Transcript Risk Assessments - American Osteopathic Association

Risk Assessments:
Analyzing and
Mitigating Safety
Threats
March 27, 2014
Brad Keyes, CHSP
Susan Lautner, RN, BSN, MSHL, CPHQ
Risk Assessments
This presentation on Risk Assessments will be
divided into two sections:
1. Risk Assessments for physical environment
issues
2. Risk Assessments for clinical issues
2
Physical Environment
Risk Assessments
The CMS Condition of Participation (§482.41)
states:
“The hospital must be constructed, arranged, and
maintained to ensure the safety of the patient,
and to provide facilities for diagnosis and
treatment, and for special hospital services
appropriate to the needs of the community”
3
Physical Environment
Risk Assessments
The phrase “to ensure the safety of the
patient…” is far-reaching and encompasses all
areas of operations in the hospital
It involves every department and activity within
the organization to ensure the safety of the
patient
4
Physical Environment
Risk Assessments
To begin with, we will look at the physical
environment and identify how “ensuring the
safety of the patient” applies within the
structure
We will also examine processes and tools that
healthcare organizations can use to analyze
the risks to safety
5
Physical Environment
Risk Assessments
HFAP standard 11.01.02 (2014 manual) says:
“The condition of the physical plant and the overall
hospital environment must be developed and
maintained in such a manner that the safety and
well-being of the patients, visitors, and staff is
assured.”
This standard requires the physical environment to
be safe… A consideration with which everyone
would be in agreement
6
Physical Environment
Risk Assessments
From the physical plant point of view, how are
you going to assure that the environment is
safe for the patients?
Start with the design of the structure… Use
current building codes and approved
standards when planning the facility
7
Physical Environment
Risk Assessments
– International Building Code (IBC)
– NFPA Life Safety Code
– Other NFPA standards
– ASME/ANSI, ASTM and UL standards
– FGI Guidelines for Design and Construction of
Health Care Facilities
– Center for Disease Control and Prevention (CDC)
– The Association for Professionals in Infection
Control and Epidemiology (APIC)
8
Physical Environment
Risk Assessments
– The Association of periOperative Registered
Nurses (AORN)
– The Association for the Advancement of Medical
Instrumentation (AAMI)
– Centers for Medicare & Medicaid Services (CMS)
– Healthcare Facilities Accreditation Program (HFAP)
– Other codes and standards as applicable
9
Physical Environment
Risk Assessments
Once the facility is designed and constructed, a
plan needs to be developed to operate the
building to ensure safety for all occupants
Complying with the previously mentioned codes
and standards after occupying the building is a
significant element of safety in the environment
10
Physical Environment
Risk Assessments
However, there are situations where codes and
standards do not address specifically what
action is required to achieve a safe environment
That is where an assessment of the risks need to
be evaluated, and recommendations made to
mitigate the risks
11
Physical Environment
Risk Assessments
Take the situation of the common behavioral health
unit in a hospital
Patients are often admitted against their will, by order
of an authority
Behavioral health patients are often ambulatory, and
can be very creative in their desire to not participate in
their treatment
12
Physical Environment
Risk Assessments
If left to their own desires, they can take action
to elope, or perhaps attempt to end their life
No amount of codes and standards will ensure a
safe environment for someone who does not
want to be retained in a place where they do
not want to be
13
Physical Environment
Risk Assessments
An assessment of the physical environment is
needed to ensure that it is safe for all concerned
The assessment can be conducted by an
individual but it is considered best practice to
use a group of individuals with different
responsibilities, such as:
14
Physical Environment
Risk Assessments
–
–
–
–
–
–
–
–
Risk manager
Safety officer
Facilities manager
Manager of the unit being assessed
Security manager
Administrative representative
Environmental services manager
Infection control practitioner
15
Physical Environment
Risk Assessments
These stakeholders bring a diverse perspective
to an issue and can help identify issues that
others may overlook
A risk assessment must be documented in order
to be considered complete… Documentation
can be in any format that works for the
organization
16
Physical Environment
Risk Assessments
The most common format is the narrative
approach, whereby a descriptive account of the
risk and the mitigating activities are recorded…
not unlike a story
One practical approach is the seven (7) step
approach documented in the Risk Assessment
tools with your handouts:
17
Physical Environment
Risk Assessments
Step 1:
Identify what is being evaluated
This is where you would list the specific issue that
your team has identified as a potential risk
For the purpose of our example, lets list “Patient
room door hinges”
18
Physical Environment
Risk Assessments
Step 1:
“Patient room door hinges could be used as a
suicide hanging point”
You identify the issue and the potential risk. In this
example, the door hinges were considered a
potential suicide hanging risk
19
Physical Environment
Risk Assessments
Step 2:
Arguments for…
In this step, you list the reasons why the patient
room door hinges are considered a potential safety
risk
20
Physical Environment
Risk Assessments
Step 2:
“Door hinges extend out from the door frame at a
90 degree angle and could support a ligature and
weight of an adult”
21
Physical Environment
Risk Assessments
Step 3:
Arguments against…
In this step, you list the reasons why the patient
room door hinges are not considered a potential
safety risk
22
Physical Environment
Risk Assessments
Step 3:
“We’ve never had an attempted suicide involving
the door hinges.”
[Okay… This is a pretty lame argument, but it has
been heard many times when the issue of patient
room door hinges is raised.]
23
Physical Environment
Risk Assessments
Step 4:
Evaluate both arguments…
Take under consideration points made under steps 2
and 3 discuss amongst the stakeholders. Don’t try to
determine a solution at this step, but just reach a
consensus: Is it a legitimate risk or is it not?
24
Physical Environment
Risk Assessments
Step 4:
“It is agreed that the style of door hinges is
considered a potential suicide hanging point.”
Both arguments have been considered and a
decision is made as to whether the issue is a risk to
patient safety, or it is not a risk to patient safety.
25
Physical Environment
Risk Assessments
Step 5:
Reach a conclusion…
Now that you have made a decision that the hinges
are a safety risk, what are you going to do about it?
There may be multiple different mitigations that can
be implemented to reduce or eliminate the risk,
such as:
26
Physical Environment
Risk Assessments
Step 5:
Reach a conclusion…
1. Install anti-ligature hinges
2. Install CCTV to monitor patient
activity inside the rooms
3. Conduct more frequent rounds on those
patients evaluated to be suicidal
27
Physical Environment
Risk Assessments
Step 6:
Submit the assessment…
The risk assessment should be documented in
writing, and signed by all involved in the evaluation.
Then it should be submitted to the proper over-sight
committee on patient safety, along with estimated
costs for the conclusion. Have the risk assessment
approved by the committee.
28
Physical Environment
Risk Assessments
Step 7:
Monitor the conclusion…
Implement the conclusions. Establish a date to reevaluate the conclusions to determine their
effectiveness.
29
Physical Environment
Risk Assessments
You cannot operate a hospital without a certain
level of risk to the patient and staff… It’s the
nature of the beast.
The process of accreditation is designed to
reduce the risk of healthcare to the patient.
30
Physical Environment
Risk Assessments
Risk assessments should be conducted on all
safety risks in the environment. They are not
reserved just for behavioral health units.
If a surveyor identifies a safety risk in the
environment, and the hospital has conducted a
documented risk assessment that effectively
mitigates the risk, then the hospital will not be
cited.
31
Physical Environment
Risk Assessments
Another common situation where a risk
assessment can help is whether or not entrance
doors to soiled utility rooms need to be locked.
There is no code or standard that requires the
door to a soiled utility room to be locked…
32
Physical Environment
Risk Assessments
But if the perception is an unauthorized
individual could be harmed or injured by the
contents of the room, then the room should be
assessed for the risks to safety to the occupants.
The risk assessment should evaluate the risks,
and determine what mitigation activities are
necessary.
33
Physical Environment
Risk Assessments
If a surveyor observes the soiled utility room is
unlocked, he/she should ask if you have
conducted a risk assessment. If you have, show
it to them.
If the surveyor agrees with the conclusion of the
risk assessment, then no finding will be cited for
the perceived risk.
34
Physical Environment
Risk Assessments
Risk assessments should be reviewed and the
risks re-evaluated on a periodic basis.
How often? That depends on the safety risks.
35
Risk Assessment Form
Date of assessment: ___________________________ Location of risk: _____________________________________
Evaluators: _____________________________________________________________________________________
Step 1: What is being evaluated? _________________________________________________________________
There is a risk
assessment form
available for you
to use, included
in your handouts.
Step 2: Arguments for:
Step 3: Arguments against:
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
___________________________________________
Step 4: Evaluate both arguments: ______________________________________________________________
___________________________________________________________________________________________
Step 5: Reach a conclusion: ___________________________________________________________________
___________________________________________________________________________________________
Step 6: Submit assessment: Submitted to: _________________________Date: _____________________________
[Note: This form serves as documentation of the risk assessment.]
Step 7: Monitor conclusion: Date to review risk for any changes: _________________________________________
Is a re-evaluation needed? ___Yes ___No
Re-evaluated By: _____________________________________
Submitted By: ________________________________________ Date: _____________________________________
36
Clinical
Risk Assessments
For risk assessments concerning clinical issues,
we now turn the presentation over to Susan….
37
12.00.13 Program Activities
HFAP Acute Care Manual
The hospital must set priorities for its performance
improvement activities that:
(1) focus on high-risk, high-volume, or problem-prone
areas;
(2) consider the incidence, prevalence, and severity of
problems in those areas; and
(3) Affect health outcomes, patient safety and quality of
care.§482.21(c)(1)(i)(ii)(iii)
38
Objectives
• Elements of a Risk Assessment
• Understanding the difference between a hazard and
a risk
• 5 steps to easy risk assessment
• How to conduct a Failure Mode & Effects Analysis
(FMEA) proactive risk assessment
39
What is a Risk Assessment?
How bad?
What can
go wrong?
A risk
assessment
seeks to answer
four simple
related
questions
Is there a
need for
action?
How
often?
40
In a risk assessment we look at:
• hazards – which are situations with the potential to cause
harm; and
• risks – which are defined as the probability that a specific
adverse event will occur in a specific time period or as a result
of a specific situation.
– Risk is the combination of likelihood and consequence of a
hazard being realized.
– A clinical risk or healthcare risk is the chance of an adverse
outcome resulting from clinical investigation, treatment or
patient care.
41
Understanding the difference between
a hazard and a risk – an example
A medicine could be described as a hazard if it has the potential to
cause harm. However, the risk of that harm may be very small
provided effective controls/measures are in place. If a patient could
suffer harm as a result of taking the medicine, the chance of the harm
occurring at a given severity may be described as a clinical risk. If harm
resulted from taking the medicine and the harm was not expected this
would be a patient safety incident.
It is important that you identify and have a clear understanding of the
significant risks of each particular hazard. To avoid confusion, describe
each risk separately and clearly. For example, when considering the
hazard of selecting the wrong drug because of similar (look-alike)
packaging, there is risk to the patient, risk to the staff involved and risk
to the organization.
42
Five steps to easy risk assessment
Step 1 Identify the hazards
(what can go wrong?)
To prevent harm it is important to understand
not only what is likely to go wrong but also how
and why it may go wrong. Consider the activity
within the context of the physical and emotional
environment, and the culture of the organization
and the staff who perform the activity.
43
Five steps to easy risk assessment
Step 2 Decide who might be harmed and how
(what can go wrong? who is exposed to the
hazard?)
People will make mistakes. It is necessary to
anticipate some degree of human error and
try to prevent the error from resulting in harm.
44
Five steps to easy risk assessment
Step 3 Evaluate the risks (how bad? how often?) and decide on
the precautions (is there a need for further action?)
Consider both consequence (how bad?) and likelihood (how
often?). Is there a need for additional action? The law requires
everyone providing a service to do everything reasonably
practicable to protect patients from harm.
45
Five steps to easy risk assessment
Step 4 Record your findings, proposed action and identify who
will lead on what action. Record the date of implementation
Risk assessments and action planning should be reviewed and
changed when necessary. This is easy only if the assessment is
well recorded and the logic behind the decisions transparent. An
efficient and succinct system of documentation is essential.
46
Five steps to easy risk assessment
Step 5 Review your assessment and update if necessary
Good documentation is important because things are always
changing. Research and new developments increase the pace of
change, and those changes can alter existing and/or introduce
new hazards.
Review your risk assessment:
1. when you are planning a change;
2. routinely at least on an annual basis;
3. when there has been a significant change.
47
Example of a proactive evaluation
• Failure Mode and Effects Analysis (FMEA)
Application of failure mode and effect analysis
(FMEA) tools assist to proactively evaluate
program plans is a useful process to better
understand where programs need to be
strengthened, before they have an opportunity
to fail and an organization experiences the
consequences associated with noncompliance.
48
FMEA
For each failure identified (whether a known
failure or a potential), an analysis is completed
that determines the following:
• The way the process/sub-process step can fail
to function or the manner in which the failure
occurs (failure mode),
• The effect of the failure mode, and an
estimate of the severity and probability for
each mode-effect combination.
49
FMEA
•
•
•
•
•
•
•
Define the FMEA boundaries
Assemble the FMEA team
Review the process
Brainstorm potential failure modes
Identify the potential cause(s) of each failure
List potential effects on the patient
Assign risk codes
50
FMEA
• Develop Actions or Countermeasures to
reduce risk
• Reassign risk codes (residual risk)
• Assign responsibility for actions
• Monitor the actions and risk reduction
51
Example risk matrix
52
Example risk matrix
Granulation Drying
water content
not meet specification of
degradation
Risk factor
(S*P*D)
Effect
Detectability (D)
[1<2<3]
Event
(Failure mode)
Probability (P)
[1<2<3<4]
Sub-Step
Severity (S)
[1<2<3]
Risk Assessment
2
3
1
6
Severity (S)
[1<2<3]
Probability (P)
[1<2<3<4]
Detectability (D)
[1<2<3]
Risk factor
(S*P*D)
Risk reduction
Risk Reduction
Comments
introduce online NIR
2
1
1
2
4
indirect measurment
introduce IPC analytic
2
2
1
4
2
humidity measurement in the exaust air
2
1
2
4
2
Actions:
Risk reduction strategy
direct measurement; time
consuming
indirect measurment;
unspecific
53
54
Summary
Major benefits are derived from a properly implemented FMEA,
such as:
• It provides a documented method for selecting a design with a
high probability of successful operation and safety.
• A documented uniform method of assessing potential failure
mechanisms, failure modes and their impact on system
operation, resulting in a list of failure modes ranked according to
the seriousness of their system impact and likelihood of
occurrence.
• An effective method for evaluating the effect of proposed
changes to the design and/or operational procedures on mission
success and safety.
• Criteria for early planning of tests.
55
Risk Assessments:
Analyzing and Mitigating
Safety Threats
Questions?
Brad Keyes, CHSP
[email protected]
(815) 629-2240
Susan Lautner, RN BSN, MSHL
[email protected]
(312) 202-8067
56
Certificate of Attendance
__________________________
Awarded 1.0 contact hours
Risk Assessments:
Analyzing and Mitigating
Safety Threats
A 60 minute audio-conference
March 26, 2014
_________________
Beverly Robins
Director of Accreditation and Certification
57