Risk management in healthcare is a complex set of clinical and
administrative systems, processes, procedures, and reporting
structures designed to detect, monitor, assess, mitigate, and prevent
risks to patients.
Currently, the numerous risk management practices and processes
that occur in healthcare organizations are a response to The Institute
of Medicine’s ("IOM") report entitled "To Err is Human: Building a Safer
Health System." This activity reviews the evaluation of risks and
highlights the interprofessional team's role in managing and
minimizing risks in the healthcare setting.
LEGAL COMMENTATORS REVIEWED THE IMPACT OF
THE ACT AND ARTICULATED SEVERAL OF ITS KEY
PRINCIPLES AND RESPONSIBILITIES. THESE DUTIES
INCLUDE:
Provision for the certification and recertification of Patient Safety
Organizations (“PSO’s”)
Collection and dissemination of information related to patient safety
Establishment of a patient safety database
Facilitation of the development of consensus among healthcare providers,
patients, and other interested parties concerning patient safety and
recommendations to improve patient safety
Provision of technical assistance to states that have (or are developing)
medical-error reporting systems
Provision of assistance to the states in developing standardized methods for
data collection and data collection from state reporting systems for inclusion
in the patient safety database.
The fundamental goal of this act was to increase the nation’s overall
patient safety by encouraging confidential and voluntary reporting of
adverse events that affected patients. Policymakers theorized that the
systematic collection of medical-error data could achieve improved
patient safety. The awareness of such error-data by health care
providers and administrators would lead to the prevention of errors
and the global reduction of their recurrence.
Relevant Definitions
Sentinel Event: Defined by the Joint Commission as “a patient safety event that
results in death, permanent harm, or severe, temporary harm” (The Joint
Commission 2017). These events are typically unrelated to the patient’s
illness/underlying condition. It is important to note that the Joint Commission
requires each accredited organization to establish its own definition for a
sentinel event to prevent, review, and respond to these occurrences.
Medical Error: The failure of a planned action to be completed as intended or
using a wrong plan to achieve an aim. In the context of this article, medical
errors may fall under the definition of sentinel events if the error is severe
enough.
Root Cause Analysis: The process for identifying the basic or causal factor(s)
underlying variation in performance. Also established by the Joint Commission,
this multi-step process is crucial to identify and fix systemic problems in patient
safety and care.
Risk Management: Clinical and administrative activities undertaken to identify,
evaluate, and reduce the risk of injury to patients, staff, and visitors and the risk
of loss to the organization itself (The Joint Commission 2017).
FIVE BASIC STEPS OF RISK
MANAGEMENT
The five basic steps of risk management
are:
Step 1: Establish the context
Step 2: Identify risks
Step 3: Analyze risks
Step 4: Evaluate risks
Step 5: Treat/Manage Risks
STEP 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.
STEP 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. The risks
identified are entered in the Risk Management
Tool (RMT) as depicted in Figure below , also
sometimes known as the Risk Register.
STEP 2: IDENTIFY RISKS
(CONT.)
Sources of risk identification
1. Discussions with department chiefs, managers and
staff
2. Patient Tracer Activity (Tracing the journey of a
patient from admission till discharge)
3. Retrospective screening of patient records
4. Reports of accreditation bodies
5. Incident reporting system & sentinel events
6. Healthcare associated infections (HAI) reports
7. Executive committee reports
8. Facility management & safety
committee report
9. Patient complaints and satisfaction
survey results
10. Specialized committee reports
(such as Morbidity and mortality
committee, medication
management and use, Infection
control, blood utilization, facility
management and safety
committee).
STEP 3: ANALYZE RISKS
Risk analysis is about developing an
understanding of the risks identified. It
includes the following:
Level of the risk or Risk score
Underlying causes
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, guidelines
Alarms and beeps
Engineering controls
Insurance coverage programs
Code teams
Trainings
Emergency arrangements
Preventative maintenance controls
STEP 3: ANALYZE RISKS (
CONT.)
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. An example of Root cause
STEP 4: EVALUATE RISKS
Risk score is calculated by multiplying the likelihood
score with the severity of impact score as below
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. Risks are assessed
on the probability of future occurrence; how likely is
the risk to occur? How frequently has this occurred?
A guide to likelihood scoring is presented below:
STEP 4: EVALUATE RISKS ( CONT.)
It should be noted that in assessing risk, the likelihood
of a particular risk materializing depends upon the
effectiveness of existing controls. Consideration
should be given to the number and robustness of
existing controls in place, with evidence available to
support this assessment. Generally the higher the
degree of controls in place, the lower the likelihood.
The assessment of likelihood of a risk occurring is
assigned a number from 1–5, with 1 indicating that
there is a remote possibility of its occurring and 5
indicating that it is almost certain to occur.
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)
as depicted in Table below:
STEP 4: EVALUATE RISKS (
CONT.)
One of the ways in which impact grades can be
defined is the severity of the injury as in Table
below.
In the above example Risk score (R) of 12 has
been classified as medium risk based on the
following cut-off values
STEP 4: EVALUATE RISKS (
CONT.)
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.
Accepting the Risk: Accepting a
risk does not imply that the risk
is insignificant. Risks in a
STEP 5: TREAT/MANAGE RISKS
(CONT.)
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.)
STEP 5: TREAT/MANAGE RISKS (
CONT.)
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.
Reduce the Likelihood of the risk occurring - e.g. by
preventative maintenance, audit & compliance programs,
supervision, policies and procedures, testing, training of staff,
technical controls and quality assurance programs.
Reduce the Severity of Impact of the risk occurring - through
contingency planning (contingency plan is a back-up plan in
case the identified risk actually takes place), disaster recovery
STEP 5: TREAT/MANAGE RISKS (
CONT.)
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.
STEP 5: TREAT/MANAGE RISKS (
CONT.)
Monitor & Review: Once the risk management is in place, monitoring and
reviewing of the process/system which was taken care of, is an integral part
of the risk management cycle. Monitoring and Reviewing utilizes the
following sources of information.
• Incident reporting
• Clinical Audit indicators
• Patient Tracers
• Safety rounds
• Patient complains
• Satisfaction survey
• Staff complains
Medical records Residual Risk: Residual risk is
the risk that remains after we apply controls.
It’s not always feasible to eliminate all the risks.
Instead, we take steps to reduce the risk to an
acceptable level. The risk that’s left is residual
risk. Residual Risk = Total Risk - Controls
CHALLENGES OF RISK
MANAGEMENT
Risk management in healthcare is done by organizations which
are conscious of the fact that healthcare interface poses risk.
Organizations actively pursuing risk management are therefore
a step higher in the ladder in ensuring safety of services and
striving for quality of care as compared to the organizations
that don’t. Risk management is advanced and proactive
methodology of tackling healthcare risks; however it is
challenging the following sense:
• Leadership commitment for ensuring risk management.
• Risks are proactively identified and prioritized
• Risks are not ignored
•Pro-active involvement of the risk
management team with the employees
and processes
•Expertise availability in the team
•Resources for risk treatment/mitigation
adequate g
•Change in the process/system is accepted
when indicated
•Monitoring and control systems are in
place
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  • 2.
    Risk management inhealthcare is a complex set of clinical and administrative systems, processes, procedures, and reporting structures designed to detect, monitor, assess, mitigate, and prevent risks to patients. Currently, the numerous risk management practices and processes that occur in healthcare organizations are a response to The Institute of Medicine’s ("IOM") report entitled "To Err is Human: Building a Safer Health System." This activity reviews the evaluation of risks and highlights the interprofessional team's role in managing and minimizing risks in the healthcare setting.
  • 3.
    LEGAL COMMENTATORS REVIEWEDTHE IMPACT OF THE ACT AND ARTICULATED SEVERAL OF ITS KEY PRINCIPLES AND RESPONSIBILITIES. THESE DUTIES INCLUDE: Provision for the certification and recertification of Patient Safety Organizations (“PSO’s”) Collection and dissemination of information related to patient safety Establishment of a patient safety database Facilitation of the development of consensus among healthcare providers, patients, and other interested parties concerning patient safety and recommendations to improve patient safety Provision of technical assistance to states that have (or are developing) medical-error reporting systems Provision of assistance to the states in developing standardized methods for data collection and data collection from state reporting systems for inclusion in the patient safety database.
  • 4.
    The fundamental goalof this act was to increase the nation’s overall patient safety by encouraging confidential and voluntary reporting of adverse events that affected patients. Policymakers theorized that the systematic collection of medical-error data could achieve improved patient safety. The awareness of such error-data by health care providers and administrators would lead to the prevention of errors and the global reduction of their recurrence.
  • 5.
    Relevant Definitions Sentinel Event:Defined by the Joint Commission as “a patient safety event that results in death, permanent harm, or severe, temporary harm” (The Joint Commission 2017). These events are typically unrelated to the patient’s illness/underlying condition. It is important to note that the Joint Commission requires each accredited organization to establish its own definition for a sentinel event to prevent, review, and respond to these occurrences. Medical Error: The failure of a planned action to be completed as intended or using a wrong plan to achieve an aim. In the context of this article, medical errors may fall under the definition of sentinel events if the error is severe enough. Root Cause Analysis: The process for identifying the basic or causal factor(s) underlying variation in performance. Also established by the Joint Commission, this multi-step process is crucial to identify and fix systemic problems in patient safety and care. Risk Management: Clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury to patients, staff, and visitors and the risk of loss to the organization itself (The Joint Commission 2017).
  • 14.
    FIVE BASIC STEPSOF RISK MANAGEMENT The five basic steps of risk management are: Step 1: Establish the context Step 2: Identify risks Step 3: Analyze risks Step 4: Evaluate risks Step 5: Treat/Manage Risks
  • 15.
    STEP 1: ESTABLISHTHE 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.
  • 16.
    STEP 2: IDENTIFYRISKS 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. The risks identified are entered in the Risk Management Tool (RMT) as depicted in Figure below , also sometimes known as the Risk Register.
  • 17.
    STEP 2: IDENTIFYRISKS (CONT.) Sources of risk identification 1. Discussions with department chiefs, managers and staff 2. Patient Tracer Activity (Tracing the journey of a patient from admission till discharge) 3. Retrospective screening of patient records 4. Reports of accreditation bodies 5. Incident reporting system & sentinel events 6. Healthcare associated infections (HAI) reports
  • 18.
    7. Executive committeereports 8. Facility management & safety committee report 9. Patient complaints and satisfaction survey results 10. Specialized committee reports (such as Morbidity and mortality committee, medication management and use, Infection control, blood utilization, facility management and safety committee).
  • 19.
    STEP 3: ANALYZERISKS Risk analysis is about developing an understanding of the risks identified. It includes the following: Level of the risk or Risk score Underlying causes Existing control measures Existing controls:
  • 20.
    When examining theexisting 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, guidelines Alarms and beeps Engineering controls Insurance coverage programs Code teams Trainings Emergency arrangements Preventative maintenance controls
  • 21.
    STEP 3: ANALYZERISKS ( CONT.) 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. An example of Root cause
  • 22.
    STEP 4: EVALUATERISKS Risk score is calculated by multiplying the likelihood score with the severity of impact score as below 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. Risks are assessed on the probability of future occurrence; how likely is the risk to occur? How frequently has this occurred?
  • 23.
    A guide tolikelihood scoring is presented below:
  • 24.
    STEP 4: EVALUATERISKS ( CONT.) It should be noted that in assessing risk, the likelihood of a particular risk materializing depends upon the effectiveness of existing controls. Consideration should be given to the number and robustness of existing controls in place, with evidence available to support this assessment. Generally the higher the degree of controls in place, the lower the likelihood. The assessment of likelihood of a risk occurring is assigned a number from 1–5, with 1 indicating that there is a remote possibility of its occurring and 5 indicating that it is almost certain to occur.
  • 25.
    Severity of impactindicates 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) as depicted in Table below:
  • 26.
    STEP 4: EVALUATERISKS ( CONT.) One of the ways in which impact grades can be defined is the severity of the injury as in Table below.
  • 27.
    In the aboveexample Risk score (R) of 12 has been classified as medium risk based on the following cut-off values
  • 28.
    STEP 4: EVALUATERISKS ( CONT.) 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. Accepting the Risk: Accepting a risk does not imply that the risk is insignificant. Risks in a
  • 29.
    STEP 5: TREAT/MANAGERISKS (CONT.) 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.)
  • 30.
    STEP 5: TREAT/MANAGERISKS ( CONT.) 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. Reduce the Likelihood of the risk occurring - e.g. by preventative maintenance, audit & compliance programs, supervision, policies and procedures, testing, training of staff, technical controls and quality assurance programs. Reduce the Severity of Impact of the risk occurring - through contingency planning (contingency plan is a back-up plan in case the identified risk actually takes place), disaster recovery
  • 31.
    STEP 5: TREAT/MANAGERISKS ( CONT.) 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.
  • 32.
    STEP 5: TREAT/MANAGERISKS ( CONT.) Monitor & Review: Once the risk management is in place, monitoring and reviewing of the process/system which was taken care of, is an integral part of the risk management cycle. Monitoring and Reviewing utilizes the following sources of information. • Incident reporting • Clinical Audit indicators • Patient Tracers • Safety rounds • Patient complains • Satisfaction survey • Staff complains
  • 33.
    Medical records ResidualRisk: Residual risk is the risk that remains after we apply controls. It’s not always feasible to eliminate all the risks. Instead, we take steps to reduce the risk to an acceptable level. The risk that’s left is residual risk. Residual Risk = Total Risk - Controls
  • 34.
    CHALLENGES OF RISK MANAGEMENT Riskmanagement in healthcare is done by organizations which are conscious of the fact that healthcare interface poses risk. Organizations actively pursuing risk management are therefore a step higher in the ladder in ensuring safety of services and striving for quality of care as compared to the organizations that don’t. Risk management is advanced and proactive methodology of tackling healthcare risks; however it is challenging the following sense: • Leadership commitment for ensuring risk management. • Risks are proactively identified and prioritized • Risks are not ignored
  • 35.
    •Pro-active involvement ofthe risk management team with the employees and processes •Expertise availability in the team •Resources for risk treatment/mitigation adequate g •Change in the process/system is accepted when indicated •Monitoring and control systems are in place