Are pathologists legally liable?

The foundation of “Medical Ethics” is based on the principle of doing “good” and “no harm”. Doctors have an obligation to their patients to use their professional abilities ethically while abiding by legal regulations. As healthcare grows more litigious, doctors must comprehend the legal implications of their diagnosis and treatment decisions to legally safeguard themselves while providing the best possible care to the patient. As Pathology is a seemingly “non-patient-facing” or “non-clinical” branch, Pathologists/Oral Pathologists often think they are not liable for medicolegal litigation due to lack of direct contact with the patient. However, there are several case laws in literature wherein Pathologists/Oral Pathologists have been implicated in cases of medicolegal negligence. This happens as they hold a crucial role in handling the human tissue specimen, which is very important in diagnosis, treatment planning, and prognosis of the disease in the patient. Thus, they form an important member of the treating team for the patient and indirectly steer the course of treatment. Hence, a Pathologist/Oral Pathologist needs to know his role, and legal liability and be cautious of certain aspects to mark himself/herself legally safe. While in healthcare, an array of things can go wrong, some may be under the control of a Pathologist/Oral Pathologist while others are not, a Pathologist/Oral Pathologist needs to be aware of what can go wrong to prevent these errors as and when needed.[1] The role of a Pathologist/Oral Pathologist starts from the moment a specimen is taken from the patient’s body. From that point onwards, various issues can be encountered, eg: lapses that occur during the process of tissue collection, handling, reporting, or disposal. The Pathologist/Oral Pathologist is not the sole person responsible for the errors about the specimen, but the surgeon and technician have an equal role to play. However, timely intimation and reporting along with documentation can help in rectifying mistakes before they snowball. Errors that occur during the biopsy Errors that a clinician might commit are the collection of inadequate tissue samples and not transferring the samples within the stipulated time, excision of samples from areas not representative of the disease or non-inclusion of healthy margins in the biopsy, mishandling of tissue during collection, not being sensitive towards the technique like too much Local Anaesthesia infusion into the targeted tissue causing tissue desiccation and transportation errors which include using wrong transport medium like normal saline, spirit etc, which may alter the results. Case history sheets that do not represent the correct picture of the case, which are casually written, without any relevant information are a dilemma for the Pathologist/Oral Pathologist. Such errors can hinder the diagnostic value of the specimen, though it is not under the Pathologist/Oral Pathologist’s control directly, they certainly affect his ability to diagnose accurately. REMEDIES The Pathologist/Oral Pathologist without any hesitation should convey their message to the surgeon, regarding the do’s and don’ts of the specimen collection in terms of handling, representative tissue, and complete case history sheets with all relevant details including clinical pictures and radiographs as required for an informed diagnosis-making process. Errors that can occur during tissue handling The handling of the patient specimen is a very important task. Many things can go wrong like misplacement or loss of specimen, wrong labeling of specimen – can be as grave as operating on the wrong side, delay in processing due to holidays. There can be errors in grossing and staining in the hands of an inexperienced technician, inadequate storage protocol, and cross-contamination of the samples. The handling of patient specimens is very important as the Pathologist/Oral Pathologist can be held legally responsible. Mislabelling of the tissue specimens resulting in wrong surgeries can be considered criminal negligence. REMEDIES Every Pathology laboratory should have standard operating protocols for procedures like tissue collection, processing, storing, and discarding. Even on weekends or longer holidays, alternative arrangements should be made in such a way so that, the tissue does not lose its diagnostic value. Every member of the pathology team must be aware of the standard operating procedures (SOP) so that he/she can be made accountable.[2] Diagnostic dilemma The success of any treatment depends on accurate and timely diagnosis. The most common cause of therapy failure is wrong diagnosis. Diagnostic errors can be due to misdiagnosis, underdiagnosis, and inconclusive diagnosis. Reporting a benign lesion as malignant can result in surgical excision of healthy tissue. Underdiagnosis can lead to incomplete excision of diseased tissue, which can lead to recurrence or even rapid growth of the lesion. An inconclusive diagnosis leads to a surgeon’s dilemma regarding his treatment options. Many a time he will have to do a re-biopsy, which in turn is a second invasive procedure for the patient and not only incurs additional cost for the patient but also delays the diagnosis and treatment. The experience of the Pathologist/Oral Pathologist plays a vital role in the accuracy of reporting. Even the most experienced Pathologist/Oral Pathologist is a human, and cannot claim 100% accuracy for every diagnosis in their career. There are limitations even to an experienced Pathologist/Oral Pathologist. For example, if he has not received the malignant portion of the tissue from the lesion, he will not be able to report it as a malignancy. REMEDIES Clarifying all doubts regarding the case history, collecting more clinical pictures, and asking if there are any other relevant findings that the Surgeon can provide to aid in reporting can minimize the risk of misdiagnosis. Whenever there is a gross discrepancy between the surgeon’s provisional diagnosis and the Pathologist’s/Oral Pathologist’s histopathological diagnosis, it is better to discuss it with the Surgeon immediately, rather than sending the pathology report. This will mentally prepare the Surgeon and thereby the patients. These conversations will build healthy relationships between the Surgeon and the Pathologists/Oral Pathologists. When in doubt, check other sections of the specimen so as not to miss any important findings. When two people gaze at the same image, the perception can be different. The interpretation can vary from person to person. It’s better to take second opinions from other Pathologists/Oral Pathologists and inform the Surgeon also, regarding the same, in such a way, that the whole process of the diagnosis becomes transparent. Reporting in oncology cases Reporting in a high-volume oncology center can be highly demanding and stressful for a Pathologist/Oral Pathologist, as here the reporting is time-bound, errors in this can lead to alterations in the course of treatment, morbidity, and death. Frozen section analysis provides real-time pathological evaluation during surgical procedures. It helps to assess the surgical margins ensuring negative margins and nodal involvement. Sometimes the Surgeon expects the physical presence of the Pathologists/Oral Pathologist during the biopsy as and when required to determine the further treatment modality—chemotherapy or radiotherapy. REMEDIES Pathologists/Oral Pathologists should develop a proper infrastructure to fulfill the needs of the patients and surgeons for treatment planning. A frozen section should be provided as and when required which will help the Surgeon to decide regarding the surgical margin and extension. Pathologists/Oral Pathologists should insist on proper orientation of the specimen especially when the excision is en mass, inform the Surgeon to tag the parts mark the margins of the specimen, and specify the positive nodes. Being present in the operating theatre can also help as a guide to correlate the clinical findings and be better oriented regarding the collected tissue specimen. Pathologists/Oral Pathologists should be involved in tumour board meetings suggesting and giving inputs for the better functioning of the treatment team.[2] Is informed consent necessary for a pathologist/oral pathologist? The main guiding principles of Informed consent involves the rights of the patients to make clear assertions of what can or cannot be done to their body parts based on unbiased and full disclosure of the benefits and risks that will ensue from treatment. Pathologists/Oral Pathologists do not directly meet the patient, but consent must be obtained before examining their sample. They can keep their consent forms with the Surgeon or they can take the consent in their office when the patient deposits the specimen. The Pathologist/Oral Pathologist has the right to analyze diseased tissue retrieved after surgery in any way he or she deems appropriate to gain diagnostic information for future therapeutic decisions. However, the tissue is still the patient’s property. The sample-based report is a confidential document that should only be shared with the relevant clinician and the patient. The patient may wish to transport the tissue sample to other histopathologists, but the Pathologist/Oral Pathologist cannot refuse the patient the right to have samples extracted for diagnostic purposes.[3] Role of the oral pathologist as expert evidence in the Court of Law Forensic odontology has opened new avenues in oral pathology. It has helped to crack criminal cases with bite marks, lip prints, and saliva analysis. Maintaining confidentiality and ethical standards is critical, especially when working with sensitive material about victims or suspects. They frequently will have to cooperate with forensic teams and law enforcement departments to investigate situations of trauma, abuse, or neglect. Legal proceedings require accurate and extensive documentation, which includes full reports and images of results. The course of justice and final verdict is heavily influenced by the report generated by the expert Oral Pathologist overseeing the case and thus, the Oral Pathologist has a crucial role in dispensing justice. Pathologists/Oral Pathologists should be trained in the etiquette in the court of law to be able to present data accurately and amenably.[1,4] CONCLUSION The Surgeon and Pathologist/Oral Pathologist should work in sync as both are equally responsible for the formulation of a correct diagnosis and treatment plan for the patient. If there is a technical error on the part of either of the two, there should be quick and effective communication to achieve a collective goal. Pathologists/Oral Pathologists are very much part of the treatment team and they are equally legally bound as the clinician. Errors on their part can also lead to medicolegal implications. Insurance coverage with a professional indemnity policy is a must for a Pathologist/Oral Pathologist, as it will give financial cover in case of medical negligence whether they are involved directly or indirectly.