Sentinel Event Policy

You are the Quality Assurance/Quality Improvement Director for Plaza Medical Center. As a member of the QA/QI Committee, you have been asked to analyze and recommend improvements to the Sentinel Event Policy, review the Root Cause Analyses and Actions (RCA2) process for its effectiveness, discuss use of the Cause and Effect Diagram (AKA Fishbone diagram) tool which provides leadership a way to explore all the potential factors that may be causing or contributing to a particular problem (effect). In addition, analyze sentinel event data provided by the Joint Commission to identify trend and problem areas to develop strategies or initiatives to address these areas (e.g., education campaign, policy and procedure changes). Analyze Sentinel Event policy provided and recommend improvements to Policy Research at least two other sentinel event policies for comparison. Discuss importance of timely response to a sentinel event. Review the Root Cause Analyses and Actions (RCA2) process. Discuss use of Cause and Effect Diagram (AKA Fishbone diagram) tool. Locate and analyze sentinel event data published by Joint Commission and recommend quality improvement activities. Hint: https://www.jointcommission.org/sentinel_event.asp… Using Microsoft Word, compose a detailed two page essay double spaced using Times New Roman, size 12 font. Provide a works cited page with at least five sources. Analysis of Sentinel Event policy _______/20Analysis of sentinel event data
_______/15Recommend ways to improve the existing
policy _______/15Discuss the Root Cause Analyses and
Actions (RCA2) process _______/15Discuss use of Cause and Effect Diagram
tool _______/15Recognize the goal and focus of health
care institutions policy _______/10Give examples of Sentinel events
identified by the TJC ________/5Correct spelling, punctuation, grammar
and formatting ________/5
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HT108
January 2017
Case Study: Sentinel Event Policy and Procedure Analysis
Homework Assignment
Student Name: ________________
Domain III:
Subdomain III.H.1:
Competency:
Curricular Consideration:
Domain V:
Subdomain V.A.1:
Competency:
Curricular Consideration:
Domain VI:
Subdomain VI.C.2:
Competency:
Curricular Consideration:
Subdomain VI.C.3:
Competency:
Curricular Consideration:
Date: ______
Informatics, Analytics and Data Use
Information Integrity and Data Quality
Apply policies and procedures to ensure the accuracy and
integrity of health data both internal and external to the
health system (BL3)
Disease management process; Quality assessment &
improvement (process, collection tools, data analysis, and
reporting techniques).
Compliance
Regulatory
Analyze policies and procedures to ensure organizational
compliance with regulations and standards (BL4)
Internal and external standards, regulations, and initiatives;
Health Insurance Portability and Accountability Act
(HIPAA), The Joint Commission, Quality Integrity
Organizations (QUIs), Meaningful Use (MU), risk
management, & patient safety.
Leadership
Work Design and Process Improvement
Identify cost-saving and efficient means of achieving work
processes and goals (BL3)
Incident response, medical reconciliation, and sentinel
events.
Work Design and Process Improvement
Utilize data for facility – wide outcomes reporting for quality
management and performance improvement (BL3)
Data for outcomes reporting; Continuous Quality
Improvement (CQI).
Objectives:
1. Identify policies and procedures that ensure compliance with data quality and integrity in
the process of quality assessment and improvement (III.H.1- BL3)
2. Examine organizational compliance with regulatory standards as it relates to the Joint
Commission and patient safety standards (V.A.1- BL4)
3. Analyze different methods of compliance with Quality Improvement Organizations
(V.A.1- P)
4. Identify performance improvement tools used in healthcare to monitor patient
performance (VI.C.1- BL3)
5. Utilize data for decision making in the process of performance improvement (VI.C.3BL3)
TASKS:
You are the Quality Assurance/Quality Improvement Director for Plaza Medical Center. As a
member of the QA/QI Committee, you have been asked to analyze and recommend
1
HT108
January 2017
Case Study: Sentinel Event Policy and Procedure Analysis
improvements to the Sentinel Event Policy, review the Root Cause Analyses and Actions
(RCA2) process for its effectiveness, discuss use of the Cause and Effect Diagram (AKA
Fishbone diagram) tool which provides leadership a way to explore all the potential factors that
may be causing or contributing to a particular problem (effect). In addition, analyze sentinel
event data provided by the Joint Commission to identify trend and problem areas to develop
strategies or initiatives to address these areas (e.g., education campaign, policy and procedure
changes).
? Analyze Sentinel Event policy provided and recommend improvements to Policy
o Research at least two other sentinel event policies for comparison.
o Discuss importance of timely response to a sentinel event.
o Review the Root Cause Analyses and Actions (RCA2) process.
o Discuss use of Cause and Effect Diagram (AKA Fishbone diagram) tool.
o Locate and analyze sentinel event data published by Joint Commission and
recommend quality improvement activities.
? Hint: https://www.jointcommission.org/sentinel_event.aspx
?
Using Microsoft Word, compose a detailed two page essay double spaced using Times
New Roman, size 12 font.
o Provide a works cited page with at least five sources.
Standards: Students must achieve a minimum of 70%.
TASKS:
Analysis of Sentinel Event policy
_______/20
Analysis of sentinel event data
_______/15
Recommend ways to improve the existing policy
_______/15
Discuss the Root Cause Analyses and Actions (RCA2) process
_______/15
Discuss use of Cause and Effect Diagram tool
_______/15
Recognize the goal and focus of health care institutions policy
_______/10
Give examples of Sentinel events identified by the TJC
________/5
Correct spelling, punctuation, grammar and formatting
________/5
Total Points:
_______/100
Instructor: ________________________________
2
Date:_____________
HT108
January 2017
Case Study: Sentinel Event Policy and Procedure Analysis
[Insert Manual Name]
Title:
[Hospital
Logo]
SENTINEL EVENT RESPONSE
AND REPORTING
I.
No.
CO-2.010
Page:
3 of 4
Origination Date: 02-08-16; 06-19-14;
09-21-12; 06-01-08; 07-22-05; 08-15-02;
08-28-00; 10-01-96
Effective Date:
xx-xx-xx
Retires Policy Dated:
xx-xx-xx
Previous Policy Dated:
xx-xx-xx
Medical Staff
Approval Date:
xx-xx-xx
Hospital Governing
Board Approval Date:
xx-xx-xx
SCOPE:
This policy applies to [insert Hospital name] (“Hospital”), its staff, Medical Staff, patients and visitors
regardless of service location or category of patient. This policy shall not be used in isolation but as a
supplement to the Hospital’s overall Clinical Risk Management/Patient Safety Plan.
II.
PURPOSE:
The purposes of this policy are to:
III.
A.
Seek to improve patient care by reviewing and responding to Sentinel Events as set forth
by The Joint Commission (TJC) Sentinel Event policy and procedures1 (see CO-2.010.01);
B.
Support the improvement of patient safety and quality improvement initiatives by
complying with the state-mandated reporting requirements; Hospital will work with
Regional Counsel to update policy against state reporting requirements annually (see CO2.010.02);
C.
Support patient safety improvement by reviewing any event which meets the description
of any one of the National Quality Forum (NQF) Safe Practices2 (see CO-2.010.01); and
D.
Evaluate all TJC reviewable Sentinel Events with Home Office Senior Director of Quality
Management and Corporate Regulatory Counsel to determine if a voluntary report shall be
made to TJC.
DEFINITIONS:
A.
“Adverse Event” means an untoward incident, therapeutic misadventure, iatrogenic injury
or other unexpected event with the potential for harm that may meet the definition of a
Sentinel Event and is directly associated with the care or services provided within the
Hospital.
B.
“Anticipated Outcome” means the outcome expected from a diagnostic or therapeutic
intervention or lack of intervention. This includes the known risks of a treatment or
procedure. Anticipated outcomes, including potential adverse anticipated outcomes, such
1TJC
Sentinel Event Policies and Procedures are set forth in the Comprehensive Accreditation Manual for Hospitals, Sentinel
Events Chapter.
2
National Quality Forum Safe Practices are available through the NQF website http://www.qualityforum.org/ and are summarized
on CO-2.010.01.
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HT108
January 2017
Case Study: Sentinel Event Policy and Procedure Analysis
as known risks, shall be disclosed as part of informed consent and ongoing communication
by the provider performing the procedure.
C.
“Care Associated with a Preventable Event” refers to the care directly related to provider
error or process failure which resulted in a Preventable Event with Permanent, Severe
Temporary, or Temporary Harm.
D.
“Disclosure” means the communication of information regarding the outcome of
diagnostic tests, medical treatment, or surgical intervention to a patient and, when
appropriate, their families about outcomes of care, including preventable events resulting
in harm/errors.
E.
“Error,” as defined by The Institute of Medicine in 2001, means a failure of a planned
action to be completed as intended. Errors are unintended, undesirable, and result from a
defect or failure of a diagnostic, therapeutic, or supportive process, at any point in the
continuum of care. Errors may be either human or technological. An error may or may not
have a negative outcome. Errors may be acts of commission or omission. Many errors are
seen as “system” failures, even when it may appear that a single person or device is at fault.
Errors shall be reported by using the Patient Safety Reporting System (PSRS) if they :
•
Require a significant change in further diagnosis or treatment;
•
Lead to initial or prolonged hospitalization;
•
Are life threatening;
•
Result in disability, death, significant cognitive impairment, or congenital
abnormality.
F.
“Event Report” means an event report that is completed to document an adverse event or
near miss event in the PSRS.
G.
“Hospital staff” means the Hospital’s employees, agency staff, contractors and volunteers.
H.
“Intense Analysis” means the review process by which all Adverse Events undergo. When
events do not meet Sentinel Event criteria for Root Cause Analysis, Intense Analyses can
be completed on those events using the Intense Analysis formats available (see Conducting
a Root Cause Analysis (RCA) procedure CO-2.010.03). Intense assessments shall be
conducted in accordance with state peer review, quality assurance, performance
improvement or other state statute.
I.
“Near Miss” means any event with process variation if reoccurrences would carry a
significant chance of a serious adverse outcome.
J.
“Outcome of Care” means the result of the performance (or non-performance) of a
diagnostic or therapeutic process. Outcomes may be preventable or unpreventable.
K.
“Preventable Event” means an outcome that differs significantly from the anticipated
result of a treatment or procedure. A Preventable Event resulting in harm associated with
the performance of a treatment or procedure may be negative or positive. Negative
Preventable Events resulting in harm are usually considered adverse events. They are
usually with an error (American Society for Healthcare Risk Management), and they are
not necessarily the result of negligence. A Preventable Event resulting in harm may or may
not be considered a reviewable Sentinel Event. Known risks without errors that are
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HT108
January 2017
Case Study: Sentinel Event Policy and Procedure Analysis
common to a procedure do not constitute a Preventable Event resulting in harm or error.
Most Preventable Events resulting in harm shall be discussed with the patient; however,
those that do not harm the patient and that do not impact current or future patient health
care decisions do not need to be disclosed but may be disclosed at the discretion of the
responsible health care professional. Preventable Events resulting in harm may involve
Hospital staff or physician error in delivery of care and result in patient temporary or
significant harm.
III.
L.
“Root Cause Analysis” means a process for identifying the base or contributing causal
factors that underlie variations in performance associated with Adverse Events, Sentinel
Events or Near Misses (see CO-2.010.03).
M.
“Sentinel Event” is a patient safety event not primarily related to the natural course of the
patient’s illness or condition that reaches a patient and results in death, permanent harm, or
severe temporary harm. (See also CO-2.010.01.) The PSRS is the mechanism for hospital
staff member to complete an event report for patient safety events or near misses (See
CO.2008 Event Reporting).
N.
“Permanent Harm” means death or permanent disability that does not allow a patient to
return to his/her level of activity that existed prior to the event.
O.
“Severe Temporary Harm” is critical, potentially life-threatening harm lasting for a
limited time with no permanent residual, but requires transfer to a higher level of
care/monitoring for a prolonged period of time, transfer to a higher level of care for a lifethreatening condition, or additional major surgery, procedure, or treatment to resolve the
condition.
P.
“Temporary Harm” involves limited injury or additional medical treatment needed in
response to a preventable event. Patient returns to normal function after a period of time.
Q.
“Unanticipated Outcome” means an outcome that is not anticipated in the normal course
of the patient’s care.
R.
“Unpreventable Event” means an outcome that is within the known risks of the procedure
and no error is involved in care delivery. Unpreventable events resulting in harm may result
in patient temporary or significant harm.
POLICY:
A.
The Risk Manager shall utilize the patient safety reporting system (PSRS) to identify,
address, document and report to their appropriate Supervisor and, Senior Director of
Patient Safety/Clinical Risk Management of all potential Sentinel Events. In response to
each Sentinel Event, the Hospital shall:
1.
timely report the event via the PSRS to the Senior Director of Patient
Safety/Clinical Risk Management (see also CO-2.008 Event Reporting);
2.
conduct a timely, thorough and credible root cause analysis via Root Cause
Meetings within 14 days of the event being identified where attendees are
multidisciplinary groups (including Medical Staff) based on the event;
3.
develop an action plan with measurable intermediate and high strength human
factor action items designed to implement improvements to reduce risk;
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HT108
January 2017
Case Study: Sentinel Event Policy and Procedure Analysis
B.
4.
implement those improvements; and
5.
monitor the effectiveness of those improvements.
Determination of Reporting of Sentinel Events to TJC
The Hospital shall perform a Root Cause Analysis for Sentinel Events and shall evaluate
reporting Sentinel Events to TJC after consultation with Home Office Senior Director of
Quality Management and Regulatory Counsel.
IV.
PROCEDURE:
A.
Hospital Implementation
The Hospital’s Risk Manager3, Event Manager, or other appropriate person with
responsibility for these functions (the “Risk Manager”) shall ensure that the following steps
are followed to comply with this policy. Some steps may occur concurrently.
B.
C.
Complete an Event Report
1.
All Hospital staff are required to report events which reach the level of a Sentinel
Event pursuant to the Hospital’s Event Reporting policy (see CO-2.008 Event
Reporting).
2.
The Risk Manager shall review all event reports to determine whether they meet
the definition of a Sentinel Event.
3.
The Risk Manager shall identify all potential Sentinel Events in the PSRS by
completing a Serious Reportable Event cue which shall notify Senior Director of
Patient Safety/Clinical Risk Management.
4.
For all potential Sentinel Events and Near Misses, the Risk Manager shall ensure
that the PSRS contains a description of the event as well as the date of event and
medical record number(s).
5.
For research subjects involved in a serious adverse event (SAE) the Risk Manager
is to be notified along with the principle investigator and Home Office Director of
Clinical Research. Refer to policy CO-2.030 Serious Adverse Events Involving
Research Patients.
Report to the Appropriate Person
1.
The Risk Manager shall report all potential Sentinel Events to Hospital
Administration and the Compliance Officer. The report shall include the following
information:
a.
Patient name and event date;
b.
Description of the event;
c.
Current status of the patient and discharge date;
The Hospital’s Patient Safety Officer/Director of Continuous Quality Improvement may also perform the duties of
the Risk Manager described in this policy.
3
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HT108
January 2017
Case Study: Sentinel Event Policy and Procedure Analysis
2.
D.
d.
If the patient expired, whether the death was related to the natural course
of the patient’s underlying condition;
e.
If the patient expired, whether the case shall be referred to the medical
examiner;
f.
Whether notification of the event has been made to the patient and/or
family; and
g.
Whether the Risk Manager believes that any state or Federal reporting
obligations are triggered (i.e., reporting to DHS; reporting restraint deaths
to the Centers for Medicare and Medicaid Services (CMS); reporting
pursuant to the Safe Medical Devices Act, etc.).
The Risk Manager shall also notify:
a.
Director of Revenue Analysis (DRA) or designee, to place the bill on hold
while the potential Sentinel Event is being investigated as described
below;
b.
The Litigation Manager or defense counsel as appropriate; and
c.
The Hospital’s Regulatory and Regional Counsel as appropriate.
d.
Regional Clinical Operations Leadership as appropriate.
Complete the Root Cause Analysis and Action Plan
Within fourteen (14) calendar days of the date of event, the Risk Manager shall complete
the RCA and human factors based action plan.
E.
Billing Procedures for Reviewable Sentinel Events
The Risk Manager shall follow the procedures outlined in Bill Hold Process for Possible
Preventable Events resulting in harm CO-2.010.04 to update accounts placed on bill hold
as required by the notification process (see Subsection V.C.2.c.).
F.
Disclose to the Patient/Family
Patients and, when appropriate, their families, shall be promptly informed about the
outcomes of care, including preventable events resulting in harm. All Preventable Events
resulting in harm shall be disclosed to the patient. In most cases, the disclosure shall be
made in the ordinary course of treatment. The disclosure shall be made as described in
Disclosure of Outcomes procedure CO-2.010.05 if an occurrence that meets Sentinel Event
definition and involves error. Near miss events are not included in this disclosure process
plan.
G.
Immediately Review Restraint Deaths
If the potential Sentinel Event involves death in or resulting from restraints (see Clinical
Operations policy CO-4.004 Restraint and Seclusion to determine reportability based on
type of restraint used),
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HT108
January 2017
Case Study: Sentinel Event Policy and Procedure Analysis
the Hospital’s Risk Manager shall immediately consult with Home Office Senior Director
of Quality or Regional Quality Management to determine whether the restraint death
requires a report to CMS in accordance with 42 C.F.R. 482.13.
H.
Review Potential Sentinel Events with Regulatory Counsel to Determine State Reporting
Obligations
The Risk Manager shall immediately consult with Regulatory Counsel when the Risk
Manager believes that state law requires a report of a Sentinel Event.
I.
Refer the Event to the Appropriate Medical Staff/Nursing Committee
If the Event Report requires physician or nursing review, the Risk Manager shall forward
the event information to the appropriate medical staff/nursing review committee for followup.
J.
Responsible Person
The Risk Manager is responsible for ensuring that all individuals adhere to the
requirements of this policy, that these procedures are implemented and followed at the
Hospital and that instances of non-compliance with this policy are reported to the [insert
title of senior individual with leadership/operational oversight for the area].
K.
Auditing and Monitoring
Audit Services will audit compliance with this policy.
L.
Enforcement
All employees whose responsibilities are affected by this policy are expected to be
familiar with the basic procedures and responsibilities created by this policy. Failure to
comply with this policy will be subject to appropriate performance management pursuant
to all applicable policies and procedures, including the Medical Staff Bylaws, Rules and
Regulations.
V.
REFERENCES:
– The Joint Commission (SE Chapter), 2015
– National Quality Forum Serious Reportable Events, 2012
– Regulatory Compliance policy COMP-RCC 4.21 Internal Reporting of Potential Compliance Issues
– Payments and Adjustments section, Conifer Standard Tables and Request Forms SharePoint site
– Medicare Conditions of Participation, Patient Rights 42 C.F.R. 482.13
– Centers for Medicare and Medicaid Services website
– Standards of Conduct
– Quality, Compliance and Ethics Program Charter
– CO-2.010.01 The Joint Commission/National Quality Forum Reporting Requirements
– CO-2.010.02 Summary of S …
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