Saudi Patient Safety Taxonomy PDF
Saudi Patient Safety Taxonomy PDF
Saudi Patient Safety Taxonomy PDF
Safety Taxonomy
Table of Contents
08 Acknowledgements 81
09 Appendix - References 83
01 Ministry of Health
Message
Patient Safety is considered as a top priority for the healthcare services provided by the ministry of
health in Saudi, which has been evident in the quality improvement carried projects and initiatives
carried out through MOH facilities. And to ensure the safety of services provided is measurable and
can be continuously improved. We made the commitment to unify the key concepts of patient safety
and categories of patient safety events. Such standardization will help healthcare facilities at MOH and
different healthcare sectors to measure, compare and improve patient safety. We aim that using the
Saudi patient safety taxonomy will support the transparency, the spread of patient safety culture and
encourage research in the field. We would like to thank all the contributing sectors to the development
of the Saudi Patient Safety Taxonomy and we are looking forward for its spread and usage among all
the healthcare facilities from the different sectors in Saudi to get the best benefit of it.
2
02 Introduction
and Executive
Summary
A key progress in the patient safety movement national efforts between expertise from different
has been the call for a common language - healthcare sectors representatives led by the
a taxonomy -for categorizing medical events. MOH and in collaboration with health matrix a
The concept of a taxonomy combines terminology Saudi patient safety taxonomy was developed.
and the science of classification - in the case of
patient safety, the Identification and classification It is important to note that this classification is a
of things that go wrong in health care, the causes conceptual framework for a national classification
why they occur, and the preventive approaches which aims to provide a reasonable understanding
that can minimize their reoccurrence. of patient safety to which existing regional and
national classifications can relate.
In this regard, multiple efforts and initiatives were
established different international organizations, In addition, it is worth mentioning that this national
to standardize the language of science of patient classification is in line with Saudi Arabia's 2030
safety, which will help researchers, patient safety Vision in health sector in the kingdom, and it is in
and quality professionals to study the common line with the National Transformation Program 2020
issues and extract information that can help objectives for the health sector in the Kingdom.
in studying patient safety issues, conduct
benchmark measurements and recommend
effective solutions. Starting with the constructed
taxonomy by the Joint commission in (2005), an
updated taxonomy was released by the World
Health Organization in (2009).
4
The conceptual framework has been developed, consisting of the following high levels
01 02 03
Domain Impact Category
04 05 06
Subcategory Details Level of harm
This framework represents the start of an on-going process of progressively improving a common
national understanding of terms and concepts relevant to patient safety.
In addition, this document provides background information about the taxonomy structure and
contents, as well as, the methodology of creating the conceptual framework. In addition, this
document includes the common terminologies related to patient safety with their definitions.
5
6
03 Saudi Patient
Safety Taxonomy
(S-PST)
7
3.1 Introduction
Patient safety taxonomy has been on the Key representative of quality and patient safety
national health agenda in the Kingdom of Saudi from the Ministry of health, and different healthcare
Arabia in the last few years. In Nov 2015, King sectors have participated in the workshop. A key
Faisal Specialist Hospital and Research recommendation of the workshop was to develop
Center (KFSH&RC) organized a closed panel and adopt a patient safety taxonomy system,
discussion session in Jeddah titled “Towards a and to take this initiative beyond MOH towards
National Patient Safety Taxonomy” panel members the national level. Hence, a multiple expertise
from different healthcare sectors participated taskforce from different health care sectors has
in assessment and ideas generation. Initiatives been formed to develop patient safety taxonomy
continued and a workshop titled “Improving for the Saudi healthcare system.
MOH incident reporting system workshop”
initiated by the Ministry of Health quality
improvement department with the collaboration
of health matrix held on the 19th of Oct, 2016
in Riyadh to discuss the implications for
improvement of MOH hospitals incident reporting
system and to come up with recommendations
and improvement plan.
8
3.2.2 What does Saudi Patient Safety Taxonomy include?
A patient Safety Taxonomy could include, but is not limited to, the following
01
Nomenclature and definition of terms and concepts related to patient safety.
02
Comprehensive Classification Structure and Algorithms that share characteristics and relationships
among the different patient safety concepts and domains.
03
Coding that include symbols and numbers for ease of data collection and abstraction utilizing
information technology.
The purpose of the national classification for Patient Safety is to enable categorization of patient
safety information using standardized sets of concepts with agreed definitions, preferred
terms and the relationships between them. The classification is designed to be a genuine
conjunction of national perceptions of the main issues related to patient safety and to facilitate the
description, comparison, measurement, monitoring, analysis and interpretation of information to
improve patient care and its related policies.
9
Facilitates research projects and comparison Allows for components of the taxonomy to
of safety research findings. drive additional investigative processes.
Enhances the internal and external comparison Facilitates the implementation of the best
of safety data analysis and benchmarking within practice in terms of clinical and non-clinical
and across healthcare organizations. classification based on various experiences in
the region.
Allows for interoperability of computer data
systems that collect information about these
incidents for analysis, public reporting and
policy making.
3.2.4 How to use the Taxonomy with paper based reporting system?
Saudi Taxonomy provides the clinical and non-clinical incident hierarchy (Categories, Sub-
Categories) based on the incident nature and how it fits into the common practice in healthcare
organizations, regardless of how it is labelled and described internally in your organization.
However, it is recommended to build the paper based form to be aligned with this Saudi taxonomy,
and this will facilitate the process in the future when moving to electronic system.
By adopting an electronic system in your organization, it would be easy to upload the taxonomy
hierarchy into your system data base by building the same levels and structure in the system. That
could be done easily by extracting the structure of the taxonomy into an excel sheet (through the
website of taxonomy stated in this book) for uploading into the electronic system.
This will improve the user experience of reporting using a well-known taxonomy structure. This
means you do not have to spend time and effort devising your own classification system and you can
start capturing incident reports straight away.
10
3.3 Future Plans for Saudi Patient Safety Taxonomy
This Saudi- National Patient Safety Taxonomy is considered as version 1, while the task force is
planning to release updated versions in the future, the upcoming version will be extended to cover
the following aspects
Taxonomy content is an important aspect where it should be maintained regularly, and the content
would need to be reviewed in order to be aligned with the practices on the ground. Therefore, taskforce
already considered the need of receiving the comments and feedback from all relevant parties in
Healthcare sector, looking for improving the taxonomy content to ensure that the health sector is
functioning optimally.
The taskforce has also developed the following mechanism to receive and follow up feedback from
healthcare facilities in the Kingdom, and to include the acceptable improvements as appropriate:
Feedback and comments related to the The representative of the Saudi Patient Safety
content of the Saudi Patient Safety Taxonomy Center collects all feedback and improvements
will need to be sent to the Saudi Patient Safety and shares them with the taskforce.
Center as per the contact details mentioned at
the end of this document.
11
Taskforce meeting will be held quarterly The representative of the Saudi Patient Safety
in order to study and process all comments Center sends the decisions to all relevant parties
and feedback, this includes what has been who sent their feedback to ensure that the loop
accepted, and what has not along with the is closed properly.
rejection reason(s).
The representative of the Saudi Patient Safety Publication and printing of the new version of
Center will be working to create a comprehensive the Saudi classification of patient safety on an
log for all accepted changes and any new annual base, including these approved changes
amendments. and amendments
The task force members believe that the current version of the taxonomy covers the majority
of aspects related to patient safety taxonomy. However, we strongly believe that such Taxonomy
would need to be kept up-to-date, having said so the task force will have frequent quarterly meeting
to discuss the potential improvement and enhancements which might need to be implemented on the
taxonomy. During these frequent meetings the task force will discuss and approve any changes on the
taxonomy based on the feedback. Healthcare organizations are encouraged to send their feedback to
the following email address: info@spsc.gov.sa.
12
3.5 Automation of Saudi Patient Safety Taxonomy (S-PST)
As a part of developing the S-PST communication channels with all relevant teams in healthcare
organizations, the taskforce decided to create a closed LinkedIn group in order to receive
contributions and inputs from whoever is concerned with patient safety taxonomy. In addition, this
group will be considered as a voting channel on the changes, improvements and any requests raised
by any team member in this group.
On another hand, and for the same purpose of promoting the contribution to this national project,
the taskforce will make this S-PST document available as an electronic copy, where users and
concerned people can extract the contents into a different formats like excel sheets. This is part
of achieving one of the technology objectives for healthcare sector in National Transformation
Program 2020.
In collaboration with Health Matrix, the task force developed an on-line portal software to maintain
the taxonomy. Health care sectors will have an access to the portal where they can download the
taxonomy in different formats, and upload it to their local Incident reporting system. The software will
be available on the Saudi Patient Safety Center website.
13
3.6 Taxonomy Implementation Plan
All healthcare sectors within Saudi Arabia as in the near future will be encouraged to report aggregated
data related to Patient Safety and Incident Reporting using the taxonomy.
14
04 Research
Resources
and Methods
15
4.1 Research Taskforce
The taskforce was comprised of experts from the fields of patient safety, quality, health informatics,
accreditation bodies, and medicine. From the start, the taskforce realized that the “problems do not lie
with the words we use, but rather with the underlying concepts". This means that it is the conceptual
definitions that are important, as well as the terms or labels assigned to the concepts. Without
universally accepted conceptual definitions, understanding will continue to be impeded.
The taskforce members have long experience in their organizations, where their contribution
was very helpful and necessary to provide the credibility to this taxonomy as they are part
of national context in Saudi. However, the taskforce members will be listed in this book under the
“Acknowledgement Section”
The project comprised a review and evaluate of an existing patient safety terminologies and
taxonomies (classifications), and identification of those that should be included in the core set of
a standardized taxonomy, assessment of the taxonomy’s face and content validity, gathering of
inputs from leaders of patient safety in multiple disciplines, voting on the proposed selections and a
preliminary study of the taxonomy’s comparative reliability.
The conceptual framework evaluated the country culture as well, ensured that this national taxonomy
fits for purpose, meaningful, useful and appropriate for classifying patient safety data and information.
In order to guide its’ work in National Taxonomy, the taskforce followed a set of principles
The purpose and potential users and uses The categories be applicable to the full
for the classification be clearly articulated. spectrum of healthcare settings in Saudi, and
GCC countries in the future.
The classification be based upon concepts
as opposed to terms or labels. The classification be complementary to
the WHO Family of International Classifications.
The language used for the definitions of the
concepts be culturally and linguistically appropriate. The conceptual framework be a genuine
convergence of national perceptions of the main
The concepts be organized into meaningful issues related to patient safety.
and useful categories.
17
4.4 Workshops Photos
18
05 Patient Safety
Terminologies
and Definitions
19
As part of the road map of building S-PST, standardization of terminologies and their definition
is essential for this process. Therefore, this section has been designed to illustrate the proposed
common language for patient safety taxonomy.
Predefined and agreed terminologies and definitions will help in facilitating the study of the taxonomy
structure in much better way to move forward to addressing the taxonomy contents smoothly in the future.
Incident
An event or circumstance that harmed or has the potential to harm a person
or a property in relation to the organisation, resulting from human behaviour
and/or system failure.
Patient Safety
Freedom from accidental or preventable injuries produced by medical care.
Thus, practices or interventions that improve patient safety are those that
reduce the occurrence of preventable adverse events.
Taxonomy
A standardized classification for key patient safety concepts. The purpose of
the International Classification for Patient Safety is to enable categorization of
patient safety information using standardized sets of concepts with agreed
definitions, preferred terms, and the relationships between them based on
explicit domain ontology It is designed to facilitate the description, comparison,
measurement, monitoring, analysis and interpretation of information to improve
patient care, and for epidemiological and health policy planning purposes.
20
Terminologies and Definitions
Moderate
Vital signs changes. Decreased level of consciousness. Additional medication/
treatment required. Invasive diagnostic procedure required.
Major
Any unexpected or unintended incident that caused permanent or long-
term harm to one or more persons.
Sentinel Event
Is any event leading to serious patient harm or death and is caused by
healthcare (human error/behaviour and/or system failure) rather than the
patient’s underlying illness.
Medication error
Is any preventable event that may cause or lead to inappropriate medication
use or patient harm while the medication is in the control of the health care
professional, patient, or consumer.
Dispensing Phase/Stage
Errors that occur at any stage during the dispensing process from the receipt
of a prescription in the pharmacy through to the supply of a dispensed
product to the patient This is dispensing error.
21
High Alert Medication
Medications that bear a heightened risk of causing significant harm when
used in error.
Administration Phase/Stage
The phase of giving of a pharmacologic or other therapeutic agent by the
healthcare professionals. (stage)
Administration Error
Inappropriate procedure or improper technique in the administration of a
drug. This is administration error.
Monitoring Phase/Stage
To observe or record relevant physiological or psychological signs during
and after medication administration. (stage)
Monitoring Error
Failure to review a prescribed regimen for appropriateness and detection
of problems, or failure to use appropriate clinical or laboratory data for
adequate assessment of patient response to prescribed therapy. (error)
Preparation Error
Drug product incorrectly formulated or manipulated before administration.
This is Preparation error.
Preparation Phase/Stage
Act or process of making the medication ready for administration.
Pharmaceutical formulation is the process in which different chemicals/
substances are combined to produce a final medicinal product. Formulation
is often used in any way that includes dosage form. (stage)
22
Prescribing Error
Incorrect drug selection (based on indications, contraindications, known
allergies, existing drug therapy, and other factors), dose, dosage form,
quantity, route, concentration, rate of administration, or instructions for use
of a drug product ordered or authorized by physician (or other legitimate
prescriber). This is a prescribing error.
Storage Phase/Stage
Process of keeping medications in a specially designed secure area or space
of a building to avoid contamination or deterioration, avoid disfiguration of
labels, maintain integrity of packaging and guarantee quality and potency of
drugs during shelf life; prevent or reduce pilferage, theft to loss; and prevent
infestation of pests and vermin.
Storage Error
Incorrect storage of a drug by the pharmacist, nurse or patient, altering the
drug’s potency. This is storage error.
Risk
Risk is the effect of uncertainty on objectives. Risk is often expressed in
terms of a combination of the consequences of an event (including changes
in circumstances) and the associated likelihood of occurrence.
Risk Assessment
Is the process where you identify hazards, analyse or evaluate the risk
associated with that hazard, and determine appropriate ways to eliminate
or control the hazard.
23
Risk Management
The process of identification, assessment, analysis and management of all
risks and incidents for every level of the organization, and aggregating the
results at a corporate level, which facilitates priority-setting and improved
decision making to reach optimal balance of risk, benefit and cost.
Risk Analysis
Process used to determine the potential severity of the loss from an
identified risk, the probability a loss will happen, and alternatives for dealing
with the risk. Also, referred to as Hazard Analysis.
Risk Identification
Process that involves finding, recognizing and describing the risks that
could affect the achievement of an organization’s objectives. It also includes
identification of possible causes and potential consequences.
Likelihood
How likely (frequency) is it that the risk event will occur / reoccur.
Outcomes
Is the quantified estimate of degree of harmor damage.
Risk Attitude
Organization's approach to assess and eventually pursue, retain, take or
turn away from risk
Risk Source
Element which alone or in combination has the intrinsic potential to give
rise to risk.
24
Risk Owner
Person or entity with the accountability and authority to manage a risk.
Level of Risk
Magnitude of a risk or combination of risks, expressed in terms of the
combination of consequences and their likelihood.
25
Terminologies and Definitions
Human Factors
The study of the interrelationships between humans, the tools they use, the
environment in which they live and work, and the design of efficient, human
cantered processes to improve reliability and safety.
Culture
Is the product of individual and groups values, attitudes, perceptions,
competencies and patterns of behaviour that determine the
commitment to, and the style and proficiency of, an organization’s
health and safety management
Environment
The circumstances, objects, or conditions surrounding an individual.
Mandatory Reporting
Refers to the legal requirement to report to authorities, which may apply to
the general public, health practitioners and other professions.
Outcome
A final result, conclusion or impact after delivering the healthcare services.
Process
A series of related actions to achieve a defined outcome.
26
Surgical Site Infection
A surgical site infection is an infection that occurs after surgery in the part of
the body where the surgery took place.
Just Culture
A process for achieving a balanced system and individual accountability in
a manner that best supports patients, staff and the organizational values
and objectives.
Human Error
Inadvertently doing other than what was intended: Skill based errors: a slip
in action, lapse in memory, or mistakes: rule based errors or knowledge
based errors.
At-risk behaviour
At-risk behaviour is a behavioural choice that increases risk where risk is not
recognized or is mistakenly believed to be justified
Reckless Behaviour
Is a behavioural choice to consciously disregard a substantial and
unjustifiable risk. It is an intentional risk taking; knowing risk associated with
action but consciously disregards it.
Quality Management
It is the act of overseeing all activities and tasks needed to maintain a
desired level of excellence. This includes the determination of a quality
policy, creating and implementing quality planning and assurance, quality
control and quality improvement.
Quality
Degree to which a set of inherent characteristics of an object fulfils requirements.
27
Terminologies and Definitions
Potential Error
Circumstances or events that have the capacity (potentiality) to cause error.
Voluntary Reporting
It is the process of reporting safety events, by anyone, being directly or
indirectly involved, in a confidential manner.
Contributing Factor
Contributory Factors are those which affect the performance of individuals
whose actions may have an effect on the delivery of safe and effective
service or products.
Benchmark
Is the comparison of an organizations or practitioners results against a
reference point (Best Practice) which enable organizations or individuals
to set a target.
System Failure
A fault, breakdown or dysfunction within an organization's operational
methods, processes or infrastructure.
28
Disclosure
Is to inform the patient, or the patient’s representative, of any adverse event
or error in his treatment.
Safety Culture
The safety culture of an organization is the product of individual and group
values, attitudes, perceptions competencies, and patterns of behaviour
that determine the commitment to, and the style and proficiency of, an
organization’s health and safety management.
Time-out
Planned periods of quiet and/or interdisciplinary discussion focused on
ensuring that key procedural details have been addressed. For instance,
protocols for ensuring correct site surgery often recommend a time out to
confirm the identification of the patient, the surgical procedure, site, and
other key aspects, often stating them aloud for double-checking by other
team members.
Best Practices
Best practices Clinical, scientific or professional practices that are recognized
by a majority of professionals in a particular field. These practices are typically
evidence based and consensus-driven.
29
Common Cause Variation
Variation in a process that is due to the process itself and is produced
by interactions of variables of that process. Common-cause variation is
inherent in all processes; it is not a disturbance in the process. It can be
removed only by making basic changes in the process.
Mitigation
An action or circumstance which prevents or moderates the progression of
an incident towards harming a patient.
30
Terminologies and Definitions
Hazard
An object or material that has the potential to cause harm.
Adverse Event
An event that results in unintended harm to the patient by an act of
commission or omission rather than by the underlying disease or condition
of the patient.
Circumstance
A situation or factor that may influence an event, agent or person(s).
Extravasation
Extravasation is when a chemotherapy medication or other drug leaks
outside the vein onto or into the skin, causing a reaction.
31
Stage 1 Pressure Injury: Non-blanchable erythema of intact skin
Colour changes do not include purple or maroon discoloration; these may
indicate deep tissue pressure injury.
32
Stage 4 Pressure Injury: Full-thickness skin and tissue loss
Full-thickness skin and tissue loss with exposed or directly palpable fascia,
muscle, tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar
may be visible. Epibole (rolled edges), undermining and/or tunneling often
occur. Depth varies by anatomical location. If slough or eschar obscures the
extent of tissue loss this is an Unstageable Pressure Injury.
Near Fall
An event in which a person feels a fall is imminent but avoids it by compensatory
action, such as grabbing a nearby object or controlling the fall.
Assisted Fall
Assisted Fall occurs when the patient begins to fall, is assisted by another
person, but nevertheless reaches the ground or other unintended surface.
33
Terminologies and Definitions
Hazmat
A hazardous material is any item or agent (biological, chemical,
radiological, and/or physical), which has the potential to cause harm to
humans, animals, or the environment, either by itself or through interaction
with other factors.
Extravasation Grade 1
Pain at infusion site, No swelling.
Extravasation Grade 2
Pain at infusion site, Swelling and No skin blanching.
Extravasation Grade 3
Pain at infusion site, Swelling, Skin blanching and Capillary refill normal.
Extravasation Grade 4
Pain at infusion site, Swelling, Skin blanching, Reduced, capillary refill, '+/-
Decreased or absent distal pulse and '+/- Blistering or skin breakdown.
34
06 Saudi Patient
Safety Taxonomy
35
06 Structure of Patient Safety Taxonomy
The taskforce designed the conceptual In addition, the conceptual framework has
framework for the Structure of National Patient identified a very significant level which is the “Level
Safety Taxonomy to provide a much needed of Harm”, and this is why it has been added as
method of organizing patient safety data and the 6th level in the patient safety taxonomy.
information so that this data and information
could be aggregated and analyzed.
36
Incident
Mortality Domain
01
Mobidity
02
Impact Impact Impact Impact
Sub-Category Sub-Category
04
02
Details 05
06
37
Domain Impact
The characteristics of the setting in which The influence, outcomes or effects of fields of
an event occurred it is also the type of event groups that are affected by event result.
criteria and it isn’t for type of individuals
involved.
Category Sub-Category
The implied or visible process that were faulty The factors and agent that led to an event,
or failed, these processes have a common describes the nature of the event or injury, and
nature, grouped because of shared and gives additional information.
agreed criteria.
38
07 Saudi Patient
Safety Taxonomy
Contents
39
7.1 Domain Level
Domain Incident
Domain Incident
40
7.3 Categories
41
7.4 Categories and Subcategories and Details:
42
No. Category Subcategory Details
43
No. Category Subcategory Details
Suspected Abuse
Security Related and Neglect
1. 1.2. 1.2.4. Elderly Neglect
Issues by Healthcare
provider/family
Suspected Abuse
Security Related and Neglect
1. 1.2. 1.2.5. Child Neglect
Issues by Healthcare
provider/family
Suspected Abuse
Security Related and Neglect
1. 1.2. 1.2.6. Adult Neglect
Issues by Healthcare
provider/family
Security Related
1. 1.3. Theft and Lost 1.3.1. Missing property
Issues
Security Related Narcotics and Controlled drug cabinet keys/
1. 1.4. 1.4.1
Issues Dangerous Drugs access issues
Security Related Narcotics and Controlled medication count not
1. 1.4. 1.4.2.
Issues Dangerous Drugs done
Security Related Narcotics and Controlled medication left
1. 1.4. 1.4.3.
Issues Dangerous Drugs unsecured
Security Related Narcotics and
1. 1.4. 1.4.4. Narcotic Broken Full ampoule/vial
Issues Dangerous Drugs
Security Related Narcotics and
1. 1.4. 1.4.5. Controlled medication spilled
Issues Dangerous Drugs
Security Related Narcotics and
1. 1.4. 1.4.6. Controlled medication-broken
Issues Dangerous Drugs
Security Related Narcotics and Controlled medication-inadvertent
1. 1.4. 1.4.7.
Issues Dangerous Drugs disposal
Security Related Narcotics and
1. 1.4. 1.4.8. Duplication Medication
Issues Dangerous Drugs
Noncompliant/
Uncooperative/
2. Behavior 2.1.
Inappropriate
Behavior
Inconsiderate/
2. Behavior 2.2. Rude/Hostile
Behavior
Discrimination/
2. Behavior 2.3. Prejudice
Behavior
44
No. Category Subcategory Details
Death Threat
2. Behavior 2.4.
Behavior
Aggression
2. Behavior 2.5.
Behavior
Disruptive
2. Behavior 2.6.
behaviors
Family/sitter
2. Behavior 2.7. interfering with
patient care
Refusal to
3. Staff related issues 3.1. perform assigned
tasks
Non-Performance
3. Staff related issues 3.2. of Duty/Breach of
Duty
Reporting for
3. Staff related issues 3.3.
Retaliation
3. Staff related issues 3.4. Bullying
Dress Code
3. Staff related issues 3.5.
Violation
Inappropriate/
3. Staff related issues 3.6. Irresponsible
Behavior
Lack Professional
3. Staff related issues 3.7.
Development
Staff
3. Staff related issues 3.8. Confidentiality/
Disclosure
3. Staff related issues 3.9. Unfair Dismissal
45
No. Category Subcategory Details
46
No. Category Subcategory Details
47
No. Category Subcategory Details
48
No. Category Subcategory Details
49
No. Category Subcategory Details
50
No. Category Subcategory Details
51
No. Category Subcategory Details
Delay in
8. Facility Maintenance 8.17. maintenance
work
Major Disruption
8. Facility Maintenance 8.18.
of power supply
Major Disruption
of water systems/
8. Facility Maintenance 8.19.
services or
Flooding
8. Facility Maintenance 8.20. Steam Drop
52
No. Category Subcategory Details
Improper
condition of
firefighting
9. Environmental/ Safety 9.12.
systems (e.g.
Over-due
inspection)
Projects safety
9. Environmental/ Safety 9.13. violations
(Internal/External)
Fire alarms not
9. Environmental/ Safety 9.14.
working
9. Environmental/ Safety 9.15. Noise pollution
Improper usage
of personal
9. Environmental/ Safety 9.16.
protective
equipment (PPE)
Emergency
9. Environmental/ Safety 9.17. call system
malfunction
Monitor Alarm
9. Environmental/ Safety 9.18.
Turned Off
Safety
9. Environmental/ Safety 9.19. precautions not
followed
9. Environmental/ Safety 9.20. Fire room blocked
Heavy hanged
9. Environmental/ Safety 9.21. equipment fall to
the floor
Lack of ramp
9. Environmental/ Safety 9.22. for emergency
evacuation
Violating Smoking
9. Environmental/ Safety 9.23.
Policy
Improper uses of
9. Environmental/ Safety 9.24.
fire hose reel
Broken medical
9. Environmental/ Safety 9.25.
gas valve box
Electrical cabinet\
9. Environmental/ Safety 9.26.
room not locked
53
No. Category Subcategory Details
High pressure
9. Environmental/ Safety 9.27. supply of Nitrous
oxide
Improper gas
9. Environmental/ Safety 9.28. storage / not
secured
Improper handling
9. Environmental/ Safety 9.29. of biohazard
waste
improper storage
9. Environmental/ Safety 9.30.
of chemicals
No call bell inside
9. Environmental/ Safety 9.31.
the bathroom
No fire alarm pull
9. Environmental/ Safety 9.32.
station
No warning sign
9. Environmental/ Safety 9.33. upon mapping
the floor
Oxygen cylinder
regulator not
9. Environmental/ Safety 9.34.
connected
properly
Oxygen cylinders
9. Environmental/ Safety 9.35.
not replaced
Sharp edge plate
9. Environmental/ Safety 9.36. on main access
door
Smoke detector
9. Environmental/ Safety 9.37.
removed
Unknown
chemical,
9. Environmental/ Safety 9.38.
potentially
hazardous
The Arrival of
candidates to
Accommodation accommodation
10. 10.1.
related issues without Prior
Notice form HR/
Recruitment
Accommodation Delay of Housing
10. 10.2.
related issues Maintenance
54
No. Category Subcategory Details
Accommodation
10. 10.3. Furniture misuse
related issues
Accommodation Lack of Cooking
10. 10.4.
related issues Facilities
Lack of
Accommodation
10. 10.5. Laundromat
related issues
Facilities
Lack of
Accommodation
10. 10.6. Refrigerator
related issues
Facilities
Accommodation
10. 10.7. Housing security
related issues
Unauthorized
Accommodation
10. 10.8. design
related issues
modification
Accommodation Unsafe
10. 10.9.
related issues Environment
Information technology Abuse of system
11. 11.1.
related issues authorities
Accessing
systems using
someone else’s
Information technology
11. 11.2. authorization
related issues
e.g. someone
else’s user id and
password
Disruption of
Information technology Information
11. 11.3.
related issues Technology
services
Information technology Information
11. 11.4.
related issues security Issues
Information
Information technology
11. 11.5. leakage due to
related issues
software errors
Information technology Spreading of
11. 11.6.
related issues viruses
Information technology
11. 11.7. Poor IT response.
related issues
55
No. Category Subcategory Details
Lack of IT
Supplies (e.g.
Information technology ink, PC, scanner,
11. 11.8.
related issues printers, DSL
Modem, phone,
pager)
Posting or sharing
official or patient
Information technology
11. 11.9. information on
related issues
social networking
websites.
Someone
Information technology asking to reset
11. 11.10.
related issues passwords not
belonging to them
Security
Information technology
11. 11.11. weakness within
related issues
the system
Inappropriate
Information technology storage facilities
11. 11.12.
related issues for patient related
information
Delay of reporting
Medical imaging and
12. 12.1. Images for
diagnostic procedure
diagnosis
Failure to comply
Medical imaging and
12. 12.2. with reporting of
diagnostic procedure
critical finding
Medical imaging and
12. 12.3. No NPO Order
diagnostic procedure
Medical imaging and High Creatinine
12. 12.4.
diagnostic procedure Level
Cold meal
13. Food services 13.1.
delivered
Delayed meal
13. Food services 13.2.
delivery
Foreign object
13. Food services 13.3.
found in food
Lack of
13. Food services 13.4. information on
meal request
56
No. Category Subcategory Details
Incorrect Storage
13. Food services 13.5.
of food
Late meal
13. Food services 13.6.
modifications
Problems related
to ordering,
13. Food services 13.7. prescription and
serving of feed/
foods/fluids
12.8. Storage of
13. Food services
V expired food
Wrong meal
13. Food services 13.9.
request
Diet for Wrong
13. Food services 13.10.
Patient
13. Food services 13.11. Wrong Diet
57
No. Category Subcategory Details
Absence/Delay
of Nutritional
14. Clinical Nutrition 14.4
Assessment of
Clinical Dietitian
Wrong Frequency
14. Clinical Nutrition 14.5. by Clinical
Dietitian
Diet order not
14. Clinical Nutrition 14.6.
updated
14. Clinical Nutrition 14.7. Known allergy
58
No. Category Subcategory Details
59
No. Category Subcategory Details
60
No. Category Subcategory Details
Injury caused by
16. Occupational health 16.11 physical or mental
strain
Traffic Accident
(Outside the
organization
16. Occupational health 16.12.
performing
organizational
duty)
Injury caused
by workplace
16. Occupational health 16.13.
violence
or assaults
Cleanliness of
17. Housekeeping 17.1.
facilities
Poor
17. Housekeeping 17.2. housekeeping
response
Lack of
17. Housekeeping 17.3. housekeeping
items supplies
Medical/non-
17. Housekeeping 17.4. medical waste
mixing
Misuse of
17. Housekeeping 17.5.
housekeepers
Grade 1/
18. Intravenous 18.1.
Extravasation
Grade 2/
18. Intravenous 18.2.
Extravasation
Grade 3/
18. Intravenous 18.3.
Extravasation
Grade 4/
18. Intravenous 18.4.
Extravasation
Accidental
18. Intravenous 18.5.
Dislodgement
18. Intravenous 18.6. Occlusion
61
No. Category Subcategory Details
Wrong Label/
18. Intravenous 18.8.
Instruction
Accidental
18. Intravenous 18.9. Removal/
Dislodge
18. Intravenous 18.10. Phlebitis
Remove /
18. Intravenous 18.11. Changed without
Order
18. Intravenous 18.12. Not Sutured
Wrong
18. Intravenous 18.13.
Connection
18. Intravenous 18.14. Wrong insertion
Long time to
18. Intravenous 18.15.
change
18. Intravenous 18.16. Leaking
62
No. Category Subcategory Details
Bruise\Skin
20. Skin lesions/ Integrity 20.2.
Lesion
20. Skin lesions/ Integrity 20.3. Cut Wound
63
No. Category Subcategory Details
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.3. Charting error
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.4. Communication problem
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.5. Compliance error
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.6. Contraindication
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.7. Medication Delivery Delay
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.8. Wrong/unclear dose
Preparation,
Prescribing,
Transcribing
64
No. Category Subcategory Details
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.9. Drug-drug interaction
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.10 .Drug passed expiry date
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.11. Wrong dosage form
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.12. Wrong frequency
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.13. Wrong/omitted height
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.14. High Alert Label Missing
Preparation,
Prescribing,
Transcribing
65
No. Category Subcategory Details
Administration,
Dispensing,
Documentation,
Wrong/omitted patient information
21. Medication 21.2. Monitoring, 21.2.15.
leaflet
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.16. Medication duplication
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, Wrong patient
21.2.17.
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.18. Omitted medicine label
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.19. Omitted medicine/ingredient
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.20. Omitted/Wrong diagnosis
Preparation,
Prescribing,
Transcribing
66
No. Category Subcategory Details
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.21. Wrong method of preparation
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.22. Wrong quantity
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
Adverse drug reaction (when used
21. Medication 21.2. Monitoring, 21.2.23.
as intended)
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.24. Wrong route
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.25. Wrong storage
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.26. Unauthorized prescriber
Preparation,
Prescribing,
Transcribing
67
No. Category Subcategory Details
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.27. Medication unavailable
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
Wrong/omitted verbal patient
21. Medication 21.2. Monitoring, 21.2.28.
directions
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.29. Wrong/omitted weight
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.30. Wrong/omitted expiry date
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.31. Wrong medicine label
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.32. Wrong/unclear strength
Preparation,
Prescribing,
Transcribing
68
No. Category Subcategory Details
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.33. Wrong drug/medicine
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.34. Wrong/unclear indication
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.35. Wrong/unclear rate
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.36. Wrong/unclear administration time
Preparation,
Prescribing,
Transcribing
Administration,
Dispensing,
Documentation,
21. Medication 21.2. Monitoring, 21.2.37. Wrong/unclear duration
Preparation,
Prescribing,
Transcribing
Poor call center
22. Communication issues 22.1.
response
Communication
between staff,
22. Communication issues 22.2.
teams or
departments
69
No. Category Subcategory Details
Communication
with the patient
22. Communication issues 22.3.
(other than
consent issues)
Failure of
22. Communication issues 22.4. Emergency-Call
system
Failure of paging
22. Communication issues 22.5.
system
Failure of
22. Communication issues 22.6.
telephone system
Out On Pass
22. Communication issues 22.7.
Policy
Transport
22. Communication issues 22.8.
Schedule/Policy
22. Communication issues 22.9. Delay of response
Difficulty in
22. Communication issues 22.10. communicating
critical lab results
Inappropriate
22. Communication issues 22.11.
communication
Inappropriate
22. Communication issues 22.12 response to
emergency call
Incorrect
22. Communication issues 22.13.
interpretation
Unprofessional
22. Communication issues 22.14.
communication
Wrong
22. Communication issues 22.15. information
communicated
22. Communication issues 22.16. Miscommunication
Acceptance/
22. Communication issues 22.17.
eligibility issues
23. Falls 23.1. Assisted Falls
1st fall and
23. Falls 23.2.
Assisted fall
70
No. Category Subcategory Details
71
No. Category Subcategory Details
Unknown/Found
23. Falls 23.26.
on Floor
Radiation treatment
(Ionizing radiation Non- Eye or face
24. 24.1.
Ionizing (US, UV, MRI, splash
Laser, other)
Radiation treatment
(Ionizing radiation Non- Radiopharmaceuticals
24. 24.2.
Ionizing (US, UV, MRI, decay
Laser, other)
Radiation treatment
(Ionizing radiation Non- Radiopharmaceuticals
24. 24.3.
Ionizing (US, UV, MRI, Expiry
Laser, other)
Radiation treatment
Radiation
(Ionizing radiation Non-
24. 24.4. unnecessary
Ionizing (US, UV, MRI,
exposure
Laser, other)
Radiation treatment
(Ionizing radiation Non- Radiopharmaceuticals
24. 24.5.
Ionizing (US, UV, MRI, mislabeling
Laser, other)
Radiation treatment
(Ionizing radiation Non- Radiopharmaceuticals
24. 24.6.
Ionizing (US, UV, MRI, leakage
Laser, other)
Radiation treatment
(Ionizing radiation Non- Radiopharmaceuticals
24. 24.7.
Ionizing (US, UV, MRI, wrong location
Laser, other)
Radiation treatment
(Ionizing radiation Non- Radiopharmaceuticals
24. 24.8.
Ionizing (US, UV, MRI, mishandling
Laser, other)
Radiation treatment
(Ionizing radiation Non- Radiopharmaceuticals
24. 24.9.
Ionizing (US, UV, MRI, missing
Laser, other)
Radiation treatment
(Ionizing radiation Non-
24. 24.10. Radiation overdose
Ionizing (US, UV, MRI,
Laser, other)
72
No. Category Subcategory Details
Radiation treatment
(Ionizing radiation Non- Radiopharmaceuticals
24. 24.11.
Ionizing (US, UV, MRI, shortage
Laser, other)
Radiation treatment
(Ionizing radiation Non-
24. 24.12. Radiopharmaceuticals spill
Ionizing (US, UV, MRI,
Laser, other)
Radiation treatment
(Ionizing radiation Non- Radiation under-
24. 24.13.
Ionizing (US, UV, MRI, dose
Laser, other)
Radiation treatment
(Ionizing radiation Non-
24. 24.14. Cluttered area
Ionizing (US, UV, MRI,
Laser, other)
Radiation treatment
(Ionizing radiation Non-
24. 24.15. Poisoning
Ionizing (US, UV, MRI,
Laser, other)
NICU Admissions
Labor and Delivery
25. 25.1. for Baby above
related issues
36wks
Labor and Delivery Placental
25. 25.2.
related issues abruption
Anesthetic
Labor and Delivery problem
25. 25.3.
related issues connected with
labor or delivery
APGAR score
Labor and Delivery
25. 25.4. less than 7 (at 5
related issues
minutes)
Labor and Delivery Born before
25. 25.5.
related issues arrival
Labor and Delivery Breech
25. 25.6.
related issues presentation
Labor and Delivery Birth – Related
25. 25.7.
related issues Trauma
Labor and Delivery
25. 25.8. Cord prolapse
related issues
73
No. Category Subcategory Details
Undiagnosed
Labor and Delivery
25. 25.9. cephalo-pelvic
related issues
disproportion
Elective
Labor and Delivery
25. 25.10. Caesarean
related issues
Section
Emergency
Labor and Delivery
25. 25.11. Caesarean
related issues
Section
Labor and Delivery
25. 25.12. Difficult delivery
related issues
Labor and Delivery
25. 25.13. Shoulder dystocia
related issues
Labor and Delivery Fetal distress with
25. 25.14.
related issues Poor Outcome
Labor and Delivery Labor assisted by
25. 25.15.
related issues forceps
Labor and Delivery Unplanned home
25. 25.16.
related issues birth
Delivery using
Labor and Delivery
25. 25.17. more than one
related issues
instrument
Labor and Delivery Intrapartum
25. 25.18.
related issues hemorrhage
Labor and Delivery IUGR or placental
25. 25.19.
related issues insufficiency
Prolonged first or
Labor and Delivery
25. 25.20. second stage of
related issues
labor
Injury or poor
Labor and Delivery
25. 25.21. outcome for the
related issues
mother
Labor and Delivery Labor or delivery
25. 25.22.
related issues – other
Labor and Delivery Delivery with PH
25. 25.23.
related issues <7
Post-partum
Labor and Delivery
25. 25.24 hemorrhage >
related issues
1,000ml
74
No. Category Subcategory Details
75
No. Category Subcategory Details
Unexpected loss
28. Sentinel Events 28.2.
of limb or function
Wrong patient,
28. Sentinel Events 28.3. wrong procedure
or wrong site
Retained
28. Sentinel Events 28.4. instrument or
sponge
Serious
medication error
28. Sentinel Events 28.5.
leading to death
or major morbidity
Suicide of a
28. Sentinel Events 28.6. patient in an
inpatient unit
28. Sentinel Events 28.7. Maternal death
Hemolytic blood
28. Sentinel Events 28.8. transfusion
reaction
28. Sentinel Events 28.9. Air Embolism
Death of a full
28. Sentinel Events 28.10.
term infant
Transmission of a chronic,
fatal diseases or illness as
a result of infusing blood
28. Sentinel Events 28.11.
or blood products or
transplanting contaminated
organs or tissue
Deviation from standard
of care (e.g. Policy,
28. Sentinel Events 28.12. procedure, protocol, delay
in management) that lead to
death or serious harm.
Child/ Infant
28. Sentinel Events 28.13.
abduction
Infant discharged
28. Sentinel Events 28.14.
to a wrong family
28. Sentinel Events 28.15. Rape
76
No. Category Subcategory Details
77
No. Category Subcategory Details
ID/Documentation/
29. 29.2. Consent 29.2.4. Wrong Procedure Listed
Consent
ID/Documentation/
29. 29.2. Consent Wrong Patient
Consent 29.2.5.
ID/Documentation/
29. 29.2. Consent 29.2.6. Wrong Side/Site Listed
Consent
ID/Documentation/
29. 29.2. Consent 29.2.7. Wrong Signature
Consent
ID/Documentation/ Absent
29. 29.3. DNR
Consent 29.3.1.
ID/Documentation/ Incomplete
29. 29.3. DNR 29.3.2.
Consent
ID/Documentation/
29. 29.3. DNR 29.3.3. Unclear
Consent
ID/Documentation/
29. 29.3. DNR Unsigned
Consent 29.3.4.
ID/Documentation/
29. 29.4 Documentation 29.4.1. Altered
Consent
ID/Documentation/
29. 29.4. Documentation Illegible
Consent 29.4.2.
ID/Documentation/
29. 29.4. Documentation 29.4.3. Inadequate
Consent
ID/Documentation/
29. 29.4. Documentation 29.4.4. Inappropriate
Consent
ID/Documentation/
29. 29.4. Documentation 29.4.5. Incorrect
Consent
ID/Documentation/
29. 29.4. Documentation 29.4.6. Misfiling
Consent
ID/Documentation/
29. 29.4. Documentation 29.4.7. Legal Guardian Signature Missing
Consent
ID/Documentation/
29. 29.4. Documentation 29.4.8. Unsigned Notes
Consent
ID/Documentation/
29. 29.4. Documentation 29.4.9. Unsigned Telephone Order
Consent
ID/Documentation/
29. 29.4. Documentation 29.4.10. Wrong Addressograph
Consent
78
7.5 Level of Harm:
Category Description
B An error occurred but the error did not reach the patient.
C An error occurred that reached the patient but did not cause patient harm.
An error occurred that reached the patient and required monitoring to confirm that it
D
resulted in no harm to the patient and/or required intervention to preclude harm.
An error occurred that may have contributed to, or resulted in temporary harm (minor
E
injury) to the individual and required intervention.
An error occurred that may have contributed to, or resulted in temporary harm
F (minor injury) to the individual and required intervention and initial or prolonged
hospitalization.
An error occurred that may have contributed to, or resulted in individual harm
G
(serious injury - prolonged the stay or extensive follow up).
I An error occurred that may have contributed to or resulted in the patient’s death.
79
7.5.2. Level of Other Types of Incidents:
Matching with
medication
Level Definition
related
Incident
Incident occurred with no harm to the patient or
None A-D
person involved.
80
08 Acknowledgements
81
This document is a joint authorship between all Healthcare sectors and healthcare organizations
in Saudi Arabia, as well as, from published researches worldwide. We are grateful to all those from
within the healthcare sector for their contribution.
82
09 Appendix
References
83
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87