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March 27, 2014


Risk Assessments: Analyzing and Mitigating Safety Threats March 27, 2014 Brad Keyes, CHSP Susan Lautner, RN, BSN, MSHL, CPHQ Today s objectives are to identify ... – PowerPoint PPT presentation

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Title: March 27, 2014


Risk Assessments Analyzing and Mitigating Safety
  • 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
  • Risk Assessments for physical environment issues
  • Risk Assessments for clinical issues

Physical Environment Risk Assessments
  • The CMS Condition of Participation (482.41)
  • 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

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

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

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

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

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)

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
  • Other codes and standards as applicable

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

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

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

Physical Environment Risk Assessments
  • If left to their own desires, they can take
    action to elope, or perhaps attempt to end their
  • 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

Physical Environment Risk Assessments
  • An assessment of the physical environment is
    needed to ensure that it is safe for all
  • 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

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

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

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
  • One practical approach is the seven (7) step
    approach documented in the Risk Assessment tools
    with your handouts

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

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

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

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

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

Physical Environment Risk Assessments
  • Step 3
  • Weve 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.

Physical Environment Risk Assessments
  • Step 4
  • Evaluate both arguments
  • Take under consideration points made under steps
    2 and 3 discuss amongst the stakeholders. Dont
    try to determine a solution at this step, but
    just reach a consensus Is it a legitimate risk
    or is it not?

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.

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
  • There may be multiple different mitigations that
    can be implemented to reduce or eliminate the
    risk, such as

Physical Environment Risk Assessments
  • Step 5
  • Reach a conclusion
  • Install anti-ligature hinges
  • Install CCTV to monitor patient
    activity inside the
  • Conduct more frequent rounds on those patients
    evaluated to be suicidal

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

Physical Environment Risk Assessments
  • Step 7
  • Monitor the conclusion
  • Implement the conclusions. Establish a date to
    re-evaluate the conclusions to determine their

Physical Environment Risk Assessments
  • You cannot operate a hospital without a certain
    level of risk to the patient and staff Its the
    nature of the beast.
  • The process of accreditation is designed to
    reduce the risk of healthcare to the patient.

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

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

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
  • The risk assessment should evaluate the risks,
    and determine what mitigation activities are

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.

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.

  • There is a risk

    assessment form
    available for
    to use, included

    in your handouts.

Clinical Risk Assessments
  • For risk assessments concerning clinical issues,
    we now turn the presentation over to Susan.

12.00.13 Program Activities HFAP Acute Care
  • 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)

  • 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

What is a Risk Assessment?
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
  • 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.

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.

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.

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.

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.

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

Five steps to easy risk assessment
  • Step 5 Review your assessment and update if
  • 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.

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.

  • 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.

  • 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

  • Develop Actions or Countermeasures to reduce risk
  • Reassign risk codes (residual risk)
  • Assign responsibility for actions
  • Monitor the actions and risk reduction

Example risk matrix
Example risk matrix
(No Transcript)
  • 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.

Risk Assessments Analyzing and Mitigating
Safety Threats Questions? Brad Keyes,
CHSP Susan Lautner, RN BSN, MSHL (815) 629-2240 (312)
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