Volume 37 Number 6 | December 2023

Aditi Sarkar, MS, MLS(ASCP)CM, ASCLS Developing Professionals Forum Chair

Aditi SarkarIn the realm of modern medicine, laboratory testing stands as a foundation for clinical decision making. These tests are potent tools guiding physicians in diagnoses, prognoses, and treatment strategies. While laboratory tests hold this pivotal role, they must be conducted with unwavering commitment to ethical principles to safeguard patients’ well-being and maintain the medical profession’s integrity.

Medical laboratory scientists are often the unsung heroes of healthcare, diligently working behind the scenes, processing and analyzing biological specimens to generate diagnostic information that provides healthcare professionals with the critical data they need to diagnose and treat patients. Thus, healthcare professionals must recognize and address the often-overlooked ethical considerations that are a paramount concern transcending disciplines and professions to ensure patient safety and the integrity of the healthcare system. This article explores the learnings and understanding of a novice medical laboratory science graduate of the vital nexus between ethical considerations that underpin laboratory testing and their profound implications for patient safety.

Ethics means “moral principles” and is fundamental in any field, because right conduct is essential for human wellbeing. Laboratory testing, encompassing a wide array of diagnostic and investigative procedures, demands strict adherence to ethical principles. At its core, ethics in laboratory testing revolves around patient safety, the autonomy and dignity of individuals, and the maintenance of professional integrity. The philosophical, social, and legal flaws encompassing ethical considerations affect the outcome of laboratory testing, potentially breaching patient safety. Laboratories and medical professionals have long faced unique ethical concerns regarding monitoring laboratory results, patient test charts, handling leftover samples, etc.

“Ensuring the integrity of test results is the cornerstone of ethical laboratory testing.”

The principles and standards of the ASCLS ethical guidelines in the ASCLS Code of Ethics help strengthen the basic understanding of ethical practice among students enrolled in professional training programs. ASCLS has steadfastly enhanced patient care and diagnostic safety for decades. Through its Patient Safety Committee, which creates and disseminates programs, tools, resources, and educational materials to enhance patient safety, health outcomes, and the overall diagnostic process, it tirelessly works to fully integrate patient safety concepts and competencies into clinical laboratory science practice and promote member understanding of the laboratory professional’s role in patient safety. We can find many edifying resources on patient safety and ethics.

Additionally, various national and international organizations, such as the International Organization for Standardization (ISO), and national bodies, like the American Society of Clinical Pathologists (ASCP), have established rigorous standards and guidelines to ensure ethical laboratory practices and promote patient safety. ISO 15189, for instance, mandates that laboratories avoid activities that could diminish confidence in their competence, maintain staff’s independence from external pressures, declare potential conflicts of interest, and uphold patient confidentiality. Patients, staff, and environmental safety should always be top priorities. Any deviation from these ethical norms undermines patient trust and the credibility of laboratory testing.

As laboratory scientists entrusted with a profound responsibility, we have a professional obligation to adhere to this framework of ethical standards and guidelines by conducting ourselves with integrity, ensuring that our actions align with the best interests of patients and the broader healthcare community. This includes wearing appropriate personal protective equipment (PPE), strictly adhering to standard operating procedures (SOPs), and refraining from unauthorized discussions or disclosures of patient information or test results.

Ethical considerations span different aspects of laboratory testing. The pre-analytical phase involves obtaining informed consent, ensuring patient privacy, and maintaining sample integrity. The analytical phase includes accurate interpretation of results, adherence to quality assurance protocols, and proper documentation. The post-analytical phase involves timely and clear communication of results, protecting patient confidentiality, and ensuring appropriate follow-up care. To gain and maintain a patient’s trust or a referring doctor, the laboratory services provided must conform to the rigorous criteria of the highest possible standards of quality and competence of the working policies, test conditions, skills, the technical assistance provided, the integrity and reliability of the results, and the completion of laboratory reports and other documents conveying laboratory results. Respect for patient privacy and the confidentiality of protected health information is non-negotiable. Laboratory testing often involves the use of leftover samples for research purposes. While this practice can contribute to scientific advancements, it raises ethical questions regarding patient autonomy and privacy. Laboratories should establish clear guidelines and obtain informed consent from patients regarding using their samples for research.

Ensuring the integrity of test results is the cornerstone of ethical laboratory testing. High-quality reagents, equipment, and consumables are essential for maintaining the accuracy and reliability of test reports. Appropriate handling of patient samples, accurate interpretation of tests, and prompt communication of the test results are essential to ensure patients receive appropriate treatment and follow-up care. Errors or inaccuracies in the results can directly impact patient care, leading to misdiagnoses, inappropriate treatments, and potentially life-threatening consequences.

Professional accountability is a key to ethical practice. It includes upholding ethical principles, honesty in reporting test results, avoidance of delinquency, taking responsibility for our actions, reporting misconduct, ensuring quality assurance, respecting patient confidentiality, maintaining competence through engaging in continuous professional development to stay at the forefront of the most recent advancements in the field, prioritizing safety, disclosing conflicts of interest, complying with legal requirements, and reporting any misconduct or unethical behavior observed within the laboratory setting. Falsifying data, neglecting quality control measures, or engaging in unethical practices undermines patient safety. Therefore, as we graduate, we commit to upholding the profession’s integrity by being ethically bound to maintain our test results’ highest accuracy and reliability.

As students, we face several ethical dilemmas during our clinical training. Often, we feel pressured to prioritize speed over accuracy in a fast-paced healthcare environment. However, ethically, patient safety should always take precedence, even if it means taking extra time to ensure reliable results. Ethical principles require students to report any errors or discrepancies in their work. This can be challenging, as it may lead to consequences, such as reprimand or retesting. However, failing to report errors jeopardizes patient safety and the profession’s integrity. Bioethics provides a framework for addressing ethical dilemmas in laboratory testing. It involves considering the moral implications of scientific advancements, balancing the potential benefits against the risks, and ensuring that the rights and well-being of patients are protected.

In conclusion, ethical considerations are the bedrock of laboratory testing. They are not mere guidelines but the moral compass that guides the actions of laboratory professionals. Upholding ethical standards is not only an ethical duty but a critical aspect of ensuring patient safety and maintaining the trust and credibility of the medical profession. In this realm, ethics is not an option; it is an imperative that underpins the essence of laboratory testing and its profound impact on healthcare outcomes.

Laboratory testing and medical professionals are vital contributors to patient safety and the ethical fabric of healthcare. Our commitment to prioritizing accuracy, integrity, confidentiality, accountability, safety, competence, and adherence to professional standards and guidelines throughout the testing process is essential for ensuring that patient care remains at the forefront of our profession. Ethical considerations should permeate every aspect of our work, from conducting tests to reporting results accurately and promptly.

We must remain steadfast in our commitment to patient safety and ethics in a constantly evolving healthcare landscape. By upholding these principles, we would protect the welfare of individual patients and contribute to the healthcare system’s overall integrity. Educating our present medical laboratory science students on these essential ethical components would prepare them as future healthcare professionals who are poised to play a significant role in shaping a safer, more ethical future for healthcare delivery.

Aditi Sarkar is a Medical Technologist in Hematology at NYP-Columbia University Irving Medical Center in New York City, New York.