National Patient Safety Guideline - Ethiopia MOH, August 2024

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Executive Summary
Global and local efforts to address healthcare quality and safety concerns have brought
encouraging gains, but the chasm is big, and much remains to be done. Evidence shows that 10%
of all patients entering health facilities are exposed to hazards, and 2% die due to the harm
sustained there. Although 50% of the healthcare harm is preventable, it claims over 3 million
lives yearly. The WHO reports that 1 in 10 patients is harmed in healthcare, and 4 in 100
people in ambulatory and primary care are harmed due to unsafe care. Similarly, other scientific
evidence shows that one in every 30 patients experiences medication errors, surgical errors
account for 10% of all medical errors, and diagnostic errors account for 5-20% of patient harm.
In addition, other critical patient safety concerns impacting health (care) outcomes are
healthcare-associated infections and conditions, fall accidents, patient mis-identification, unsafe
blood transfusions, and venous thrombosis.
In recent decades, Ethiopia has made remarkable achievements in increasing healthcare access
and reducing mortality. The achievements were made possible through creating enabling policy
environments, improved health infrastructure, and increased financing for health programs. The
Health Sector Transformation Plan (HSTP) I, implemented from 2015 to 2020, prized quality of
care as one of its transformation agendas and resulted in the birth of the first National
Healthcare Quality Strategy. HSTP II has been implemented from 2021-26 and emphasizes
improving the quality of healthcare and patient safety as the priority agendas. Accordingly, the
MOH – Ethiopia has implemented numerous initiatives to provide high-quality and safe care for
all citizens, including safe surgery, infection prevention and control initiatives, a safe childbirth
checklist, and system bottleneck-focused reforms.
Nevertheless, healthcare quality and patient safety concerns and reports of medico-legal issues
have recently grown in Ethiopia. There are alarming reports of medication administration
errors, surgical site infections, and healthcare-associated infections and conditions. For instance,
a survey of 40 health facilities 2023 showed gaps in the availability and readiness of health
infrastructure, such as infection prevention and control, lab equipment, personal protective
equipment, and trained and motivated staff. In addition, the unavailability of and low adherence
to practice standards and guidelines was documented in health facilities. Lack of an
institutionalized patient safety culture, gaps in using data for decision-making, and inadequacy of
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staff training on patient safety were reported to be the health system challenges to quality of
care and patient safety. The lack of national guidelines was a challenge topped the assessment
findings and was suggested to be critical to addressing the country's healthcare safety and
quality pitfalls.
Most healthcare safety challenges in Ethiopia are amenable. They can be addressed by instituting
infection prevention and control, adhering to accepted practices and care standards, educating
patients, and promoting a patient safety culture. Therefore, the national patient safety guidelines
document is developed to assist with structuring, implementing, and coordinating healthcare
safety practices in the country and shall apply to public and private health facilities during all
circumstances. The guidelines provide principles, guiding frameworks, and interventions to
prevent and reduce the risk of exposure to hazards and errors and the occurrence of avoidable
harms and manage them by applying accepted practices. It also envisions introducing
mechanisms to institute accountability and patient safety culture, including incident reporting
and learning.
The Ministry of Health – Ethiopia calls all health facilities, health workers, and health system
staff to implement these guidelines to achieve the objective set out in it. We will continue to
work with all partners and appreciate them for their unreserved support in developing the
guidelines document. Health experts and researchers took part in developing the guidelines,
consulted literature and discipline specialists, and efforts were made to ensure the
recommended interventions and principles were based on the best scientific evidence available.
However, the MOH-Ethiopia will update the guidelines when new evidence emerges and
advances in the discipline become apparent.
Abas Hassen Yesuf (Ph.D)
Lead Executive Officer (LEO), Health System Innovation and Quality
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Acknowledgment
Stakeholders at every tier of the healthcare system played an integral role in shaping the
National Safety guidelines through diverse engagement methods. The Ministry of Health
expresses appreciation to the writing team, members of the national safety guideline developing
team, and participants in consultative workshops for their valuable insights and contributions.
Special recognition is extended to the world health organization for its generous financial and
technical support during the guideline’s development. The following are the list of contributors
for the guideline development.
Guideline Development Team
Contributors
Dr Ayele Teshome Gonche
Dr Abas Hassen Yesuf
Mr Deneke Ayele Abebe
Mr Eyobed Kaleb Bereded
Sr Almaz Seid Amedie
Dr Dessalegn Bekele Taye
Dr Habtamu Milkias Woldie
Sr Aynalem Legesse Asfaw
Mr Eshetu Cherinet Teka
Mr Wondosen Shiwarega Sitotaw
Mr Molla Godif Fisehatsion
Dr Fahmi Mohammed Ahmed
Ms Muluembet Fikadu Nida
Mr Eyob Assegid Negash
Dr Tariq Ahmed
Organization
MoH, State Minister
MoH, HSIQ LEO
MoH, HSIQ Desk
MoH, HSIQ Expert
MoH, HSIQ Expert
MoH, State Minister Advisor, UNOPS
MoH, HSIQ Expert
MoH, HSIQ Expert
MoH, HSIQ Expert
MoH, Pharmaceutical and Medical Device
LEO
Resolve To Save Life
WHO
WHO
WHO
WHO
Dr Biniam Yohannes Wotango
Ghandi Memorial Hospital
Dr Ashenafi Tigabu Gebre
Yekatit 12 Hospital Medical College
Dr Bisirat Tamene Bekele
AACAHB, CDC Project
Dr Tesfaye Aga Dinagde
Tikur Anbesa Specialized Hospital
Dr Birhane Tesfaye Kidanu
Tikur Anbesa Specialized Hospital
Dr Mulugeta Bogale Zewudie
St Paul Hospital Millennium Medical College
Mrs Aynalem Hailemichael Firew
Emory University
Debrebirhan Comprehensive
Hospital
Dr Nigussie Tefera Habiteyohannis
III
specialized
Dr Nuhamin Shimelis Gebre
Alert Hospital
Dr Yordanos Mengistu Chemere
Alert Hospital
Dr Wubet Mihretu Workineh
Ghandi Memorial Hospital
Dr Merahi Kefyalew Merahi
Tikur Anbesa Specialized Hospital
Dr Bereket Yakob Yota
Fenot-Harvard University
Dr Leul Adane Chemeda
Tikur Anbesa Specialized Hospital
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Table of Contents
Executive Summary .........................................................................................................................................I
Acknowledgment ..........................................................................................................................................III
Acronyms and abbreviation ........................................................................................................................ VII
Evidence for the Guideline ........................................................................................................................... IX
Frequency of guideline revision .....................................................................................................................X
Guideline Development Process ..................................................................................................................XI
Definitions ................................................................................................................................................... XII
1. Introduction ...............................................................................................................................................1
1.1. Background ......................................................................................................................................... 1
1.2. Scope ...................................................................................................................................................3
2. Purpose ......................................................................................................................................................4
3. Patient Safety Culture ................................................................................................................................5
4. Leadership for Patient safety ..................................................................................................................... 9
5. Patient and Family Engagement ............................................................................................................... 12
6. Communication for Patient Safety .......................................................................................................... 15
7. Patient Identification ................................................................................................................................18
8. Medication and Medical Device Safety .................................................................................................... 21
8.1. Medication Safety ..............................................................................................................................21
8.2. Medical Device Safety ....................................................................................................................... 25
9. Infection Prevention and Control ........................................................................................................... 28
9.1. General IPC for Patient Safety ......................................................................................................... 28
9.2. Safety Measures for Anti-Microbial Resistance ................................................................................ 31
10. Health Workforce Safety ...................................................................................................................... 33
11. Surgical and Anesthesia Care Safety ......................................................................................................36
12. Healthcare Acquired Conditions .......................................................................................................... 40
12.1 Blood Transfusion ............................................................................................................................40
12.2 Pressure Ulcer ................................................................................................................................. 42
12.3. Venous Thromboembolism ............................................................................................................ 44
12.4. Mental Health ................................................................................................................................. 46
12.5. Fall Prevention ................................................................................................................................ 49
13. Continuous Learning and Improvement ............................................................................................... 52
14. Ethical, Legal, and Regulatory considerations ....................................................................................... 56
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References ................................................................................................................................................... 59
Annexes ....................................................................................................................................................... 62
Annex I: Safety walk round checklist ...................................................................................................... 62
Annex II: Patient Safety Huddle Agenda ................................................................................................ 64
Annex III: Sample hand overing format ................................................................................................... 65
Annex IV: Sample wrist ID bands ............................................................................................................66
Annex V: Medical history record form ................................................................................................... 67
Annex VI: VTE risk groups and risk assessment tools ............................................................................68
Annex VII: Fall Risk Assessment Tools ................................................................................................... 71
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Acronyms and abbreviation
AACAHB: Addis Ababa City Administration Health Bureau
AMR: Antimicrobial Resistance
AMS: Antimicrobial Stewardship
BTS: Blood Transfusion Safety
CLI: Continuous Learning and Improvement
CME: Continuous Medical Education
CPS: Communication for Patient Safety
ELR: Ethical Legal Regulatory
FPS: Fall Prevention Strategy
HSIQ: Health System Innovation and Quality
HWS: Health Worker Safety
IPC: Infection prevention and control
LPS: Leadership for Patient Safety
MDS: Medical Device Safety
MHS: Mental Health Safety
MSS: Medication Safety Strategy
NQSS: National Quality and Safety Strategy
OSH: Occupational Safety and Health
PFE: Patient and Family Engagement
PIS: Patient Identification Strategy
PSC: Patient Safety Culture
PUS: Pressure Ulcer Strategy
SAS: Surgical and Anesthesia Safety
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VTE: Venous Thromboembolism
WHO: World Health Organization
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Evidence for the Guideline
This patient safety guideline is developed based on a comprehensive review of current scientific
evidence and best practices. Here's an overview of the key sources informing the
recommendations:
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Research Studies: Published research studies investigating the effectiveness of various
patient safety interventions in healthcare settings. Studies with strong methodologies
and robust findings demonstrating improvements in patient outcomes are prioritized.
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Clinical Practice Guidelines: Guidelines from reputable organizations like the
Agency for Healthcare Research and Quality (AHRQ), the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO), and relevant professional
societies related to the specific patient safety topic addressed by the guideline. These
guidelines synthesize research evidence and offer practical recommendations for
implementation.
•
Systematic Reviews and Meta-Analyses: Reviews that analyze and summarize
findings from multiple studies on patient safety interventions. These summaries
provide a broader perspective on the overall evidence base for different approaches.
All evidence was critically appraised for its methodological rigor and clinical practice
applicability, and the best-available evidence influenced the guideline recommendations.
Who are these guidelines for?
These guidelines can be appropriately adapted and used by all healthcare practitioners. This will
inform important standard principles for patient safety. Consequently, they are aimed at health
facility managers, members of quality and safety teams, and individual healthcare practitioners.
At an individual level, they are intended to influence the quality and clinical effectiveness of
patient safety related decision-making. The dissemination of these guidelines will also help
patients and care providers to understand patient safety measures they can expect all
healthcare workers to implement to protect them from unsafe care.
Guideline structure
Each set of guideline follows an identical format, which consists of:
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a brief introduction;
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the intervention heading;
•
a headline statement describing the key issues being addressed; and guideline
activity recommendation(s).
Frequency of guideline revision
The frequency of this guideline revision is crucial to ensuring the highest standards of care. This
guideline will be reviewed and updated every 3-5 years, but may be revised more frequently if
new evidence emerges or significant changes occur in health system innovation and quality
strategy, or health policy due to continuous advancements in medical research, real-world
incidents, audits, or feedback from healthcare professionals.
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Guideline Development Process
The development of this patient safety guideline was structured and comprehensive in nature
with the sole aim of coming up with practical, evidence-based interventions. The process began
with an identification of critical issues in patient safety. Incident reports, feedback from patients,
and data analyses have informed the identification of issues pertinent to patient safety.
Prioritization of issues was done according to their effect on patient outcome and the likelihood
of feasibility in terms of intervention.
After the identification of key issues, a multidisciplinary team was set up that included
healthcare professionals from various fields, such as physicians, nurses, pharmacists, and quality
improvement specialists, as well as representatives from partner organizations. This step brought
together diverse perspectives to enable the development of guidelines that would be
comprehensive and consider the practical realities in different clinical settings. Then defined the
guidelines' scope, which identified what exactly in terms of safety problems were to be tackled.
Once the scope had been laid down, the very next step was an extensive review of literature and
research. This particular step was important in ensuring that the guidelines were based on the
most current and strong evidence.
Following this research period, the team drafted the preliminary activities that were to be
conducted under each intervention. After circulating for review by a bigger team of experts and
implementers, feedback from these reviews was considered and integrated into the final draft.
Further scrutiny was then made to the final draft before formal approval by the relevant bodies.
This ensured that this guideline was scientifically accurate, practical, and feasible in real-world
application.
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Definitions
Adverse Event: An unfavorable or harmful outcome or event that occurs during or after the
use of a drug or other intervention but is not necessarily caused by it.
Adverse Reaction: An adverse reaction occurs when unexpected harm results from a
justified action when the correct process is followed for the context in which the medication
was used.
Error: The failure of a planned action to be completed as intended (i.e., error of execution)
and the use of a wrong plan to achieve an aim (i.e., error of planning). It also includes failure of
an unplanned action that should have been completed (omission).
Hazard: Is a process, phenomenon or human activity that may cause loss of life, injury or
other health impacts, property damage, social and economic disruption or environmental
degradation.
Medication Error: Any preventable event that may cause or lead to inappropriate medication
use or patient harm while the medication is controlled by the healthcare professional, patient,
or consumer.
Near Miss: An error of commission or omission that could have harmed the patient, but
severe harm did not occur as a result of chance.
Patient Safety: Is a healthcare discipline that aims to prevent and reduce risks, errors, and
harm that occur to patients during the provision of health care.
Risk: The chance or likelihood that a specific adverse event, error, hazard, or any health
outcome will occur at a particular time or due to a specific situation.
Safe Care: Safe care involves making evidence-based clinical decisions to maximize an
individual's health outcomes and minimize potential harm.
Side Effect: A side-effect is a known effect, other than that primarily intended, relating to the
pharmacological properties of a medication.
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1. Introduction
1.1.Background
Patient safety is a developing discipline and refers to the steps taken to prevent, reduce, and
mitigate unsafe acts during healthcare and apply best practices leading to better outcomes. It
aims to prevent errors and reduce risk and adverse effects on patients, caretakers, and
healthcare providers through continuous quality improvement, instituting an accountability
mechanism, developing a safety culture, and enhancing learning.
In the 21st century, rapid advancements in healthcare have revolutionized the development of
new drugs, vaccines, diagnostic tools, and treatment technologies. However, the persistence of
safety shortcomings within healthcare systems has eroded public trust and confidence, resulting
in financial burdens for both patients and healthcare providers worldwide. The escalating
prevalence of medico-legal issues has led to professional repercussions and legal consequences
for care providers.
The global issue of unsafe healthcare practices causing patient harm has emerged as a critical
public health concern, with significant implications for mortality and disability rates on a global
scale. Studies reveal that one out of every ten patients in high-income nations experiences harm
due to unsafe care, with estimates suggesting that up to 40% of patients in primary and
ambulatory care settings suffer harm that could have been prevented. In low- and middleincome countries, an alarming 134 million adverse events occur annually, leading to three
million deaths and accounting for two-thirds of all adverse events and disability-adjusted life
years globally.
Moreover, healthcare workers involved in severe incidents resulting in patient harm may
experience lasting psychological impacts. The economic consequences of patient harm are
substantial; potentially reducing global economic growth by 0.7% annually, with trillions of
dollars in indirect costs incurred each year.
In Ethiopia, medication administration errors (wrong timing, omission, and missed doses) are
reported to be 68.1%, and surgical site infections among women who had cesarean section
varied between 9.8% and 12.4%. On the other hand, healthcare-associated infections (HCAIs)
have become significant patient safety concerns, with a reported pooled prevalence of 7 - 17%
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(25.8% occurring in intensive care units, 24.2% in the pediatric ward, and 23.8% in the surgical
wards). The most common HCAIs reported in Ethiopia are surgical site infections (Surgical Site
Infections, 39.7%), urinary tract infections (27.7%), bloodstream infections (19.9%), and
respiratory tract infections (13.5%). Samples collected from patients with HCAIs (30.2%) had
anti-microbial resistant bacteria, adding further challenge to an ever-increasing concern of AMR
in Ethiopia and abroad.
Based on a recent landscape survey conducted in selected healthcare facilities in Ethiopia,
substantial healthcare safety concerns were revealed. According to the survey, only 39% and
43% of patients were told the dose and frequency of their drugs, 12% were told the side effects
of the drugs, and only 10% of the patients would seek advice from healthcare providers if they
experienced side effects. Similarly, 36% - 62% of drug order forms lacked prompts to allergies,
patient height, and patient weight. Another finding pointed out shortage of care providers (45%),
staff overburdening (75%), blaming staff for mistakes (48%), and focusing on errors rather than
learning (27.0%) in health facilities. With regards to clinical incident reporting, about 39% - 41%
of healthcare staff said they would not report errors because of fear of embarrassment or
punishment. These evidences indicate the existence of poor patient safety practices and
potentially preventable medical errors in health facilities across the country.
Patient safety gaps such as those reported above are caused by discrepancies in following the
patient safety protocols, poor health infrastructure, poor management, and lack of
accountability frameworks. They present an imperative to improve quality care, prevent errors
and adverse events continuously, and institute accountability in medical care. Healthcare errors
and the harms caused by them are grave. Still, they are preventable if the standard safety
protocols are followed and a patient safety culture is instituted in the health facilities.
Recognizing the increasing burden of unsafe care and the need to prioritize patient safety,
Ethiopia revised its national strategy for quality and patient safety in 2021. The revised national
strategy (2021-2025) was developed based on the second Health sector Transformation Plan
(HSTP II) priorities and goals and is aimed to implement interventions aiming at improving
patient outcomes, focusing on high-risk clinical conditions such as Medication safety, Safety of
Surgical and Anesthesia Care and Infection Prevention and Control. Similarly, the recent Health
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Sector Medium-term Development and Investment Plan (HSDIP) has given a due emphasis for
improving patient safety and reducing avoidable harms in healthcare facilities.
In modern healthcare systems, the establishment and implementation of national patient safety
guidelines are crucial for ensuring top-quality care for patients. These guidelines standardize
care processes, improve outcomes, reduce risks, enhance communication, and support
professional development within the healthcare industry.
To successfully implement these guidelines, careful planning and coordinated efforts across all
levels of the healthcare system are essential. Strong leadership commitment, both nationally and
within organizations, is key to advocating for the guidelines, allocating resources, and setting
expectations for compliance. Additionally, establishing multidisciplinary teams comprising
various healthcare professionals can facilitate effective implementation by promoting
collaboration and shared responsibility in adhering to the guidelines.
1.2.Scope
This national patient safety guideline is designed to be universally applicable and mandatory for
all private and public healthcare facilities in Ethiopia, including agencies under the Ministry of
Health. It is intended to govern the provision of care to both ill and healthy patients across the
entire spectrum of healthcare services, spanning from preventive interventions to diagnosis,
treatment, follow-up, and rehabilitation.
The guideline's scope encompasses all healthcare settings, be it hospitals, clinics, primary care
centers, or temporary facilities established during emergencies. It mandates adherence to
patient safety principles in all facets of care delivery, ensuring the well-being and safety of
individuals at every stage of their healthcare journey.
Additionally, this guideline extends beyond the physical boundaries of healthcare facilities to
encompass community healthcare initiatives, public health programs, and any other activities
carried out under the umbrella of healthcare provision in Ethiopia. By embracing a holistic
approach to patient safety, this guideline aims to foster a culture of excellence, accountability,
and compassion in the delivery of healthcare services across the nation.
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2. Purpose
The overarching goal of the National Patient Safety Guideline is to enhance the quality of
healthcare delivery in Ethiopia by establishing a robust framework that prioritizes patient safety
across all healthcare settings. By promoting a culture of safety, continuous improvement, and
accountability, this guideline aims to safeguard the well-being of patients and optimize health
outcomes throughout the healthcare system. This Patient Safety Guideline is designed to be a
comprehensive resource for healthcare facilities in Ethiopia. It aims to:
 Reduce patient harm by promoting best practices in medication safety, surgical
procedures, infection prevention, and other key areas.
 Enhance patient care quality by fostering clear communication between healthcare
providers, patients, and families.
 Create a culture of safety within Ethiopian health facilities where errors are reported,
analyzed, and addressed to prevent future occurrences.
 Empower healthcare providers with the knowledge and tools necessary to deliver safe
and effective care to their patients.
 Adapt/adopt best practices to the Ethiopian context, considering resource limitations,
cultural considerations, and communication challenges.
 Improve patient identification and verification processes to prevent errors related to
patient misidentification and ensure accurate and safe care delivery.
 Promote patient engagement and involvement in their care by fostering open
communication, shared decision-making, and education to enhance patient safety
awareness and outcomes.
 Encourage a culture of incident reporting and learning from adverse events, near misses,
and errors to drive continuous quality improvement and prevent future occurrences.
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3. Patient Safety Culture
Patient safety culture encompasses the shared beliefs, attitudes, and behaviors within a
healthcare organization that prioritize the safety and well-being of patients and staff. A strong
patient safety culture fosters an environment where healthcare professionals feel empowered
to speak up about safety concerns, report errors without fear of reprisal, and collaborate
effectively to mitigate risks and prevent harm to patients.
Activities to cultivate patient safety culture include implementing standardized protocols and
procedures, providing comprehensive staff training on safety principles, and establishing
mechanisms for reporting adverse events and near misses. Engaging patients and families in care
decisions, promoting open communication, and fostering a culture of learning from errors are
also essential components of patient safety culture. By prioritizing patient safety culture and
integrating it into organizational values and practices, healthcare organizations can create safer
environments for patients/staffs, enhance the quality of care, and reduce the occurrence of
preventable harm.
Principles of patient safety culture
 Open Communication: Encouraging open and honest communication among
healthcare team members fosters transparency and enables the identification and
resolution of safety concerns.
 Teamwork and Collaboration: Healthcare professionals must work together through
collaboration to address patient safety issues and deliver optimal care.
 Leadership Commitment: Leaders should demonstrate a dedication to safety by
prioritizing it in organizational policies, allocating resources, and actively participating in
safety improvement efforts.
 Patient Engagement: Involving patients in their care and decision-making processes
empowers them to actively participate in their own safety.
 Reporting and Feedback Mechanisms: Implementing systems for reporting adverse
events, near misses, and safety concerns allows for the identification of potential hazards
and opportunities for improvement.
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 Non-Punitive Response to Errors: Creating an environment where healthcare
professionals feel comfortable reporting errors without fear of punitive action is essential
for fostering a culture of safety.
 Reliability: Developing and adhering to standardized protocols and procedures helps
streamline processes and reduce variability, which can contribute to errors.
 Just Culture: A just culture balances accountability for actions with an understanding of
human fallibility. It distinguishes between unintentional errors, reckless behavior, and
intentional harm.
Strategies for Ensuring Patient Safety Culture
PSC 1. Healthcare facilities should ensure reliability of care processes across
service units and providers and reduce variations in care
Activities
 Develop/implement clinical guidelines, standardized protocols and procedures for clinical
processes and ensure adherence
 Ensure consistency in care delivery across different settings and healthcare providers
 Implement checklists and decision support tools to guide healthcare providers through
critical
tasks
and
ensure
adherence
(for
selected
high
risk/error
prone
conditions/procedures/treatments)
 Establish standardized communication protocols for handoffs between healthcare
providers during shift changes, transfers of care, and patient referrals
 Perform regular audits and assessments of clinical processes, systems, and outcomes to
identify areas for improvement and ensure compliance with established standards
 Implement systems for monitoring performance metrics related to reliability, such as
adherence to protocols, error rates, and patient outcomes
 Foster a culture that values reliability, accountability, and continuous improvement in
patient care
PSC 2. Healthcare facilities should regularly utilize the accountability algorithm,
and the policies and practices that manifest it when needed.
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Activities
 Conduct simulation exercise and regular discussions about the concepts of accountability algorism
in staff meetings.
 Conduct evaluation of the involved staff member’s actions using the accountability algorithms
(When something goes wrong and a patient is harmed), (Refer Annex- Accountability algorithm)
and Ethiopian laws and regulations governing patient care, including Proclamation No.
661/2009, which mandates reporting professional malpractice.
 Integrate patient safety goals into performance evaluations for all leadership and staff.
 Regularly review and evaluate compliance with patient safety guidelines.
PSC 3: Organizations should establish mechanisms for conflict resolution within
the healthcare facility
 Invest in comprehensive conflict resolution training for all leadership personnel
 Enable staff to understand and apply the five known mechanisms of negotiation that
occur among individuals and groups: Avoidance, Accommodation, Competition,
Compromise and Collaboration.
 Establish a visible "open door policy" where staff feel comfortable discussing concerns or
conflicts with leadership.
 Identify and empower staff members with strong conflict resolution skills as "Conflict
Resolution Champions." Train them to provide peer support and guidance to
colleagues navigating disagreements.
 Encourage post-conflict debriefing sessions, led by a neutral party, after resolved
disagreements.
PSC 4: Health facilities should encourage and promote a system of just culture
• Promotion of Just culture
 A just culture fosters a blame-free environment where staff feels comfortable
reporting errors, discussing safety concerns, and participating in safety
improvement initiatives without fear of retribution.
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 Implement
policies and procedures that emphasize learning from errors,
encourage reporting of safety incidents, and ensure a fair and non-punitive
approach to error management.
• Implement a non-punitive system for reporting errors and near misses, allowing
healthcare providers to identify and address potential safety issues without fear of
retribution.
• Utilize anonymous reporting systems if necessary to encourage participation.
• Analyze reported errors and near misses to identify systemic issues and implement
corrective actions to prevent future occurrences.
• Conduct regular surveys and feedback sessions with patients, families, and healthcare
providers to assess communication effectiveness.
• Use feedbacks to identify areas for improvement and tailor communication strategies
accordingly.
PSC 5: Health facilities should take the responsibility establishing a strong team
that practices working together though effective communication
 Practice
the five key properties of an effective team that includes common goal,
commitment, competence, communication and coordination assigned with collaborative
tasks
 Ensure
all team members possess a variety of competencies including individual
knowledge, skills, behaviors, and attitudes necessary to accomplish their assigned roles
PSC 6: Health facilities should establish an operational transparency for leaders,
staff, patients and their families, organizations, and the community to be able to
visibly see the activities involved in the health service process
 Encourage the use of learning boards as an integral part of daily work in health facilities
 Practice transparency/disclosure with patients/families, specifically after an adverse event,
involves clearly describing what happened and what is being done to prevent it from
happening again.
 Ensure robust information sharing with the community for them to make informed
decision and access the care they need
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 Facilitate transparency among clinicians to ensure problems are discussed and suggestions
are raised without fear/intimidation
4. Leadership for Patient safety
Leadership and governance interventions play a crucial role in institutionalizing patient safety
culture within healthcare organizations. Strong leadership is a cornerstone of any successful
patient safety initiative. Leaders at all levels of the healthcare system play a critical role in
creating a culture of safety, promoting safe practices, and fostering continuous improvement.
This section outlines key principles and recommendations for healthcare leaders to enhance
patient safety within their institutions.
Some of the leadership and governance interventions which healthcare organizations implement
and can strengthen their commitment to patient safety, drive cultural change, and create a safer
care environment for both patients and healthcare professionals include:
Core Principles of Patient Safety Leadership
 Commitment: Leaders must demonstrate a visible and unwavering commitment to patient
safety. This includes allocating resources, establishing clear policies, and holding staff
accountable for safe practices.
 Accountability: Leaders are responsible for fostering a culture where safety is everyone's
responsibility. This includes holding themselves and staff accountable for adherence to
safety protocols and addressing identified risks.
 Empowerment: Effective leaders empower staff to take ownership of patient safety. This
includes providing training and resources, encouraging innovation, and recognizing safety
efforts.
 Continuous Improvement: Leaders champion a culture of continuous learning and
improvement. This involves actively seeking feedback, analyzing data, and implementing
evidence-based strategies to address patient safety concerns.
Leadership Strategies for Patient Safety Practice
LPS 1: The health facility Leadership shall focus on creating an environment where
patient safety is everyone's priority.
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Activities
 Develop a clear patient safety strategy.
 Establishing
clear safety goals provides a focus for improvement efforts,
motivates staff to work towards common objectives, and reinforces the
organization's safety commitment.
 Set measurable safety goals aligned with patient safety priorities and regularly
monitor progress towards achieving these goals.
 Conduct leadership safety walk rounds to directly observe safety practices and identify
areas for improvement.
 Visible
support from leaders fosters a culture of safety, encourages staff
engagement, and reinforces the importance of patient safety as a priority within
the organization.
 Leaders participate in safety rounds, safety huddles, and safety events, visibly
demonstrating their commitment to patient safety. (Annex I: Safety walk round
checklist and Annex II: Patient Safety Huddle Agenda)
 Host regular safety briefings to educate staff on current safety issues and best practices.
 Recognize and celebrate achievements in patient safety to reinforce positive behaviors.
LPS 2: The health facility Leadership shall prioritize and provide the necessary
resources for staff to effectively implement patient safety activities.
Activities
 Allocate sufficient budget for patient safety initiatives, including training and technology.
 Streamline processes to minimize staff workload and prevent burnout.
 Provide dedicated time and opportunity for staff to participate in safety training and
improvement activities.
 Leadership Development Programs:
 Equipping leaders with the necessary knowledge and skills to lead patient safety
initiatives effectively and embed safety principles into daily leadership practices.
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 Provide leadership training and development programs focused on patient
safety, quality improvement, and fostering a culture of safety within the
organization.
LPS 3: Health facility Leadership should champion Continuous Improvement in
Patient Safety.
Activities
 Establish a dedicated patient safety committee with staff representation.
 Create
a multidisciplinary committee consisting of leaders, clinicians, and
patient representatives to oversee patient safety initiatives.
 The committee can provide strategic direction, review safety data, identify
improvement opportunities, and champion patient safety efforts throughout
the organization.
 Facilitate regular safety huddles to discuss potential risks and identify solutions.
 Analyze patient safety data to identify trends and implement targeted prevention
strategies.
 Encourage staff to participate in safety improvement initiatives.
 Acknowledge and reward staff efforts to promote a positive safety culture.
11
5. Patient and Family Engagement
Patients and families are crucial partners in ensuring patient safety. Their firsthand experience
with the healthcare system makes them uniquely positioned to identify potential risks and
breakdowns in communication that healthcare providers might miss. By actively engaging
patients and families, healthcare professionals can improve communication, empower patients
to participate in their care decisions, and rebuild trust after safety events. This collaboration
ultimately leads to better patient outcomes and a safer healthcare environment for everyone.
Benefits of Patient Engagement and Communication
 Improved Accuracy of Information: Patients are a valuable source of information about
their medical history, allergies, and current medications. Active participation in
information sharing helps to ensure accuracy and reduces the risk of errors.
 Enhanced Adherence to Treatment Plans: When patients understand their treatment
plans and feel involved in decision-making, they are more likely to adhere to medication
schedules, follow discharge instructions, and participate in preventative care measures.
 Early Detection of Adverse Events: Patients are often the first to notice signs and
symptoms of potential complications. Encouraging open communication allows for early
identification and intervention, improving patient outcomes.
 Empowerment and Reduced Anxiety: Active participation in their care plan fosters a
sense of control and reduces patient anxiety.
Strategies for Enhancing Patient Engagement
PFE 1:
Engage patients, families and civil society organizations to improve
healthcare safety through institutional Protocols and guidelines.
Activities
 Develop institutional standards for patient and family engagement, and develop a practice
of improvement based on patient experience
 Create patient and family advisory councils that are focused on patient safety.
 Create clear steps to follow national healthcare laws, like treating everyone fairly,
respecting patient choices, explaining procedures, involving patients in decisions, handling
emergencies, allowing patients to see their records, and being honest about mistakes.
12
 Appoint patient and family representatives to be part of the organization’s boards and
committees.
 Include patients or family members who have experienced incidents in planning how to
prevent them from happening again.
PFE 2: Learn from the experience of patients and families exposed to unsafe care
to improve understanding of the nature of harm and foster the development of
more effective solutions.
Activities
 Create a culture of listening by integrating patient and family stories of avoidable harm
into all aspects of our patient safety efforts
 Regularly have patients or families share their experiences, in their own words, at
board/managerial meetings. This will help healthcare leaders understand how unsafe care
truly affects people.
PFE 3: Build the capacity of patient advocates and champions in patient safety
Activities
 Conduct a wide-ranging review to assess the involvement of patients in the improvement
of safety in health care within the organization.
 Institute measures to fully engage with patients and families to enhance their
opportunities to contribute to processes to improve patient safety.
 Develop a strategy for involving patient safety advocates and champions as educators.
PFE 4: Establish the principle and practice of openness and transparency
throughout health care, including through patient safety incident disclosure to
patients and families
Activities
 Develop institutional policies for patients to understand and agree to treatment
(informed consent), access their medical records, and get help quickly in emergencies
(escalation systems) - all within the hospital itself.
13
 Develop and implement disclosure policies and procedures to inform patients and families
when incidents happen in their care, even if no harm resulted.
 Ensure that patients, families and health workers are given ongoing psychological and
other support in the aftermath of a serious patient safety incident.
PFE 5: Provide information and education to patients and families for their
involvement in self-care and empower them for shared decision-making
Activities
 Structure care processes to support information sharing, care planning, self-management
and shared decision-making, and implement patient-centered tools for patients and
clinicians to support shared decision-making.
 Educate patients and families about their health and health care, support patients in
managing their own health, and train families to deliver the care.
 Develop patient information materials on clinical procedures, including safety risks, to
empower patients when seeking information from health care professionals.
 Leverage visual aids like diagrams, pictures, or anatomical models, especially for complex
medical concepts.
 Implement communication mechanisms
that
help
clinicians understand
patient
perspectives and concerns.
 Healthcare providers use clear and concise language, avoiding medical jargon, and tailoring
explanations to the patient's educational background.
 Utilize teach-back methods where patients repeat information in their own words to
confirm understanding.
 Acknowledge and respect cultural beliefs and practices surrounding illness and healthcare.
 Utilize trained interpreters or cultural mediators to bridge language gaps.
 Be mindful of non-verbal communication cues that may differ across cultures.
 Obtain informed consent for procedures after ensuring patients understand the risks,
benefits, and alternatives in a way that aligns with their cultural context.
 Provide written information in local languages whenever possible, summarizing key details
about medications, diagnosis, prognosis, and discharge instructions.
14
6. Communication for Patient Safety
Communication is a key safety and quality issue. Communication is a critical part of effective
teamwork. When healthcare professionals work together as a team efficiently, they can identify
and address potential risks and errors, leading to better patient outcomes. Actions in this
guideline outline the high-risk situations in which effective communication and documentation
are required. They include transitions of care (clinical handover), when critical information
about a patient’s care emerges or changes, and when it is important to ensure that a patient is
correctly identified and matched to their intended care.
This section outlines strategies for communication with patients, families, and healthcare
providers within Ethiopian health facilities, fostering a culture of safety and improved healthcare
outcomes. Recognizing that communication is a variable process, organizations will need to
develop, describe and adapt these systems to their service context to ensure that
communication processes are flexible, and appropriate for the nature of the organization and
the consumers who use their service.
Strategies for Communication
CPS 1: The health facilities shall have structured clinical handovers used to
effectively communicate about the health care of patients.
Activities:
• The health service organization, in collaboration with clinicians, defines the:
 Minimum information content to be communicated at clinical handover, based on
best-practice guidelines
 Risks relevant to the service context and the particular needs of patients, care
givers and families
 Clinicians who are involved in the clinical handover
• Clinicians use structured clinical handover processes that include:
 Preparing and scheduling clinical handover
 Having the relevant information including medications, allergies, recent procedures,
vital signs, laboratory results, and any specific concerns at clinical handover
 Organizing relevant clinicians and others to participate in clinical handover
15
 Being aware of the patient’s goals and preferences
 Supporting patients, care givers and families to be involved in clinical handover, in
accordance with the wishes of the patient
 Ensuring
that clinical handover results in the transfer of responsibility and
accountability for care
• Utilize electronic medical records (EMR) systems, if available, to facilitate clear and timely
communication and documentation.
• Regularly evaluate and update communication protocols and educational materials based
on new evidence and best practices
CPS 2: Team coordination to effectively communicate critical information and
risks when they emerge or change are used to ensure safe patient care.
Activities:
• Health facilities shall implement SBAR (Situation, Background, Assessment and
Recommendation) tool for effective communication
• Clinicians and multidisciplinary teams use clinical communication processes to effectively
communicate critical information, alerts and risks, in a timely way.
• Foster an environment where open communication, collaboration, and mutual respect are
encouraged among all healthcare providers.
• Address potential power imbalances between different professions to ensure all voices
are heard and concerns are addressed.
• Conduct regular team huddles or briefings to discuss patient care plans and potential risks.
CPS 3: Essential information is documented in the healthcare record to ensure
patient safety.
Activities
• Maintain clear, concise, and accurate documentation in patient medical records using
standardized terminology including:
 Critical information, alerts and risks
 Reassessment processes and outcomes
 Changes to the care plan
16
• Document medication administration, procedures, patient responses, assessments, and
treatment plans in a timely manner.
• Encourage timely updates to medical records by all healthcare providers involved in a
patient's care to ensure continuity of care and reduce errors.
CPS 4: The health facility shall provide regular staff training and development
regarding communication
Activities
• Provide ongoing training for healthcare providers on effective communication skills,
including active listening techniques, cultural competency training, and clear explanation
methods.
• Provide ongoing training for healthcare professionals on effective communication
techniques and tools like SBAR
• Train staff on the use of standardized communication tools like I-PASS (Illness severity,
Patient summary, Action list, Situation awareness and contingency planning, Situation
awareness) and handover protocols. (See Annex III: Patient Hand-overing tool)
• Integrate patient safety principles and communication best practices into all levels of
healthcare worker training.
CPS 5: Health facilities shall promote effective verbal communication for patient
safety across different healthcare professional interactions
Activities

Define clear guidelines for verbal communication between different healthcare
professionals such as nurse to nurse, physician to physician, nurse to physician, tele phone
communication, order and oral consultation etc

telephone orders, including “read back” whereby the verbal or telephone
order is written down completely by the receiver, who then reads back the
order, which is confirmed by the person who gave the order

Health facilities shall address verbal communication gaps before they lead to adverse
events.
17
7. Patient Identification
Ensuring accurate patient identification is the cornerstone of safe healthcare.
Confusing
patients can lead to serious consequences, such as administering wrong medications,
performing procedures on the incorrect person, or misinterpreting test results. By requiring
two patient identifiers (like name and date of birth) before any treatment or procedure,
healthcare providers can significantly reduce these risks. This simple step verifies they are
caring for the right person, ultimately protecting patients and fostering trust in the healthcare
system.
Importance of Patient Identification
 Prevents Errors: Accurate patient identification is the first step in preventing medication
errors, transfusion errors, wrong-site surgery, and other patient safety incidents.
 Improves Care Coordination: Ensuring correct patient identification facilitates seamless
care transitions between different healthcare settings and providers.
 Enhances Patient Safety Culture: A strong focus on patient identification reflects a
commitment to patient safety and fosters trust between patients and healthcare providers.
Patient Identification Strategies
PIS 1: Health facilities shall establish and strengthen a system to consistently and
correctly identify individuals.
Activities
 Always identify patients using at least two approved identifiers and ask to verbalize at
least (Full name and date of birth) before providing any health care services or
interventions.
 Provide a unique patient identifier for all patients (UPI) from the time of admittance or
acceptance for procedure/service.
 Regularly conduct audit of patient identification practices.
PIS 2: Implement the consistent use of standardized patient wristbands containing
accurate identification information.
18
 Immediately upon admission to the healthcare facility, each patient should be provided
with an ID band. (Annex IV: Sample of wrist ID bands)
 Remove any other identification before attaching the current band.
 Replace damaged or illegible ID bands promptly to maintain accurate patient identification.
 Provide comprehensive training to healthcare staff on the importance of patient
identification and the proper procedures for issuing, verifying, and maintaining ID bands.
PIS 3: Health facility shall engage patients and care givers in identifying the correct
patient
Activities
 Highlight their role in maintaining safety; to always wear their ID band; to check that
paperwork given to them has the correct patient information and / or the correct patient
label attached
 Encourage patients and care givers to raise concerns about misidentification with the
health care team
PIS 4: When a patient is unable to communicate for themselves; the health facility
should develop policies to help them be identified.
Activities
 Be aware of the cultural and linguistic needs of patients who are not able to communicate
for themselves. This may require using an interpreter or providing written materials in a
language that the patient understands.
 Be patient and understanding when identifying patients who are not able to communicate
for themselves. It may take more time and effort to identify these patients, but it is
important to get it right.
 ID bands are strictly recommended in the case of patients may be too young, confused or
unconscious, or they may not know areas local language as their first language.
PIS 5: Health facility shall put in place a system to identify correct patient during
transition of care and shall secure and accurately identify all specimens.
Activities
19
 Ensure that the at least two core identifiers are used in all handover, transfer, and
discharge documentation.
 Ensure the adhesive patient labels match the patient for whom they are intended.
 Have the receiving staff member check the patient ID label with the patient.
 Check all relevant health records to make sure that they belong to the correct patient.
 Confirm that all specimens are correctly labeled with date, patient identity, the
specimen’s name, and the location (site and side)
 Have one team member read the specimen label aloud and another verbally confirms
agreement
PIS 6: Health facility should assess risk of mismatching /or wrong patient
identification
Activities
 Make sure that all incidents of patient misidentification are reported, regardless of
whether they resulted in harm to the patient.
 Investigate all incidents of patient misidentification thoroughly
 Review all incidents of patient misidentification regularly.
 Make sure that all staff is aware of the hospital's policy on patient misidentification and
that they are trained on how to identify patients correctly.
 Make sure that the hospital's system for reporting, investigating, and reviewing incidents
of patient misidentification is easy to use and that staff are encouraged to report incidents.
20
8. Medication and Medical Device Safety
8.1. Medication Safety
Ensuring safe medication use and having the processes in place to improve medication safety
should be considered of central importance to countries working towards achieving UHC.
Patients living in low-income countries experience twice as many disability-adjusted life years
lost due to medication-related harm than those in high-income countries. As the burden is very
high, the third WHO global patient safety challenge was medication without harm, intending to
reduce severe avoidable medication-related harm by 50% globally.
Key Stages of Medication Safety
The medication use process can be broken down into five key stages:
 Prescribing: Physicians consider a patient's medical history, allergies, and current
medications to prescribe the appropriate medication, dosage, and duration.
 Transcribing and Verifying: The prescribed medication order is accurately transcribed
from the physician's order into the electronic or written medical record. A second
healthcare professional should then verify the transcribed order for accuracy.
 Dispensing: The pharmacist dispenses the correct medication, dosage, and quantity based
on the verified order. They also counsel patients on proper medication use, potential side
effects, and interactions with other medications.
 Administration: Nurses or other qualified healthcare professionals administer the
medication according to the prescribed order and document the administration
accurately in the patient's medical record.
 Monitoring and Reporting: Healthcare professionals monitor patients for any adverse
reactions or side effects from the medication. Patients are encouraged to report any
concerns or changes in their condition.
Strategies for Medication Safety
MSS 1: Prescribers shall prescribe drugs by their generic names and Prescribing
should be tailored to individual patients.
Activities
21
 Provide direction to all prescribers to use only generic names.
 Inform patients to keep a list of their medications, including both the trade and generic
name of each drug.
 Before prescribing a medication, the prescriber should stop and think, if there is anything
about the patient that should alter the choice of medication.
MSS 2: Healthcare providers involved in the medication use process should learn
and practice collecting complete medication histories, identifying discrepancies and
reconciling.
Activities
 Avail standard medication history recording form (Electronic medical record (EMR) or
manual) (See annex V: medical record form)
 Ensure the medication that patient actually takes matches the prescription, specially
across transitions of points
 Ensure the collected medication history and compare with prescribed medication to
identify discrepancies.
 Identify discrepancies to be resolved (reconciled) and documented.
 Follow that all healthcare providers involved in the medication use process, patient and
caregiver are integrated in the process.
MSS 3: Health facilities shall ensure Healthcare professional has checking habit
while prescribing, dispensing, administering, and monitoring drugs.
Activities
 Promote and Monitor Healthcare professional build a checking and double–checking habit
 Healthcare professional shall check the 5Rs and check for allergies before dealing with any
medication use process.
 Team leaders shall monitor to double-check colleagues’ and their own actions,
MSS 4:
The health facility shall establish a clear and transparent system to
document each transaction in the medication use process.
Activities
22
 Ensure prescriptions are documented in a correct, &complete way, and kept for the
period specified by Ethiopian Food and Drug Authority (EFDA).
 Sign and complete logbooks while administering parental drugs.
 Document any change in medication and medication history record forms.
 Record and document Incidents on medication safety in addition to reporting.
 Take corrective and preventive actions following a medication safety incident.
 Conduct clinical record audit to ensure the quality of the healthcare services
MSS 5: Prescribers and other health care providers involved in medication
provision shall have access to high-quality memory aid tools and reference
materials at the time of practice.
Activities
 Provide reference materials in the clinical.
 Promote Healthcare providers to practice and rely on memory aids as a marker of safe
practice.
 Promote healthcare providers to be familiar and use selected, evidence-based memory
aids, pocket-sized pharmacopoeias, and information technology.
MSS 6: Healthcare facilities should identify high-risk medications at a facility level
and ensure their safe use.
Activities
 The drug and therapeutics committee should ensure the identification of high-risk
medications being used at the facility.
 Ensure that Look Alike Sound Alike (LASA) medications are checked thoroughly.
 Ensure availability of a designated controlled environment for the storage of medications
with an increased risk of harm.
 Establish standardized and systematized medication use processes and documentation
that can reduce harm from high-risk (high-alert) medications.
 Follow the Storage and distribution standards of EFDA.
 Follow the disposal of waste pharmaceuticals standards of EFDA.
23
MSS 7: Healthcare providers should communicate clearly with their colleagues,
with patient, and caregiver.
Activities
 Instruct healthcare professional to avoid bad hand writing when prescribing.
 Contact the prescribers if the hand writing is not readable
 Always use the 5 Rs as a useful way of remembering the important points about a
medication that needs to be communicated.
 Promote establishment of prescription partnerships among healthcare professionals and
monitor the practice of communication
MSS 8: Elements of medication safety should be incorporated into undergraduate,
postgraduate, and continuing professional development.
Activities
 Incorporate all elements of medication safety into the curricula
 Evaluate and feedback for performance, within the professional’s work structure and as
part of formal credentialing and professional appraisal.
MSS 9: Healthcare providers shall practice talking openly about errors and should
be aware of what processes are in place to report adverse drug events.
Activities
 Establish facility level reporting system of errors
 Report errors at a national level through the existing systems of Adverse Drug Event
(ADE) reporting (including the yellow card, toll-free number, in-person reporting).
 Establish an appropriate documentation of the reports and a platform to disclose and
learn from the event.
MSS 10: Hospital should ensure that Healthcare providers have the desired
capability at the point of care.
Activities
 Encourage professionals to engage in their own continuous capacity building activities
24
 A prescriber should never prescribe a medication that s/he does not know much about.
 Create a platform for continuous knowledge and skill development of health care
providers
MSS 11: Patients shall be an integral part of the medication use process and should
be encouraged to be actively involved in their own care and the medication process.
Activities
 Plan and conduct patient education intervention about their medication(s) and any
associated hazards
 Communicate plans clearly with patients.
 Encourage Patients to keep a written record of their medications and any allergies
 Conduct regular public education platform to improve medication literacy.
8.2. Medical Device Safety
Medical devices are an essential component of modern healthcare, ranging from simple devices
such as thermometers to complex machines like ventilators. These devices play a critical role in
diagnosing, monitoring, and treating various medical conditions, but they also pose potential
risks to patients if not used correctly or if they malfunction.
Patient safety is an integral part of healthcare, and medical device safety is an essential
component of it. The use of medical devices can pose significant risks to patients, including
injuries, infections, and even death. The goal of medical device safety is to minimize these risks
by ensuring that medical devices are designed, manufactured, and used safely.
Key Considerations for Medical Device Safety
 Selection and Procurement: Carefully evaluate the intended use, compatibility with
existing equipment, and safety profile of a medical device before selection and
procurement.
 Competency and Training: Healthcare professionals using medical devices must undergo
thorough training to ensure proper device operation, potential risks, and troubleshooting
procedures.
25
 Maintenance and Inspection: Regular preventative maintenance and inspection of medical
devices are crucial to identify potential malfunctions and ensure safe operation.
 Safe Use Practices: Develop and implement clear protocols for the safe use of medical
devices, including proper handling, cleaning, disinfection, and disposal procedures.
 Incident Reporting and Monitoring: Encourage healthcare professionals to report any
device malfunctions, near misses, or adverse events associated with medical devices.
Analyze reported incidents to identify trends and implement corrective measures.
 User Manuals and Labeling: Ensure user manuals and labeling for medical devices are clear,
concise, and readily available in the local language to facilitate safe and effective use by
healthcare providers.
Strategies with Medical Device Safety
MDS 1: Health care facilities shall follow the standard medical device selection and
management
Activities
 Establish a multidisciplinary team comprising to oversee the procurement and selection of
medical devices.
 Implement a systematic process for periodic surveillance and risk assessments of medical
devices to ensure safety and effectiveness.
 Identify existing devices and systems, assess compatibility, and develop a plan for seamless
integration with the new medical device.
 Collaborate with manufacturers to address training and support needs.
MDS 2: Health care facilities follow appropriate medical device management
protocols
Activities
 Assign a unique identifier to each medical device and track its location and movement
 Develop and adhere to standard Operating Procedures (SOPs) for appropriate use of
medical devices
26
 Develop and implement preventive maintenance (PM) schedules based on risk
assessments and track all PM activities.
 Establish repair and replacement strategies, including contracts with qualified service
providers and maintenance of spare parts inventory for critical devices.
 Develop a risk assessment process for identifying medical devices with potential recall
risks
 Prepare communication plans to notify stakeholders of safety issues.
 Implement a surveillance system (e.g., Camera) for ensuring safety of critical medical
devices
 Implement the infection control policies and procedures for medical devices by training
staffs and monitor its effectiveness
 Ensure proper device setup and configuration by adhering to manufacturer's instructions
 Establish protocols for monitoring and responding to device alarms including training
staffs
 Dispose of medical devices responsibly when no longer needed, adhering to
environmental regulations and guidelines.
27
9. Infection Prevention and Control
9.1. General IPC for Patient Safety
Preventing harm to patients, health workers and visitors due to infection in health care facilities
is fundamental to provide quality care. Achieving patient safety and reducing healthcareassociated infections (HAIs) and antimicrobial resistance (AMR) is essential.
Clean, safe care is a patient right and the duty and pride of all health care workers. In acutecare hospitals, HAIs affect a significant proportion of patients, especially in low- and middleincome countries (LMICs). Effective Infection Prevention and Control (IPC) programs are vital
for enhancing care quality and patient safety, as endorsed by the World Health Organization
(WHO).
Core Principles of IPC
 Standard Precautions: Standard precautions assume every patient is potentially infectious
and mandate the consistent use of personal protective equipment (PPE) such as gloves,
gowns, masks, and eye protection during all patient interactions.
 Hand Hygiene: Hand hygiene is the single most effective measure to prevent the spread of
infections. Regular hand washing with soap and water or using alcohol-based hand rub is
crucial before and after patient contact, after removing gloves, and when moving between
different tasks.
 Aseptic Technique: Maintain aseptic technique during procedures that involve sterile
equipment or body sites to minimize the risk of contamination.
 Environmental Cleaning and Disinfection: Regularly clean and disinfect environmental
surfaces, equipment, and medical devices to prevent the spread of pathogens.
 Antimicrobial Stewardship: Promote the judicious use of antibiotics and other
antimicrobials to combat the growing threat of antimicrobial resistance.
 Immunization: Ensure healthcare workers are up-to-date on recommended vaccinations
to protect themselves and patients from vaccine-preventable diseases.
Strategies for Effective IPC
IPC 1: Strengthening IPC Program Interventions at facility level
28
Activities
 Establish an IPC program with a dedicated, trained person/team for the purpose of
preventing HAI and combating AMR.
 Avail Evidence-based IPC guidelines, and ensure their implementation
 Conduct IPC education for all health care workers.
 Conduct Facility-based HAI surveillance.
 Conduct IPC activities using multimodal strategies to improve practices and reduce HAI
and AMR.
 Conduct regular monitoring/audit of IPC practices according to IPC standards and
provide feedback.
 Monitor bed occupancy and compare with the facility’s capacity and health care worker
staffing levels.
IPC 2: Healthcare facilities shall improve Hand Hygiene practice of health-care
workers to ensure prevention of harms
Activities
 Avail all the Necessary infrastructures and supplies for proper hand hygiene Practice.
 Promote and support proper hand hygiene Practice.
 Conduct continuous monitoring on hand hygiene compliance among healthcare workers.
IPC 3: Healthcare facilities shall improve Safe Injection practice
Activities
 Adhere to the basic principles of injection safety at all injection and medication rooms.
 Avail all the necessary infrastructure, equipment and supplies including PPEs in injection
rooms to make injections safe
 Provide basic orientations/ trainings for hospital staff members
 Prepare Standard Operating Procedures for safe injection implementation
 Promote all Healthcare workers to always follow the standard procedures to ensure
Injection safety
29
IPC 4: Health facilities shall enhance the facility’s hygiene and waste management
practice
Activities:
 Designate a specific area within the healthcare facility for the sterilization of medical
devices.
 Implement standardized procedures for medical device decontamination and instrument
processing, ensuring compliance with IPC guidelines.
 Regularly monitor the effectiveness of the decontamination process, conducting audits as
per IPC guidelines to maintain high standards of hygiene.
 Provide necessary supplies and equipment for cleaning, develop Standard Operating
Procedures (SOPs) for cleaning protocols, and conduct periodic cleaning audits to ensure
cleanliness and safety of patient environments.
 Establish proper healthcare waste management practices, including proper disposal of
safety boxes and liquid waste.
 Allocate adequate space and resources for laundry services, to ensure proper linen
processing.
IPC 5: Improve infection prevention practice to minimize the burden of common
healthcare associated infections (HCAI’s).
Activities

Implement the recommended prevention measures for Surgical Site Infection (SSI)

Implement the recommended prevention measures for Catheter associated urinary
infections (CAUTI)

Implement the recommended prevention measures (Bundles) for Centerline blood
stream Infections (CLABSI)

Implements the recommended prevention measures (Bundles) for healthcare associated
pneumonia.

Implement the recommended prevention measures for healthcare associated infectious
diarrhea

Implement all the recommended IPC practices in special healthcare settings
30
9.2. Safety Measures for Anti-Microbial Resistance
The discovery of antimicrobials has significantly contributed to the decline in morbidity,
mortality, and healthcare costs over the past seven decades. However, due to the misuse and
overuse of these agents, there has been a growing problem of antimicrobial resistance (AMR),
which threatens our ability to treat common and life-threatening infections.
World Health Organization has declared that AMR is one of the top 10 global public health
threats facing humanity. Ethiopia has joined the global community to combat AMR by
developing and implementing the National Strategy for the Prevention and Containment of
AMR. In order to provide evidence- and expert consensus-based recommendations to
effectively reduce antimicrobial resistant infections the following six key interventions are
prepared.
AMR 1: Health facilities shall establish the AMS program, committee and teams.
Including availability of guidelines and capacity building.
Activities
 Report data to regional health bureau as per WHO AMS self-assessment tool quarterly
(referred to National AMS guidelines).
 Establish Multidisciplinary AMS committee/team and allocate required budget.
 Avail the guidelines for the implementation of AMS program.
 Provide orientation to its staff and encourage training on AMS program
AMR 2: Health facilities shall build the capacity of the medical staff working in the
facility and the community
Activities
 Conduct CME for every medical staff in public or private health facility
 Conduct community AMR education and awareness program.
 Avail and implement updated AMR surveillance and AMC surveillance guidelines.
AMR 3: Health facilities shall integrate AMS activities with IPC activities using
multimodal strategies to improve practices and reduce HAI and AMR. The
surveillance of HAI and AMR surveillances should also be integrated
31
Activities
 Integrate AMS with existing healthcare initiatives such as healthcare quality improvement
activity, Drugs and Therapeutic Committee (DTC), Drug Information Center (DIC), CPS
and other such initiatives.
 Conduct integrated AMR and HAI surveillance.
 Ensure the availability of enabling structures and supporting resources
 Provide timely and regular feedback to key stakeholders through the facility network
 Report data timely and in complete form to District Health Information System (DHIS)
AMR 4: Health facilities shall implement an effective monitoring, audit & feedback
collection system for the successful implementation of AMS program
Activities
 Assign a person responsible to conduct periodic monitoring of the score of AMS selfassessment tool.
 Adopt, use and implement the National Antimicrobial use policy as per local context.
 Implement the restrictive and persuasive approaches to control the unnecessary
antimicrobial prescription practices.
 Avail fully functional microbiology laboratory (Tertiary and Secondary Health facilities)
32
10. Health Workforce Safety
Ensuring the safety and well-being of the healthcare workforce is not just an ethical imperative
but also a critical element of patient safety.
Exhausted, stressed, or injured healthcare
professionals are more prone to errors and may struggle to deliver optimal care. Neglecting
occupational safety and health (OSH) is linked to staff turnover, weakening the healthcare
workforce. OSH risks faced by healthcare workers include exposure to infectious agents,
ergonomic hazards from patient handling, hazardous chemicals, radiation, and psychological
stressors. Interventions targeted at healthcare workers will protect and fosters a culture of
safety within healthcare institutions. This ultimately leads to a healthier, more resilient
workforce and improved patient care.
Why is Healthcare Workforce Safety Important?
 A healthy and well-rested workforce is better equipped to provide safe, high-quality care
to patients. Reduced fatigue and stress lead to improved decision-making and a more
positive patient experience.
 Workplace hazards such as musculoskeletal injuries, exposure to infectious diseases, and
work-related violence can lead to staff absenteeism and contribute to medical errors.
Promoting a safe work environment reduces these risks.
 A focus on workforce safety fosters a positive work environment, improves staff morale,
and reduces burnout. This leads to higher staff retention rates, ensuring continuity of care
for patients.
 Workforce injuries and illnesses incur significant costs for healthcare institutions.
Investing in safety programs can yield significant cost savings in the long run.
Strategies for Promoting Health Workforce Safety
HWS 1: Health facilities shall designate a person with authority for occupational
health, and offer ongoing education and training for all involved parties
Activities
 Assign responsible person to be a focal person for the health facility
 Develop and approve Customized Job description for OSH focal person
33
 Allocate required budget as per the plan for OSH activities and should be part of the
health facility fiscal year budget plan
 Avail sufficient personal protective equipment and supplies at all times including buffer
stocks
 Undertake training/capacity building as per required
 Foster collaboration with other health facilities through regular learning sessions to
influence peer to peer learning and to share best practices and Benchmarking
 Conduct awareness to the general public/communities
HWS 2: Develop a written policy on safety, health and working conditions for
health work force protection at the workplace.
Activities
 Develop policy documents (SOPs, guidance and protocols for implementation of OSH
such as protocol on, handling infectious and hazardous chemicals, fire prevention,
Ergonomics)
 Monitor adherence of the recommended guideline to achieve successful implementation
of safety interventions
HWS 3: Create joint health workers–management health and safety committees
with appropriate worker and management representation.
Activities
 Develop TOR to establish the committee with appropriate workers and management
representation
 Integrate OSH committee with Quality and clinical governance unit
 Conduct regular meeting with documented minutes
HWS 4: Health facilities shall identify hazards and hazardous working conditions
Activity
 Conduct risk assessment to identify hazards and hazardous working conditions
 Develop and implement clear protocols for handling hazardous materials, sharps, and
medical equipment to minimize the risk of injuries.
34
 Monitor adherence of the recommended guideline to achieve successful implementation
of safety interventions.
 Implement strategies to prevent workplace violence, including security measures, deescalation training, and clear reporting procedures.
HWS 5: Measures to promote psychological safety of healthcare workers should be
in place
 Offer programs and resources to support the mental and emotional well-being of
healthcare workers, addressing stress, burnout, and fatigue.
 Promote healthy work-life balance practices through flexible work arrangements,
adequate staffing levels, and fair scheduling practices to prevent overwork and fatigue.
HWS 6: Provide healthcare worker safety by offering pre-service and ongoing
immunizations against vaccine-preventable diseases in the workplace at no cost
and guaranteeing access to comprehensive care for blood borne illnesses.
Activities
 Establish health workers immunization recording and reporting system
 Identify health workers who need vaccination based on their immunization records
 Avail hepatitis B vaccine
 Provide hepatitis B vaccine for eligible health workers
 Allocate all required drugs and diagnostic supplies
 Avail PEP algorithm and treatment protocols for hepatitis and HIV
 Provide care and support service for affected health workers
35
11. Surgical and Anesthesia Care Safety
Surgical procedures, while often lifesaving, carry a risk of complications, many of which can be
prevented. This risk is especially high in developing countries, where mortality rates can be ten
times greater than in developed nations. Despite existing safety measures, these complications
persist due to a lack of awareness of surgical safety as a public health concern, poor data
collection, and inconsistent implementation of safety protocols. In order to minimize
unnecessary loss of life and serious complications, operating teams have six key interventions
which the WHO guideline for safe surgery supports in any surgical case.
Strategies for Enhancing Surgical and Anesthesia Safety
SAS 1: The operating surgeon shall operate on the correct patient and on correct
site
Activities
 Confirm that the patient is correctly identified. (Refer to the patient identification)
 Confirm that the patient has given informed consent for the procedure
 Confirm the correct site and procedure with the patient.
 Mark the site of surgery by the surgeon at bedsides in cases involving laterality or multiple
structures or levels (e.g., a finger, toe, skin lesion, and vertebra).
 Both the anesthesia provider and the nurse shall check the site to confirm that it has been
marked by the surgeon performing the operation and reconcile the mark with the
information in the patient’s records.
 The surgical team collectively verifies the correct patient, site and procedure during a
‘time out’ or pause immediately before skin incision. (Annex 1: WHO Surgical Safety
Checklist)
SAS 2: The team shall use methods known to prevent harm from administration of
anesthetics, while protecting the patient from pain.
Activities
 Ensure continuous presence of professionally trained anesthesia provider.
36
 During all general anesthesia procedures, all necessary equipment including supplemental
oxygen and a cardiac defibrillator should be readily available within the operating theater.
 Necessary monitoring techniques as per the clinical guideline should be continuously used
during surgery
 Develop and/or adopt Standard definitions of anesthesia-related mortality
 Identify and report anesthesia-related mortality rate
SAS 3: The team shall recognize and effectively prepare for life-threatening airway
or respiratory function loss.
Activities
Pre-operative
 Ensure preoperative fasting as per the protocol
 Undertake objective evaluation of airway before induction of anesthesia for all patients.
 Ensure that the results of the airway evaluation and a description of the ease or difficulty
of intubation are properly recorded.
 When a patient is known to have a difficult airway, alternative methods of anesthesia shall
be considered, including regional anesthesia or awake intubation under local anesthetic.
 Plan a strategy for managing the airways and be prepared to execute it, even if airway loss
is unexpected.
Intra-operative
 When difficult airway is suspected, assistance during induction shall be immediately
available, and a backup plan for airway management should be clearly identified.
 Confirm endotracheal tube placement after intubation
 Ensure all essential equipment for managing difficult airways is available.
SAS 4: The team shall recognize and effectively prepare for the risk of high blood
loss
Activities
 Assess every surgical patient as per standard guideline for potential major blood loss
37
 Communicate with the blood bank and confirm the availability of blood products if
needed.
SAS 5: The team shall consistently use evidence-based standards and protocols to
minimize the risk for surgical site infection
Activities
 Every surgical patient requires thorough completion of all preoperative assessment,
precautions and activities as per the standard guideline
 Prior to each surgery, meticulously follow established sterilization protocols for all
surgical instruments, devices, and materials.
 The operating team should follow hand scrub and skin preparation techniques as per the
standard guideline
 Positive pressure air flow should be maintained in the operating room
 Operating room should be cleaned thoroughly after ‘dirty’ or ‘infected’ cases and at the
end of each operating day.
 Implement ongoing surveillance by trained professionals, share infection rate data with
leadership, and offer annual infection prevention training to surgical teams
SAS 6: The team shall prevent inadvertent retention of instruments and sponges in
surgical wounds.
Activities
 Sponges, sharps, instruments, and anything else used during surgery must be meticulously
counted at the start, end, and whenever new items are added.
 Entering a body cavity like the abdomen or chest triggers a full recount of all surgical
items.
 One person loudly announces the count while another observes for accuracy.
 Record the final count, who performed it, and if correct. Clearly inform the surgeon of
the final tally.
 Before stitching up, thoroughly explore the wound to ensure no items are left behind.
38
SAS 7
health facilities shall ensure the well-being and safety of patients after
surgery which can help to identify and treat any potential complications early on,
such as respiratory problems or bleeding.
Activities
 Health facilities ensures proper executions of vital sign, pain management, assessment of
surgical site, mobility and activity, Preventing Infections, Fluid and Nutrition Management
Monitoring the patient's airway, Medication Management, Patient Education and Support
 Hospital ensures proper post anesthesia care services
39
12. Healthcare Acquired Conditions
12.1 Blood Transfusion
Transfusions are a critical medical intervention that can save lives, but they also carry a
significant risk of harm if not done correctly. Patient safety is essential in transfusion medicine,
and healthcare providers must take steps to minimize the risk of harm to patients. One of the
primary factors that contribute to transfusion safety risks is human error. Transfusion errors
can occur at any point in the transfusion process, from the identification of the patient, for
instance misidentification of the patient, to the administration of the blood product, such us
selection of wrong blood product. Product contamination and allergic reactions are other
factors that can contribute to transfusion safety risks. To minimize the risk of harm to patients,
caregivers and healthcare providers must take steps to ensure transfusion safety. This includes
following established protocols for patient identification, blood product selection, and
administration. Healthcare providers must also be vigilant for signs of adverse events and be
prepared to respond promptly if an adverse event does occur.
Strategies for Safe Blood Transfusion Practices
BTS 1: Health facilities providing transfusion therapy shall have procedures in place
to ensure the safe storage and where relevant, transport of blood and blood
products.
Activities
• Store blood products in accordance with national or international.
• Manage the transport of blood products between facilities, including packing
configurations and the use of validated shipping containers, in compliance with national or
international guidelines or standards.
BTS 2: Health facilities providing transfusion therapy shall have procedures and
processes in place to ensure clinicians are able to obtain and document informed
consent for the use of blood products.
Activity
40
• Inform patient and caregiver about the transfusion therapy and obtain written Informed
consent from the patient or their legally authorized representative prior to transfusion.
BTS 3: Ensure correct patient identification and procedure verification for
transfusion-related activities.
Activities
• Health facilities shall establish and implement procedures to verify patient identity using at
least two unique identifiers and confirm the compatibility of the blood component with
the intended recipient.
• Healthcare providers shall ensure pre-transfusion specimen collection, specimen labeling
requirements and related procedures comply with national protocol
BTS 4: Health facilities shall have processes in place to support clinicians in their
obligations to provide safe, effective and appropriate use of blood products when
clinically indicated.
Activities
• Health facilities policies shall define which clinical staffs are authorized to request blood
and what training they need.
• Have processes in place to support clinicians to safely administer blood products when
clinically indicated.
• Trained healthcare professionals who follow aseptic techniques and use appropriate
transfusion equipment shall administer transfusions.
• Healthcare professionals shall closely follow and monitor patients during and after
transfusion for any signs of adverse reactions or complications.
• Establish a system to maintain accurate and complete documentation of transfusion
details, including vital signs, transfusion start and end times, blood component details, and
any adverse events or reactions.
BTS 4: Health facilities shall establish systems and processes in place to support the
appropriate identification, management, notification, and follow up of adverse
outcomes of transfusion, transfusion reactions, and incidents relating to transfusion
activities.
41
Activities
• Health facilities shall have a system in place to promptly report adverse events or
reactions related to blood transfusions
• Health facilities shall have a system in place for the management of transfusion related
incidents.
• The Transfusion Committee or authorized responsible body shall review adverse event
reports, identify root causes, and implement corrective and preventive actions.
BTS 6: Health facilities that provide transfusion therapy shall have a system in
place for the review of blood product issues.
Activities
• Establish Hospital transfusion Committee (HTC) or an equivalent quality or patient safety
improvement team as relevant to the size and function of the service.
• The established committee shall design a quality management system for blood
transfusion services, including

Regular internal audits, quality control checks, performance improvement
initiatives, ensuring implementation and monitor compliance with national
regulations and guidelines.
12.2 Pressure Ulcer
Pressure ulcers, also known as bedsores, are a common and preventable health issue
worldwide. They are painful and costly complications that many individuals are at risk for.
Pressure ulcers have a significant impact on the quality of life for patients and their caregivers.
Overall, pressure ulcers are a significant health problem that causes pain, financial burden, and
reduced quality of life for patients and their caregivers. Preventive measures and interventions
are crucial to reducing the prevalence and impact of pressure ulcers.
Strategies to Prevent and Manage Pressure Ulcer
PUS 1: Health facilities shall design a system to asses risk related to pressure ulcer
• Conduct risk assessment as soon as possible (but within a maximum of eight hours after
admission) to identify individuals at risk of developing pressure ulcers
42
• Repeat the risk assessment as often as required by the individual’s acuity or if there is any
significant change in the individual’s condition
• Document all risk assessments
• Educate health professionals on how to undertake a comprehensive skin assessment that
includes the techniques for identifying blanching response, localized heat, edema, and
induration (annex Conducting Skin and Tissue Assessment)
PUS 2: Health facilities shall establish preventive measures for preventing pressure
ulcer.
• Develop and implement a risk-based prevention plan for individuals identified as being at
risk of developing pressure ulcers.
 Avoid positioning the individual on an area of erythema whenever possible
 Keep the skin clean and dry
 Do not massage or vigorously rub skin that is at risk of pressure ulcer
 Develop and implement an individualized continence management plan
 Protect the skin from exposure to excessive moisture with a barrier product in
order to reduce the risk of pressure damage
 Consider using a skin moisturizer to hydrate dry skin in order to reduce risk of
skin damage
• Screen nutritional status for each individual at risk of or with a pressure ulcer using valid
and reliable nutrition screening tool
• Reposition all individuals at risk of, or with existing pressure ulcers, unless contraindicated
PUS 3: Health facilities shall put in place assessment and management framework
for pressure ulcer.
• Complete a comprehensive initial assessment of the individual with a pressure ulcer.
• Use the Norton Scoring System Pressure Ulcer Classification System to classify and
document the level of tissue loss.
• If pressure ulcer already developed depending on stage follow Standard Procedure for
ulcer management
• Assess the pressure ulcer initially and re-assess it at least weekly.
43
• With each dressing change, observe the pressure ulcer for signs that indicate a change in
treatment is required (e.g., wound improvement, wound deterioration, more or less
exudate, signs of infection, or other complications.
• Use the findings of a pressure ulcer assessment to plan and document interventions that
will best promote healing
• Assess all individuals for pain related to a pressure ulcer or its treatment and document
findings.
• Work with the multi-disciplinary health care team to develop a holistic plan to manage
chronic pressure ulcer pain.
PUS 4: Health facilities shall design to engage in educating individuals, family and
health care providers.
• Educate the individual, caregivers, and health care providers about prevention, causes,
assessment and management of pressure ulcer pain.
12.3. Venous Thromboembolism
Thromboembolism is a significant health concern in the inpatient setup worldwide, contributing
to substantial morbidity and mortality. The exact magnitude of thromboembolic events in
hospitals can vary depending on various factors such as patient population, healthcare practices,
and preventive measures implemented. However, studies have consistently highlighted the
negative impact of thromboembolism in hospitalized patients.
Venous thromboembolism (VTE) is a major preventable disease that affects millions of people
worldwide. Several studies have found that the incidence of VTE events in Ethiopia ranging from
5.5% to 6.84%. Prolonged immobilization and acute infection were the most frequently seen
VTE risk factors in Ethiopia. Furthermore, history of major bleeding or blood transfusion, lung
disease (non-infectious), and prior history of surgery were also common risk factors for the
development of thrombotic events. Effective prevention of VTE is achieved through assessment
of risk factors and the provision of appropriate prophylaxis. Purpose
This interventions cover assessing and reducing the risk of venous thromboembolism (VTE
including deep vein thrombosis and pulmonary embolism) in patients admitted in hospitals. It
aims to help healthcare professionals identify people most at risk and describes interventions
that can be used to reduce the risk of VTE.
44
Strategies to Prevent and Manage VTE
VTE 1: Health facilities must have systems in place to support clinicians to assess
and manage VTE risk in patients.
Activities
• Identify, assess and reassess patient groups at risk of developing VTE and undergo a VTE
risk assessment (Annex I)
• Avail standardized and approved risk assessment tools (Annex II) for all clinical staff.
• Balance the person's individual risk of VTE against their risk of bleeding when deciding
whether to offer pharmacological thromboprophylaxis to all patients.
• Enable clinicians to reassess patients identified at risk at the point of discharge.
Consideration should be made regarding the need for extended prophylaxis.
• Support clinicians to document a risk assessment, interventions and their outcome.
VTE 2: Implement evidence-based protocols for thromboembolism prevention,
including mechanical prophylaxis and pharmacological prophylaxis.
Activities
• The choice of pharmacological and/or mechanical prophylaxis must be informed by
evidence.
• Ensure that systems are in place to provide clinicians with access to evidenced-based
guidelines, a clinical specialty protocol, as well as reference to drugs and diagnostic
supplies available on the hospital formulary.
• If pharmacological and/or mechanical prophylaxis is required and appropriate, prophylaxis
should be prescribed and administered as early as possible during the patient’s admission
or as scheduled after the commencement of care and risk assessment is carried out.
• The decision to commence pharmacological prophylaxis should be made after considering
the benefits of treatment i.e., reducing VTE risk, against the risk associated with
treatment (bleeding and other contraindications).
VTE 3: Educate patients about thromboembolism risks, signs, and symptoms,
emphasizing the importance of early reporting to initiate prompt intervention.
Activities
45
• On admission ensure that people understand the reason for having a risk assessment for
VTE and bleeding.
• For people admitted to hospital who are at increased risk of VTE, give them and their
family members or care givers (as appropriate) verbal information on the
 Person's risks and possible consequences of VTE,
 The importance of VTE prophylaxis and its possible side effects,
 The correct use of VTE prophylaxis and how people can reduce their risk of VTE
before offering VTE prophylaxis.
VTE 4: Health facilities must ensure they have in place a monitoring and evaluation
program that includes regular review of effectiveness of VTE prevention strategies
Activities
• All patients who present on admission with a VTE resulting from a previous
hospitalization (within 90 days of discharge) or who develop a VTE during hospitalization
must have the incident documented in the patient’s health care record and reported into
the incident reporting system.
• Regular clinical auditing is required to capture the necessary data to inform health
facilities on VTE prevention indicators
• The health facilities VTE prevention monitoring and evaluation program must include a
system of communicating VTE indicator data to clinicians in a timely manner to enable
practice and quality improvement.
• Clinical staff should be provided with continuous capacity building on VTE prevention
strategies and protocols
12.4. Mental Health
People with mental illness face unique patient safety issues when receiving healthcare.
Unfortunately, there is still a lack of awareness about these unique issues among healthcare
providers at all levels, as well as a lack of evidence related to these issues. Although many of the
same patient safety risk factors that exist in medical settings apply to mental health settings,
there are unique patient safety issues that arise in the mental health context that are either
more common among individuals with mental illness or are a typical of those arising in acute
46
medical care. Some of these include patient safety issues around seclusion and restraint use,
self-harming behavior and suicide, absconding, and reduced capacity for self-advocacy.
Patients receiving mental health treatment are at risk of patient safety incidents that are
uniquely or strongly associated with mental health settings as well as adverse events that occur
in general medical settings.
Strategies for Mental Health Safety
MHS 1: Mental health facilities should have a risk management policy in place to
identify potential risks and implement measures to prevent or mitigate them.
Activities
• Conduct comprehensive risk assessments for all patients upon admission and regularly
throughout their treatment.
• Implement individualized safety plans that address identified risks, including self-harm,
violence towards others, and elopement.
• Regularly assess and monitor patients for signs of deterioration or adverse events.
• Ensure appropriate communication and documentation of risk assessments, management
plans, and any changes in risk status.
MHS 2: Mental health facilities should ensure that healthcare practitioners are
competent and compliant with patient safety protocols.
Activities
• Ensure that all mental health professionals and staff receive appropriate training on patient
safety, risk assessment, and crisis intervention.
• Provide ongoing education and updates on best practices related to patient safety in
mental health settings.
• Promote a culture of safety by encouraging reporting of safety incidents, near misses, and
potential risks.
MHS 3: The health service organization should have a system of providing services
to patients who have cognitive impairment or are at risk of developing delirium.
Activities
47
• Incorporate best-practice strategies for early recognition, prevention, treatment and
management of cognitive impairment in the care plan, including the Delirium Clinical Care
Standard
• Manage the use of antipsychotics and other psychoactive medicines, in accordance with
best practice and based on Food, Medicine and Health Care Administration and Control
Proclamation …..Page 5157
MHS 4: The health service organization has processes to identify, mitigate and
manage situations that may precipitate aggression and violence.
Activities
• Develop strategies for recognizing and managing aggression or violence among patients
and establish protocols for staff safety during escalated situations.
MHS 5: Mental health facilities should minimize the use of restraints and seclusion.
Activities
• Minimize and, where possible, eliminate the use of seclusion
• Govern the use of seclusion in accordance with Ethiopian legislation
• Report use of seclusion to the governing body
• Where restraint is clinically necessary to prevent harm, the health service organization
should have systems that:
 Minimize and, where possible, eliminate the use of restraint
 Govern the use of restraint in accordance with legislation
 Report use of restraint to the governing body
• Where seclusion is clinically necessary to prevent harm and is permitted under legislation,
the health service organization has systems that:
MHS 6: Mental health facilities should have Conducive environment and resources
in place to prevent patients from harm prevention and management and leaving
without permission.
Activities
• Mental health facilities should ensure that they have adequate staff resources to provide
safe and effective care.
48
• Ensure seamless transitions and timely follow-up care through effective coordination
between mental health providers, primary care physicians, and social support networks.
• Tailor care plans based on patient risk assessments, providing appropriate levels of
supervision and security measures.
• Design secure facility environments with controlled access, surveillance, and regular
security assessments.

Regularly inspect the physical infrastructure to identify and address potential
hazards or safety concerns.
• Ensure well-trained staff, effective communication, and clear crisis response procedures
to address and deter absconding incidents.
12.5. Fall Prevention
A fall is a sudden, unintentional change in position causing an individual to land at a lower level
(either on an object or on the floor) other than as a consequence of sudden onset of paralysis,
epileptic seizure or overwhelming external force. It is one of the most common, but often
avoidable, adverse events involving a patient/ long term care resident (in short residents). Falls
frequently result in fractures, soft tissue or head injuries, post-fall anxiety, depression, and
decreased mobility due to apprehension about further falls. Longer hospital stays and higher
rates of discharge to long-term care facilities have also been linked to inpatient falls.
Patient falls in hospitals and other healthcare settings are among the most serious risk
management issues confronting the healthcare system, causing morbidity, mortality, and
financial burdens. Non-fatal injuries, such as hip fractures or head injuries can result in
functional declines in mobility and other daily activities. The majority of falls are caused by a
combination of factors therefore, managing the risk of falling begins with identifying the factors
that contribute to fall risk. This section outlines evidence-based practices for preventing falls
and managing fall events to minimize patient harm.
Strategies for Fall Prevention and Management
FPS 1: Healthcare facilities shall conduct fall risk assessment for all admitted
patients and post fall assessment shall be done if fall happened.
Activities
49
• Conduct multidimensional risk assessment including medical, functional and behavioral
aspects within 24 hours of admission. (ANNEX VII: Fall Assessment checklist)
• Reassess fall risk for patients when there is a change in the patient’s status or
environment.
• Ensure involvement of all members of the multi-disciplinary healthcare team during risk
assessment.
• Record the level of risk and the identified risk factors in the patient’s medical records
FPS 2: Health facilities shall implement multifactorial fall prevention approach
Activities
• Introduce a fall prevention program which comprise multifactorial interventions
incorporating both general and individual-specific/ tailored strategies.
 General Interventions: Environmental safety (Flooring and lighting include Clear
obstacles and clutter at bedside and along passageways, provide night lights at
bedsides, hallways and toilets, provide grab bars in toilets and on slopes, use nonslip flooring and keep floor dry, highlight the edge of steps and slopes, covering
sharp edged equipment to protect, irregular/slippery surface etc. …)
 Provide individual-specific interventions: increased observation for “at risk”
patients - provide assistance for patients at fall risk, patients with altered mental
status, medication review, providing tailored exercise, providing assistive medical
devices and post falls analysis.
 Provide education: patient/family education on fall prevention in the wards and
education for health care workers
• Assess and monitor frequently patient’s movement and activities of daily living during
their stay in the hospital.
• Implement a safe physical environment as part of a general strategy to reduce the risk of
falls. This includes
 Inform staff of patients at risk of falls through labeling using colored stickers
behind beds, clinical/nursing notes and/or distinctively colored identification
bracelets.
50
 Assist patients with transfers and mobilization, use non-slip footwear, refer to
physiotherapy for gait, balance, strength training, and prescription of walking aids,
and avoid bed rest unless ambulation is contraindicated.
 Design a system to give health education for family and caregivers on fall
prevention.
FPS 3: Post-fall assessment should be conducted accompanied by attention to
patients’ injuries, medical review to exclude acute causes of fall, investigation into
the circumstances of fall to determine any underlying root cause.
Activities
• Design protocol to respond to fall incidents, review every fall and complete a falls report,
including recommendations for the immediate and longer-term care required
• Implement post fall interventions; the four-post fall interventions are

Assessment

Notification and communication

Monitoring and reassessment

Documentation: classification, reporting and analysis
Time of assessment by nurse
Potential cause or contributing factors of fall
Location of fall
Medications (especially contribute to fall, bleeding risk)
Review of recent laboratory results.
Vital signs and Pain assessment
Physical examination completed (Skin assessment, Musculoskeletal
evaluation, Neurological evaluation, Mental status assessment)
Injury status
Plan of care updated
Family notification addressed.
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13. Continuous Learning and Improvement
In healthcare, incident reporting serves as a cornerstone for fostering a culture of safety and
continuous improvement. It encompasses the systematic identification, documentation, and
analysis of adverse events, near misses, and other safety concerns within healthcare
organizations. By encouraging frontline staff and others to report incidents, healthcare
organizations can proactively identify potential risks, mitigate harm to patients and staff, and
drive quality improvement initiatives. Incident reporting not only enables timely intervention
and resolution but also provides valuable data for identifying trends, patterns, and areas for
enhancement. Moreover, it facilitates organizational learning and knowledge sharing, allowing
healthcare providers to implement preventive measures and best practices to prevent
recurrence of similar incidents. Embracing a culture of continuous improvement in healthcare
requires not only robust incident reporting mechanisms but also a commitment to transparency,
accountability, and collaboration across all levels of the organization. By integrating incident
reporting with quality improvement efforts, healthcare institutions can effectively enhance
patient safety and deliver higher-quality care to their patients.
CLI 1: Healthcare facilities should have a system in place for identifying, managing
and reporting any clinical incident which has resulted in actual or potential patient
harm.
Activities
• Develop/adapt incident reporting and learning manual for clinical incidents
• Establish a safe and just culture that encourages clinical incident reporting including near
misses
• Make incident reporting easier through anonymous reporting mechanisms
• Ensure leadership support
CLI 2: Specific roles and responsibilities should be assigned to individuals for
recording and reporting all clinical incidents to the quality/patient safety unit
/incident officer/ using reporting tools as soon as possible after the incident has
been recognized.
Activities
52
• Designate roles and responsibilities for recording clinical incidents
• Report sentinel clinical incidents immediately
CLI 3: Healthcare facilities should have a clear procedure for clinical incident
analysis and should include incidents that are subject to analysis, the method of
analysis and the roles and responsibilities for those involved with the incident
analysis process.
Activities
• Ensure the clinical incident reporting and learning manual has robust incident analysis
methods
• Identify incidents that should always be investigated
• Describe the roles and responsibilities of incident analysis team members
CLI 4: Healthcare professionals should provide an immediate care for the
patient/care provider or staff involved in a harmful incident.
Activities
• Provide immediate care for the victim and provide prophylaxis for the healthcare worker
if applicable
• Secure items related to the event such as medical equipment, IV solutions, medications
etc. for testing and analysis by the analysis team.
• Begin a disclosure process (at least immediate and post analysis disclosure)
• Reduce the risk of imminent recurrence of the incident
CLI 5: An incident investigation committee should undertake a thorough analysis of
a clinical incident in order to identify the root causes and contributing factors
resulting in the incident that will help for further action and learning.
Activities
• Conduct initial preliminary assessment including a high-level sequence/chronology of
events and documentation of known facts about the incident
• Use the incident decision tree whenever an accountability review is indicated by the
preliminary findings
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• Conduct incident analysis/investigation using a variety of methods including Fishbone
diagram, tree/constellation diagram etc.
• Follow a team approach including care providing clinicians, patients and family
• Coordinate a series of meetings
• Conduct interviews, record reviews and other methods of data collection
• Summarize findings and develop recommended actions
CLI 6: Facilities should provide comprehensive education and training to
healthcare staff on the importance of incident reporting, how to recognize
incidents and the reporting process itself.
Activities
• Provide training on the use of incident reporting systems,
• Provide training on confidentiality policies
• Orient on non-punitive reporting culture for both staff and leadership
CLI 7: Establish a timely review process for incident report to address gaps and
maximize learning.
Activities
• Investigate/analyze and take corrective actions within 90 days
• Ensure prompt action /QI projects or action plans/ is taken to address the identified gaps
by assigning responsible individuals
CLI 8: Quality/safety unit or Incident officer should monitor the implementation of
the recommended actions after incident investigation.
Activities
• Monitor and assess the effectiveness of recommended actions after implementation
CLI 9: Healthcare facilities should conduct regular reviews and aggregate analysis
of reported incidents to identify trends, patterns, and areas of concern.
Activities
• Use data-driven insights to prioritize interventions
54
• Allocate resources effectively to address systemic issues
• disseminate
CLI 10: Healthcare facilities should share what was learned from the clinical
incident analysis/investigation to both those within the organization and outside the
organization to prevent additional harm and ensure safer care.
Activities
• Documentation of the clinical investigation
• Continuous organizational learning and sharing results
55
14. Ethical, Legal, and Regulatory considerations
Ensuring patient safety within healthcare settings is a multifaceted endeavor that involves
navigating regulatory, legal, and ethical frameworks. Regulatory standards, mandated by
governmental bodies, are essential in governing healthcare practices and safety protocols to
uphold patient safety and maintain high-quality care. Legal responsibilities extend to protecting
patient rights, preserving confidentiality, and mitigating risks to prevent legal consequences for
both patients and healthcare providers. Ethical considerations underscore the ethical obligations
of healthcare professionals to prioritize patient welfare by upholding principles of beneficence,
non-maleficence, autonomy, and justice. By integrating these regulatory, legal, and ethical
aspects into clinical practice, a culture of safety, trust, and accountability is fostered, leading to
improved patient outcomes and increased public confidence in healthcare services.
ELR 1: Healthcare facilities shall adhere to legal compliance and accountability
standards.
Activities
 Strict documentation protocols ensures accurate recording of patient information,
treatment plans, and outcomes.
 Healthcare facilities must adhere to Ethiopian laws and regulations governing patient care,
including Proclamation No. 661/2009, which mandates reporting professional malpractice.
 Healthcare providers should ensure compliance with Health Professionals Proclamation
No. 431/2005, which regulates licensing, registration, and conduct standards.
 Establish mechanisms for reporting and addressing medical malpractice, ensuring
accountability and protection of patient rights.
ELR 2: Healthcare facilities obliged to prioritize patients' well-being by respecting
their autonomy and involving them in care decisions and must adhere to principles
of beneficence, prioritizing patients' welfare, and non-maleficence; ensuring actions
do not harm patients.
Activities
 Healthcare providers should uphold ethical principles such as beneficence, nonmaleficence, autonomy, and justice in all patient interactions.
56
 Develop policies and protocols for handling ethical dilemmas, respecting patients' rights
and dignity.
 Provide training on ethical decision-making to healthcare professionals to promote a
culture of ethical conduct.
ELR 3: Regulatory Compliance and Quality Assurance: health facilitates shall follow
the countries regulatory standards.
 Ensure compliance with Ethiopian Health Policy directives to enhance healthcare service
delivery and prioritize patient safety.
 Implement Ethiopian Health Care Quality Strategy measures to improve healthcare
quality, including patient safety initiatives.
 Adhere to Ethiopian Health Care Quality Standards to maintain safe and high-quality care
in healthcare facilities.
 Health facilities should strive to engage in facility accreditation process
ELR 4: Health facilitates shall conduct Training and Education on legal, ethical and
regulatory activities.
Activities
 Provide ongoing training to healthcare professionals on legal obligations, ethical principles,
and regulatory requirements related to patient safety.
 Conduct regular education sessions for patients to inform them about their rights, safety
measures, and avenues for reporting concerns.
 Collaborate with regulatory bodies and professional organizations to develop and
disseminate educational resources on patient safety.
ELR 5: Monitoring, Evaluation and learn to improve legal, ethical and regular
standards.
 Establish monitoring systems to track compliance with legal, ethical, and regulatory
standards related to patient safety.
 Conduct regular audits and assessments to identify areas for improvement and address
gaps in implementation.
57
 Utilize feedback from patients, healthcare professionals, and regulatory agencies to inform
continuous improvement efforts.
ELR 6: Health facilities shall collaborate and advocate for the redesign and
implementation of new acts and legal codes aimed at enhancing safety measures.
Activities
 Foster collaboration between healthcare providers, regulatory bodies, patient advocacy
groups, and government agencies to promote patient safety initiatives.
 Advocate for policy changes and reforms that prioritize patient safety and strengthen legal
and regulatory frameworks.
 Engage in knowledge-sharing and best practice dissemination forums to facilitate
continuous learning and improvement
58
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61
Annexes
Annex I: Safety walk round checklist
Leader Conducting Walk:
Safety Walk Round Checklist
Observer(s) Participating:
Date:
Location:
Personal
Protective Equipment
(PPE)
Workplace Cleanliness
Safety
Equipment
Emergency
Preparedness
Hazard
Identification
Employee
Engagement
Documentation
and Record-Keeping
Action Items
Purpose of Safety Walk Round: The purpose of this Safety Walk Round is to ensure that all safety protocols and
procedures are being followed effectively, identify any potential hazards, and promote a safe working environment for all
employees.
Are all employees wearing the necessary PPE for their tasks?
Are PPE items in good condition and being used correctly?
Is the workspace tidy and free of stuff that shouldn't be there?
Are spillages promptly cleaned up?
Are walkways and emergency exits clear and unobstructed?
Are all equipment and machinery properly maintained?
Are safety guards and devices in place and operational?
Are employees trained in the safe operation of equipment?
Are emergency exits clearly marked and accessible?
Are fire extinguishers, first aid kits, and other emergency
equipment readily available and in good condition?
Are employees aware of emergency procedures and evacuation
routes?
Are there any potential hazards such as loose wires, uneven
flooring, or slippery surfaces?
Are hazardous materials properly stored and labeled?
Have near misses or incidents been reported and addressed?
Are employees actively engaged in safety practices?
Do employees feel comfortable reporting safety concerns or
incidents?
Are safety inspections and maintenance activities documented?
Are records of safety training and drills up to date?
Identify any areas needing immediate attention or improvement.
Assign responsibility for addressing each identified issue.
62
Round.
Set deadlines for completing action items.
Follow up on the progress of action items during the next Safety Walk
Additional Comments
63
Annex II: Patient Safety Huddle Agenda
Patient Safety Huddle Agenda
Date:
Time:
Location:
Participants:
Goal: Review yesterday, plan for today, and keep everyone safe!

Briefly share any patient safety concerns from yesterday.
 What happened? (Simple explanation)

What can we do differently to avoid it in the future?

Are there any patients today who might need extra care?

Briefly review any previously identified safety issues.

Raise any other concerns that may affect patient safety today.

Updates or announcements?

Briefly discuss next steps (who does what).
64
Annex III: Sample hand overing format
I-PASS tool: A Communication Tool for patient handover
The I-PASS tool is a widely adopted mnemonic used to improve communication during patient
handoffs between healthcare providers. It stands for:
 Illness severity: Briefly describe the patient's current condition, including the primary
diagnosis, any secondary diagnoses, and the urgency of the situation.
 Patient summary: Provide a concise overview of the patient's medical history, allergies,
medications, and current social situation.
 Action list: Clearly outline the essential actions that need to be taken for the patient's
care in the coming period. This includes medications, treatments, investigations, and any
specific monitoring requirements.
 Situational awareness/contingency planning: Discuss potential concerns or
anticipated changes in the patient's condition. Outline contingency plans for managing
these situations to ensure continuity of care.
 Synthesis of the information by the incoming provider: The receiving healthcare
provider should actively listen, ask clarifying questions, and summarize their understanding
of the patient's condition and care plan.
How to use I-PASS
Providing the specific information identified in each step of I-PASS will foster effective handoffs
within teams. In particular, addressing contingency planning will help ensure staff beginning to
support a patient are prepared for situations they might not have considered before the handoff
occurred.
Patient Name: ______________________ Age: _______ Sex: ________ MRN: _______
Date: ______________ Time: ______________
I: Illness Severity
P: Patient Summary
A: Action List
S: Situation Awareness &
Contingency Planning
S: Synthesis of the information by the
incoming provider
Stable, Sub-critical, Critical
Summary Statement
Events leading up to admission or care transition
Hospital course or treatment plan
Ongoing assessment
Contingency plan
To-do list
Timelines and ownership
Know what's going on
Plan for what might happen
Receiver summarizes what was heard
Asks questions
Restates key actions/to-do items
65
Annex IV: Sample wrist ID bands
A hospital wristband is an armband that ensures positive patient identification and a time-saving
communication of sensitive data in a demanding healthcare environment. Thus, its use not only
benefits patient safety but also facilitates the workflow of healthcare providers.
66
Annex V: Medical history record form
Inpatient Medication Profile Form (follow instructions while completing)
Patient name:
Sex:
Age:
Weight:
Height:
Date of Admission
Diagnosis:
Past medical
history:
Indication
MRN
Admission Medication History
Past medication history
Any substance use:
(Name, dose, frequency, duration)
Allergies:
Any adherence problem:
Pregnancy/lactation status:
Immunization status for
Pedi:
Current Medications
Drug
Start date
(Name, Strength, Dosage form, Dose, & Time
Route, and frequency)
67
Stop date &
Time
(optional)
Initials
& Sig.
Annex VI: VTE risk groups and risk assessment tools
VTE risk groups
Venous thromboembolism (VTE) can affect individuals in various risk groups. These risk groups
are categorized based on factors that increase the likelihood of developing VTE. Here are some
of the common VTE risk groups.
Hospitalized Patients
Individuals who are admitted to
hospitals, especially for certain
medical conditions, surgeries, or
trauma, are at an increased risk
of VTE due to factors such as
immobility and medical
interventions.
Cancer Patients:
Pregnant Women and
Postpartum Period
Elderly Population
Previous VTE History:
Family History
Immobility
Inherited Thrombophilia
Antiphospholipid Syndrome
Medical Patients
 Admitted following acute stroke with significant reduction in
mobility
 Critically ill patients
 Hospitalized for decompensated heart failure
 Active inflammatory bowel disease
Surgical Patients:
 Those undergoing major surgeries, especially orthopedic,
gynecologic, and general surgeries, are at higher risk for VTE.
 Total hip arthroplasty or total knee arthroplasty
 Fragility fractures of the pelvis, hip and proximal femur
 Major trauma surgery (including traumatic brain injury, acute spinal
cord injury, traumatic spinal injury, and complex traumatic pelvic/
lower extremity injury)
 Craniotomy
 Cardiac surgery
 Abdominal aortic aneurysm repair surgery
 Thoracic surgery patients with primary or metastatic cancer
 Elective spinal surgery (with hospital admission) resulting in reduced
mobility
Cancer and cancer treatments can increase the risk of VTE due to
factors like hypercoagulability and the effects of certain medications.
Pregnancy and the postpartum period are associated with an increased
risk of VTE, primarily due to changes in blood clotting factors and
reduced mobility during pregnancy.
Advanced age is a risk factor for VTE due to factors like decreased
mobility and changes in blood clotting mechanisms that occur with
aging.
Individuals who have had a previous episode of VTE are at a higher risk
of experiencing recurrent VTE.
A family history of VTE can increase an individual's risk of developing
VTE.
Prolonged immobility, such as long-distance travel, extended bed rest,
or paralysis, can increase the risk of VTE.
Certain genetic conditions, such as Factor V Leiden mutation or
prothrombin gene mutation, can predispose individuals to VTE.
This autoimmune disorder can lead to a higher risk of VTE.
68
VTE risk assessment tool
Assessing the risk of venous thromboembolism (VTE) often involves using various risk assessment tools
or clinical scoring systems to identify individuals who may benefit from prophylactic measures. The
choice of a specific tool may depend on the clinical setting and the population being assessed. It's
important for healthcare professionals to use these tools in conjunction with their clinical judgment to
make appropriate recommendations for VTE prevention.
Recommended VTE risk assessment tools are:
1.
Padua Prediction Score: This tool is designed to assess the risk of VTE in hospitalized
medical patients. It considers various clinical and laboratory parameters, as well as predisposing
factors, to determine the risk level.
Padua Risk Assessment Model for Medical Patients
Baseline Features
Score
Active Cancer1
3
Previous VTE (excluding superficial vein thrombosis)
3
2
Reduced mobility
3
Already known thrombophilic condition3
3
Recent (less than or equal to 1 month) trauma and/or surgery
2
Elderly age (70 years or older)
1
Heart and/or respiratory failure
1
Acute myocardial infarction or ischemic stroke
1
Acute infection and/or rheumatologic disorder
1
Obesity (BMI 30 kg/m2 or greater)
1
Ongoing hormonal treatment
1
Total score
1
Patients with local or distant metastases and/or chemotherapy or radiation therapy in the last 6 months.
2
Bed rest with bathroom privileges (either due to patient limitation or physician order) for at least 3
days.
3
Carriage of defects of antithrombin, protein C or S, factor V Leiden, G20210A prothrombin mutation,
antiphospholipid syndrome.
The total Padua Prediction Score is calculated by adding all points for the patient. The corresponding
VTE risk level can be interpreted using the table below which also shows recommendations for VTE
prophylaxis.
Total Score and VTE Risk Level for non-surgical patients based on Padua model
Total Score
VTE Risk Level
VTE Prophylaxis recommended?
Less than 4
Low
No
4 or more
High
Mechanical prophylaxis or Pharmacological prophylaxis
69
2. Caprini Risk Assessment Model: The Caprini model is a comprehensive tool that
assesses the risk of VTE in surgical and medical patients. It takes into account multiple
risk factors, including surgery type, age, and comorbid conditions, to categorize patients
into different risk levels and recommend appropriate VTE prophylaxis.
Caprini’s Risk Assessment Model for Surgical Patients
1 point
2 points
per risk factor
per risk factor
Age 41–60 years
Age 61 to 74 years
Minor surgery (less than 45 mins)
Arthroscopic surgery
planned
BMI 25 kg/m2 or greater
Major open surgery
(>45 minutes)
Swollen legs (current)
Laparoscopic surgery
(>45 minutes)
Varicose veins
Malignancy
Pregnancy or postpartum less than
one month
History of unexplained or recurrent
spontaneous abortion
Oral contraceptives or hormone
replacement therapy
Sepsis (<1 month)
3 points
per risk factor
Age ≥75 years
History of VTE
Family history of VTE
Factor V Leiden
Prothrombin 20210A
Confined to bed (>72
hours)
Immobilizing plaster cast
Central venous access
Serious lung disease, including
pneumonia (<1 month)
Abnormal pulmonary function
Acute myocardial infarction
Congestive heart failure (<1 month)
History of inflammatory bowel
disease
Medical patient at bed rest
Other risk factors:
Subtotal:
Subtotal:
TOTAL RISK FACTOR SCORE:
5 points
per risk factor
Stroke (<1 month)
Elective major lower
extremity arthroplasty
Hip, pelvis or leg fracture
Multiple traumas within the last
month
Acute spinal cord injury
(paralysis) within the last month
Lupus anticoagulant
Anticardiolipin
antibodies
Elevated serum
homocysteine
Heparin-induced
thrombocytopenia
Other congenital
or acquired
thrombophilia
If yes: Type
Subtotal:
Subtotal:
The Total Caprini VTE Risk Score is calculated by adding all points for the patient. The
corresponding VTE risk level can be interpreted using the table below which also shows
recommendations for VTE prophylaxis.
Total Score and VTE Risk Level for non-surgical patients based on Caprini model
Total Score VTE Risk Level
VTE Prophylaxis recommended?
0
Very Low
No
1-2
Low
Mechanical prophylaxis
3-4
Moderate
Mechanical prophylaxis and/or Pharmacological prophylaxis
5 or more
High
Mechanical prophylaxis and Pharmacological prophylaxis
70
Annex VII: Fall Risk Assessment Tools
Morse Fall Tool
Item
1.
Item Score
3.
History of falling (immediate or
previous)
Secondary diagnosis (≥ 2 medical
diagnoses in chart)
Ambulatory aid
4.
Intravenous therapy
5.
Gait
6.
Mental status
2.
Patient Score
No
Yes
No
Yes
None/ bed-rest/ nurse assist
Crutches/ cane/ walker
Furniture
No
Yes
Normal/ bed-rest/ wheelchair
Weak*
Impaired*
Oriented to own ability
Overestimates/forgets
limitations
0
25
0
15
0
15
30
0
20
0
10
20
0
15
* Weak Gait: Short steps (may shuffle), stooped but able to lift head while walking, may seek
support from furniture while walking, but with light touch (for reassurance).
* Impaired Gait: Short steps with shuffle; may have difficulty arising from chair; head down;
significantly impaired balance, requiring furniture, support person, or walking aid to walk.
Risk Level
Low Risk
Moderate Risk
High Risk
MFS Score
0 – 24
25-45
45 and Higher
Action
None
Refer Patient safety guideline
71
72
73