March 27, 2014Brad Keyes, CHSP

Susan Lautner, RN, BSN, MSHL, CPHQ

Risk Assessments:Analyzing and

Mitigating Safety Threats

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

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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”

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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

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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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:

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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

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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

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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:

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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”

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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

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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

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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”

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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

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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.]

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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?

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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.

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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:

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Physical Environment Risk Assessments

Step 5:Reach a conclusion…

1.Install anti-ligature hinges 2.Install CCTV to monitor patient activity inside the rooms3.Conduct more frequent rounds on those patients evaluated to be suicidal

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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.

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Physical Environment Risk Assessments

Step 7:Monitor the conclusion…

Implement the conclusions. Establish a date to re-evaluate the conclusions to determine their effectiveness.

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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.

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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.

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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…

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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.

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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.

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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.

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There is a risk assessment form available for you to use, included in your handouts.

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Risk Assessment Form

Date of assessment: ___________________________ Location of risk: _____________________________________ Evaluators: _____________________________________________________________________________________ Step 1: What is being evaluated? _________________________________________________________________ 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: _____________________________________

Step 2: Arguments for: ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________

Step 3: Arguments against: ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________

Step 4: Evaluate both arguments: ______________________________________________________________ ___________________________________________________________________________________________

Step 5: Reach a conclusion: ___________________________________________________________________ ___________________________________________________________________________________________

ClinicalRisk Assessments

For risk assessments concerning clinical issues, we now turn the presentation over to Susan….

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12.00.13 Program ActivitiesHFAP 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)

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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

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What is a Risk Assessment?

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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.

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Understanding the difference betweena 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.

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Five steps to easy risk assessment

Step 1 Identify the hazards(what can go wrong?)To prevent harm it is important to understandnot only what is likely to go wrong but also howand why it may go wrong. Consider the activitywithin the context of the physical and emotionalenvironment, and the culture of the organizationand the staff who perform the activity.

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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 toanticipate some degree of human error andtry to prevent the error from resulting in harm.

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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 reasonablypracticable to protect patients from harm.

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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.

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Five steps to easy risk assessment

Step 5 Review your assessment and update if necessaryGood 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.

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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.

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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.

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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

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FMEA

• Develop Actions or Countermeasures to reduce risk

• Reassign risk codes (residual risk)• Assign responsibility for actions• Monitor the actions and risk reduction

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Example risk matrix

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Example risk matrix

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Risk Assessment

Sub-StepEvent(Failure mode)

Effect

Sev

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)[1

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3]

Pro

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3<4]

Det

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(D)

[1<

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Ris

k fa

cto

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*P*D

)

Granulation Drying water contentnot meet specification of degradation

2 3 1 6

Risk Reduction

Actions:Risk reduction strategy

Sev

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y (S

)[1

<2<

3]

Pro

bab

ilit

y (P

)[1

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3<4]

Det

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(D)

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Ris

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Comments

introduce online NIR 2 1 1 2 4 indirect measurment

introduce IPC analytic 2 2 1 4 2direct measurement; time consuming

humidity measurement in the exaust air 2 1 2 4 2indirect measurment; unspecific

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SummaryMajor 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.

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Risk Assessments:Analyzing and Mitigating

Safety Threats

Questions?

Brad Keyes, CHSP Susan Lautner, RN BSN, MSHLbkeyes@hfap.org slautner@hfap.org(815) 629-2240 (312) 202-8067

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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

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