Volume 38 Number 6 | December 2024
The Laboratory’s Role Goes beyond Performing any Ordered Test
Glen McDaniel, MS, MBA, MLS(ASCP), DLM(ASCP)
Bioethics involves many areas, but in the public’s mind, the concentration is on the topical issues of embryo and stem cell research, assisted reproduction, human cloning, and end-of-life issues. As in most things having to do with the testing of human specimens, clinical laboratory science plays a prominent, but rarely examined, role.
Bioethics broadly refers to practices in all life sciences, but more commonly is used interchangeably with medical ethics, which encompasses the study of moral issues in the fields of medical testing, treatment, and research. Medical ethics traces its roots to several early codes, such as the ancient Greek Hippocratic Oath, which required physicians above all to “do no harm,” and are reflected in professional codes of ethics such as those of the American Medical Association and the American Society for Clinical Laboratory Science.
Technology has advanced to the degree that it is possible not simply to diagnose disease but to predict risks and even how different individuals will react to treatment. The sobering countermanding question, however, is, “Should one do something just because one can?” Whether standing face-to-face with a patient or testing a specimen, laboratorians can use certain standards to ensure that they are acting ethically.
Following our code of ethics, regulatory guidelines, and best practices should guide us to act ethically and contribute to patient safety. Starting with proper patient identification, unique specimen labeling, running quality control, analyzing a sample according to established procedure, protecting patient confidentiality, and providing results in a timely manner to someone who has a right to know and can act on the result. All those steps are not just good practice but are part of the need to act ethically.
“Ethical conduct proceeds from the constant reminder that the laboratorian’s primary responsibility is to the patient—everyone else is secondary.”
There are a few basic premises, however, that we may not consider within our purview as medical laboratorians, but they are.
- Use available tests equitably. It is unethical to deprive an individual of a test that would improve their diagnosis, treatment, or quality of life. While there are technological, geographical, and financial considerations, these should not be invoked arbitrarily.
- Ensure tests are used appropriately. Tests should not be routinely used unless they are based on sound science. However, with rapid technology (so-called black boxes or simple kits) and individuals willing to pay out-of-pocket, there might be a temptation to offer whatever a manufacturer sells or a consumer asks for.
Additionally, laboratorians should be wary of facilitating the inappropriate use of legitimate tests. As an example, we know that mutation of the BRCA1 and BRCA2 genes can increase a woman’s lifetime risk of developing breast cancer up to 60-85 percent, as well as raise the risk for developing ovarian cancer to 26 percent. For those patients with a family history of these cancers, a physician might suggest aggressive intervention, such as prophylactic removal of breast or ovary. Since the results are predictive and not diagnostic, is that an ethical use of the test? There are equally common tests for a host of other risk factors from Huntington’s disease to diabetes to carpal tunnel syndrome. Ethical obligations include consideration of how these tests are used, not simply performing a test because “the doctor ordered it” or “we have a contract with that insurance company, that’s their business.” - Offer full disclosure. One basic principle of bioethics is that the autonomy and dignity of patients must be respected by telling them the full story and then allowing them to choose. That means that we should never perform a test without a patient’s informed consent; they should know the risks, interpretations, and alternatives. Who owns a specimen once it is collected? How about after it’s tested and discarded? Ethics are often gray—not black and white.
- Do not discriminate based on results. Many, including employers and insurance companies, with access to results may use such results to discriminate against patients they consider high risk, often because of incomplete information or erroneous interpretation of results. The laboratorian’s role is to minimize such discrimination as much as possible through strict confidentiality of information and education as to what results mean.
When in doubt as to what is ethical, the laboratorian should go back to the basic four principles which underlie modern ethics: autonomy (the right of each patient to choose), beneficence (always do good), nonmaleficence (do no harm), and justice (the obligation to be fair and equitable). A breach or question in any area is a red flag and should raise some concern.
Our professional code of ethics outlines the laboratorian’s relationship with, and obligation to, peers and clients. Standards of professional behavior are guided by considerations other than potential financial gain or expediency. It implies a firm contract to maintain the patients’ rights and dignity.
Doing what is right and ethical for the patient always requires a degree of mindfulness and the courage to speak up when we see unethical practices. While this smacks of whistle blowing, the engaged MLS must be willing to report and act on instances of omission or commission that compromise patient care—no matter whom the perpetrator. Ethical conduct proceeds from the constant reminder that the laboratorian’s primary responsibility is to the patient—everyone else is secondary.
Glen McDaniel is a medical laboratory scientist, speaker, and freelance writer. His interests include mediation, leadership, change, and ethics. He is currently Manager of Lab Quality Assurance and Compliance for the Kaiser Permanente Georgia Region.