An Act To Amend Sentinel Events Reporting Laws To Reduce Medical Errors and Improve Patient Safety
Maine Legislature, Session 124, LD 1435
Committee Amendment CA_A_S248 (Senate)
Amends: 22 MRSA §8752, 22 MRSA §8753, 22 MRSA §8753-A, 22 MRSA §8754, 22 MRSA §8755

COMMITTEE AMENDMENT " A" to S.P. 519, L.D. 1435, Bill, "An Act To 
Amend Sentinel Events Reporting Laws To Reduce Medical Errors and Improve Patient 
Safety" 
Amend the bill by striking out everything after the enacting clause and before the 
summary and inserting the following: 
'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. 
Division. 
"Division" means the Department of Health and Human Services, 
Division of Licensing and Regulatory Services within the Bureau of Medical Services. 
'2. Health care facility. "Health care facility" or "facility" means a state institution 
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 facility or licensed under 
ch.apter ~ 
1664. "Health care facility" includes a general and specialty hospital, an 
ambulatory surgical facility, an end-stage renal disease facility and an intermediate care 
'facility for persons with mental retardation or developmental disabilities. 
2-A. Immediate jeopardy. "Immediate jeopardy" means a situation in which the 
provider's noncompliance with one or more conditions of participation in the federal 
Medicare program has caused, or is likely to cause, serious injury, harm or impairment to 
or death of a patient. 
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3. Major permanent loss of function. "Major penllanent loss of function" means 
sensory, motpr, physiological or intellectual impairment that was not present at the time 
of admission and requires continued treatment or imposes persistent major restrictions in 
activities of daily living. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A "to S.P. 519, L.D. 1435 
3-A. Near miss. "Near miss" means 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" means a structured process for 
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 eyeHt. "Sentinel event" means: 
A. 
One of the follo',ving 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 
underlying condition or that results from the elopement of a hospitalized inpatient 
"'o'ho lacks the capacity, as defined in Title 18 A, section 5 801, subsection (c), to 
make decisions: 
(1) An unanticipated death; or 
(2) A major permanent loss of function that is not present ""hen the patient is 
admitted to the health care facility; 
B' I Surgery on the wrong patient or wrong 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 '""here the patient receives inpatient 
eare= , 
E. 
Infant abduction or discharge to the '.'>'Fong family; or . 
F. 
Rape of a patient. 
4-A. Sentinel event. "Sentinel event" means: 
A. 
An' unanticipated death, or patient transfer to another health care facility, 
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 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 that is present at the time of the discharge of the 
patient. If within 2 weeks of discharge from the facility, evidence is discovered that 
the major loss of function was not permanent, the health care facility 'is not required 
to submit a report pursuant to section 8753, subsection 2; 
C. An unanticipated perinatal death or major permanent loss of function in an infant 
with a birth weight over 2,500 grams that is unrelated to the natural course of the 
infant's or mother's illness or underlying condition or proper treatment of that illness 
or underlying condition in a health care facility; and 
D. 
Other serious and preventable events as identified by a nationally recognized 
quality forum and determined in rules adopted by the department pursuant to section 
8756. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "/JC to S.P. 519, L.D. 1435 
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 notify 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 a sentinel e\ent has occurred, as provided in this chapter. 
1. Notification. A health care facility shall notify the division of the occurrence of a 
sentinel event by the next business day after the sentinel event flas occurred or the next 
business day after the facility detennines 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 shall file a written report no later than 45 
days following the notification of the occurrence of 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 the following. 
(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; an action plan that identifies changes that can 
be implemented to reduce risks or formulates a.rationale for not undertaking such 
changes; and, where improvement actions are planned, an identification of who is 
responsible for implemelltation, when the action will be implemented and how 
the effectiveness of the action will be evaluated. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "It" to S.P. 519, L.O. 1435 
(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, 
including those identified as "not applicable" or "no problem," and includes the 
consideration of any relevant literature. 
(3) The root cause analysis submitted to the division may exclude protected 
professional competence review information pursuant to the Maine Health 
Security Act. 
.. Cooperation. A health care facility that has filed Ii notification or a report of the 
occurrence 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 near miss, a suspected sentinel 
event or a sentinel event or provides a root cause analysis pursuant to this chapter is 
immune from any civil or criminal liability for the act of reporting or participating in the 
review by the division. "Good faith" does not include instances when a false report 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 MRSA §8753-A is enacted to read: 
§8753-A. Standardized procedure 
A health care facility shall have a written standardized procedure for the 
identification of sentinel events. The division shall develop the standardized reporting and 
notification procedures by adoption of routine technical rules under Title 5, chapter 375, 
subchapter 2-A. 
Sec. 4. 22MRSA §8754, sub-§l, 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 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. UpOIl receipt of a notification or report of a suspected sentinel event the 
division shall determine whether the event constitutes a sentinel event and complete an 
initial review and may take such other action as the division determines to be appropriate 
under applicable rules and within the jurisdiction ofthe division. The division may 
conduct on-site reviews of medical records and may retain the services of consultants 
when necessary to the division. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A" to S.P. 519, L.D. 1435 
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 to the 
division's licensing section only incidences of immediate jeopardy and each condition 
of participation in the federal Medicare program related to the immediate jeopardy 
for which the provider is out of compliance. 
Sec. 5. 22 MRSA §8754, sub-§3, as enacted by PL 200 I, c. 678, § I and affected 
by §3, is amended to read: 
3. Confidentiality. Notifications and reports of sentinel events filed pursuant to this 
chapter and all information collected or developed as a result of the filing and 
proceedings pertaining 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 I, 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. 
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 State 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 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. 6. 22 MRSA §8754, sub-§4, as enacted by PL 200 I, c. 678, §I and affected 
by §3, is amended to read: 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT" A" to S.P. 519, L.D, 1435 
4. Report. The division shall develop submit an annual report by February 1 st each 
year to the Legislature, health care facilities and the public that includes summary data of 
the number and types 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. The resort must be submitted bv Februarv 1 st each vear. 
Sec. 7. 22 MRSA §8755, as enacted by PL 200 I, c. 678, § I and affected by §3, is 
repealed and the following enacted in its place: 
§8755. Compliance 
1. Oversight. The division shall place primary emphasis on ensuring effective 
corrective action by the facility. 
2. Penalties. When the division determines that a health care facility failed to report ' 
a sentinel event pursuant to this chapter, the health care facility is subject to a penalty 
imposed in conformance with Title 5, chapter 375, subchapter 4 and payable to the State 
of not more than $10,000 per violation. If the facility in good faith notified the division of 
a suspected sentinel event and the division later determines it is a sentinel event, the 
facility is not subject to a penalty for that 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. 
3. . Administrative hearing and appeal. To contest the imposition of a penalty 
under this section, a health care facility must submit to the division a written request for 
an admin istrative hearing within 10 days of notice of imposition of a penalty pursuant to 
this section. Judicial appeal must be in accordance with Title 5, chapter 375, subchapter 
1,. 
4. 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. 
. 
5. Enforcement. The Office of the Attorney General may file a complaint with the 
District Court seeking injunctive relief for violations of this chapter. 
Sec. 8. Author,ity to submit legislation. After reviewing recommendations in 
the CY 2008 Sentinel Events report dated April 28, 2009, the Joint Standing Committee 
on Health and Human Services may submit legislation related to the recommendations of 
the report to the Second Regular Session of the 124th Legislature.' 
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SUMMARY 
This amendment replaces the bill. It removes the definition of "health care facility 
acquired infection," modifies the definitions of "major permanent loss of function" and 
"sentinel event" and modifies notification requirements related to transfers of patients 
from one facility to another. It removes provisions related to mandatory reporting of 
suspected sentinel events, immunity for expressions of' regret or apologies, the 
Department of Health and Human Services' responsibility for determining the 
reportability of sentinel events and the confidentiality of records for final administrative 
actions. The amendment also gives the Joint Standing Committee on Health and Human 
COMMITTEE AMENDMENT 
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COMMIITEE AMENDMENT "It." to S.P. 519, L.D. 1435 
Services authority to submit a bill related to the recommendations of the CY 2008 
Sentinel Events report dated April 28, 2009 to the Second Regular Session of the 124th 
Legislature. 
The amendment retains the addition and modification of several provisions that relate 
to requirements for hospitals to follow standardized procedures for the identification, 
notification and reporting requirements. The amendment also retains the addition of root 
cause analysis to the reporting requirements while adding a provision to exclude 
protected professional competence review information from the root cause analysis 
submitted to the department's Division of Licensing and Regulatory Services. 
The 
amendment maintains the provision related to immunity for good faith reporting of near 
misses, suspected or actual sentinel events or root cause analysis as well as the provision 
on voluntary notification of a near miss. 
The amendment requires the division to determine whether a suspected sentinel event 
constitutes a sentinel event, to complete an initial review and to take other action within 
the jurisdiction of the division. It retains provisions allowing the division to conduct on-
site visits and to report immediate jeopardy to the division's licensing section, but adds 
language to clarifY that personnel responsible for sentinel event oversight shall repOli 
only immediate jeopardy as defined in the Maine Revised Statutes, Title 22, section 8752, 
subsection 2-A and each condition of participation in the federal Medicare program 
related to the immediate jeopardy for which the provider is out of compliance. 
This amendment maintains the provisions related to compliance, which increases the 
penalty for violations and authorizes the division to collect the penalty without going to 
court. The amendment reduces the penalty from the bill's proposal of $25,000 per 
unreported sentinel event to $10,000 per violation. It retains other provisions from the bill 
related to administrative hearings, appeals and injunctive relief. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 05/25109 
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LD 1435 
LR 1908(02) 
An Act To Amend Sentinel Events Reporting L~ws To Reduce Medical Errors and Improve Patient 
Safety 
Fiscal Note for Bill as Amended by Committee Amendment 'A" 
Committee: Health and Human Services 
Fiscal Note Required: Yes 
Fiscal Note 
Minor cost increase - General Fund 
Minor revenue increase - General Fund 
Minor revenue increase,.. Other Special Revenue Funds 
Correctional and Judicial Impact Statements 
Increases the number of civil suits. 
The collection of additional filing fees' may also increase General Fund revenue by minor amounts. 
Fiscal Detail and Notes 
The Department of Health and Human Services may experience an increase in Other Special Revenue Funds revenue 
from penalties. 
LR 1908(02) - Fiscal Note - Page 1 of 1 
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