Consider legal and ethical implications. These include the patient’s right to information, correct diagnosis and prognosis, properly signed and witnessed consent forms, and explanations and instructions regarding chain-of-custody requirements and risks as well as benefits of tests.
Chain of custody is a legal term descriptive of a procedure to ensure specimen integrity from collection, to transport, to receipt, to analysis and specimen storage. A special form is used to provide a written record. The right to informed consent before certain tests and procedures pertains to patient autonomy, the ethical right of self-determination, the legal right to be free of procedures to which one does not consent, and the right to determine what will be done to one’s own body. Risks, benefits, and alternatives are explained, and written consent should be obtained well in advance of the procedure.
The patient must be of legal age and demonstrate appropriate cognitive and reasoning faculties to sign a legally valid consent. Conversely, a patient may not legally give consent while under the immediate influence of sedation, anesthetic agents, or certain classes of analgesic drugs and tranquilizers. If the patient cannot validly and legally sign a consent form, an appropriately qualified individual may give consent for the patient.
Guidelines and wishes set forth in advance directives or living will documents must be honored, especially in life-threatening situations. Such directives may prevent more sophisticated invasive procedures from being performed. Some states have legislated that patients can procure do not resuscitate (DNR) orders and medical DNR bracelets that indicate their wishes. A copy of a patient’s advance directives should be in the healthcare record.
A collaborative team approach is essential for responsible, lawful, and ethical patient-focused care. The healthcare provider who orders the test has a responsibility to inform the patient about risks and test results and to discuss alternatives for follow-up care. Other healthcare providers can provide additional information and clarification and can support the patient and family in achieving the best possible outcomes. The duty to maintain confidentiality, to provide freedom of choice, and to report infectious diseases may result in ethical dilemmas.
When faced with ethical dilemmas, choosing the correct course of action is sometimes a challenge. The responsibility to provide safe, effective care may conflict with the ethics of privacy, confidentiality, quality of life, and patient safety. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 has set forth regulations regarding patient confidentiality. Protected health information (PHI) is addressed under HIPAA regulations and includes any information—whether oral, written, electronic, or recorded in any manner—that is created or received by a healthcare provider; relates to the patient’s past, present, or future healthcare management; identifies the patient (e.g., Social Security number, medical record number); or can be used to identify a patient. HIPAA also provides rights to patients (e.g., the right to request, amend, correct, or limit their PHI).
Respect for the dignity of the individual reflects basic ethical considerations. Patients and family have a right to consent, to question, to request other opinions, and to refuse diagnostic tests. Conversely, caregivers have the right to know the diagnoses of the patients they care for so that they can minimize the risks to themselves.