This document is a controlled document.

Facility reserves the right to amend or terminate any of its content at any time
without prior notice. The information should only be used for internal use.

DEPARTMENT Facility Wide ISSUE DATE

PROCESS OWNER Quality Department January 1, 2020

Occurrence Variance Reporting System REVISION DATE

TITLE/DESCRIPTION
(OVR)
November 15, 2023
EXPIRY/NEXT REVIEW DATE
POLICY NO. AMB-TQM-PP-02 Version #: 03
November 15, 2026

Facility Name/Stamp

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TABLE OF CHANGES

Section Change Explanation

Overall Issued on January 1, 2020 Version 01 – New

Overall Reviewed on January 1, 2022 Version 02 – Updated Approval Section

Version 03- Title page: added version number to the tile
page, changed the revision frequency to 3 years as per the
Tile page, footer
Reviewed on November 15, revised Mother policy.
and approval
2023 Footer: removed dates from the footer, added policy title
section
Approval section: removed preprinted names and added
section for handwriting the approvals names

Note: this section lists the latest changes in this document only. For detailed revisions,
please refer to the sections referenced on this list.

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1. PURPOSE

1.1. To establish guidelines for a systematic mechanism in identifying, reporting, investigating,

analyzing, solving and preventing variances and near misses.

2. SCOPE

2.1. This policy and procedure applies to all departments and employees of Facility.

3. DEFINITION

3.1. An Occurrence: Any occurrence that is not consistent with the routine operation of an
institution, and which includes any event that might result in any other adverse situation
that violates the code of conduct or a claim against the organization.
3.2. Variance: Any event or circumstance not consistent with the standard routine operations
of the Facility and its staff or the routine care of a patient/visitor.
3.3. Occurrence Variance Report: A Form used to document the details of the
occurrence/event and the investigation of an occurrence and the corrective actions taken.
3.4. Incident: An event which happens in the Facility or its grounds, which is not consistent
with routine operations and or
3.4.1. May have the potential to negatively affect patient outcome.
3.4.2. May or may not result in injury
3.4.3. May result in loss or damage to property or equipment
3.4.4. May involve loss or damage to the property of a patient, staff or visitors.
3.4.5. May be behavioral and involve a patient, staff, contractor or visitor.
3.5. Adverse Event: A patient safety event that resulted in harm to a patient. An unexpected
incident, therapeutic misadventure, iatrogenic injury or other adverse occurrences
directly associated with care or services provided.
3.6. Sentinel Event: See Sentinel Event Policy.
3.7. Near Miss: (or close call) is a patient safety event that did not reach the patient.
3.8. No Harm Event: a patient safety event that reaches the patient but does not cause harm.
3.9. Hazardous Condition(s): or unsafe condition(s) is a circumstance (other than a patient’s
own disease process or condition) that increases the probability of an adverse event.
3.10. Clinical Incident: Any untoward event or near miss that involves a patient, e.g. drug
errors, patients falling, patient complaint.
3.11. Non-clinical Incident: An untoward event that involves any person, e.g. member of
staff, visitors, voluntary workers, contractors, etc. It may also involve a patient where the
event relates to health and safety issues rather than clinical issues.

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3.12. Root Cause Analysis: A process for identifying the basic or causal factor(s) that
underlies variation in performance, including the occurrence or possible occurrence of
sentinel event.

4. POLICY:

4.1. All Facility employees are required to understand the definition of an untoward
reportable incident and near misses,
4.2. This reporting process includes reporting of accidents, occupational ill health,
dangerous occurrences and near misses.” Also refer to the attachment for list of
reportable variances and incidents and near misses.
4.3. Culture of Safety Issues: Reporting of Culture of safety and ethical conduct issues and
incidents:
4.3.1. Reporting under the OVR reporting scheme also includes the anonymous
reporting of culture of safety and ethical conduct issues and incidents.
4.3.2. TQM shall identify OVRs related to the culture of safety and/or ethical conduct
issues and incidents when sorting received OVRs and route those to the process
for handling ethical concerns and culture of safety issues in accordance with the
Facility policies on Ethical Framework Policy and Promoting Culture of Safety
Policy
4.4. Reporting Timeframes: Incidents and near misses shall be reported with the following
timeframes:
4.4.1. Sentinel Events: reporting timeframe in accordance with the Sentinel Event
Policy
4.4.2. Other Patient Related Incidents and Near Misses shall be reported as follows:
4.4.2.1. The OVR shall be completed by the end of the working day, shift in the
day/shift it was identified.
4.4.2.2. Incident written report can be deferred if patient care is needed, however
verbal reporting is still required before the end of the working day/shift for
patient related incidents.
4.4.3. Non patient related, no harm incidents and near misses:
4.4.3.1. Shall be reported within 24 hours

4.5. Incident investigations timeframes: incidents shall be investigated in accordance with

this policy within the following timeframes: (See Incident Risk Categorization Process
attached to this policy)

INCIDENT RISK LEVEL TIME FRAME

Incident in the Yellow/ Complete Investigation within 5 working days and
Green Risk Zone send the feedback to the TQM Department.

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Incident in the Amber Risk Complete Investigation within 10 working days and
Zone send the feedback to the TQM Department.
Incident in the Red Risk Complete RCA and action plan within 14 working
Zone days.
4.4 A copy of the original OVR form will be forwarded to the Total Quality Management
(TQM) Department as soon as possible.
4.5 A separate OVR Form is to be completed for each person involved or affected by an
accident or incident.
4.6 The minimum information that should be included on the report form include, but
not limited to the following:
4.6.1 Description of the incident/accident including
4.6.1.1 Date, time, and location of the incident
4.6.1.2 Date, time and department of report
4.6.1.3 Name of reporter (optional)
4.6.2 The persons affected
4.6.3 Brief description of incident, including action taken by immediate
supervisor
4.6.4 Physician follow-up (if medical intervention is required) including:
4.6.4.1 Assessment/diagnosis
4.6.4.2 Injury outcome
4.6.4.3 Nature of treatment/exam
4.6.4.4 Physician notes
4.6.5 Incident risk classification and rating
4.6.5.1 Type of incident
4.6.5.2 Contributing factors
4.6.5.3 Follow up by TQM
4.7 For patient-related serious adverse incidents, the patients should be advised and
the advice should be documented in patient’s health record. (OVR Form should
NEVER be filed in patient’s medical record).
4.8 Investigation of circumstances should be performed to ensure that:
4.8.1 Witnesses are interviewed while recollections are clear and statements
are taken as necessary.
4.8.2 Immediate action is taken to make safe the situation following an event, in
order to prevent recurrence, and document this on the incident report.
4.8.3 Evidence is secured, i.e. witness statements, equipment, records and
photographic evidence, risk assessments (pre-accident and reviewed
assessment).
4.8.4 The head of Employee Clinic is informed if an employee is absent for over
three days as a result of a work-related accident or incident.

5. PROCEDURES

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5.1. The employee directly involved in, present at the time of an incident, or to whom an
incident is reported, is required to report the incident immediately. He/she will complete
the OVR Form. This should be done as soon as possible after the incident and prior to the
end of the working shift. (See Incident Reporting Flow Chart in the attachment of this
policy)
5.2. If the incident resulted in injury or harm then the individual must seek immediate
medical attention, and fill OVR only after care has been received.
5.3. Incident reports should be written legibly, clearly and factually immediately following
the incident. Abbreviations must not be used.
5.4. Staff must record only facts and not opinion. DO NOT erase, overwrite or ink out. Error
or alteration should be scored out with a single line and the corrected entry written
alongside the date and signature. AVOID offensive, personal or humorous comments.
5.5. Incident reports must be submitted to the employee’s immediate supervisor or
manager.
5.6. Supervisor/manager will complete the OVR, including the risk classification and rating
section (with assistance from TQM department if needed).
5.7. Initiating department will conduct investigation and take action.
5.8. If the incident is in the Red/Amber zone, the medical director must be notified
immediately for further investigation and sentinel event analysis.
5.9. Otherwise, the TQM department will receive the original OVR form and do the following:
5.9.1. Assess whether action taken is satisfactory.
5.9.2. Classify incident as soon as the OVR is received.
5.9.3. Enter the incident to the OVR database.
5.9.4. If the action is not satisfactory:
5.9.4.1. Coordinate with corresponding department(s) if required.
5.9.4.2. Review feedback and whether action taken is satisfactory from
corresponding department(s).
5.9.5. Provide feedback to all concerned departments.
5.9.6. File the original form in the OVR file.
5.9.7. Close the OVR.
5.10. The OVR form shall be used in investigating an incident. Following an incident investigation,
any lessons learnt that have been identified should be implemented. An action plan should
be developed to ensure that any changes necessary are implemented. Successful changes
can then be shared with the wider health organization.
5.11. Incidents are reported and investigated in a timely manner.
5.12. Immediate remedial actions are taken as well as actions to prevent recurrence of similar
incidents.
5.13. Patients receive response when involved in significant incidents with documentation in the
medical records.
5.14. Incidents are monitored over time and the resulting information is used for improvement.
5.15. Staff are educated on the incident reporting process through in-service or classroom
lectures.

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5.16. All adverse events related to medical devices with the actions taken to resolve the events
will be reported to Saudi Food and Drug Association (SFDA) through the National Center for
Medical Devices Reporting (NCMDR).
5.17. Assign a SFDA officer from the biomedical team with the following responsibilities:
5.17.1. Respond to the weekly report Field Safety Corrective Actions (FSCA), if the center
is affected by this week report or not.
5.17.2. Disseminate and share the information with other Departments within
healthcare facility.
5.17.3. Ensure that the healthcare facility is free of any affected device/product.
5.17.4. Communicate with the Authorized Representative of the manufacturer if there is
any device/product affected by a FSCA (the weekly report of Field Safety
Corrective Actions).
5.17.5. Keep record of all reported adverse events related to medical devices.

5.18. Data is collected and analyzed for at least the following:

5.18.1. All confirmed transfusion reactions
5.18.2. All serious adverse drug events
5.18.3. All significant medication errors
5.18.4. All major discrepancies between preoperative and postoperative diagnoses;
5.18.5. Adverse events or patterns of adverse events during moderate or deep sedation
and anesthesia use.
5.18.6. Adverse events or patterns of adverse events during procedural sedation
regardless of administration site.
5.18.7. Adverse events or patterns during anesthesia regardless of administration site.
5.18.8. Adverse events related to patient identification.
5.18.9. Other adverse events; for example, health care–associated infections and
infectious disease outbreaks
5.19. Reportable incidents and Near Misses:
5.19.1. Please refer to the attachment for list of reportable incidents and OVR reporting
process.
5.20. Culture of Safety and Ethical Conduct Reporting:
5.20.1. Examples of culture of safety issues and incidents:
5.20.1.1. Staff refusal to comply with IPSG such as refusal to mark the site, perform
time out, wash hands, etc…
5.20.1.2. Staff refusal to follow Facility policies
5.20.1.3. Any act that endangers patients, staff or visitors
5.20.1.4. Staff refusal to provide patient care
5.20.2. Unacceptable behavior
5.20.2.1. Verbal, written or physical attacks that are personal, irrelevant, or
beyond the bounds of fair professional conduct, leveled at other
appointees to the medical staff, Facility personal, patients or patients’
families, or others who are connected with the Facility.

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5.20.2.2. Impertinent and inappropriate verbal or written comments or

illustrations that criticize the quality of care in the Facility or attack
particular physicians, associates, or Facility policies which are made
verbally or in patient medical records or other official documents or
settings.
5.20.2.3. Criticism leveled at the recipient in such a way that it intimidates,
undermines confidence, belittles, or implies stupidity or incompetence,
criminal or immoral activity, or other untrue claims or allegations.
5.20.2.4. Intentional violation of any Facility rules
5.20.3. Professional Misconduct
5.20.3.1. Conduct that threatens the life or well-being of a patient
5.20.3.2. Patients, staff or visitors put at risk of injury or risk to their health, safety
or welfare
5.20.3.3. Conduct that disrupts the normal operations of the Facility
5.20.3.4. Conduct that undermines the reputation and confidence of the Facility.
5.20.3.5. Improper or unethical conduct by the holder of a professional or official
position
5.20.3.6. Knowingly falsifying patient records;
5.20.3.7. Refusing to accept or to properly discharge medical staff or Facility
assignments;
5.20.3.8. Knowingly or persistently ordering or performing unnecessary tests or
procedures;
5.20.3.9. Using Facility property or plans for unauthorized personal gain.
5.20.3.10. The act or an instance of improper practice or allegations of
incompetence
5.20.3.11. Conduct that could be construed as negligence: by doing an act or
failing to do an act to exercise a degree of care that, in the
circumstances, the law or regulations require for the protection of
other persons or those interests of other persons who may be injured
by such care
5.20.3.12. Failure to comply with the Facility Medical Staff Code of Conduct
5.20.3.13. The healthcare provider breaks laws, rules and/or regulations that
govern health care practice and delivery of health care services in the
KSA
5.20.3.14. Healthcare provider refuses to follow patient safety goals, e.g. refuse
to participate or stops the process for completing surgical safety (Time
Out)
5.20.4. Gross misconduct
5.20.4.1. Consumption, production, sale or distribution of alcohol
5.20.4.2. Unauthorized production, sale, distribution or use of unauthorized drugs
5.20.4.3. Theft
5.20.4.4. Offences against KSA law

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5.20.4.5. Fraud
5.20.4.6. Breach of confidentiality
5.20.4.7. Malicious damage (including throwing instruments, charts or other
missiles)
5.20.4.8. Assault (this includes pushing, slapping or spitting on an individual)
5.20.4.9. Gross insubordination
5.20.4.10. Inappropriate sexual or harassing behaviors to other staff or patients/
visitors.

6. RESPONSIBILITY

6.1 Heads of departments are responsible for ensuring that their staff receive appropriate
orientation to ensure they are fully aware of the procedures for reporting and formally
recording all accidents and incidents relating to their work, workplace or workforce.
6.2 It is the responsibility of all employees to immediately report any untoward
incidents/accidents, using the OVR Form.
6.3 The heads of the involved departments are responsible for investigating reported
incidents using RCA, taking actions as appropriate and reporting results to the TQM
Director.
6.4 The TQM department will maintain the database on which all incident reports will be
stored. This department will:
6.4.1 Ensure all reported incidents are graded according to their seriousness.
6.4.2 Ensure standard cause code definitions are recorded for all reported incidents.
6.4.3 Request reports of further information from department heads, following
investigation.
6.4.4 Enter all events onto the incident database.
6.4.5 Analyze data and produce reports periodically.
6.4.6 Conduct further investigations when necessary, using RCA.
6.4.7 Provide periodic reports of findings to corporate office.
6.5 For medico-legal cases Head of Security/Administration/HR receives and manages
security-related information, accidents and incidents as well as providing support and
advice managers with security investigation and remedial action planning.
6.6 The Medical Department will support staff providing confidential care and advice relating
to accidents and incidents.
6.7 The Patient Safety Officer is responsible to supply quarterly summary reports to Safety
Committee for non-clinical incidents; and to the Medical Director for clinical incidents.

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7. FORMS

7.1 OVR Form

8. ATTACHMENTS

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Grading of the Incident:

All incidents must be graded once reported, at the time of reporting the incident using
the Impact Assessment Table and Risk Evaluation Matrix:
Determine the potential likelihood of recurrence.
The Person in Charge at time and place of the incident / the reporter's direct manager
Use the tables for determining:
 Likelihood of Occurrence Categorization Table
 Risk Impact Table
Grade according to the actual impact/severity on the individual and/or organization.
If two or more areas have been affected by the incident, consider which has been
affected the most, to assist in your judgment of the impact/severity of the incident.
Calculate overall risk level (i.e. Red, Amber, Yellow or Green).
Follow the tables on:
 Harm Level for medication Related Incidents
 Risk Matrix Table
 Level of Investigation Required
Likelihood “time-frame-based” scores with descriptors and example definitions
Score 1 2 3 4 5
Descriptor Rare Unlikely Possible Likely Almost Certain
Frequency: This will We don’t It might It will probably It will
General probably never expect it to happen or happen or undoubtedly
description happen or happen or recur recur, but it is happen or
recur. recur, but it is occasionally. not persisting recur, possibly
possible it may issue. frequently.
do so.
Frequency: Never Expected to Expected to Expected to Expected to
“Time frame- expected to occur at least occur at least occur at least occur at least
based” occur for annually. monthly. weekly. daily.
years.
Probability: Less than 0.1% 0.1-1% chance 1-10% chance 10-50% chance Greater than
Will the risk chance the risk the risk will the risk will the risk will 50% the risk
occur or not? will occur. occur. occur. occur. will occur.

Risk Impact Consequence score (severity levels) and examples of descriptors

Score 1 2 3 4 5
Domains Negligible Minor Moderate Major Catastrophic

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Impact on the Minimal injury Minor injury or Moderate Major injury Incident
safety of patients, requiring illness injury leading to long- leading to
staff or public no/minimal requiring requiring term death
(physical/ intervention or minor professional incapacity/ Multiple
psychological treatment intervention intervention disability permanent
harm) No time off Requiring time Requiring time Requiring time injuries or
work required off work for > off work for off work for irreversible
3 days 4 – 14 days >14 days health effects
Increase in Increase in Increase in An event
length of length of length of which impacts
Facility stay by Facility stay by Facility stay by on many
1 – 3 days 4 – 15 days >15 days patients
An event Mismanagemen
which impacts t of patient care
on a small with long-term
number of effects
patients
Adverse publicity/ Rumors 2 or less 2-4 More than 4 All
reputation Potential for newspapers. newspapers. newspapers Newspapers.
public concern Hashtag Hashtags (major ones). Hashtags
(escalation 1 (escalation Hashtags (escalation
tweet per 3-5 tweet per 1.5- (escalation tweet per 1-30
min) 3 min). tweet per 30-90 sec)
Influencers sec) Influencers
participate Influencers participate
participate heavily
Financial Damage/loss Damage/loss Damage/loss Damage/loss to Damage/loss
*provisional to equipment to equipment to equipment equipment or to equipment
or facility or facility or facility facility assets or facility
assets of < assets of assets of 50,001-500,000 assets >
5,000 SAR 5,000-10,000 10,001 – SAR 500,000 SAR
SAR 50,000 SAR.

Risk Matrix Likelihood

1 2 3 4 5
Impact Scores Rare Unlikely Possible Likely Almost certain
5 Catastrophic 5 10 15 20 25
4 Major 4 8 12 16 20
3 Moderate 3 6 9 12 15
2 Minor 2 4 6 8 10
1 Negligible 1 2 3 4 5

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Risk Rating Action Guide

Risk Rating Risk evaluation descriptor Suggested action

1-3 Low risk Maintain existing control
4-6 Moderate risk Review existing control
8 - 12 High risk Improve existing control
15 - 25 Extreme risk Improve existing control measures
immediately

Level of investigation required

Incident Level of investigation required

Grading/ Type
Green (Low) These incidents generally require minimum investigation that can be undertaken
adequately by the ward/departmental manager. However, they must be
monitored regularly to identify patterns or trends and, when necessary, develop
and implement actions.
It is acceptable for the ward/departmental manager to close such incidents
following investigation and recording of findings and lessons learned on electronic
reporting system or OVR database (if paper system is used). Investigation of this
grade of incident should normally be completed and closed within 5 working days.
Yellow (Medium) These incidents generally require minimum investigation that can be undertaken
adequately by the ward/departmental manager. However, they must be
monitored regularly to identify patterns or trends and, when necessary, develop
and implement actions.
It is acceptable for the ward/departmental manager to close such incidents
following investigation and recording of findings and lessons learned on electronic
reporting system or OVR database (if paper system is used). Investigation of this
grade of incident should normally be completed and closed within 10 working
days.
Amber (High) The degree of seriousness of these incidents may require multidisciplinary or
independent investigation. The Head of Service/General Manager for the area
where incident occurred is responsible for ensuring an appropriate level of
investigation is conducted, formal recording and dissemination of findings, actions
taken, lessons learned and closure of these incidents. Where necessary advice can
be taken from the TQM Director or Risk Manager. Investigation of this grade of
incident should normally be completed and closed within 14 working days.

Red (Extreme) The Facility/organization director is responsible for ensuring that a thorough
investigation is undertaken. The organization Director will agree with the Director

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Quality and Safety and Risk Manager whether a Root Cause Analysis is required
and will appoint a lead investigating officer (who is appropriately trained),. The Risk
Management Department maintains a list of staff trained in Root Cause Analysis.
Investigation of this grade of incident should, when possible, be completed within
14 working days. Closure or down-grading of red incidents requires approval by
the TQM Director, who, in conjunction with the Risk Manager will review
investigation/closure of red incidents monthly.

Risk classification system:

Risk Category Explanation Examples

Risk related to financial stability of Inefficient Utilization of resources
Financial Risks the organizations. - Delay in funding
- Invoices processing related risks
- Misuse of funds

Risks associated with the delivery of

2. Clinical/ Patient Safety care to residents, patients and other - Failure to follow evidence -based
healthcare customers. practice, medication errors, Facility
acquired conditions (HAC)
Risks related to the workforce, such - Workplace Injury
3. Human Capital as turnover and absenteeism. - Absenteeism

Strategic risks are concerned with - Merger

4. Strategic Risks risks that can impact organization
development and delivery of its
strategic objectives. Strategic risks
pertain to brand, reputation, and
business strategy.
Risks pertain to exposure to legal - Violence of law
5. Legal/Compliance Risks penalties; an organization faces
when it fails to act in accordance
with industry laws and regulations.
Risk associated with adoption of - Loss of Information
6. Technology Risks technology system such as
electronic health record, and using
advanced technology such as bar
coding, and medical monitoring
devices.
Risks related to the physical loss of - Fire
7. Natural Disaster/Hazard assets such as risks arising from - Earthquakes
earthquakes, windstorms, fire. - Windstorm

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9. REFERENCES

9.1 CBAHI Ambulatory Standards 2016, Standard QM.14.

9.2 JCI Facility Standards 7th Edition, Standard QPS.7, QPS.7.1, QPS.8, and QPS.9.

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11. CORPORATE LEVEL APPROVALS

DESIGNATION NAME, SIGNATURE & DATE

PREPARED BY Corporate TQM Director

Nursing Director

REVIEWED BY Corporate Admin Affairs

VP, Medical Affairs

VP, Operations

APPROVED BY

Corporate VP, Strategic Planning

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