. 12
    
13.
Declaration of Geneva. Available from: http://www.wma.net/en/30publications/10policies/g1/WMA_DECLARATION-OFGENEVA_A4_EN.pdf. [Last accessed on 2016 Jan 09].  Back to cited text no. 13
    
14.
Declaration of Helsinki. Available from: http://www.wma.net/en/30publications/10policies/b3/17c.pdf. [Last accessed on 2016 Jan 09].  Back to cited text no. 14
    
15.
Belmont Report. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. [Last accessed on 2016 Jan 09].  Back to cited text no. 15
    
16.
Allen MJ, Powers ML, Gronowski KS, Gronowski AM. Human tissue ownership and use in research: What laboratorians and researchers should know. Clin Chem 2010;56:1675-82.  Back to cited text no. 16
    
17.
Charo RA. Body of research – Ownership and use of human tissue. N Engl J Med 2006;355:1517-9.  Back to cited text no. 17
    
18.
van Diest PJ. No consent should be needed for using leftover body material for scientific purposes. For. BMJ 2002;325:648-51.  Back to cited text no. 18
    
19.
Bathe OF, McGuire AL. The ethical use of existing samples for genome research. Genet Med 2009;11:712-5.  Back to cited text no. 19
    




 

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