Bioethics in Laboratory Medicine

Abstract

Medical laboratory professionals are answerable to the ethical codes of their profession. This idea also holds for laboratory medicine. All patients should be treated equally and without distinction in the laboratory. Data gathering for the accurate patient and specimen identification is where laboratory medicine ethics begin. Ethical principles are upheld when gathering samples, conducting the tests, and disclosing the results. When a patient presents themselves at a lab with a request form and readily consents to the standard collecting procedures, consent can be assumed for most laboratory procedures. The laboratory must always conduct tests by the relevant standards. Laboratory test results are kept private unless disclosure is permitted. The results will typically be reported to the requesting doctor, with the patient’s permission or as required by law; they may also be reported to other parties. Medical records should be stored and kept following ethical standards. Instead of being spelled out in an operating manual, laboratory staff members must uphold ethics in laboratory medicine. This calls for medical laboratory professionals to be aware of their responsibilities and diligently approach their work.

1. Introduction

A set of moral guidelines, medical ethics, applies ethical standards to clinical medicine and scientific research. Professionals can turn to a group of values that form the foundation of medical ethics in case of any uncertainty or conflict. These values include respect for one’s autonomy, beneficence, justice, trustworthiness, and non-maleficence.

2. Bioethics in laboratory medicine

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

Medical laboratory professionals are answerable to the ethical codes of their profession. The general principle of healthcare ethics is that the patient’s welfare is paramount. The laboratory should treat all patients fairly and without discrimination.

The three main groups medical laboratories are responsible for our patients, coworkers, and society. The expected behavior of laboratory physicians is defined as “ethical medical practice,” and striving to uphold the highest ethical standards is crucial for advancing medicine [1]. Maintaining their professional integrity is laboratory doctors’ main priority.

3. Why is ethics important in laboratory medicine?

Currently, lab testing makes up about 70% of medical diagnoses [2]. This accentuates the crucial role that laboratory physicians play in patient care. The intermediary clinician, acting as the patient’s lawyer, must endorse the same ethical framework as the laboratory physician to ensure that investigation results are practiced in the patient’s best interest. Verdicts about diagnosis, prognosis, and treatment are frequently based on the results and interpretations of laboratory tests [3, 4].

Clinical laboratories must consider ethical considerations when gathering patient data, collecting samples, performing tests, stocking samples, following storage protocol, and keeping records. Other ethical issues surrounding clinical laboratories include those unrelated to patients such as managing biomedical waste and financial arrangements.

Several countries and professional organizations have developed guidelines on ethical issues related to laboratory medicine. 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 laboratory medicine. The IFCC task force has recommended that all medical specialties, including laboratory medicine, should adhere to ethical standards and guidelines. The outcome, results, and analysis of laboratory tests are typically used to determine prognosis and medications associated with specific medical conditions.

Laboratory professionals face ethical dilemmas daily, but ethics needs to receive the attention it deserves. A report by the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on Ethics shows that many laboratory medicine training programs do not formally teach ethics and that there is a need for training programs for ethical considerations in laboratory medicine.

Clinical laboratories must consider ethical considerations when gathering patient information, collecting specimens, performing tests, stocking samples, following storage protocol for results reporting, and keeping 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 [12].

3.1 Basic ethical principles in the pre-analytical phase

3.1.1 Collection of information

Ethics in laboratory medicine commence from collecting information for proper recognition of patients and specimens. The laboratory should collect sufficient information to correctly identify the patient and representative. The Clinical and Laboratory Standard Institute (CLSI) makes suggestions for enhancing the precision of inpatient and outpatient identification. In accordance with CLSI guidelines, inpatients should be asked for their complete name, address, birthdate, age, and/or unique identification number.

Although it is also legal (for billing and the security of other patients), irrelevant personal information should not be gathered. The patient should be informed of the reason behind the data collection [13, 14].

3.1.2 Collection of specimen

Consent can be assumed for most laboratory procedures when patients present themselves at the lab with a request form and readily consents to standard data collection techniques such as venipuncture. Unique methods, such as those that are more invasive (such as bone marrow aspirations), call for a more thorough explanation and, occasionally, written consent. Adequate privacy for the patient must be made available (type of specimen collected).

Sample collection should be carried out following generally accepted safety precautions to protect both the patient and the healthcare professional. Additional samples should not be taken from patients without informing the institution’s ethics committee and receiving their permission. The specimens need to be clearly labeled. The integrity of the sample should be protected during transportation.

Specimen integrity is the second most important prerequisite for lowering laboratory error during the pre-analytical phase. The amount of procedures carried out, such as specimen collecting, specimen physiology maintenance, transportation, and processing, affect the integrity of the specimen. The actions listed below will guarantee specimen integrity:

The laboratory should develop simple-to-understand procedures for gathering, handling, and transporting samples. Standard operating protocols (SOPs) for phlebotomy must be followed by the laboratory, and they cover things like the right way to collect samples, how to take the necessary safety precautions when collecting samples, and how to dispose of syringes, needles, and other supplies.

The only way to do this is to go through training, which starts at the new employee orientation period and includes a continuing education program that is completed annually or as needed, followed by an annual proficiency and competency exam. All non-laboratory and laboratory staff involved in specimen collecting should receive this training.

To ensure the validity of analytical results, laboratories should establish evidence-based standards for specimen acceptance that must be put into practice for managing the specimens prior to testing [11]. A standardized workflow for identifying and handling hemolyzed, clotted, and inadequate specimen material should be developed by laboratories.

Counseling will be required for human immunodeficiency virus (H.I.V.) testing and specific genetic testing such as hereditary cancer genetic test, prenatal genetic test, and genome screening. In emergencies, consent is not possible, and under these circumstances, it is sufficient to perform necessary procedures, provided they are in the patient’s best interest. Laboratories performing H.I.V. testing shall pursue the National AIDS Control Organization guidelines, which include pretest and posttest counseling. Specific genetic testing will require pretest counseling to ensure the patient fully realizes the significance of the test result [15, 16, 17].

3.1.3 Patient autonomy

The patient’s right to refuse to be tested should be respected. However, in certain situations, the patient’s autonomy is not absolute. For instance, when the patient is unconscious, mentally ill, or under the influence of drugs, they may be presumed incapable of deciding their health. Schedule-Y, FDA, ICH-GCP, WHO, and ICMR guidelines all list vulnerable populations as including low-income individuals, patients who are illiterate, children, patients in psychiatric facilities, inmates, fetuses, and pregnant women. Children are generally not supposed to make decisions for them. When a patient is incompetent for a reason (age or mental state), consent may be given by a parent or other authorized proxy.

Poor women with HIV/AIDS are one such susceptible group; on occasion, these participants are not aware of the process of informed consent. Many researchers lament that because respondents have varied perceptions of diseases, it might be challenging to explain the study’s biological foundation and treatment plans to them. However, this should not be the justification for not getting subjects’ informed consent. In order to better comprehend the informed consent process and HIV/AIDS, developing nations such as India conduct Group Education and Counseling (GEC). Through seminars and questionnaires, fundamental information on HIV/AIDS and the informed consent process was imparted. Many individuals could comprehend the significance of informed consent with only a small amount of education, and occasionally it is important to abandon the traditional paradigm in favor of a new one.

Specific populations, including intravenous drug users and prisoners, require mandatory testing. In these exceptional circumstances, laboratory professionals have a responsibility to consider the policies set forth by the organization in which they work and to balance the advantages of the testing against the risks of a patient’s autonomy is lost.

It offers affordable access to several laboratory tests. When better tests are available, the laboratory should assess whether it is necessary to discontinue older tests and whether any opportunities exist to replace them. No patients should be given preference to simplify or speed up the collection process at the expense of other patients.

3.2 Analytical phase

3.2.1 Performance of tests

The laboratory shall always use test procedures, which meet the applicable standards. The preferred methods have been documented in reputable, peer reviewed textbooks, texts, or journals and in international, national, or regional guidelines. If internal processes are used, they must be thoroughly documented and validated adequately for their intended use.

The laboratory is accountable for meticulously reporting laboratory results and ensuring that the results are correctly interpreted and used in the patient’s best interests. In some situations, the laboratory should refuse to attempt a test rather than produce an unreliable result that could harm the patient. The maxim “a wrong result is worse than no result” is a guiding principle.

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

Patients can decline to have their samples examined after sample collection and processing. Confidentiality should be respected and maintained in such a situation. To the greatest extent possible, confidentiality should be respected during point-of-care testing.

3.3 Post-analytical phase

This phase includes reporting and interpreting test results, storing residual samples, and accessing the data.

3.3.1 Reporting of results

The requesting clinician will typically receive a report of the findings. The patient’s permission, or as required by law, may be obtained to disclose the results to other parties. The laboratory should have written policies outlining how different requests are to be handled, and patients should have access to this information upon request.

Although reporting of test results must be consistent for all patients, speedy reporting may be demanded some results including “critical” and “significant risk” results. The International Federation of Biomedical Laboratory Science (I.F.B.L.S.) suggests upholding strict confidentiality of patient data and test results, protecting patients’ privacy and dignity, and, most importantly, taking responsibility for the caliber and integrity of clinical laboratory services rendered. Similarly, the American Society of Clinical Pathologists (A.S.C.P.) has also given laboratory staff advice on how to treat patients and coworkers with respect, care, and consideration; how to perform tasks accurately, precisely, promptly, and responsibly; and how to keep patient information private while adhering to the law. Laboratory test results are kept confidential unless disclosure is permitted by law, under exceptional circumstances, or both. For instance [18, 19]:

1. When sending a patient to another hospital.

2. When a court or the police issue a written request requesting.

3. By the Insurance Act, the insurance provider must obtain the patient’s reports when the patient waives their right to get insurance.

4. When required by consumer protection and workers’ compensation laws.

5. Notification of disease through disease registration.

6. Research into infectious diseases.

7. Studies on vaccination.

8. Reporting of adverse drug reactions.

9. By the Right to Information Act, a person’s medical records should be made public if admitted to a government hospital while in police or judicial custody.

The laboratory is also responsible for taking all necessary precautions to guarantee the security and dependability of the method of transmitting results to interested clinicians and other authorized parties. A quality reporting system is one that makes sure the right results are sent to the right medical practitioners in a timely manner that assures patient safety without placing an undue strain on the medical staff or the laboratory staff [20]. According to the definition of this system, two crucial flaws could endanger patient safety if they are not resolved. First is “delivering the report within a time frame” and second is “delivery to the appropriate [health care professional].” Regarding the first concern, the reporting of critical values—defined as values that represent circumstances that could become life-threatening unless some kind of medical intervention is made and for which such interventions are feasible—may offer a particularly significant risk to patient safety. It is also important to consider the second issue, “delivery to the appropriate [health care professional],” which has to do with who should be informed and who should receive test results.

Whether the transmission occurs via electronic, postal, or courier service, decisions concerning implied consent for reporting results to other practitioners involved (such as consultant practitioners to whom the patient has been referred) should be made carefully, considering local customs.

The laboratory is also liable for ensuring that the turnaround time for results is acceptable, considering the type of test and the patient’s condition. Urgent results should be reported as soon as they are available. The facility should be to report critical results as soon as they are available. Reporting delays ought to be prevented. Inaccurate outcomes can result in poor management. Errors should be reported to ordering clinicians as soon as they are discovered, and test results should be updated as quickly as possible. The modification on the report should be noted, and any incorrect results should be clearly labeled. The laboratory has to ensure that the results are correctly interpreted and used in the patient’s best interest, in addition, to accurately reporting the results of the tests.

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

Because the patient has not paid, withholding laboratory results should be avoided. A policy on the use of residual samples should be developed. Residual models are often used without the patient’s knowledge. There is a dilemma about patients’ profit share if financial gains are derived from leftover samples. Fleischman argues that the most crucial concern surrounding remaining dried blood spots now is whether they may be preserved and utilized for upcoming studies without endangering the crucial public health objectives of newborn screening programs. Yes, he replied, “as long as we exercise caution.”

Would it be a breach of confidentially if we discovered the patient had a certain genetic condition for which he or she had not given consent to a genetic test and this was actionable? “Genetic exceptionalism” refers to the notion that genetic testing is distinct from testing for other illnesses [18]. Genetic data is personal and directly relates to a person’s identity. The results of a genetic test may have an impact on the entire family, making confidentiality a problem not only for work but also for medical care. If a person has or is genetically predisposed to the condition, that person’s parents, children, siblings, and even extended relatives may also be afflicted. A person may also rely important decisions on the results of a genetic test [21].

3.3.2 Storage and retention of medical records

All of the records should be organized, easily readable, and stored in a convenient location. Test results must only be changed or corrected if done so by legally qualified individuals following established protocols. Facilities must create a suitable environment to guard against loss, devaluation, destruction, and unauthorized access. According to national, regional, or local legal regulations, records may be kept for a convenient retention period. Laboratories should develop protocols indicating retention time for different results, specimens, and slides. Test results should be physically available for ready authorized access. When medical records must be destroyed, this should be carried out with the minimal risk of inadvertent disclosure. The following techniques can be used to destroy paper records: burning, shredding, pulping, and pulverizing. Destruction techniques for microfilm or microfiche include recycling and pulverizing.

3.3.3 Access to medical records

Access should be available to the clinicians, patients, hospital staff, and other authorized individuals. The laboratory should develop protocols to handle special requests considering local laws and customs. The person’s identity must be confirmed by the laboratory when an authorized person requests to access the result. In exceptional circumstances, the prohibition of health information from individuals usually authorized to receive it may be justified. An example of such a circumstance is when disclosure may be contrary to a patient’s best interests.

For various tests, different techniques might be used in the same laboratory. For instance, an authorized person requesting the results of an H.I.V. test may be required to provide much more proof of their identity than someone asking for the results of a routine hemoglobin test. For each circumstance, laboratories should establish the proper protocols.

3.3.4 Financial arrangements

When financial agreements with referring clinicians motivate patient referrals, medical laboratories should not enter into those agreements. Private laboratory collection rooms should be entirely independent of the rooms used by the referring clinicians. Any financial arrangements must only include an element of encouragement if this is feasible. Laboratories must be able to function independently and try to avoid situations that could lead to conflicts of interest.

3.3.5 Conscientiousness of the laboratory personnel

• The laboratory personnel must assess 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 (Unauthorized altering or falsification of data) 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 welfare.

3.3.6 Research ethics

As science and modern medicine continue to advance, new moral and ethical dilemmas frequently appear. The human genome project’s completion, the expansion of genetic engineering, and stem cell research are just a few examples of things that are at the forefront of ethical discussions today. The focus on ethical misconduct in the media and the growing scrutiny of science’s intricate financial ties to business and industry both serve to emphasize the importance of ethics in scientific conduct. We as scientists must develop our moral and ethical character because science ethics are becoming more and more important.

According to the researcher, the patient’s informed consent must be obtained before using any samples. Without fabricating (Unauthorized altering or falsification of data) any reports, the researcher must accurately report the information, tools, and techniques used in the lab. The confidentiality of patient data gathered for research purposes must be upheld at all times by the researcher.

3.3.7 Histopathology and cytology

Specific observations (such as the presence of spermatozoa) that are unrelated to the examination’s goal may be made during a histopathological or cytological assessment. It is essential to carefully consider whether or not to report such observations because doing so could have critical social repercussions.

Like clinical pathology, tissue diagnosis must offer details that help the treating physician properly inform the patient of the diagnosis and its repercussions.

3.3.8 Reproductive technology

Discussions of reproductive technology may bring up issues that touch on deeply held beliefs and religious principles, as well as perceptions of what it means to be a human being or a person, about identity, about the family, and the idea that one’s traits continue to exist in some way after death.

Judaism permits the use of all assisted reproductive technologies when the oocyte and spermatozoon come from the husband and wife, respectively. Among Christian groups, there are differences in attitudes toward reproductive practices. Even though the Vatican does not support assisted reproduction, Protestant, Anglican, and other religious groups may use it. The majority of assisted reproductive technologies are prohibited by traditional Christian beliefs because they hold that the embryo has moral status as a human being from the moment of conception. IVF and embryo transfer are acceptable in Islam, but they are only permitted for husband and wife to use them. New religious questions are posed by advances in science and technology, along with the clinical applications that follow, often without clear-cut solutions.

The way various societies and religions approach these issues varies, just as do these convictions and perceptions. As a result, it is impossible to reach a consensus among ethical thinkers on this issue. Examples of this concern are the various and firmly held opinions on artificial insemination by donors, in vitro fertilization, gamete intrafallopian transfer, and other procedures and techniques.

3.3.9 Recommendation for ethical practices in a laboratory

• Standardization of all procedures.

• Safe environment including proper wiring and upkeep of all electrical appliances and diagnostic equipment.

• Administration assurance of the safety of the laboratory staff from healthcare risks.

• Automation including bar coding that decreases manual error.

• Different tiers of checking/monitoring systems to detect the errors promptly.

• Repeated training of the staff.

• Reducing distractions such as mobile devices.

4. Conclusion

Medical mistakes typically occur when a planned action is not carried out as intended or when the wrong plan is carried out. Instead of being spelled out in an operating manual, laboratory staff members must uphold ethics in laboratory medicine. To achieve this, medical laboratory professionals must be aware of their responsibilities and diligently approach their work. For ethical practice, the laboratory physician must never forget the fundamental virtues of compassion, discernment, trustworthiness, integrity, and conscientiousness. It is necessary to create an ethics policy for laboratory professionals (similar to code of conduct for various companies or business) and include it in the quality control manual for the laboratory. The code of ethics usually includes the six universal moral values that state you expect employees to be trustworthy, respectful, responsible, fair, caring, and good citizens. The creation and implementation of an ethics training program for laboratory personnel should be done to support the growth of laboratory personnel’s professional lives, emphasizing human values and responsibility, and honesty in their work.