NABH Standard

4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

ANALYSIS OF SENTINEL EVENTS POLICY

1.0 POLICY: All sentinel events shall be analyzed thoroughly in order to reduce their
frequency in future.

2.0 PURPOSE:

A .To ensures prompt assessment and response to all incidents resulting in injury to Patients,
Employees, or Visitors.

B. To identify and analyze contributing factors/conditions that led to the incident and to
identify steps to be taken, to prevent the recurrence of a similar incident.

3.0 DEFINITIONS:

Events – Any unusual or unexpected occurrence that results in injury or injury to patients,
staff, or visitors. Threats or actions of violence, inappropriate sexual behavior, fires and
environmental emergencies. Any event that results in damage or potential damage to or loss
of hospital property, patient property or specified employee property.

Adverse Event- An injury related to medical management, in contrast to complications of

disease. Medical management includes all aspects of care, including diagnosis and treatment,
failure to diagnose or treat, and the systems and equipment used to deliver care.
Adverse events may be preventable or non-preventable.

No Harm- This is used synonymously with Near Miss. However, some authors draw a
distinction between these two phrases.
A Near Miss is defined when an error is realized just in the nick of the time and abortive
action is instituted to cut short its translation. In the NO Harm scenario the error is not
recognized and the deed is done but fortunately for the health care professional, the
expected adverse event does not occur. The distinction between the two is important and is
best exemplified by reaction to administered drugs in allergic patients. A prophylactic

Page 1 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

injection of Cephalosporin may be stopped in time because its suddenly transpires that the
patient is known to be allergic to penicillin (Near Miss).
If this vital piece of information is overload and the Cephalosporin is administered, the
patient may fortunately not develop an anaphylactic reaction (No Harm Event)

Sentinel Event- A relatively infrequent, unexpected incident, related to system or process

deficiencies, which leads to death or major and enduring loss of function for a recipient of
health care services.

Major and enduring loss of function refers to sensory, motor, physiological or psychological
impairment not present at the time services were sought or begun. The impairment lasts for
a minimum period of two weeks and is not related to an underlying condition.

Root Cause Analysis: A "Root Cause Analysis" is a process for identifying the basic or causal
factor(s) that underlie variation in performance including the occurrence or possible
occurrence of a Sentinel Event.

4.0 ABBREVIATIONS:
HOD= Head of the Department
RCA= Root Cause Analysis

5.0 SCOPE:

It includes patients, hospital employees, and visitors.

6.0 RESPONSIBILITY:
Sentinel event investigation Committee

7.0 DISTRIBUTION:
Hospital Wide

8.0 PROCEDURE

Page 2 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

Creation of Committee: The Hospital head shall form a temporary committee for in-depth
investigation and analysis of the event. The Committee shall be organized and conduct its
proceedings and investigate and analyze the event.

Composition of the Sentinel event investigation Committee: The committee shall be

composed of the following:

 Managing Director
 Medical Director
 Administrator
 Matron
 Departmental head
 Any other member as deemed necessary by the hospital

Duties of the Committee:

The Committee shall:

 Investigate an occurrence or process variation

 Determine whether such occurrence or process variation meets the definition of a Sentinel
event
 Ensure completion of a thorough and credible Root Cause Analysis and resulting Action
Plan describing the Hospital’s risk reduction strategies when a Sentinel Event occurs in the
hospital or is associated with services that the hospital provides, or provides for.

Page 3 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

Sentinel events

1. Surgical events

 Surgery performed on the wrong body part

 Surgery performed on the wrong patient
 Wrong surgical procedure performed on the wrong patient
 Retained instruments in patient discovered after surgery/procedure
 Patient death during or immediately post surgical procedure
 Anesthesia related event

2. Device or product events patient death or serious disability associated with:

 The use of contaminated drugs, devices, products supplied by the organization

 The use or function of a device in a manner other than the device’s intended use
 The failure or breakdown of a device or medical equipment
 Intravascular air embolism

3. Patient protection events n infant to the wrong person

 Patient death or serious disability associated with elopement from the health care
facility

Page 4 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

 Patient suicide, attempted suicide, or deliberate self-harm resulting in serious

disability
 Intentional injury to a patient by a staff member, another patient, visitor, or other
 Any incident in which a line designated for oxygen or other came to be delivered to a
patient and contains the wrong gas or is contaminated by toxic substances
 Nosocomial infection or disease causing patient death or serious disability

4. Environmental events

Patient death or serious disability while being cared for in a health care facility
associated with:
 A burn incurred from any source
 A slip, trip, or fall
 An electric shock
 The use of restraints or bedrails

5. Care management events

 Patient death or serious disability associated with a hemolytic reaction due to the
administration of ABO-incompatible blood or blood products

Page 5 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

 Maternal death or serious disability associated with labour or delivery in a low-risk

pregnancy
 Death or disability developed after sterilization surgery
 Medication error leading to the death or serious disability of patient due to incorrect
administration of drugs, for example:
 Omission error
 Dosage error
 Dose preparation error
 Wrong time error
 Wrong rate of administration error
 Wrong administrative technique error
 Wrong patient error
 Patient death or serious disability associated with an avoidable delay in treatment or
response to abnormal test results

6. Criminal events

 Any instance of care ordered by or provided by an individual impersonating a clinical

member of staff
 Abduction of a patient
 Sexual assault on a patient within or on the grounds of the health care facility

Page 6 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

 Death or significant injury of a patient or staff member resulting from a physical

assault or other crime that occurs within or on the grounds of the health care facility.

Reporting requirements

All sentinel events occurring in the hospital shall be reported to their departmental head and
administrator within 12 hours of occurrence.
Sentinel events must be reported using the Sentinel Event Notification Form and include the
hospital identification code, the date on which the event occurred, a brief description of the
sentinel event. The name of a contact person must be included.

Additional reporting requirements

One sentinel event can give rise to several reporting requirements. In addition to Medical
Director Sentinel events shall be reported to the relevant regulatory bodies as per the law of
land.

Investigation of sentinel event

Sentinel events indicate serious breakdown in the healthcare system and hence require
thorough investigation and response. Investigation of a sentinel event in the hospital shall
involve a comprehensive and systematic evaluation of the facts to identify contributing
factors

Page 7 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

The principles of natural justice shall be followed in every sentinel event investigation. For
this-
i) Persons involved in an incident shall be given adequate opportunity to present their case.
ii) Decision-makers hearing the case shall be unbiased.
The following methodologies shall also be used:

Root Cause Analysis

(RCA) methodology shall be adopted for investigating sentinel events.

Root Cause Analysis is a process for identifying the basic or causal factors that underlies
variation in performance, including the occurrence or possible occurrence of a sentinel
event. A Root Cause Analysis focuses primarily on systems and processes and not on
individual performance.

Purpose of Root Cause Analysis The purpose of the Root Cause Analysis is to understand how
and why a Sentinel or High Risk Event occurred and to prevent the same or similar Event
from occurring in the future. The Root Cause Analysis is expected to uncover any underlying
hospital’s systems and processes that can be changed to reduce the likelihood of human
fallibility in the future.

Completion of Root Cause Analysis and Action Plan: The committee shall investigate and
understand the causes that underlie the event within seventy-two (12) hours and complete a
thorough and credible Root cause analysis and resulting Action Plan describing the
Hospital’s risk reduction strategies, within 15 days of the known occurrence of the Sentinel
Event.

Report: The committee shall after completing the Root Cause Analysis and Action Plan,
produce full documentation of the Root Cause Analysis and Action Plan to head of the
Hospital. The head of the hospital shall subsequently direct the Root Cause Analysis and
Action Plan to be reported to and thoroughly reviewed by the Hospital’s other relevant
committees if deems appropriate

Page 8 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

Action Plan: The committee shall create a work plan that identifies changes to be
implemented with target dates for accomplishing specific objectives.

Focus on Systems and Processes : The Root Cause Analysis must focus primarily on
systems and processes, not individual performance; it shall identify changes and
improvements that could be made in system and processes, either through correction of
existing systems or processes or development of new systems or processes, that would
reduce the risk of such events occurring in the future

Procedure

1. Whenever a sentinel event occurs, the occurrence report shall be immediately

reported to the Departmental head, Vice president-Medical services, Vice President -
Operation
2. The attending physician shall be notified immediately when the variance involves a
patient.
3. 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. A sentinel event involving patient in clinical area, will
be reported by the nursing staff.
4. 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/HOD

Page 9 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

(Head of Department) immediately. The Supervisor shall then immediately notify the same
to the Administrator
Upon completion of the Variance/Sentinel Event Report the reporting employee will submit
the report to his/her immediate supervisor
All sentinel event reports must be finally submitted to the CEO
5. As soon as the sentinel event is reported, the Administrator and Managing director
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
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 and the system(s) related to its
occurrence. This analysis of the related processes and systems shall include relevant
literature and benchmarking information.
6. The root cause analysis will be performed by the Multi-Disciplinary Committee of the
hospital

Page 10 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

The Multi-Disciplinary Committee 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 Management Committee. Members of Multi-
Disciplinary Committee as mentioned above.
7. 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.
8. When monitoring performance of specific clinical processes, certain events always elicit
intense

Page 11 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

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.
9. 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.
10. Performance improvement plan will include the following components:
 Identification of who is responsible for implementation.
 When actions will be implemented

Page 12 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

 How monitoring for effectiveness will be conducted.

 Review of implementation of recommendations.
The terms “sentinel event” and “medical error” are not synonymous i.e. not all sentinel
events occur because of an error and not all errors result in sentinel events.

Documents related to sentinel events are confidential

The Root Cause Analysis, Action Plan, and other related documents produced by the
committee are confidential Root Cause Analysis and the Action Plan are documents prepared
by the committee and constitute final product containing recommendations identifying
strategies that the Hospital intends to implement to reduce the risk of Sentinel Events
occurring in the future.

Disclose of unanticipated outcomes of care that relate to sentinel events. The hospital has
designated the Medical Superintendent or his or her designee’s responsible to inform the
patient and when appropriate, the patients’ family about these outcomes of care.

Legal implication of release of above information: Once the event is identified as sentinel
event, no employee of the hospital or committee members are allowed to release any kind of
information related to it to any external individual or agency. All the matters related to
release of any information of occurrence of sentinel event, processes followed and action
taken, either to patient, family, police, media, social organizations etc. are taken by director
on discretion of legal advisor.

9.0 REFERENCES: Nil

10.0 RECORDS AND FORMATS:

Page 13 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director
 NABH Standard
4th Edition Hospital Quality Manual

Issue Date 02/01/2021 Revision Date 02/01/2021 Issue No 02

Review Date 01/01/2022 Doc. Number A00 Revision No 02

Incidence Form, Record of Safety Committee meetings

11.0 SUPERSESSION DETAILS:

In case of new document this heading will be excluded.

Page 14 of 14
Prepared By: Review By: Approved by:
Dr. Samashrita Shukla Dr. M.N. Verma Dr. A. K. Kaushik
Quality Manager Medical Superintendent Director