Medico-legal problems experienced by histopathologists differ from those of other clinicians as they are rarely in direct contact with patients. Nevertheless, the pathologist owes a duty of care to the patient and is liable for medical negligence. In the absence of local guidelines, it is prudent to follow guidelines published by learned Colleges elsewhere. This is also true when delegating duties to non-pathologists, technical and other support staff. Errors in diagnosis and documentation pose the most common problems in histopathology. In this, liability also depends on many factors including the provision of adequate clinical information by clinicians and competence of laboratory staff. Clinicopathological discussions, participation in quality assurance programmes and adherence to standard operating procedures are important audit activities to minimize and detect errors as well as prevent grievous outcome to patients. Issues also arise over the retention of specimens and reports. In general, wet, formalin-fixed tissues should be kept until histopathological assessment is finalized and preferably after clinicopathological sessions, and even longer if there is potential litigation. Reports should be archival. Paraffin blocks should be kept for at least the lifetime of the patient, and histology slides for at least 10 years, to facilitate review and reassessment. Despite adverse publicity in the foreign press over the use of human organs and tissues for research and education, it is accepted that processed tissues can be used for research and educational purposes provided the patient's identity is kept confidential. Nevertheless, it would be prudent to revise consent forms for surgery and autopsies to include the possibility that tissues removed can be stored or used for research and education. Good medical practice in pathology encourages a willingness to consult colleagues when in doubt, but advises that the treating clinician be informed if histopathological material is referred away for a second opinion. The Telemedicine Act of Malaysia (1997) requires practitioners outside Malaysia providing diagnosis through telepathology to hold a certificate to practice telemedicine issued by the Malaysian Medical Council. It is likely that the medico-legal scene in histopathology will change in the coming years with the advent of other new ancillary investigative techniques.
The past century has seen tremendous changes in the scope and practice of pathology laboratories in tandem with the development of the medical services in Malaysia. Major progress was made in the areas of training and specialization of pathologists and laboratory technical staff. Today the pathology laboratory services have entered the International arena, and are propelled along the wave of globalization. Many new challenges have emerged as have new players in the field. Landmark developments over the past decade include the establishment of national quality assurance programmes, the mushrooming of private pathology laboratories, the establishment of a National Accreditation Standard for medical testing laboratories based on ISO 15189, and the passing of the Pathology Laboratory Act in Parliament in mid-2007. The Pathology Laboratory Act 2007 seeks to ensure that the pathology laboratory is accountable to the public, meets required standards of practice, participates in Quality Assurance programmes, is run by qualified staff, complies with safety requirements and is subject to continuous audit. The Act is applicable to all private laboratories (stand alone or hospital) and laboratories in statutory bodies (Universities, foundations). It is not applicable to public laboratories (established and operated by the government) and side-room laboratories established in clinics of registered medical or dental practitioners for their own patients (tests as in the First and Second Schedules respectively). Tests of the Third Schedule (home test blood glucose, urine glucose, urine pregnancy test) are also exempted. The Act has 13 Parts and provides for control of the pathology laboratory through approval (to establish and maintain) and licensing (to operate or provide). The approval or license may only be issued to a sole proprietor, partnership or body corporate, and then only if the entity includes a registered medical practitioner. Details of personnel qualifications and laboratory practices are left to be specified by the Director-General of Health, providing for a formal recognition process and room for revision as pathology practices evolve. Encompassed in the responsibilities of the licensee is the requirement that samples are received and results issued through, and management vested in, a registered medical or dental practitioner. This effectively prohibits "walk-ins" to the laboratory and indiscriminate public screening. The requirement for a person-in-charge in accordance with class and speciality of laboratory ensures that the laboratory is under the charge of the pathology profession. Examined carefully, the requirements of the Act are similar to laboratory accreditation, but are backed by legislation. Many of these details will be spelt out in the Regulations, and these in turn are likely to fall back on National professional guidelines, as accreditation does. Although not at first obvious, enforcement of the Act is based on self-regulation by pathology laboratory professionals. Sincere professional input is thus required to embrace its philosophy, ensure rational and transparent enforcement of legislation, and develop National guidelines for good pathology practices upon which enforcement may be based.