4.__Sentinel event.__"Sentinel event" means:

A.__A serious injury that is not related to the natural course of the illness or underlying condition of a patient and that results in death or major permanent loss of function or requires that the patient undergo significant additional diagnostic or treatment measures;

B.__A serious incident that adversely affects the health of a patient, such as surgery on the wrong patient or wrong body part, a poisoning within the facility, equipment malfunction or user error, medication error, hemolytic transfusion reaction involving administration of blood or blood products that have blood group incompatibilities or other incident that results in serious injury not anticipated in the normal course of events;

C.__An incident in which the patient is harmed or the patient's safety is placed in jeopardy by a serious criminal act or an administrative error, such as the release of an infant to the wrong family;

D.__Abuse that results in serious physical or mental harm;

E.__An accident such as a fall, burn, electrocution or other similar event occurring within the facility that is not related to patient treatment and that results in serious head injury, coma or permanent injury or that requires significant additional therapeutic intervention or hospitalization; or

F.__Suicide of a patient in a setting where the patient receives in-patient care.

§373.__Duties of center

Utilizing the sentinel event reports submitted through the process described in section 374 and other available data, the center shall:

1.__Assist health care facilities and health care practitioners.__Provide direct assistance to health care facilities and practitioners to improve the quality of care to patients and implement the requirements of this chapter;

2.__Research.__Conduct research to:

A.__Develop a more complete understanding of the types and causes of medical errors in a variety of settings, levels of care and patient populations;

B.__Clarify the impact of systems and professional and organizational cultures on reducing medical errors and improving patient safety; and

C.__Evaluate the efficacy of automated information and diagnostic systems in improving clinical decision making, reducing errors and advancing patient safety;

3.__Education.__Create a clearinghouse for the most recent information and data relative to patient safety.__The information must be accessible to health care facilities and the public in summary form.__The center also shall conduct forums and seminars for the purpose of disseminating information pertaining to patient safety.__The forums must be conducted jointly with health care facilities; and

4.__Reports.__Develop an annual report to the Legislature, health care facilities and the public that includes summary data of the number and type of sentinel events of the prior calendar year by type of health care facility, rates of change and other analyses and an outline of areas to be addressed for the upcoming year.

§374.__Mandatory reporting of sentinel events

The department shall adopt rules pursuant to section 376 establishing a mandatory reporting system for sentinel events.__ The reporting system must be designed to collect information, allow for data analysis and protect patient confidentiality.

1.__Reporting requirements.__A health care facility shall report a sentinel event that occurs to a patient while the patient is in the care or custody of the health care facility to the facility's licensing authority or entity and as provided in subsection 2.

2.__Reporting.__A health care facility shall file a written report under subsection 1 within one week of the occurrence of the sentinel event.__The written report must contain the following information:

A.__The name of the facility, including the names and titles of the person in charge of the facility at the time of the sentinel event and the health care practitioner or other person who may have caused the sentinel event to occur;

B.__The name, title and phone number of the reporting individual;

C.__The date and time of the sentinel event;

D.__Patient information, including name, age, sex, ambulatory status and, where applicable, activities of daily living status and cognitive level;

E.__The type of sentinel event and a brief description of the sentinel event;

F.__The nature of the harm to the patient;

G.__The activity of the patient at the time of the incident and the location where the incident occurred;

H.__Any safety precautions taken prior to the sentinel event and any equipment or safety devices in use during or prior to the sentinel event;

I.__A brief description of corrective action taken;

J.__The name and title of any witness to the sentinel event; and

K.__The date and type of notification provided to the patient and the patient's family, legal guardian or next of kin.

§375.__Investigation of sentinel events; quality improvement

Upon receipt of a report of a sentinel event, the__center may complete an investigation and undertake quality improvement planning as provided in this section.

1.__Investigation.__The center shall investigate the sentinel event to determine the cause of the sentinel event.__When the investigation is complete, the center shall issue a sentinel event report for release to the health care facility and the public.__The report must protect patient confidentiality.

2.__Quality improvement.__The center shall work with the health care facility to ensure that the facility establishes and implements a quality improvement plan to address the cause of the sentinel event when such a plan is appropriate.__The plan must be time-limited, must address the problem or problems that resulted in the sentinel event and must reduce the risk of a similar event happening in the future.

§376.__Rulemaking

The department, the Department of Mental Health, Mental Retardation and Substance Abuse Services, the Board of Licensure in Medicine, the State Board of Nursing and the Maine Board of Pharmacy shall adopt rules to implement this chapter.__Rules adopted pursuant to this section must require the appropriate state agency or board to provide a copy of the appropriate state agency or board's report on a sentinel event to the center.__ Rules adopted pursuant to this chapter are routine technical rules as defined in Title 5, chapter 375, subchapter II-A.

SUMMARY

This bill establishes the Maine Health Care Quality Improvement Center to improve the quality of health care provided to patients, increase patient safety and reduce medical errors. The bill creates a mandatory reporting system for medical errors and events and incidents injurious to patients that involve health care facilities designating these events and incidents "sentinel events."