Madhu Sinha¹, Swati Sharma², Abhijit Das¹, Anuj Sud³, Megha Rastogi², Swati Raj^1
1 Department of Pathology, Janakpuri Super Speciality Hospital Society, New Delhi, India
² Department of Microbiology, Janakpuri Super Speciality Hospital Society, New Delhi, India
³ Department of Microbiology, Lok Nayak Hospital, New Delhi, India

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• The laboratory staff must treat all the patients equally. No special preference is given to a patient based on their acquaintances among the staff, their class, or caste
• Informed consent is taken from all the patients before sample collection, explaining the reason for performing the required tests in a language that he/she understands
• Information only relevant to the patient's investigations is collected. No other personal details are collected
• The information received from each patient is confidential, and the patient should be aware of the reason for providing such information
• Special guidelines apply to certain infections, such as HIV, wherein the patient has to be given pre- and post-test counseling apart from taking informed consent. Pretest counseling includes providing information on HIV/AIDS, window period, routes of transmission, prevention, care, support and treatment services, explaining the benefits of HIV testing, and explaining that the individual has the right to opt out of HIV testing and this will not affect their access to any other health-related services. Informed consent has to be taken individually and in private and documented in a register. The result of the HIV test has to be kept strictly confidential. Post-test counseling involves explaining the test result, risk education counseling, condom demonstration and provision of condoms, information about the window period, and retesting. Besides these, guidelines for counseling in a certain specific subgroup of patients are available on the NACO website and must be followed^[2]
• Special guidelines apply in case of noninvasive prenatal testing (NIPT) as well. NIPT should only be offered in a healthcare setting by healthcare professionals with the knowledge and skills needed to support women and couples to make informed choices. High-quality education and training must be compulsory for all health and social care professionals involved in NHS prenatal screening
• Proper privacy has to be provided to the patient during sample collection, depending upon the site. Only authorized personnel and the donor may be present in the area where the collection takes place. The collector must give the donor visual privacy while providing the specimen. An enclosed toilet must be available for individual privacy
• Standard guidelines for proper sample collection in local language should be displayed in the collection area and the toilet and the staff should be trained for sample collection
• Feedback should be taken from the patients regarding satisfaction toward clinical laboratory services after the sample collection procedure. A predesigned proforma may be made available at the collection center for the same.

• Tests should be performed as per established standard protocol derived from standard national/international guidelines
• The procedure for in-house testing must be standardized and validated. The standard protocol must include all documents related to the standardization.^[3]

• The results of the investigations are always confidential unless disclosure of the same is required under special circumstances or by the law,^[4] for example:



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 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 communicable diseases
7. Vaccination studies
8. Reporting of adverse drug events
9. If a person is admitted to a government hospital during police or judicial custody, his health records should be disclosed under the RTI Act



• Results may be used for statistical or epidemiological purposes anonymously (when the patient's personal details are excluded and only the patient data are being used). For instance, when preparing a trend analysis for antimicrobial resistance in the hospital or calculating the rates of hospital-acquired infection.

• Collection and storage of human biological materials like tissue, blood samples, body fluids, urine have become integral to disease diagnosis, and human research. Laboratory medical practice of retention of diagnostic samples for testing and retesting as per the integrity and stability of the samples may be viewed as a resource for research by the community
• Stored samples should not be used for performing tests other than for which informed consent has been taken from the patient. The samples may be stored for retesting in case of any fallacious results. If the stored sample has to be used for performing some higher tests in the interest of patient care, the patient must be informed.

• The laboratory staff must evaluate his/her conduct and maintain professional integrity
• The staff must take great care in performing the test procedure and recording the results
• The patient's sample must be carefully stored by the staff
• No fabrication of the sample to be tested or the result should be done
• Great care has to be taken in delegating tasks to the staff, keeping in mind the importance of each patient's sample
• No financial or personal interests should supersede patient's interest.^[5]

• The laboratory should have transparent policies indicating the reason for performing the concerned tests. Unnecessary testing has to be avoided.

• No sample should be used by the researcher without taking 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.

• 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 healthcare 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 workflow of the laboratory (fixed protocol of work in different sections of the laboratory with the display of all instructions)
• Accountability of the technical staff and reporting doctors for safe and lawful practice
• Alleviating distracting elements like mobile phones to avoid negligence by the laboratory staff.

Conclusion

• 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 the 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.

References

1.	Bezuidenhout L. Ethics in the minutiae: Examining the role of the physical laboratory environment in ethical discourse. Sci Eng Ethics 2015;21:51-73.
2.	National HIV Counseling & Testing Services Guideline, Dec 2016. Available from: http://naco.gov.in/sites/default/files/National%20HIV%20Counselling%20&%20Testing%20Services%20Guideline,%20Dec%202016_0.pdf. [Last accessed on 2018 Oct].
3.	Specific Criteria of Accreditation of Medical Laboratories (NABL 112; Issue No: 03, Issue Date: 09.05.2016, Amendment No: 0). Available from: http://www.nabl-india.org/nabl/index.php?c=publicaccredationdoc& m=index&docType=both. [Last accessed on 2018 Oct].
4.	Watwe JM. Disclosure of confidential medical information. Indian J Med Ethics 1998;6:56-7.
5.	Arora DR, Arora B. Ethics in laboratory medicine. Indian J Med Microbiol 2007;25:179-80.   [PUBMED]  [Full text]
6.	Sinha M, Saini S, Gupta P, Gulati NS, Das A, Kumar A, et al. Current status and way forward for National Accreditation Board for testing and calibration laboratories accreditation of laboratories in government organizations. Indian J Pathol Microbiol 2018;61:461-3.   [PUBMED]  [Full text]

Correspondence Address:
Swati Sharma
Department of Microbiology, Janakpuri Super Speciality Hospital Society, New Delhi - 110 058
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/IJPM.IJPM_533_18