SECTION 51H. Reporting about healthcare-associated infections and serious reportable events, and serious adverse drug events; charges or reimbursement for resulting services prohibited

(a) As used in this section the following words shall, unless the context clearly requires otherwise, have the following meanings:

''Facility'', a hospital, institution for the care of unwed mothers or clinic providing ambulatory surgery as defined by section 25B.

''Healthcare-associated infection'', a localized or systemic condition that results from an adverse reaction to the presence of an infectious agent or its toxins that: (i) occurs in a patient in a facility, (ii) was not present or incubating at the time of the admission during which the reaction occurs, and (iii) if occurring in a hospital, meets the criteria for a specific infection site as defined by the federal Centers for Disease Control and Prevention and its national health care safety network.

''Serious adverse drug event'', any untoward, preventable medical occurrence associated with the use of a drug in humans that results in any of the following outcomes: (i) death; (ii) a life-threatening outcome; (iii) inpatient hospitalization or prolongation of existing hospitalization; (iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; (v) a congenital anomaly or birth defect; or (vi) any other kind of harm as determined by the department in regulation; provided, however, that adverse medical occurrences directly associated with the use of a drug in humans that may not immediately result in 1 of the outcomes listed in clauses (i) to (vi), inclusive, may be considered a serious adverse drug event when they develop into or result in any of the outcomes listed in clauses (i) to (vi), inclusive.

''Serious reportable event'', an event that results in a serious adverse patient outcome that is clearly identifiable and measurable, reasonably preventable, and that meets any other criteria established by the department in regulations.

(b) A facility shall report data and information about healthcare-associated infections, serious reportable events, and serious adverse drug events. A serious reportable event shall be reported by a facility no later than 15 working days after its discovery. Reports shall be made in the manner and form established by the department in its regulations. The department may require facilities to register in and report to nationally recognized quality and safety organizations. A facility that discovers a serious adverse drug event resulting from a patient's use, consumption or interaction with any pharmaceutical or drug preparation, shall report the event to the federal Food and Drug Administration's MedWatch Program, as well as the pharmacy from which the drug was produced, compounded or dispensed in addition to all other reporting requirements.

(c) The department, through interagency service agreements, shall transmit data collected under this section to the Betsy Lehman center for patient safety and medical error reduction, the bureau of healthcare safety and quality within the department and the board of registration in pharmacy for publication on the center for health information and analysis consumer health information website and for reporting quality data to providers. Any facility failing to comply with this section may: (i) be fined up to $1,000 per day per violation; (ii) have its license revoked or suspended by the department; or (iii) be fined up to $1,000 per day per violation and have its license revoked or suspended by the department.

(d) The department shall promulgate regulations prohibiting a health care facility from charging or seeking reimbursement for services provided as a result of a healthcare-associated infection or the occurrence of a serious reportable event. Except as the executive office of health and human services otherwise provides for services to MassHealth members consistent with section 2702 of the Patient Protection and Affordable Care Act (P.L. 111–148), a health care facility shall not charge or seek reimbursement for a healthcare-associated infection or a serious reportable event that the facility has determined, through a documented review process and under regulations promulgated by the department, was: (i) preventable; (ii) within its control; and (iii) unambiguously the result of a system failure based on the health care provider's policies and procedures; provided, however, that for services to MassHealth members, the health care facility shall perform this documented review process and determination solely for the purposes of reporting to the department.