Requires the reporting of serious medical errors to the department of health and the medical facilities' patient safety committee. Requires open disclosure of serious medical errors to patients and their families. Requires medical facilities to develop a mediation model for handling serious medical errors.

A BILL FOR AN ACT

SECTION 1. The legislature finds that patient safety reforms are needed to ensure that adverse medical events and errors are reported, tracked, and analyzed. These reforms enable physicians and hospitals to identify system weaknesses and learn from their mistakes before more consequential events occur. These reforms encourage open, frank communications between patients and physicians, apologies, and quick resolution of claims through mediation to avoid bitter and protracted lawsuits.

The purpose of this Act is to require:

SECTION 2. Chapter 321, Hawaii Revised Statutes, is amended by adding a new part to be appropriately designated and to read as follows:

"Part   . PATIENT SAFETY

§321-A Scope. This part relates to the reduction of medical errors for the purpose of ensuring patient safety.

§321-B Definitions. The following words and phrases when used in this part shall have the meanings given to them in this section unless the context clearly indicates otherwise:

"Department" means the department of health.

"Health care worker" means an employee, independent contractor, licensee, or other individual authorized to provide services in a medical facility.

"Incident" means an event, occurrence, or situation involving the clinical care of a patient in a medical facility that could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The term does not include a serious event.

"Infrastructure" means structures related to the physical plant and service delivery systems necessary for the provision of health care services in a medical facility.

"Infrastructure failure" means an undesirable or unintended event, occurrence, or situation involving the infrastructure of a medical facility or the discontinuation or significant disruption of a service that could seriously compromise patient safety.

"Licensee" means an individual who is all of the following:

"Medical facility" means a health care facility that has been issued a certificate of need under chapter 323D.

"Patient safety officer" means an individual designated by a medical facility under section 321-F.

"Serious event" means an event, occurrence, or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident.

§321-C Department responsibilities. The department shall:

§321-D Patient safety plans. (a) Each medical facility shall develop, implement, and comply with an internal patient safety plan that shall be established for the purpose of improving the health and safety of patients. The plan shall be developed in consultation with the licensees providing health care services in the medical facility.

(b) A patient safety plan shall:

(c) Within sixty days from the effective date of this section, a medical facility shall submit its patient safety plan to the department for approval consistent with the requirements of this section. Unless the department approves or rejects the plan within sixty days of receipt, the plan shall be deemed approved.

(d) Upon approval of the patient safety plan, a medical facility shall notify all health care workers of the medical facility of the patient safety plan. Compliance with the patient safety plan shall be required as a condition of employment or credentialing at the medical facility.

§321-E Reporting and notification. (a) A health care worker who reasonably believes that a serious event or incident has occurred shall report the serious event or incident according to the patient safety plan of the medical facility, unless the health care worker knows that a report has already been made. The report shall be made immediately or as soon thereafter as reasonably practicable, but in no event later than twenty-four hours after the occurrence or discovery of a serious event or incident.

(b) A medical facility through an appropriate designee shall provide written notification to a patient affected by a serious event or, with the consent of the patient, to an available family member or designee, within seven days of the occurrence or discovery of a serious event. If the patient is unable to give consent, the notification shall be given to an adult member of the immediate family. If an adult member of the immediate family cannot be identified or located, notification shall be given to the closest adult family member. For unemancipated patients who are under eighteen years of age, the parent or guardian shall be notified in accordance with this subsection. The notification requirements of this subsection shall not be subject to section 321-H(a). Notification under this subsection shall not constitute an acknowledgment or admission of liability.

(c) A health care worker who reports the occurrence of a serious event or incident in accordance with subsection (a) or (b) shall not be subject to any retaliatory action for reporting the serious event or incident and shall have the protections and remedies set forth in section 378-62.

(d) Nothing in this section shall limit a medical facility's ability to take appropriate disciplinary action against a health care worker for failure to meet defined performance expectations or to take corrective action against a licensee for unprofessional conduct, including making false reports or failure to report serious events under this chapter.

§321-F Patient safety officer. A patient safety officer of a medical facility shall do all of the following:

§321-G Patient safety committee. (a) A hospital's patient safety committee shall be composed of the medical facility's patient safety officer, at least three health care workers of the medical facility, and two residents of the community served by the medical facility who are not agents, employees, or contractors of the medical facility. No more than one member of the patient safety committee shall be a member of the medical facility's board of trustees. The committee shall include members of the medical facility's medical and nursing staff. The committee shall meet at least monthly.

(b) A patient safety committee of a medical facility shall do all of the following:

§321-H Confidentiality and compliance. (a) Any documents, materials, or information solely prepared or created for the purpose of compliance with section 321-G(b) or of reporting under section 321-C, 321-D(b)(3), 321-E(a), 321-F(4), 321-G(b)(5), or 321-I that arise out of matters reviewed by either the patient safety committee or the governing board of a medical facility pursuant to section 321-G(b) are confidential and shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding. Any documents, materials, records, or information that would otherwise be available from original sources shall not be construed as immune from discovery or use in any civil or administrative action or proceeding merely because they were presented to the patient safety committee or governing board of a medical facility.

(b) No person who performs responsibilities for or participates in meetings of the patient safety committee or governing board of a medical facility pursuant to section 321-G(b) shall be allowed to testify as to any matters within the knowledge gained by the person's responsibilities or participation on the patient safety committee or governing board of a medical facility; provided that the person shall be allowed to testify as to any matters within the person's knowledge that was gained outside of the persons' responsibilities or participation on the patient safety committee or governing board of a medical facility pursuant to section 321-G(b).

(c) The confidentiality protections set forth in subsections (a) and (b) shall only apply to the documents, materials, or information prepared or created pursuant to the responsibilities of the patient safety committee or governing board of a medical facility set forth in section 321-G(b).

(d) Except as set forth in subsection (f), any documents, materials, or information received by the department from the medical facility, health care worker, patient safety committee, or governing board of a medical facility solely prepared or created for the purpose of compliance with section 321-G(b) or of reporting under section 321-C, 321-D(b)(3), 321-E(a), 321-F(4), 321-G(b)(5) or 321-I shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding. Any records received by the department from the medical facility, health care worker, patient safety committee, or governing board of a medical facility pursuant to the requirements of this part shall not be discoverable from the department in any civil or administrative action or proceeding. Documents, materials, records, or information may be used by the department to comply with the reporting requirements under subsection (f).

(e) No current or former employee of the department shall be allowed to testify as to any matters gained by reason of the employee's review of documents, materials, records, or information submitted to the department by the medical facility or health care worker pursuant to the requirements of this part; provided that the prohibition to testify does not apply to findings or actions by the department that are public records.

(f) The department shall have access to the information under section 321-I(a) or (c) and may use that information for the sole purpose of any licensure or corrective action against a medical facility; provided that this exemption shall not be used to permit the disclosure of any information obtained under section 321-I(a) or (c) for any other purpose. The board of medical examiners shall have access to the information under section 321-I(a) and may use that information for the sole purpose of any licensure or disciplinary action against a health care worker; provided that this exemption shall not be used to permit the disclosure of any information obtained under section 321-I(a) for any other purpose.

(g) In the event an original source document as set forth in subsection (a) is determined by a court of competent jurisdiction to be unavailable from the health care worker or medical facility in a civil action or proceeding, then, in that circumstance alone, the department may be required pursuant to a court order to release that original source document to the party identified in the court order.

(h) Any documents, materials, or information made confidential by subsection (a) shall not be subject to requests under chapter 92F.

(i) Notwithstanding any other provision of law, no person providing information or services to the patient safety committee, governing board of a medical facility, or department shall be held, by reason of having provided that information or services, to have violated any criminal law or to be civilly liable under any law, unless the information is false and the person providing the information knew, or had reason to believe, that the information was false and was motivated by malice toward any person directly affected by that action.

§321-I Medical facility reports and notifications. (a) A medical facility shall report the occurrence of a serious event to the department within twenty-four hours of the medical facility's confirmation of the occurrence of the serious event. The report to the department shall be in the form and manner prescribed by the department and shall not include the name of any patient or any other identifiable individual information.

(b) A medical facility shall report the occurrence of an incident to the department in a form and manner prescribed by the department and shall not include the name of any patient or any other identifiable individual information.

(c) A medical facility shall report the occurrence of an infrastructure failure to the department within twenty-four hours of the medical facility's confirmation of the occurrence or discovery of the infrastructure failure. The report to the department shall be in the form and manner prescribed by the department.

(d) If a medical facility discovers that a licensee providing health care services in the medical facility during a serious event failed to report the event in accordance with section 321-E(a), the medical facility shall notify the licensee's licensing board of the failure to report.

(e) The department may impose an administrative penalty of $1,000 per day for failure to:

(4) Notify a licensure board in accordance with this part.

§321-J Mediation. (a) Each medical facility shall develop and implement a mediation model that:

(b) Mediation statements or settlement offers tendered shall not be admitted into any subsequent proceedings involving the case, including a contested case hearing or a court proceeding.

(c) Mediation sessions shall not constitute a meeting for purposes of chapter 92. Mediator notes under this section shall be exempt from section 92-21 and chapter 92F. Section 91-10 shall not apply to mediation proceedings."

SECTION 3. This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun, before its effective date.

SECTION 4. This Act shall take effect upon its approval.