Introduced by Senator Sears of Bennington District and Senator Leddy of Chittenden District
Subject: Health; court procedure; medical errors; Sorry Works program
Statement of purpose: This bill proposes the following provisions related to reporting and notification of medical errors:
(1) Making an expression of regret or apology made by or on behalf of a health care provider inadmissible in any civil or administrative proceeding against the provider;
(2) Requiring health care providers to report medical errors to patients;
(3) Establishing a program called Sorry Works intended to reduce medical malpractice litigation and insurance premiums through reporting of medical errors. Health care providers who choose to participate in this voluntary program would be required to report unexpected patient injuries to the patient, the provider’s patient safety officer, and the program which maintains a confidential database of all such incidents. The program is authorized to award grants to health care providers to offset their costs of participation.
AN ACT RELATING TO REPORTING MEDICAL ERRORS AND ESTABLISHING A SORRY WORKS PROGRAM
It is hereby enacted by the General Assembly of the State of Vermont:
Sec. 1. SHORT TITLE
This act may be referred to as the Vermont Sorry Works and Medical Safety Act.
Sec. 2. 12 V.S.A. § 1912 is added to read:
§ 1912. EXPRESSION OF REGRET OR APOLOGY BY HEALTH
CARE PROVIDER INADMISSIBLE
(a) An expression of regret or apology or an explanation of how a medical error occurred made by or on behalf of a health care provider, including one that is made in writing, orally, or by conduct, that is provided within 14 days of when the provider knew or should have known of the consequences of the error, does not constitute a legal admission of liability for any purpose and shall be inadmissible in any civil or administrative proceeding against the health care provider, including any arbitration or mediation proceeding.
(b) In any civil or administrative proceeding against a health care provider, including any arbitration or mediation proceeding, the health care provider or any other person who makes an expression of regret, apology, or explanation on behalf of the health care provider, including one that is made in writing, orally, or by conduct, that is provided within 14 days of when the provider knew or should have known of the consequences of the potential adverse outcome may not be examined by deposition or otherwise with respect to the expression of regret, apology, or explanation.
(c) As used in this section, “health care provider” means a medical doctor licensed to practice under chapter 23 of Title 26, an osteopathic physician licensed pursuant to subdivision 1750(9) of Title 26, an advance practice registered nurse licensed pursuant to subdivision 1572(4) of Title 26, or a physician’s assistant certified pursuant to section 1733 of Title 26 acting within the scope of the license under which the health care provider is practicing.
Sec. 3. 18 V.S.A. § 9421 is added to read:
§ 9421. REPORTING AND NOTIFICATION
(a) As used in this section:
(1) “Health care facility” shall have the same meaning as in subdivision 9402(7) of this title.
(2) “Health care worker” means an employee, independent contractor, licensee, or other person authorized to provide services in a health care facility.
(3) “Incident” means an event, occurrence, or situation involving the clinical care of a patient in a health care facility which 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.
(4) “Serious event” means an event, occurrence, or situation involving the clinical care of a patient in a health care 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.
(b) A health care worker who reasonably believes that a serious event or incident has occurred shall report the serious event or incident to the worker’s health care 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 24 hours after the occurrence or discovery of a serious event or incident.
(c) 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 18 years of age, the parent or guardian shall be notified in accordance with this subsection. Notification under this subsection shall not constitute an acknowledgment or admission of liability.
(d) A health care worker who reports the occurrence of a serious event or incident in accordance with subsection (a) or (b) of this section shall not be subject to any retaliatory action for reporting the serious event or incident and shall have the protections and remedies of section 508 of Title 21.
(e) 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.
Sec. 4. SORRY WORKS PROGRAM
(a) As used in this section:
(1) “Commissioner” means the commissioner of the department of banking, insurance, securities, and health care administration.
(2) “Health care facility” shall have the same meaning as in subdivision 9402(7) of this title.
(3) “Health care provider” shall have the same meaning as in subdivision 9402(8) of this title.
(4) “Medical error” means an unexpected occurrence involving death or serious physical or psychological injury or the risk of such injury, including any process variation of which recurrence may carry significant chance of a serious adverse outcome.
(5) “Patient safety database” means the database established by the commissioner pursuant to subsection (e) of this section.
(6) “Patient safety event” means an occurrence, incident, or process that either contributes to or has the potential to contribute to a patient injury or degrades the ability of health care providers to provide the appropriate standard of care.
(7) “Patient safety officer” means the person designated by a program participant pursuant to subdivision (c)(1) of this section who is responsible for ensuring that the conditions for participation in the program are met.
(8) “Root cause analysis” means an examination or investigation of an occurrence, event, or incident to determine if a preventable medical error took place or the standard of care was not followed and to identify the causal factors that led to such occurrence, event, or incident.
(b)(1) There is established in the department of banking, insurance, securities, and health care administration a medical error disclosure and compensation program to provide for the confidential disclosure of medical errors in order to improve patient safety and health care quality, reduce rates of preventable medical errors, ensure patient access to fair compensation for medical injury due to medical error, negligence, or malpractice, and reduce the cost of medical liability for doctors, hospitals, health systems, and other health care providers.
(2) The commissioner shall develop applications for the program which incorporate the conditions of program participation described in subsection (c) of this section, review applications and determine eligibility for the program, and oversee the operation of the program consistent with the requirements of this section.
(3)(A) The commissioner shall award grants to further the purposes of this section. In order to be eligible to receive a grant under this subdivision, a program participant shall submit an application to the commissioner, who shall designate the form, time, and manner of the application.
(B) Grants may be awarded under this subdivision to program participants for purposes of:
(i) developing and implementing communication programs to help health care providers disclose medical errors and other patient safety events to patients; and
(ii) procuring information technology products, including hardware, software, and support services, to facilitate the reporting, collection, and analysis of patient safety data required under this section.
(c)(1) Participation in the program established by this section shall be available to the following:
(A) A health care facility.
(B) A health care provider.
(C) A provider, in whole or part, of medical malpractice insurance for doctors and other designated health care providers, including:
(i) mutual insurance companies;
(ii) privately held or publicly traded liability insurance companies;
(iii) self-insured hospitals;
(iv) captive insurance companies or providers covered by captive insurance companies; and
(v) risk-retention groups and any other alternative malpractice insurance mechanisms.
(D) Any other entity determined to be eligible by the commissioner.
(2) A program participant that is a medical liability insurer shall provide all or a subset of its insured an opportunity to participate in the program.
(d) All program participants shall:
(1) Designate a patient safety officer to ensure that the conditions of participation established in this subsection are met.
(2) Submit a comprehensive plan, as part of the application for participation in the program, to reduce the incidence of medical errors and improve patient safety.
(3) Allocate an amount equal to not less than 50 percent of the projected annual savings for the first year of participation in the program, not less than 40 percent of the actual savings reported for the second year, and not less than 30 percent of the actual savings reported for the third and each subsequent year of participation to:
(A) in the case of a program participant that is a medical liability insurer, the reduction of medical liability premiums for doctors or other designated health care providers; and
(B) in the case of a program participant that is a health care facility or provider, activities that result in the reduction of medical errors or that otherwise improve patient safety.
(4) Require health care facilities or providers included in the program to submit to the patient safety officer a report of:
(A) any incident or occurrence involving a patient that is thought to either be a medical error or patient safety event; and
(B) any legal action related to the medical liability of a health care facility or provider.
(5) Ensure that reports filed under subdivision (4) of this subsection are submitted to the database in a standardized format as designated by the commissioner.
(6) Ensure that a root cause analysis of any report submitted to the patient safety officer pursuant to subdivision (4) of this subsection is performed within 90 days after the report is submitted.
(7) If a patient was harmed or injured as the result of a medical error or as a result of the relevant standard of care not being followed, ensure that the report of the incident or occurrence prepared pursuant to subdivision (4)(A) of this subsection is disclosed to the patient not later than five business days after the completion of the root cause analysis under subdivision (6) of this subsection.
(8) Disclose information contained in any report submitted to the patient safety officer pursuant to subdivision (4) of this subsection upon request from the patient who was the subject of the report.
(9) At the time of disclosure to a patient pursuant to subdivision (7) of this subsection, offer to:
(A) negotiate compensation with the patient involved in accordance with subsection (e) of this section;
(B) provide, at the discretion of the health care facility or provider involved, an apology or expression of regret; and
(C) share, where practicable, any efforts the health care facility or provider will undertake to prevent reoccurrence.
(10) Prepare and submit entries to the database as required by the commissioner in accordance with subsection (e) of this section.
(e) If a patient elects to negotiate compensation with a program participant pursuant to subdivision (d)(9) of this section, the following rules shall apply:
(1) The negotiation proceedings shall be confidential.
(2) Any apology or expression of regret by a doctor or other designated health care facility or provider shall be kept confidential and shall be inadmissible as provided in section 1912 of Title 12.
(3) The program participant shall provide to the patient written notification of the patient’s right to legal counsel. The notification shall include an affirmative declaration that no action was taken to dissuade a patient from using counsel for the negotiations.
(4) Both parties may agree to the use of a neutral third party mediator to facilitate the negotiation.
(5) The parties shall agree that if an agreement on the terms of compensation is not reached within six months from the date of the disclosure required to the patient under subdivision (d)(7) of this section:
(A) the patient may proceed directly to the judicial system for a resolution of the issues involved; or
(B) the parties may sign an extension of the agreement to provide an additional three-month negotiation period.
(6) Upon reaching an agreement under this subsection, the program participant shall provide the negotiated compensation, if any, to the patient within an agreed‑upon time.
(7) Upon receipt of the final payment of the accepted settlement as negotiated under this subsection, the patient shall agree to the final settlement of the incident described in the report and findings of the root cause analysis under subdivision (d)(7) of this section, and further litigation with respect to the matter in federal or state court shall be prohibited.
(f)(1) The commissioner shall establish a patient safety database. The database shall:
(A) adopt standardized patient safety taxonomy in consultation with the joint commission on accreditation of the healthcare organizations and other entities with relevant expertise;
(B) include necessary elements, common and consistent definitions, and a standardized electronic interface for the entry and processing of data by program participants, as developed by the commissioner in consultation with patient safety organizations, health care providers, and the health information technology industry; and
(C) allow for the comprehensive collection and analysis of the patient safety data required to be submitted by program participants under subdivision (5) of this subsection.
(2) All information submitted to the database shall be privileged and confidential, and shall be protected from disclosure in accordance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. Inclusion of information in the database shall not be construed to limit access to information that is otherwise discoverable.
(3) Access to the patient safety data contained within the database shall only be provided through application to and approval by the commissioner.
(4) All entries into the database shall:
(A) be presented in a form and manner which deletes, omits, or renders illegible any information identifying the health care provider, patient, or program participant;
(B) be in a standardized electronic format to be determined by the commissioner; and
(C) if related to a single occurrence or incident, be given a common identifier to link entries of related data.
(5) Subject to the requirements of subdivision (4) of this subsection, the patient safety officer of a program participant shall be required to prepare and enter into the database:
(A) reports filed by a health care facility or provider under subdivision (c)(4) of this section;
(B) a summary of the findings of the root cause analysis filed by a health care facility or provider pursuant to subdivision (c)(6) of this section, entered within five business days of its completion;
(C) the terms of any agreement reached through negotiations pursuant to subsection (d) of this section;
(D) any awards given by a program participant to a patient as compensation for harm or injury, whether provided through negotiations under subsection (d) of this section or through other means;
(E) any disciplinary actions taken against a health care facility or provider as a result of involvement in any incident or occurrence involving a patient that is thought to be a medical error or patient safety event; and
(F) any other data determined appropriate by the patient safety officer or the commissioner.
Sec. 5. APPROPRIATION
The amount of $75,000.00 is appropriated from the general fund to the department of banking, insurance, securities, and health care administration to implement the sorry works program established by Sec. 4 of this act and to award the grants authorized by subdivision (a)(3) of Sec. 4.
The Vermont General Assembly
115 State Street