An Act To. Amend Sentinel Events Reporting Laws To Reduce Medical Errors and Improve Patient Safety
Maine Legislature, Session 124, LD 1435
Committee: Health and Human Services
Sponsors: BOWMAN, BARTLETT, PINGREE, PRIEST
Amends: 22 MRSA §8753, 22 MRSA §8754

MAINE STATE LEGISLATURE 
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124th MAl E LEGISLATURE 
Legislative Document 
No. 1435 
S.P.519-
In Senate, April 7, 2009 
An Act To. Amend Sentinel Events Reporting Laws To Reduce 
Medical Errors and Improve Patient Safety 
Reference to the Committee on Health and Human Services suggested and ordered printed. 
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Presented by Senator BOWMAN of York. (GOVERNOR'S BILL) 
JOY J. O'BRIEN 
Secretary of the Senate 
Cosponsored by Senator: BARTLETT of Cumberland, Representatives: Speaker PINGREE of 
North Haven, PRIEST of Brunswick. 
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l'rintl!J UI1 fl!cydl.!J paper 
Be it enacted by the People of the State, of Maine as follows: 
Sec. 1. 22 MRS A §8752, as enacted by PL 200 I, c. 678, § I and affected by §3 
and corrected byRR 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 
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As used in this chapter, unless the context otherwise indicates, the following terms 
have the following meanings. 
1. 
Division. 
"Division" means the Department of Health and Human Services, 
Division of Licensing and Regulatory Services ,'lithin the Bureau of Medical Services. 
2. Health care f~cility. "Health care facility" or "facility" means a state institution 
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as defined under Title 34-B, chapter 1 or a health care facility licensed by the division, 
except that it does not include a facility licensed as a nursing faciiity or licensed under 
chapter +66§. 1664. "Health care facility" includes an ambulatory surgical facility, an 
' end-stage renal disease facility, and an intermediate care facHity fOf persons with mental 
retardation or developmental disabilities. 
20. 
2-A: 
Health care facilitv acquired infection. ,"Health' care facility acquired 
infection" means an infection aCquired' in a health care facility by a patient who was 
admitted for a reason other than that infection and there is no documentation of infectiori 
present at the time of admission. 
2-B. Immediate jeopardy. "Immediate jeopardy" means a situation in which the 
provider's noncompliance with one or more requirements ofpal1icipation in the federal 
Medicare program has caused, or is Iikely'to cause, serious injury, harm or impairment to 
or death of a resident. 
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3. Major permanent loss of function. "Major permanent loss of ftinction" means 
sensory, motor, physiologicitl or intellectual impairment that requires continued treatment 
or imposes persistent major restrictions in activities of daily living was not present at the 
. time of admission and requires continued treatment or lifestyle change. 
3-A. Near miss. A "near miss;' is an event or situation that did not produce patient 
injury, but only because of chance, which may include, but is not limited to, robustness of 
the patient or a fortuitous, timely intervention. 
3-B. 
Root cause analysis. 
"Root cause analysis'" is a structured process for 
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identifYing the causal or contributing factors underlying adverse events. The root cause 
analysis follows a predefined protocol for identifYing these specific factors in causal 
categories. 
4. Sentinel event. "Sentinel event" means: 
"A. 
One of the follov,ring that is determined to be unrelated to the natural course of 
the patient's illness or underlying condition or proper treatment of that illness' or 
underlvine: condition or that results from the elonement of a hosnitalized innatient 
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v .. ho lacks the capacity, as defined in Title 1 ~ A, section 5 80 I, subsection (c), to 
make decisions: 
(1) An unanticipated death; or 
(2) A major permanentloss of function that is not present when the patient is 
admitted to the health care facility; 
B. 
Surgery on the >""rang patient or >""rong body part; 
C. 
Hemolytic transfusion reaction involving administration of blood or blood 
products having major blood group incompatibilities; 
D. 
Suicide of a patient in a health care facility vt'here the patient receives inpatient 
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E. 
Infant abduction or discharge to the wrong family; or 
F. 
Rape ofa patient. 
4-A. Sentinel event. "Sentinel event" means an unexpected occurrence involving 
death or a serious physical or psychological injury or a serious reportable event as set out 
in paragraph E. "Sentinel event" includes the following: 
A. An unanticipated death unrelated to the natural course of the patient's illness or 
underlying condition or proper treatment of that illness or underlying condition in a 
health care facility: 
B. A major permanent loss of function. A major permanent loss of function that 
cannot be determined immediately becomes a reportable sentinel event upon the 
discharge of the patient when the patient has a continued loss of function or upon the 
elapsing of 2 weeks with. the patient having a persistent major loss of function, 
whichever occurs first; 
C. Health care facility acquired infections reSUlting in death; 
D. 
Any perinatal death or permanent loss of function unrelated to a congenital 
condition in an infant with a birth weight over 2,500 grams; and 
E. Serious reportable events including: 
(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 surgelY or other 
procedure; 
(5) 
Intraoperative or immediately postoperative death in a patient who was 
categorized as a normal. healthy patient: 
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(6) Patient death or serious disability associated with the use of contaminated 
drugs. devices or biologics provided by the health care facility; 
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(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 "II'ong person; 
(10) Patient death or serious disability associated with patient leaving the facility 
without permission; 
(II) Patient suicide or attempted suicide resulting in serious disability while the 
patient is being cared for in ahealth 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 deliveIY 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 forin 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 feliilization with the wrong donor sperm or wrong 
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(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; 
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(25) Any instance of care ordered by or provided by someone impersonating a 
physician, nurse, pharmacist or other licensed health care provider; 
(26) Abduction ofa patient of any age; 
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(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 '""hile the patient is in the health care facility as provided in this section whenever 
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it has reason to believe that a suspected sentinel event or a sentinel event has occurred, as 
provided in this chapter. 
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1. Notification. A health care facility shall notify the division of the occurrence of!! 
suspected sentinel event or a sentinel event by the next business day after the sentinel 
event has occurred or the next business day after the facility determines discovers that the 
event occurred. If the patient requires transfer from one health care facility to another. 
health care facility, both the sending and receiving facilities shall notify the division of a 
suspected sentinel event or a sentinel event by the next business day after the event has 
occurred or the next business day after the facility discovers that the event occurred. The 
notification must include the date and time of notification, the name of the health care 
facility and the type of sentinel event pursuant to section 8752, subsection 4 4-A. 
2. Reporting. A The health care facility where the sentinel event occurred shall file 
a written report no later than 45 days following the notification of the occurrence of a 
suspected sentinel event or a sentinel event pursuant to subsection 1. The written report 
must be signed by the chief executive officer of the facility and must contain the 
following information: 
A. 
Facility name and address; 
B. 
Name, title and phone number of the contact person for the facility; 
C. 
The date and time of the sentinel event; 
D. 
The type of sentinel event and a brief description of the sentinel event; and 
E. 
Identification of clinical and organizational systems or processes that may have 
contributed to the sentinel event; 
F. 
Identification of changes that could be made that ',,,,ould reduce the risk of such a 
sentinel event occurring in the future; and 
G. 
A brief description of any corrective action taken or planned. 
H. A thorough and credible root cause analysis. A root cause analysis is thorough 
and credible only in accordance with subparagraphs (n and (2). . 
(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 
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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 actiOli '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. 
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3. Cooperation. A health care facility that has filed a notification or a repOli of the 
OCCUlTence of a sentinel event under 'this section shall cooperate with the division as 
necessary for the division to fulfill its duties under section 8754. 
4. Immunity. A person who in good faith reports a suspected sentinel event or a 
sentinel event, provides a root cause analysis or expresses regret or an apology to the 
patient, or family or other individual pursuant to this chapter is immune from any civil or 
criminaJ liability for the act of reporting or participating in the review by the division. 
"Good faith" does not include instances when a false repOli is made and the person 
reporting knows the report is false. This subsection may not be construed to bar civil or 
criminal action regarding perjury or regarding the sentinel event that led to the report. 
5. Near miss notification. A health care facility may notify the division of the 
occurrence of a near miss. Should a facility report a near miss, the notification must 
include the date and time of notification, the name of the health care facility and the type 
of event or situation pursuant to section 8752, subsection 4-A that is related to the near 
miss. 
Sec. 3. 22 MRS A §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 MRS A §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 
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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-§lj as enacted by PL 2001, c. 678, § 1 and affected 
by §3, is amended to read: 
1. 
Initial review; other action. 
Upon receipt of a notification or report of a 
suspected sentinel event ,or a sentinel event, the division shall complete an initial review 
and may take such other action as the division determines to be appropriate under 
applicable rules and within the jurisdiction of the division. The division may conduct on-
site reviews of medical records and may retain the services of consultants when necessary 
to the division. 
A. 
The division may conduct on-site visits to health care facilities to determine 
compliance with this chapter. 
B. Division personnel responsible for sentinel event oversight shall report potential 
immediate jeopardy to the licensing section of the division. 
Sec. 6. 22 MRSA §8754,sub-§1-A is enacted to read: 
I-A. Determination. The division is responsible for determining the repmiabillty of 
sentinel events. 
Se,c. 7. 22 MRS A §8754, sub-§3, as enacted by PL 2001, c. 678, § 1 and affected 
, by §3, is amended to read: 
3. Confidentiality. Notifications and repmis €if sentinel events filed pursuant to this 
chapter and all information collected or developed as a result of the filing and 
proceedings peliaining to the filing, regardless of format, are confidential and privileged 
information. 
. 
A. Privileged and confidential information under this subsection is not: 
(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' 
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(3) 
Admissible as evidence in any civil, criminal, judicial or administrative 
proceeding. 
B. The transfer of any information to which this chapter applies by a health care 
facility to the division or to a national organization that accredits health care facilities 
may not be treated as a waiver of any privilege or protection established under this 
chapter or other laws of this State. 
C. 
The division shall take appropriate measures to protect the security of any 
information to which this chapter applies. 
D. This section may not be construed to limit other privileges that are available 
under federal law or other laws of this S'tate that provide for greater peer review or 
confidentiality protections than the peer review and confidentiality protections 
provided for in this subsection. 
E. For the purposes of this subsection, "privileged and confidential information" does 
not include: 
(1) Any final adm in istrative' action; 
(2) 
Information independently received pursuant to a 3 rd-party complaint 
investigation conducted pursuant to department rules; or 
(3) Information designated as confidential under rules and laws of this State. 
F. Records preceding a final admi.nistrative action are privileged and confidential 
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under this chapter. 
This subsection does not affect the obligations of the department relating to federal law. 
Sec. 8. 22 MRS A §8755, as enacted by PL 2001, c. 678, § 1 and affected by §3, is 
repealed and the following enacted in its place: 
§8755. Compliance 
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1. Civil penalty. When the division makes a determination that a health care facility 
violated any provision of this chapter or rules adopted pursuant to this chapter, the health 
care facility is subject to a civil penalty payable to the State of not more than $25,000 per 
unreported sentinel event. Funds collected pursuant to this section must be deposited in a 
dedicated' special revenue account to be used to support sentinel event reporting and 
education. 
2. Appeal. To appeal the imposition of a penalty under this section, a health care 
facility must submit to the division a written request for an administrative hearing within 
days of notice of imposition of a penalty pursuant to this section. 
3. Injunction. Notwithstanding any other remedies provided by law, the Office of 
the Attorney General may seek an injunction to require compliance with the provisions of 
this chapter. 
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4. Enforcement. The Office of the AttorneyGeneral may file a complaint with the 
District Court seeking injunctive relief for violations of this chapter. 
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. 
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This bill requires health care facilities to repOli suspected sentinel events as well as 
sentinel events. 
This bill also requires hospitals to follow a standardized procedure for the 
identification, notification and repOliing requirements. 
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This bill allows health care facilities to voluntarilynotify the Depaliment 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. 
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