SB 346 - This act creates the "Medical Harm Disclosure Act" to require reporting of medical harm events. A "medical harm event" is defined as harm to a patient as a result of medical care or in a health care setting including, but not limited to the National Quality Forum's list of Serious Reportable Events. The categories of events are described under the act, but include surgical, anesthesia, medication, product, device, care management or environmental death events. Death of a previously healthy person undergoing medical care is also included.
A health care facility, which includes both hospitals and long-term care facilities, shall report a medical harm event to the Department of Health and Senior Services no later than five days after the event has been detected. If the event is an ongoing urgent or emergent threat to the health, welfare or safety of patients, personnel, or visitors, such event shall be reported no later than 24 hours after the event has been detected. On a quarterly basis, each health care facility that has had no medical harm events to report during the quarter shall affirmatively declare this fact to the department.
Each health care facility shall create facility-wide patient safety programs to routinely review patient records for medical harm, analyze these events to determine if they were preventable and implement changes to prevent similar harmful events. Each health care facility shall provide an annual summary of its patient safety program to the department.
Each health care facility shall inform the patient, in a process prescribed under the act, of the medical harm event by the time the report is made to the department. Each health care facility shall interview patients, family members, and parties responsible for the patient about medical harm events and document a detailed summary of that interview in the patient's medical record. If the medical harm event contributed to the death of a patient, the health care facility shall include that event as a contributing cause on the patient's death certificate.
This act creates the "Medical Harm Reporting Advisory Committee." The members to be appointed by the director of the Department of Health and Senior Services are listed under the act. The advisory committee shall assist the department in the development of all aspects of the department's methodology for collecting, analyzing, and disclosing the information collected under this act. In developing the methodology for collecting the data on medical harm events, the department and advisory committee shall use the forms developed by the Agency for Healthcare Research and Quality as "Common Formats", or a similar standardized collection method.
The department shall also at least quarterly check the accuracy of information reported by health care facilities under this act by comparing the information with other available data such as patient safety indicators from hospital patient discharge data, complaints filed with the licensing division, death certificates, inspection and survey reports, and medical malpractice information. The department shall annually conduct random reviews of health care facility medical records.
Every three years, the department shall have an independent audit conducted by a state university not affiliated with any health care facility required to report under this act. The data collection, analysis and validation methodologies shall be disclosed to the public. The results of the audit shall be available to the public on the department's website within one month of receiving the final report.
Each quarter, the department shall publish details of the fines assessed to health care facilities for failure to report medical harm events and shall issue a news release about that publication. The department shall annually submit a report to the general assembly detailing medical harm events reported at each health care facility. The report may include policy recommendations, as appropriate. The list of items to be included in the report are detailed under the act. Each quarter, the department shall make information regarding outcomes of inspections and investigations conducted pursuant to its hospital and long-term care facility regulatory duties readily accessible to the public on the department website. No health care facility report or department public disclosure may contain information identifying a patient, employee, or licensed health care professional in connection with a specific infection incident. The act provides for patient social security numbers or any other information that could be used to identify an individual patient to kept private.
This act also prohibits health care facilities retaliating against any employee or applicant for employment for actions taken in furtherance of the enforcement of the provisions of this act.
This act creates the "Patient Safety Trust Fund" to be administered by the Department of Health and Senior Services which shall include funds from annual patient safety surcharges on licensing fees charged to medical facilities required to report under this act. Spending from the fund shall be used for regulatory oversight and public accountability for safe health care.
In any case in which the department receives a report from a health care facility indicating an ongoing threat or imminent danger of death or serious bodily harm, the department shall make an onsite inspection or investigation within 48 hours or two business days, whichever is greater, of the receipt of the report and shall complete that investigation within 45 days.
The department may assess the health care facility a civil penalty in an amount not to exceed 100 dollars for each day that the adverse event is not reported following the initial five-day period or twenty-four-hour period, as applicable. If the health care facility disputes a determination by the department regarding alleged failure to report an adverse event, the licensee may, within ten days, request an administrative hearing.
The department shall promote public awareness regarding where and how consumers can file complaints about health care facilities, including a requirement that information about filing complaints be posted in a visible manner on websites, public areas of the health care facilities and all health care facility correspondence and billing documents.