Dr. Ram Manohar Lohia Combined
Hospital , Lucknow
Quality Operating
Process
Document No :
RML/SEP/01
Manual of Operations
Sentinel Event Policy
Date of Issue :
15/1/2008
Service Name :
Sentinel Event
Date Created :
15-01-2008
Operational Policy
Chief Medical Superintendent
Approved By :
Name
:
Signature :
Medical Superintendent
Reviewed By :
Name :
Signature :
Director
Issued By :
Name :
Signature :
Medical Superintendent
Responsibility of Updating :
Name :
Signature :
1
Manual of Operation
Dr. Ram Manohar Lohia Combined
Hospital , Lucknow
Quality Operating
Process
Document No :
RML/SEP/01
Manual of Operations
Sentinel Event Policy
Date of Issue :
15/1/2008
Page of Contents:
Sl.Order Particulars
A
Purpose
B
Definitions
C
Policy
D
Procedure
E
List of Identified Sentinel Events
2
Manual of Operation
Dr. Ram Manohar Lohia Combined
Hospital , Lucknow
Quality Operating
Process
Document No :
RML/SEP/01
Manual of Operations
Sentinel Event Policy
Date of Issue :
15/1/2008
A. Purpose:
To provide a confidential mechanism of identification, tracking, trending, and follow-up of
all incidences that poses an actual or potential safety risk to patients, families, visitors and
staff. Variances include events ranging from “falls” to near misses or sentinel events with
serious adverse outcomes, occurring in the hospital setting.
B. Definitions:
i.
Error - an unintended act, either of omission or commission, or an act that does not
achieve its intended outcome.
ii.
Variance - defined as any event or circumstance not consistent with the standard
routine operations of the hospital and its staff or the routine care of a patient/visitor.
iii.
Near Miss - any process variation which did not affect the outcome but for which a
recurrence carries a significant chance of a serious adverse outcome.
iv.
Sentinel Event - an unexpected occurrence involving death or serious physical or
psychological injury, or the risk thereof to a patient, visitor, or an employee. Serious
injury specifically includes loss of limb or function.
v.
Root Cause Analysis - a thorough evaluation of the underlying and less than obvious
reasons for the occurrence of a sentinel or other significant event.
vi.
The phrase, “or the risk thereof”, includes any process variation for which a
recurrence would carry a significant chance of a serious adverse outcome.
C. Policy:
The sentinel event policy applies only to events that meet the following criteria:
a. The event has resulted in an unanticipated death or major permanent loss of function,
not related to the natural course of the patient’s illness or underlying condition.
i. “Major permanent loss of function” means sensory, motor, physiologic or intellectual
3
Manual of Operation
Dr. Ram Manohar Lohia Combined
Hospital , Lucknow
Quality Operating
Process
Document No :
RML/SEP/01
Manual of Operations
Sentinel Event Policy
Date of Issue :
15/1/2008
impairment not present on admission requiring continued treatment or life-style change.
b. The event is one of the following (even if the outcome was not death or major
permanent loss of function):
i. Attempted suicide of a patient in a setting where the patient receives around-the-clock
care.
ii. Rape (The determination of “Rape” is to be consistent with applicable law and
regulation).
iii. Hemolytic transfusion reaction involving administration of blood or blood products
having major blood group incompatibilities.
iv. All events of surgery on the wrong patient or wrong body part.
c. A sentinel event:
i. Potentially involves a continuing threat to a patient care or safety;
ii. Has significant potential for being reflective of serious underlying systems problems in
the organization;
iii. Potentially undermines public confidence in the hospital.
d. In all cases, a sentinel event requires immediate action to examine, in depth, the event
to determine why the incident occurred and how to reduce the likelihood of
reoccurrence.
D. Procedure:
i. Whenever a sentinel event occurs , the occurrence report shall be immediately reported to
the Director , Chief Medical Superintendent and Medical Superintendents ( Male and
Female Wing).
ii. The attending physician shall be notified immediately when the variance involves a
patient.
iii. If a patient or visitor is injured in a common area (i.e. sidewalks, stairwell, elevator,
waiting area, etc.) the hospitals security shall be responsible for completing a Variance/
Sentinel even report.
4
Manual of Operation
Dr. Ram Manohar Lohia Combined
Hospital , Lucknow
Quality Operating
Process
Document No :
RML/SEP/01
Manual of Operations
Sentinel Event Policy
Date of Issue :
15/1/2008
iv. The employee identifying the Variance/Sentinel Event, or the employee to whom the
Variance/Sentinel Event is first reported, shall be responsible for initiating the
completion of the Variance Report Form prior to the end of their scheduled shift of
duty.
Note: If the Variance/Sentinel Event occurrence is a potential Sentinel Event or Near Miss
the individual responsible for reporting the variance shall notify their Supervisor
immediately. The Supervisor shall then immediately notify the same to the Chief Medical
Superintendent and Medical Superintendent (M&F wing) .
v. Upon completion of the Variance/Sentinel Event Report the reporting employee will
submit the report to his/her immediate supervisor. Incase the supervisor is not available; the
report shall be submitted to the Emergency Medical Officer on duty.
All sentinel event reports must be finally submitted to the Chief Medical Superintendent who
is the head of the Quality Assurance Team. In his absence the same should be submitted to
either of the Medical Superintendents (M&F wing).
vi. As soon as the sentinel event is reported, the CMS/MS (M&F wing) shall determine if a
root cause analysis should be conducted .Usually Event Root-Cause Analysis shall be
considered when an occurrence meets any of the following criteria:
• The occurrence involves an unanticipated death or major permanent loss of function.
• The occurrence is associated with significant deviation from the usual process (es) for
providing health care services or managing the organization.
• The event has undermined or has significant potential for undermining the public’s
confidence in the organization.
For such events the organization shall immediately conduct an analysis to determine the
proximate cause of the event and the process (es) and the system(s) related to its occurrence.
This analysis of the related processes and systems shall include relevant literature and
benchmarking information.
vii. The root cause analysis will be performed by the Quality Assurance Team of the hospital
consisting of relevant organization staff and Medical Staff under the leadership of the
Medical Superintendent (Male wing)
5
Manual of Operation
Dr. Ram Manohar Lohia Combined
Hospital , Lucknow
Quality Operating
Process
Document No :
RML/SEP/01
Manual of Operations
Sentinel Event Policy
Date of Issue :
15/1/2008
The Quality Assurance Team also summarizes each variance and refers them to the
department(s) involved for investigation and resolution as needed. A resolution /
corrective action related to conducting proactive risk reduction activities and the patient
outcome shall be forwarded to the Quality Assurance Team for reporting to the Quality
Management Committee.
viii. A written summary of the Root-Cause Analysis of a Sentinel Event shall focus primarily
on organizational systems and processes. The Root-Cause Analysis must include:
• Determination of the direct or “proximate” cause of the Sentinel Event and the processes
and systems related to its occurrence.
• Analysis of the related systems and processes.
• Analysis of special causes in clinical processes and common causes in organization
processes.
• Determination of appropriate risk reduction activities in order to minimize the likelihood of
such risks in the future, or a determination that no such improvement opportunities exist.
• Establishment of a plan to address identified opportunities for improvement or formulation
of a rationale for not undertaking such changes.
• Identification of who is responsible for implementation and how the effectiveness of the
actions shall be evaluated.
ix. When monitoring performance of specific clinical processes, certain events always elicit
intense analysis. Based on the scope of services provided, intense analysis is performed on
the following:
• Confirmed transfusion reactions
• Significant adverse drug reactions
• Significant medication errors and hazardous conditions
Hazardous conditions refer to any set of circumstances (exclusive of disease or condition for
which the patient is being treated), which significantly increases the likelihood of a serious
adverse outcome.
x. An intense analysis may also be performed when the following events occur:
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Manual of Operation
Dr. Ram Manohar Lohia Combined
Hospital , Lucknow
Quality Operating
Process
Document No :
RML/SEP/01
Manual of Operations
Sentinel Event Policy
Date of Issue :
15/1/2008
• Major discrepancies, or patterns of discrepancies, between preoperative and postoperative
(including pathologic diagnoses, including those identified during the pathologic review of
specimens removed during surgical and invasive procedures; and
• Significant adverse events associated with anesthesia use.
If the root cause analysis determines that the sentinel event is related to the “process” issue,
then the investigating team shall design ,implement and evaluate an improvement plan to
correct the system deficiency. This improvement plan and results shall be reported to the
hospital quality assurance committee.
xi. Performance improvement plan will include the following components :
1.
2.
3.
4.
Identification of who is responsible for implementation.
When actions will be implemented
How monitoring for effectiveness will be conducted.
Review of implementation of recommendations.
E. Identified Sentinel Events:
Followings are the Sentinel Events identified and defined by the Dr.Ram Manohar Lohia
Combined Hospital.
1.
Wrong Surgery on wrong Part.
2.
Adverse Drug Reaction.
3.
Mismatched Blood Transfusion.
4.
Baby Charring in NICU.
5.
Gangrene of the Limb of the Baby.
6.
Aspiration Pneumonia.
7.
Displacement of Joint due to Mal Positioning by the Staff.
8.
Occupational Hazards.
9.
Bed Sore.
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Manual of Operation
Dr. Ram Manohar Lohia Combined
Hospital , Lucknow
Quality Operating
Process
Document No :
RML/SEP/01
Manual of Operations
Sentinel Event Policy
Date of Issue :
15/1/2008
10. Hospital acquired infection.
11. Fall from Bed.
12. Green Stick Injury.
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Manual of Operation