An Act To Amend Sentinel Events Reporting Laws To Reduce Medical Errors and Improve Patient Safety
Sec. 1. 22 MRSA §8752, as enacted by PL 2001, c. 678, §1 and affected by §3 and corrected by RR 2001, c. 2, Pt. A, §37 and affected by §38 and amended by PL 2007, c. 324, §17, is further amended to read:
§ 8752. Definitions
As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.
(1) An unanticipated death; or
(2) A major permanent loss of function that is not present when the patient is admitted to the health care facility;
(1) Surgery performed on a wrong body part;
(2) Surgery performed on a wrong patient;
(3) Wrong surgical procedure performed on a patient;
(4) Unintended retention of a foreign object in a patient after surgery or other procedure;
(5) Intraoperative or immediately postoperative death in a patient who was categorized as a normal, healthy patient;
(6) Patient death or serious disability associated with the use of contaminated drugs, devices or biologics provided by the health care facility;
(7) Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended;
(8) Patient death or serious disability associated with intravascular air embolism that occurs while the patient is being cared for in a health care facility;
(9) Infant discharged to the wrong person;
(10) Patient death or serious disability associated with patient leaving the facility without permission;
(11) Patient suicide or attempted suicide resulting in serious disability while the patient is being cared for in a health care facility;
(12) Patient death or serious disability associated with a medication error;
(13) Patient death or serious disability associated with a hemolytic reaction due to the administration of incompatible blood or blood products;
(14) Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while the patient is being cared for in a health care facility;
(15) Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility;
(16) Death or serious disability associated with failure to identify and treat hyperbilirubinemia in a newborn while the patient is being cared for in a health care facility;
(17) Stage 3 or 4 pressure ulcers acquired after admission to a health care facility;
(18) Patient death or serious disability due to spinal manipulative therapy;
(19) Artificial insemination or fertilization with the wrong donor sperm or wrong egg;
(20) Patient death or serious disability associated with an electric shock while the patient is being cared for in a health care facility;
(21) An incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances;
(22) Patient death or serious disability associated with a burn from any source that occurred while the patient is being cared for in a health care facility;
(23) Patient death or serious disability associated with a fall that occurred while the patient is being cared for in a health care facility;
(24) Patient death or serious disability associated with the use of restraints or bedrails while the patient is being cared for in a health care facility;
(25) Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist or other licensed health care provider;
(26) Abduction of a patient of any age;
(27) Sexual assault on a patient within or on the grounds of a health care facility; and
(28) Death or significant injury of a patient resulting from a physical assault that occurs within or on the grounds of a health care facility.
Sec. 2. 22 MRSA §8753, as enacted by PL 2001, c. 678, §1 and affected by §3, is amended to read:
§ 8753. Mandatory reporting of sentinel events
A health care facility shall report to the division a sentinel event that occurs to a patient while the patient is in the health care facility as provided in this section whenever it has reason to believe that a suspected sentinel event or a sentinel event has occurred, as provided in this chapter.
(1) A thorough root cause analysis must include a determination of the human and other factors most directly associated with the sentinel event and the processes and systems related to its occurrence; an analysis of the underlying systems and processes to determine where redesign might reduce risk; an inquiry into all areas appropriate to the specific type of event; an identification of risk points and their potential contributions to the event; a determination of potential improvement in processes or systems that would tend to decrease the likelihood of such an event in the future, or a determination, after analysis, that no such improvement opportunities exist; and an action plan that identifies changes that can be implemented, who is responsible for implementation, when the action will be implemented and how the effectiveness of the action will be evaluated.
(2) A credible root cause analysis must include participation by the leadership of the health care facility and by the individuals most closely involved in the processes and systems under review, is internally consistent without contradictions or unanswered questions, provides an explanation for all findings of "not applicable" or "no problem" and includes consideration of any relevant literature.
Sec. 3. 22 MRSA §8753-A is enacted to read:
§ 8753-A. Standardized procedure
A health care facility shall follow a standardized procedure for the identification, notification and reporting requirements under this chapter. The division shall develop the standardized procedure by adoption of routine technical rules under Title 5, chapter 375, subchapter 2-A.
Sec. 4. 22 MRSA §8753-B is enacted to read:
§ 8753-B. Expression of regret
An individual expression of regret or apology to the patient or family or other individual regarding an adverse event that is provided within 14 days after the event is discovered does not constitute a legal admission of liability and is inadmissible in a civil or administrative proceeding, including an arbitration or mediation proceeding. An individual expression of regret or apology may not be examined in any deposition or civil or administrative proceeding.
Sec. 5. 22 MRSA §8754, sub-§1, as enacted by PL 2001, c. 678, §1 and affected by §3, is amended to read:
Sec. 6. 22 MRSA §8754, sub-§1-A is enacted to read:
Sec. 7. 22 MRSA §8754, sub-§3, as enacted by PL 2001, c. 678, §1 and affected by §3, is amended to read:
(1) Subject to public access under Title 1, chapter 13, except for data developed from the reports that do not identify or permit identification of the health care facility;
(2) Subject to discovery, subpoena or other means of legal compulsion for its release to any person or entity; or
(3) Admissible as evidence in any civil, criminal, judicial or administrative proceeding.
(1) Any final administrative action;
(2) Information independently received pursuant to a 3rd-party complaint investigation conducted pursuant to department rules; or
(3) Information designated as confidential under rules and laws of this State.
This subsection does not affect the obligations of the department relating to federal law.
Sec. 8. 22 MRSA §8755, as enacted by PL 2001, c. 678, §1 and affected by §3, is repealed and the following enacted in its place:
§ 8755. Compliance
summary
This bill defines additional terms in the law dealing with sentinel event reporting, including "health care facility acquired infection," "immediate jeopardy," "near miss" and "root cause analysis." This bill also amends the definition of "sentinel event." It also adds a list of serious reportable events derived from a publication of the National Quality Forum.
This bill requires health care facilities to report suspected sentinel events as well as sentinel events.
This bill also requires hospitals to follow a standardized procedure for the identification, notification and reporting requirements.
This bill allows health care facilities to voluntarily notify the Department of Health and Human Services, Division of Licensing and Regulatory Services of the occurrence of a near miss.
This bill gives immunity to a person who in good faith reports a suspected sentinel event or a sentinel event, or expresses regret or an apology to the patient or the patient's family.
This bill increases the civil penalty to no more than $25,000, instead of $5,000, authorizes the division to collect the civil penalty without going to court and gives the health care facility the right to request an administrative hearing to contest the imposition of a penalty.
This bill provides injunctive relief to require compliance with the sentinel events reporting law.