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

Operational Policy
Date Created : / 15-01-2008
Approved By : /

Chief Medical Superintendent

Name :
Signature :
Reviewed By : / Medical Superintendent
Name :
Signature :
Issued By : /

Director

Name :
Signature :
Responsibility of Updating : / Medical Superintendent
Name :
Signature :

Page of Contents:

Sl.Order / Particulars
A / Purpose
B / Definitions
C / Policy
D / Procedure
E / List of Identified Sentinel Events

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:

  1. Error - an unintended act, either of omission or commission, or an act that does not achieve its intended outcome.
  1. 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.
  1. 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.
  1. 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.
  1. Root Cause Analysis - a thorough evaluation of the underlying and less than obvious reasons for the occurrence of a sentinel or other significant event.
  1. 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

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.

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)

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:

• 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.  Identification of who is responsible for implementation.

2.  When actions will be implemented

3.  How monitoring for effectiveness will be conducted.

4.  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.
  10. Hospital acquired infection.
  11. Fall from Bed.
  12. Green Stick Injury.

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Manual of Operation