International Laws Governing Medical Laboratory Practice

The American Association for Clinical Chemistry (AACC) has also recommended fifteen principles of ethical behavior for laboratories. Key highlights include:[11] (i) being honest in all professional achievements and maintaining a high level of personal truthfulness; (ii) the need to avoid scientific or occupational crime; (iii) should report any professional who deteriorates laboratory standards and professionalism that would impact patient care; (iv) maintain high quality reagents, equipment and consumables. They must also confirm the reliability of the test reports and the quality of the confidentiality of the reports. (v) Preserve the privacy and confidentiality of protected health information; (vi) make continuous efforts to improve professional qualifications, knowledge and skills and to present them accurately; (vii) promoting patient, staff and environmental safety; (viii) disclose actual conflicts of interest; (ix) Promote open and honest discussion between physicians, other health care providers and/or facility managers; (x) comply with relevant laws and amend if they are contrary to the interests of the patient. It is important to understand that OSHA PELs and substance-specific standards do not cover all hazardous chemicals. It is the responsibility of the laboratory director, in accordance with the laboratory standard and its general mandatory clause, to apply scientific evidence to protect workers from risks, although there may not be a specifically applicable OSHA standard. If exposure limit values or for working with particularly dangerous substances are exceeded, laboratories must keep exposure monitoring and medical surveillance records. As with hazardous materials, the off-site transportation of hazardous waste is regulated by the Department of Transport under the Uniform Transportation of Dangerous Goods Safety Act. These regulations apply not only to those who actually transport, but also to those who initiate or receive hazardous waste.

DOT regulations for the transport of laboratory chemicals include packaging, labelling, labeling, display and notification of releases. Anyone who prepares dangerous goods for transportation must also meet certain training requirements. The RCRA was enacted by Congress in 1976 to address the problem of improper disposal of hazardous waste. Subtitle C of this Act introduced a system for controlling hazardous waste from generation to disposal, often referred to as “cradle-to-grave”. Under the RCRA, the EPO will be given a major responsibility for enacting detailed rules for the generation, transport, treatment, storage and disposal of hazardous (chemical) waste. CJRA and EPA regulations apply to laboratories that use chemicals. See Chapter 5, Section 5.F for practical and non-legal information on shipping laboratory equipment. Medical laboratory professionals uphold the dignity and respect of the profession and maintain a reputation for honesty, integrity, competence and reliability.

Medical laboratory professionals contribute to the advancement of the profession by enhancing and disseminating knowledge, adopting scientific advances for the benefit of the patient, maintaining high standards of practice and training, and striving to provide equitable socio-economic working conditions for professionals. The Technical Instructions for the Safe Transport of Dangerous Goods by Air, published by the International Civil Aviation Organization (ICAO), are legally binding international regulations. Each year, the International Air Transport Association (IATA) publishes Dangerous Goods Regulations (DGR), which contain ICAO regulations and may add other restrictions. ICAO rules apply to all international flights. For domestic flights (i.e. flights within a country), national civil aviation authorities apply national legislation. This is usually based on ICAO regulations, but may include variations. Status and operating deviations are published in the ICAO Technical Instructions and the IATA DGR. There are a number of federal, state, and local laws, regulations, ordinances, and standards that relate to laboratory activities and conditions that affect the environment, health, and safety. These are briefly discussed in this chapter.

For the laws and safety standards described in detail elsewhere in this book, reference is made to this section in this chapter. Within the diagnostic medical laboratory, there are several ethical questions. Key ethical challenges such as; Consent, confidentiality, codes of conduct, conflicts of interest, use of laboratories, proficiency and direct access testing are much more common in resource-limited environments. Currently, decisions about the diagnosis and treatment of the patient are often made based on the results and interpretations of laboratory test results. Therefore, ethics plays an important role in laboratory medicine. In addition to lab results, lab staff is another important aspect of the lab. Therefore, it is strongly recommended that ethical knowledge help protect trust. operational integrity, capacity, impartiality and safety of personnel. Many countries and their professional societies have developed guidelines and guidelines on ethical issues in the field of laboratory medicine. Organizations in particular; The International of Federation of Clinical Chemistry (IFCC), the American Association of Clinical Chemistry (AACC) and the International Organization for Standardization (ISO) have developed ethical recommendations for clinical laboratories. They generally describe the responsibility of laboratory professionals to their profession, the patient and society.

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