The document discusses patient safety in healthcare. It provides definitions of patient safety and discusses some key facts: - An estimated 134 million adverse events worldwide result in 2.6 million deaths annually, especially in low- and middle-income countries. Medical errors are among the most common adverse events. - Investments in patient safety can improve outcomes and save costs by preventing unnecessary harm and treatment expenditures. - Common adverse events include medication errors, healthcare-associated infections, surgical complications, diagnostic errors, and radiation errors. - Patient safety is enhanced through risk management, which identifies risks, analyzes their causes and impacts, evaluates their severity, and develops treatment plans to control, transfer, or avoid risks.

1. Patient Safety & Clinical Risk
Babitha K Devu, RN, RM, M.Sc (N), MBA
Assistant Professor, SMVD College of Nursing, J & K
Research Scholar, Ph.D (N), Amity University, Gurugram

2. 2
Patient Safety in the World
• “First, do no harm,” the principle of non-maleficence, is the fundamental principle
to ensuring safety and quality of care.
• Patient safety is defined as the prevention of errors and adverse effects
associated with healthcare.
• Available evidence suggests hospitalizations in low- and middle-income
countries lead annually to 134 million adverse events, contributing to 2.6 million
deaths.
• About 134 million adverse events worldwide give rise to 2.6 million deaths every
year.
• Estimates indicate that in high-income countries, about 1 in 10 patients is
harmed while receiving hospital care.
• Many medical practices and care-associated risks are becoming major
challenges for patient safety and contribute significantly to the burden of harm
due to unsafe care.

3. 3
Patient Safety in the World
• The Organisation of Economic Co-operation and Development (OECD) has
estimated that adverse events engender 15% of hospital expenditures and
activities.
• For all these reasons, investments in patient safety are necessary to improve
patient outcomes and to obtain financial savings which could be reinvested in
healthcare.
• Prevention expenditures are lower than treatment ones and they add important
value to the national healthcare systems.

4. 4
Most Frequent Adverse Events
• A medication error is an unintended failure in the drug treatment procedure
which could harm the patient. Medication errors can affect all steps of the
medication process and can cause adverse events most often relating to
prescribing, dispensing, storage, preparation, and administration.
• Healthcare-associated infections are the infections that occur in patients under
care, in hospitals or in another healthcare facilities.
• Unsafe surgical procedures cause complications for up to 25% of patients. Each
year almost 7 million surgical patients are affected by a complication and about 1
million die.
• Unsafe injections can transmit infections such as HIV and hepatitis B and C,
endangering both patients and healthcare workers. The global impact is very
pronounced, especially in low- and middle-income countries where it is
estimated that about 9.2 million disability-adjusted life years (DALYs) were lost in
the 2000s.

5. 5
Most Frequent Adverse Events
• A diagnostic error is the failure to identify the nature of an illness in an accurate
and timely manner and occurs in about 5% of adult outpatients.
• Venous thromboembolism is one of the most common and preventable causes
of patient harm and represents about one third of the complications attributed to
hospitalization. This issue has a significant impact both in the high-income
countries, where 3.9 million cases are estimated to occur yearly, and in low- and
middle-income countries, which see about 6 million cases each year.
• Radiation errors include cases of overexposure to radiation and cases of wrong-
patient and wrong-site identification. Each year, more than 3.6 billion X-ray
examinations are performed worldwide, of which 10% are performed on children.
• Unsafe transfusion practices expose patients to the risk of adverse transfusion
reactions and transmission of infections. Data on adverse transfusion reactions
from a group of 21 countries show an average incidence of 8.7 serious reactions
per 100 000 distributed blood components.

6. 6
Definition – Patient Safety
• The WHO defines Patient safety is defined as “the absence of
preventable harm to a patient and reduction of risk of
unnecessary harm associated with health care to an acceptable
minimum.“
• It is to decrease the risk of preventable damage associated with
the healthcare to an acceptable minimum limit.

7. 7
Relationship between Patient Safety & Informatics
• In 1999 the Institute of Medicine’s (IOM) released report “To err is human” called
for developing and testing new technologies to reduce medical error, and the
subsequent 2001 report “crossing the quality chiasm” called for using information
technology as a key in transforming and changing the healthcare environment to
achieve better and safer care.
• Electronic physician’s orders and E-prescribing. Computerized physician
order entry entails the use of electronic or computer support to enter physician
orders including medication orders using a computer or mobile device platform.
• It usually integrated with a clinical decision support system (CDS), which acts as
an error prevention tool through guiding the prescriber on the preferred drug
doses, route, and frequency of administration.
• In addition, some CPOE systems may have the feature of prompting the
prescriber to any patient allergies, drug-drug or drug-lab interactions or with
sophisticated systems it might prompt the prescriber towards interventions that
should be prescribed based on clinical guideline recommendation example
venous thromboembolism prophylaxis)

8. 8
Relationship between Patient Safety & Informatics
• Clinical decision support:Clinical decision support provides the health care
professional with information and patient-specific information.
• This information is intended to enhance the decision of the healthcare provider
and is rationally filtered and presented to the healthcare professional at
appropriate times. Clinical decision support includes a range of tools to enhance
decision-making and the clinical workflow.
• These tools include notifications, alerts and reminders to care providers and
patients, clinical guidelines, condition-specific order sets, patient specific clinical
summaries, documentation templates, investigation and diagnostic support,
among other tools.
• Electronic sign-out and hand-off tools: Sign-out / “hand-over” communication
relates to the process of passing patient-specific information from one caregiver
to another, from one team of caregivers to the next, or from caregivers to the
patient and family for ensuring patient care continuity and safety.
• Breakdown in handover of patient information has been found to be one of the
leading root causes of sentinel events

9. 9
Relationship between Patient Safety & Informatics
• Electronic sign-out applications are tools used as standalone or integrated with
the electronic medical record to ensure a structured transfer of patient
information during healthcare provider handoffs.
• Bar code medication administration: Bar code medication administration
systems are electronic systems that integrate electronic medication
administration records with bar code technology. These systems are intended to
prevent medication error by ensuring that the right patient receives the right
medication at the right time.
• Smart pumps: Smart pumps are intravenous infusion pumps that are equipped
with medication error-prevention software. This software alerts the operator
when the infusion setting is set outside of pre-configured safety limits.
• Automated medication dispensing technology: Automated dispensing
cabinets (ADC) are electronic drug cabinets that store medication at the point of
care with controlled dispensing and tracking of medication distribution.

10. 10
Relationship between Patient Safety & Informatics
• Retained surgical items prevention technology: There are various
technologies that are used to enhance the prevention of retained surgical items
which include: bar coding and radiofrequency (RFID) tagging of surgical items.
• Patient electronic portals: A patient portal is a secure online application that
provides patients access to their personal health information and 2-way
electronic communication with their care provider using a computer or a mobile
device.
• Telemedicine: Telemedicine is defined as the use of telecommunication
technologies to facilitate patient to provider or provider to provider
communication. Communication maybe synchronous with real-time 2-way video
communication or asynchronous transmission of patient clinical information. In
addition to communication, telemedicine may provide health information that is
collected remotely from medical devices or personal mobile devices. This
information may be used to monitor patients, track or change their behavior.

11. 11
Relationship between Patient Safety & Informatics
• Electronic incident reporting: Electronic incident reporting systems are web-
based systems that allow healthcare providers who are involved in safety events
to voluntarily report such incidents. Such systems can be integrated with the
electronic health record (EHR) to enable abstraction of data and automated
detection of adverse events through trigger tools. Electronic incident reporting
systems potentially have the following advantages; standardize reporting
structure, standardize incident action workflow, rapid identification of serious
incidents and trigger events, while automating data entry and analysis.

12. Risk Management Process

13. 13
Risk Management
• Risk Management is a process of identifying factors that provide excellent,
efficient, effective and safe patient care. The aim of risk management is to
ensure variety of risks are identified and assessed at an early stage along with
ensuring best way of managing, controlling or reducing their effect. The main
purposes/functions are
• Enhance patient safety
• Minimize occurrence of errors
• Improve safety of the employees
• Enhance safety of the visitors
• Reduce financial lose
• Formulate plan to manage risk
• Protect resources
• Protection of patient’s records
• Identification and fixing of deficiencies in system.

14. 14
Functions of Risk Management
• Risk is an integral part of human activities, both in living and working
environments.
• First of all, it is necessary to embed the two activities of “risk assessment” and
“investigation of adverse events” in the organizational processes of health
systems.
• Both activities may provide reasons for study and research, or be linked to
organizational objectives such as patient safety, cost containment or, compliance
with regulatory obligations.
• The assessment of risk as an organizational function should permeate both the
choices of clinicians and managers, if we accept that patient safety is an
essential goal of health organizations.
• The analysis of adverse events could be an activity entrusted to specialists in the
investigation of accidents, or shared between both the frontline and the bottom
end as an integral part of the risk assessment process, if it is meant and used for
organizational development.

15. 15
Functions of Risk Management
The functions are divided into three:-
• Protection of Patient’s Records
• Use of contingency plans
• Identification and fixing of deficiencies in system

16. 16
Components of Risk Management
• Education & Training Risk management plans need to detail employee training
requirements which should include new employee orientation, ongoing and in-
service training, annual review and competency validation, and event-specific
training.
• Patient & Family Grievances To promote patient satisfaction and reduce the
likelihood of litigation, procedures for documenting and responding to patient and
family complaints should be described in the Risk Management Plan. Response
times, staff responsibilities, and prescribed actions need to be articulated and
communicated.
• Purpose, Goals, & Metrics Risk management plans should clearly define the
purpose and benefits of the healthcare risk management plan. Specific goals to
reduce liability claims, sentinel events, near misses, and the overall cost of the
organization’s risk should also be well-articulated. Additionally, reporting on
quantifiable and actionable data should be detailed and mandated by the plan.

17. 17
Components of Risk Management
• Communication Plan While it is critical that the healthcare risk management
team promote open and spontaneous dialogue, information about how to
communicate about risk and with whom should be provided in the healthcare risk
management plan.
• Contingency Plans Risk management plans also need to include contingency
preparation for adverse system-wide failures and catastrophic situations such as
malfunctioning EHR systems, security breaches, and cyber attacks. The plan
needs to include emergency preparedness for things like disease outbreaks,
long-term power loss, and terror attacks or mass shootings.
• Reporting Protocols Every healthcare organization must have a quick and
easy-to-use, system for documenting, classifying, and tracking possible risks
and adverse events. These systems must include protocols for mandatory
reporting.
• Response & Mitigation Plans for healthcare risk must also include collaborative
systems for responding to reported risks and events including acute response,
follow-up, reporting, and repeat failure prevention.

18. 18
Risk Management Process
• Five Basic Steps of Risk
Management: The five
basic steps of risk
management are outlined
below and also in
• Step 1: Establish the
context
• Step 2: Identify risks
• Step 3: Analyze risks
• Step 4: Evaluate risks
• Step 5: Treat/Manage
Risks

19. 19
Risk Management Process
1. Establish the context: Context is very important in risk identification and
management. ICU (Intensive care unit), O.R(Operation room), E.R (Emergency
room), blood transfusion services, CCU (coronary care unit), medication
management including medication administration are contextually high priority
areas for risk management in relation to patient care.

20. 20
Risk Management Process
2. Identify Risks: Risk identification is the process whereby the healthcare
professional and the healthcare employees become aware of the risks in the
health care services and environment.
Sources of risk identification
a. Discussions with department chiefs, managers and staff
b. Patient Tracer Activity (Tracing the journey of a patient from admission till
discharge)
c. Retrospective screening of patient records
d. Reports of accreditation bodies
e. Incident reporting system & sentinel events
f. Healthcare associated infections (HAI) reports
g. Executive committee reports
h. Facility management & safety committee report
i. Patient complaints and satisfaction survey results
j. Specialized committee reports (such as Morbidity and mortality committee,
medication management and use, Infection control, blood utilization.

21. 21
Risk Management Process
3. Analyze Risks: Risk analysis is about developing an understanding of the risks
identified.
• It includes Level of the risk or Risk score, finding Underlying causes and
Existing control measures.
• Existing controls: When examining the existing control measures, consideration
should be given to their adequacy, method of implementation and level of
effectiveness in minimizing risk to the lowest reasonably practicable level.
These include all measures put in place to eliminate or reduce the risk and may
include Policies, procedures, protocols, guideline, Alarms and beeps,
Engineering controls etc.
• Root Cause Analysis (RCA) represents a systematic approach to identifying the
underlying causes of adverse occurrences so that effective steps can be taken
to modify processes and prevent future losses. Brain storming with a team of
relevant and informed people still remains the best method to do Root cause
analysis.

22. 22
Risk Management Process
3. Analyze Risks: contd.
• Risk Score (R) = Likelihood (L) x Severity Impact (S)
• Likelihood assessment (L) [5] Likelihood scoring is based on the expertise,
knowledge and actual experience of the group scoring the likelihood. In
assessing likelihood, it is important to consider the nature of the risk.
• Severity of impact indicates the impact of harm to service users, employees,
service provision, environment or the organization. The scoring ranges from 1
(Negligible impact) to 5 (Extreme impact).

23. 23
Risk Management Process
4. Evaluate Risks: The purpose of risk evaluation is to prioritize the risks based
on risk analysis score and to decide which risks require treatment and the
mode of treatment. Like Negligible, Minor, Moderate, Major, and Extreme.
4. b. Accepting the Risk: Accepting a risk does not imply that the risk is
insignificant.
5. Risk Treatment: (Also known as Risk reduction, Risk mitigation): The decisions
in risk treatment should be consistent with the defined internal, external and
risk management contexts and taking account of the service objectives and
goals. Risk treatment plan should have:
• Proposed actions
• Resource requirements
• Person/s responsible for action
• Timeframes (Dates for actions to be completed and date for review.)
Risk can be treated in three ways as given below

24. 24
Risk Management Process
 Controlling the Risk: The most effective methods of risk control are those which
redesign the systems and processes so that the potential for an adverse
outcome is reduced. Other methods of controlling the risk include reducing the
likelihood of the risk and/or reducing the severity of the impact of the risk.
 Transferring the risk: Transferring the risk involves another party bearing or
sharing some part of the risk through contractual terms, insurance, outsourcing,
joint ventures, etc.
 Avoiding the risk: This is achieved by either deciding not to proceed with the
activity that contains an unacceptable risk, choosing an alternate more
acceptable activity.

25. THANK
YOU
25