Section 3.10 - Qualified Patient Care Assessment Program - Specified Requirements in the Practice of Medicine(1)Informed Consent. A Qualified Patient Care Assessment Program must require licensees in the facility to adhere to the following guidelines relevant to Informed Consent: (a) The health care facility must have written policies and procedures designed to address the informed consent process. At a minimum, the policies should address: 1. Medical procedures and treatments for which informed consent is required and the content of the information provided.2. Designation of persons responsible for obtaining informed consent from the patient.3. The manner of documentation of consent, consistent with 243 CMR 3.00.4. Designation of appropriate persons, other than the patient, from whom consent may be obtained, and the circumstances when consent may be obtained from a person other than the patient.(b) Consent should be obtained for all major therapeutic and diagnostic procedures where disclosure of significant medical information, including major risks involved, would assist a patient in making an intelligent decision whether to undergo the proposed procedure.(c) It shall be a physician's responsibility to obtain the informed consent of the patient, and to discuss sufficient medical information to enable the patient to decide whether to undergo the proposed treatment. Although the physician is responsible for informing the patient, health care facility personnel may assist in the completion of documentation.(d) A patient's consent shall be documented with sufficient clarity and detail so as to satisfy the reader that the patient was given and understood the medical information provided.(2)Medical Records.(a)Alterations Prohibited. The health care facility shall prohibit the alteration of medical records when such alteration distorts any facts or circumstances reflected in the original writing.(b) Medical records shall meet the requirements set forth in the current Accreditation Manual for Hospitals, published by the Joint Commission on Accreditation of Hospitals.(3)Prescription Practice and Medication Errors. All licensees shall adhere to requirements for the safe administration of drugs and biologicals, set forth in the current Accreditation Manual for Hospitals, published by the Joint Commission on Accreditation of Hospitals.(4)Guidelines in Specialties. (a)Anesthesiology. All licensees shall adhere to any Standards for Basic Intra-Operative Monitoring established by the American Society of Anesthesiologists.(b)Other Patient Care Assessment Standards. The Board views the Standards for Basic Intra-Operative Monitoring as an example of patient care assessment standards for other specialties. On or after November 1, 1987, the Board may promulgate regulations relevant to Patient Care Assessment Standards in other medical specialties. Prior to such promulgation, the Board of Registration in Medicine may receive suggested Patient Care Assessment Standards from appropriate local, state or national specialty societies and organizations.