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3M Health Care AcademySM
© 3M 2016. All Rights Reserved
3M Health Care AcademySM
Risk Assessment in the Sterile Processing Department: It’s not what you know but what you don’t
February 2, 2017
3M Sterile U Webinar
3M Health Care AcademySM
© 3M 2016. All Rights Reserved
Welcome!Topic: Risk Assessment in the Sterile Processing Department:
It’s not what you know but what you don’t
Facilitators: Andres Scherson, 3M Nikki Einerson, 3M
Speaker: Jacqueline Daley, HBSc (Microbiology and Immunology) MLT, CIC, CSPDS
For more information: www.3M.com/IPEd
© 3M 2017. All Rights Reserved 3
House Keeping
From the GoToWebinar page:• Click on the orange box with a
white arrow to expand your control panel (upper right-hand corner of your screen).
• Type a question in the question box and click send.
© 3M 2017. All Rights Reserved 4
House Keeping
Continuing Education
Each 1 hour web meeting is approved by IAHCSMM, CBSPD and
is 3M Health Care Provider approved by the California Board of
Registered Nurses CEP 5770 for one contact hour.
Post webinar email
• Link to Course Evaluation
• CS Tech CE Certificate Included
• Forward eMail to others in attendance
© 3M 2017. All Rights Reserved 5
DisclosureJacqueline Daley
HBSc (Microbiology and Immunology)MLT, CIC, CSPDS
• Manager, Infection Prevention, Clinical
Epidemiology and the Vascular Access
Service at the Sharp Metropolitan Medical
Campus in San Diego, California
• Educational Consultant for 3M
© 3M 2017. All Rights Reserved 6
Learning Objectives
• Discuss the purpose of performing risk assessments
• List three areas in the SPD where risk assessment is
needed
• Discuss the steps in the risk assessment process
© 3M 2017. All Rights Reserved
© 3M 2017. All Rights Reserved
The Joint CommissionIC.01.03.01
• The hospital identifies risks for acquiring and transmitting infections.
Expectation is that a multi-disciplinary team performs a risk assessment and put in place infection control activities.
Customized to the organization
Risk assessment should be prioritized
In order of level of probability and potential for harm
Prioritized risk are documented (Likelihood of occurrence / severity of impact)
IC.02.02.01
• The hospital reduces risk of infections associated with medical equipment, devices, and supplies.
Cleaning and performing low-level disinfection of medical equipment, devices and supplies.
Performing intermediate and high-level and sterilization of medical equipment, devices and supplies.
Disposing of medical equipment, devices, and supplies.
When reprocessing single-use devices, the hospital implements infection prevention and control activities that are consistent with regulatory and professional standards.
The Joint Commission. Hospital Accreditation Standards. January 2017
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Challenging Standards - January 1, 2016 – June 30, 2016
IC.02.02.01 The hospital reduces risk of infections associated with medical equipment, devices, and
supplies.
•Hospitals - 59%
•Ambulatory Care – 49%
•Critical Access Hospital – 73%
•Office-Based Surgery Practices – 53%
Joint Commission Online. August 31, 2016
© 3M 2017. All Rights Reserved
Joint Commission – Analysis of Hazards
Safe Practice 4: Identification and Mitigation of Risks
and Hazards
Health care organizations must systematically identify and mitigate patient safety risks and hazards with an
integrated approach in order to continuously drive down preventable patient harm.
The Joint Commission. Improving Patient and Worker Safety: Opportunities for Synergy, Collaboration and Innovation. Oakbrook Terrace, IL: The Joint Commission, Nov 2012. https://www.jointcommission.org/improving_patient_worker_safety/ (accessed January 18, 2017)
© 3M 2017. All Rights Reserved
Continuous Quality Improvement (CQI) – AAMI ST 79 Section 11
• CQI programs are used to assess and improve all components of the sterilization process
Desired outcome of improving patient care by consistently delivering sterile product to the user
No single “right way” to implement CQI
Team approach
Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Section 11
© 3M 2017. All Rights Reserved
Medical Device Processing Risk Analysis
“The sterilization risk [medical device processing] analysis should be part of the health care facility’s overall infection prevention and control risk analysis in accordance with accreditation agency requirements.” Risk assessment (FMEA) - PROACTIVE
Risk management (ANSI/AAMI ST79, Root cause analysis) - REACTIVE
Risk communication (Recall procedure) – HARDWIRE LEARNING
“It should be performed at least annually and should be reevaluated whenever significant changes occur.”
Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 11.2.2
© 3M 2017. All Rights Reserved
Sterilization Risk Analysis
• Risk assessment
Identify sources of
potential sterilization
failures
Estimate likelihood that
each failure will occur
Assess the consequences
if that failure does occur
• Risk management Determine which of the
potential sterilization failures identified require management
Select and implement the plans or actions needed to ensure those failures are controlled
AAMI ST79 describes the accepted means of managing these risks
Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013Clause 11.2.2
© 3M 2017. All Rights Reserved
Sterilization Risk Analysis • Failure Modes and Effects
Analysis (FMEA) (WHAT IF?)
Proactive risk assessment
Assess the relative impact of
different failures, in order to
identify the parts of the process
that are most in need of change.
LD.04.04.05, EP 10 At least every
18 months, the hospital selects
one high-risk process and
conducts a proactive risk
assessment.
• Root Cause Analysis (WHY?)
Reactive/Retrospective Process
identify deficiencies or root
cause for the error or adverse
event
Cause and effect fishbone diagram
Answers the “Why” questions
Based on analysis, identify improvements and implement to avoid recurrence
The Joint Commission. Improving Patient and Worker Safety: Opportunities for Synergy, Collaboration and Innovation. Oakbrook Terrace, IL: The Joint Commission, Nov 2012. https://www.jointcommission.org/improving_patient_worker_safety/ (accessed January 18, 2017)http://www.ihi.org/
© 3M 2017. All Rights Reserved
Risk Assessment
Success depends upon previous preparation and without such preparation there is sure to be failure.
Confucius
© 3M 2017. All Rights Reserved
Risk Assessment
• PATIENT SAFETY
• EMPLOYEE SAFETY
• VISITOR SAFETY
© 3M 2017. All Rights Reserved
Transportationto CSD
Cleaning/Decontamination
Assembly/Inspection/Packaging
Sterilization
Staff Education P&P Special Issues (FMEA) Sterile StorageTransportation to
Point of use
Prevent Infections
Sterile Processing - Ishikawa (Fishbone) Diagram
Hand Hygiene--
Covered Cart --
Sharps Removed --
Sorting --
Items kept moist --
-- Hands on Training -- RestrictedAccess
Equipment maintenance --
Proper Packaging --
Check locks,hinges, etc. --
Verification of Cleaning--
Detergent --
-- Product Testing
-- Receipt of new devices
-- Regulation
Mechanical Monitors --
-- Use of dustbarriers
-- Case Cart
-- IUSS
-- Covered/Closed Containers
Bowie- Dick Test --
Biological Indicator --Maintenance of Equipment --
PPE Use --
-- Occupational Health
-- Flash Sterilization
-- Continuing EducationAnnual Retraining
-- Competency
-- Inspection of packagingAnd indicators before use
-- Extended Cycle
-- Tracking
-- Storage facilities
-- Hire/orientation
Lumens etc. --
ChemicalIndicator Placement --
Qualification Testing --
-- Review atleast annually
-- Standards & Guidelines
-- Instrument Design
-- Loaner
-- Power Equipment
Loading Sterilizer --
-- Carts
-- Event relatedoutdating
-- Sterilization Monitoring
-- Attire
Product Recall
- Recall procedures
Dedicated lifts -Presoak -
Disassembly -
Assembly -Sterilization parameters -
Unloading sterilizer -
- Distribution
- Recall order
- Recall report
- Quality control/Process improvement
- QualificationDepartment Design
- Design criteria
- Work flowpatterns
- Traffic control
- Physical facilities
- CJD
Record Keeping -
- Aseptic presentation
© 3M 2017. All Rights Reserved
Risk Assessment – Where to Start?
Adverse Event Reporting
Risk management department
Review of root cause analysis
Occupational exposures to bloodborne
pathogens
Internal Documentation
Failed biological or chemical indicators
Items returned from the OR because of
residual contamination
Repeated equipment failures
Recalls more than expected
OR Complaints
Joint Commission Sentinel Event Reports
Previous Accreditation Surveys
Joint Commission Safety Alerts
Media Reports
Paper
Electronic
CDC Alerts
HAN
FDA Medwatch
Standards, Guidelines, Regulations …
SDSs, manufacturers’ written instructions for
use
Identify Actual and Potential Risks
© 3M 2017. All Rights Reserved
CDC Health Alert Network (HAN) Alert - 0382• The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug
Administration (FDA) are alerting healthcare providers and facilities about the
public health need to properly maintain, clean, and disinfect or sterilize reusable
medical devices. Recent infection control lapses due to non-compliance with
recommended reprocessing procedures highlight a critical gap in patient safety.
Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and
doctors’ offices) that utilize reusable medical devices are urged to immediately
review current reprocessing practices at their facility to ensure they:
are complying with all steps as directed by the device manufacturers, and
have in place appropriate policies and procedures that are consistent with current
standards and guidelines.
CDC HAN 0382 Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. September 11, 2015.https://emergency.cdc.gov/han/han00382.asp (accessed January 18, 2017)
© 3M 2017. All Rights Reserved
CDC Health Alert Network (HAN) Alert - 0383Audit and Feedback
Healthcare facilities should regularly audit (monitor and document) adherence to
cleaning, disinfection, sterilization, and device storage procedures. Audits should assess
all reprocessing steps, including:
Performing prompt cleaning after use, prior to disinfection or sterilization procedures
Using disinfectants in accordance with manufacturers’ instructions (e.g., dilution, contact time, storage,
shelf-life)
Monitoring sterilizer performance (e.g., use of chemical and biological indicators, read-outs of sterilizer
cycle parameters, appropriate record keeping)
Monitoring automated endoscope reprocessor performance (e.g., print out of flow rate, time, and
temperature, use of chemical indicators for monitoring high-level disinfectant concentration)
Audits should be conducted in all areas of the facility where reprocessing occurs.
Healthcare facilities should provide feedback from audits to personnel regarding their
adherence to cleaning, disinfection, and sterilization procedures.0383 - 9/29/2015 - CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. https://emergency.cdc.gov/han/han00383.asp (accessed January 18, 2017)
© 3M 2017. All Rights Reserved
CDC HAN Alert - 0383
• As a follow-up to HAN 00382 (distributed September 11, 2015), the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are providing this update to rescind the following recommendation:
If healthcare facilities contract maintenance and repair of these devices to third-party vendors, healthcare facilities should verify that these vendors are approved or certified by the manufacturer to provide those services.
We are making this change because there are currently no formal standardized programs or processes through which all manufacturers certify third-party vendors.
We are also further clarifying that healthcare facilities which hire contractors to perform device reprocessing should verify that the contractor has an appropriate training program (i.e., consistent with what would be required in the healthcare facility) and that the training program includes the specific devices used by the healthcare facility.
0383 - 9/29/2015 - CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. https://emergency.cdc.gov/han/han00383.asp (accessed January 18, 2017)
© 3M 2017. All Rights Reserved
Cleaning Disinfection Rinsing Record Keeping
Staff Education P&P Special Issues (FMEA) StorageTransportation to
Point of use
Prevent Infections
Flexible Endoscopy- Ishikawa (Fishbone) Diagram
-- Hands on Training -- RestrictedAccess
Track to patient -------------Water quality ---------
Verification of Cleaning--
-- Receipt of new devices
-- Regulation
-- Covered/Closed Containers
Maintenance of Equipment --
-- Occupational Health
-- Continuing EducationAnnual Retraining
-- Competency
-- Tracking
-- Storage facilities
-- Hire/orientation
Alcohol flush----------
-- Review atleast annually
-- Standards & Guidelines
-- Instrument Design
Forced air drying-----
-- Sterilization Monitoring
-- Attire
Product Recall
- Recall procedures
AER----------
Manual ----------
Print out------------ - Recall order
- Recall report
- Quality control/Process improvement
- Qualification
Department Design
- Design criteria
- Work flowpatterns
- Traffic control
- Physical facilities
Pre-cleaning ---
Manual cleaning -----
Leak testing ------
Cleaning verification -------
Visual Inspection ----------------
Transport to processing room ----------
----MIFU
Test disinfectant -----
Dating of endoscope -------
Drying cabinet ----
© 3M 2017. All Rights Reserved
The Outbreaks: In the news but not new…..There is a well documented history of outbreaks
© 3M 2017. All Rights Reserved
“Flexible endoscope reprocessing has been shown to have a narrow margin of safety. Any slight deviation from the recommended reprocessing protocol can lead to the survival of microorganisms and an increased risk of infection.”
Alfa, M.J., et al. (2006). American Journal of Infection Control, 34(9), 561-570.
RISK….
© 3M 2017. All Rights Reserved
Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg. Alexandra M. Dirlam-Langlay, Cori L. Ofstead, Natalie J. Mueller, Pritish K. Tosh, Todd H. Baron, Harry P. Wetzler. American Journal of Infection Control 2013 Dec;41(12):1188-94.
Looked for reprocessing lapses in peer-reviewed literature,
government reports, state health departments, CDC, FDA,
Department of Veteran Affairs and media reports
The study was limited to Jan. 2005 – June 2012.
They found that improper endoscope reprocessing is an
ongoing and pervasive problem.
Over 30,500 people exposed and this is just the “tip of the
iceberg”.
> 99% of these cases were not found in peer-reviewed medical
journalsReprocessing lapses are rarely reported in medical journals leading to the false conclusion that reprocessing lapses are rare.
© 3M 2017. All Rights Reserved
Risk assessment means …
GOING BEYOND THE OBVIOUS!
© 3M 2017. All Rights Reserved
What does risk assessment mean in SPD?
• Determine where harm could occur in
all areas where instruments, device
and equipment processing occurs
through a systematic process
Inpatient / outpatient
Sterile processing department /
Endoscopy department
• Department-wide or individual
process / new device or instrument
Customize to meet needs
• Performed by a multi-disciplinary
team
At a minimum, infection preventionist, risk
manager, OR staff, SPD staff, surgeon
Review at a minimum, annually or when a
change in process or an adverse event
occurs
© 3M 2017. All Rights Reserved
What you don’t know can hurt your patient!
Therefore …
Identify and remove or reduce
identified risks and implement
practices and protocols
Walk the current process
Gap analysis / Hazard vulnerability
analysis
Qualitative or quantitative
Analyze and evaluate
High, moderate or low risk
Minimize, reduce or eliminate and /
or control the risk
Are existing measures in place to
control hazards / risk adequate
• if not identify measures to mitigate
the risks
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What you don’t know can hurt your patient!
And …
Prioritize risks that have been found on analysis and the control
measures
Determine the likelihood of occurrence or severity of impact if it occurs
Establish future process
Walk the future process prior to hardwiring
Monitor to ensure measures put in place to eliminate or minimize
the risk is communicated and hard wired
© 3M 2017. All Rights Reserved
Risks in Sterile Processing Department – Hazard Identification
• Instruments requiring extended cycles
• Original packaging changed for sterilization
• Flexible endoscopes not properly processed for patient use
• Late arrival of loaner instruments to allow for reprocessing according to IFU and quarantine implants for BI results
• Wrong BI process challenge device is run during routine testing
• Improperly reprocessed eye sets with improper reprocessing to prevent TASS
• Daily verification of mechanical cleaning equipment not done at least daily
• Manufacturer’s IFU for cleaning not followed
Young, Martha Top 10 Risk in Sterile Processing. AAMI Horizons Spring 2012
© 3M 2017. All Rights Reserved
Risks in Sterile Processing Department – Hazard Identification
Environment of Care
Utility Systems
EC.02.05.01: The hospital manages risks associated
with its utility systems.
EP 9: The hospital has written procedures for responding to
utility system disruption.
EP 15: In critical care areas designed to control airborne
contaminants (such as biological agents, gases, fumes, dust),
the ventilation system provides appropriate pressure
relationships, air-exchange rates, filtration efficiencies,
temperature, and humidity.
The Joint Commission. Hospital Accreditation Standards. January 2017
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Risks in Sterile Processing Department – Hazard Identification
The Joint Commission. Hospital Accreditation Standards. January 2017
Environment of Care
Construction and renovation
EC.02.06.05: The hospital manages its environment
during demolition, renovation, or new construction
to reduce risk of those in the organization.
EP 3: The hospital takes action based on its assessment
to minimize risks during demolition, construction, or
renovation.
Equipment EC.02.04.03: The hospital inspects, tests, and
maintains medical equipment. EP 4: The hospital conducts performance testing of and
maintains all sterilizers. The activities are documented.
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Risks in Sterile Processing Department – Hazard Identification
Instrument Management
Critical (sterile space), semi-critical (mucous membranes) and
non-critical (intact skin) devices
Reprocessing
Sterilization, high-level disinfection, intermediate-level disinfection and
low-level disinfection
People
HR.01.02.01 The hospital defines staff qualifications
Specific to job responsibilities
HR.01.02.05 The hospital verifies staff qualifications
HR.01.04.01 The hospital provides orientation to staff.
HR.01.05.03 Staff participate in ongoing education and training
HR.01.06.01 Staff are competent to perform their responsibilities
The Joint Commission. Hospital Accreditation Standards. January 2017
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Risks in Sterile Processing Department – Hazard Identification
Processes
Center for Medicare & Medicaid Services (CMS)
Draft and subject to changes
Policies and procedures
Early release of implants
Prion contaminated devices
Immediate Use Steam Sterilization (IUSS)
Loaner instruments
Robotics
High-level disinfection processes
Semi-critical devices
Endoscopes
Storage of clean and disinfected devices
© 3M 2017. All Rights Reserved
© 3M 2017. All Rights Reserved
Manage the Risk : Did the assessment identify new risks? Is it complete?
Review of RCAs – Limited pattern or
widespread
FMEA – new risks determined
Action plans – Closing the gaps / address
the risk
RACI matrix – Responsibility assignment matrix
Responsible, Accountable, Consultation, Informed
Policies and procedures (new or revised)
Competency assessment
Education and training
Resources
Staffing, equipment
Control Methods - Eliminate the risk
Administrative Control
Process Control
Personal protective equipment
Engineering Controls
Ventilation
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Risk Prioritization
Determine level of risk in the
assessment
Product information / manufacturer
written instructions for use (device,
cleaning/disinfecting agent,
equipment, etc)
Past experience
Federal / State / Local regulations
OSHA
SDS
Applicable standards and guidelines
Peer reviewed literature / evidence-
base best practices
Results of BI/CI
Environment – Temperature /
Humidity
Adverse events, near miss
Other items that contribute to risk
Environment layout/design
Staff experience/competency/supervision
System designs and control
© 3M 2017. All Rights Reservedhttps://www.jointcommission.org/webinar_replay_refresh_safer_matrix/ (accessed January 18, 2017)
The Joint Commission Safer Matrix
© 3M 2017. All Rights ReservedManuele, F.A. (2005, May). Risk assessment and hierarchies of control. Professional Safety, 50(5), 33-39. www.asse.org
© 3M 2017. All Rights Reserved
Decision Making
Manuele, F.A. (2005, May). Risk assessment and hierarchies of control. Professional Safety, 50(5), 33-39. www.asse.org
© 3M 2017. All Rights Reserved
Risk Prioritization - ExampleEstablish top priorities
SMH - 2016
Frequent/
High
Occasional/
Med
Uncommon/
Low
Rare/
None
Life
Threatening
Permanent
Disability,
Prolonged
Hospitalization
Temporary,
Recoverable,
Treatable
None None Poor Fair Good
SCORE 3 2 1 0 3 2 1 0 4 3 2 1
Evaluation/Action
Annual Infection Prevention and Control Program Risk Assessment and Analysis 2016
(Standard IC.01.03.01, IC.01.04.01 and IC.02.02.01 and NPSG 7)
Risk Priority
</= 6: no
risk to low
7-11:
medium
>/=12: high
PROBABILITY (Likelihood of Occurrence)
Infection Issues, Condition,
Problem and Events
PreparednessOutcome Severity (Harm)
Rank the identified risk - Is the risk High, Moderate or Low?
Probability x Outcome x Preparedness = Risk Priority
Ref. Sharp Memorial Infection Prevention Risk Assessment 2016
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Risk Prioritization - Determine what level of risk you are willing to accept?
High/Very High Risk – (e.g., >/=12)
Risk reduction a priority / unacceptable
Urgent implementation of risk reduction strategies in a defined time period
May need to stop or restrict the activity / apply interim solutions until completed
May be resource intensive to implement additional measures
Monitor to ensure that control measures are hard wired to prevent harm
Very Low (No Risk) / Low Risk – (e.g.,
</=6)
Acceptable
No further action is necessary
Monitor for increase in risk and current
practices maintained
Medium / Moderate Risk – (e.g., 7- 11)
Can the risk be lowered to an acceptable
level?
Risk reduction strategies should be
implemented promptly
Monitor for increasing risk especially if harm
could result
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Risk Prioritization
Develop goals and objectives based on findings in the risk assessment
Written to address highest priorities
Written to address how strategies will be put in place to reduce the risk adverse events such
as infection transmission from instruments, devices and medical equipment
Each goal should have measurable objectives
Evaluation process
According to the Joint Commission,
“By adding objectives to goals, organizations move beyond communicating intent to
incorporating specific numeric targets and timeframes for outcomes.”
Approved by the Infection Prevention Committee
Becomes a part of the infection prevention and control plan
The Joint Commission Resources. Using the Risk Assessment to Set Goals and Develop the Infection Prevention and Control Plan. Chapter 3
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Risk Mitigation Efforts• Minimizing risks begins with
• Correct handling procedures in preparation for processing, to include precleaning steps at the point of use (e.g., bedside procedures), disassembly of parts, and safe transport.
• Cleaning according to the specific manufacturer's written IFU is then required to ensure that patient soil and other materials are removed prior to the antimicrobial processes of high-level disinfection or sterilization.
• Cleaning is followed by disinfection or sterilization to reduce or completely remove microbial contamination. At a minimum, it is recommended that devices are subjected to high-level disinfection after each use.
• When possible and practical, flexible and semi-rigid endoscopes should be sterilized due to the greater margin of safety built into sterilization.
• High-level disinfection is a multi-step process and is expected to be able to inactivate most pathogenic bacteria, viruses, and fungi but may not reliably inactivate certain types of microorganisms including bacterial spores.
• When these devices are used in sterile tissue procedures, sterilization is recommended
Reprinted from ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities
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Name(s) Date
Remaining issues that can be anticipated.
- Any failure modes to watch out for? Any unintended consequences?
Ensure ongoing P-D-C-A.
Target(s)/Goal(s)
The specific outcome required for the business.
- What is the specific change you want to accomplish now.?
- How will you measure success?
Analysis
The root cause(s) of the problem.
- Why are we experiencing the symptom?
- What constraints prevent us from the goal?
Choose the simplest problem-solving tool for this issue:
- Five whys
- Fishbone
- QC Tools
- LSS Tools
Follow Up:
A3
Why you are talking about it.
What is the business reason for choosing this issue?
Background:
Current Conditions:
Where things stand today.
- What’s the problem with that, with where we stand?
- What is the actual symptom that the business feels that requires action?
Show visually – pareto charts, graphs, drawings, maps, etc.
Title
A chart or table that shows actions/outcomes, timeline and responsibilities.
May include details on the specific means of implementation.
- Who will do what, when and how?
Indicators of performance, of progress.
- How will we know if the actions have the impact needed?
- What are the critical few, visual, most natural measures?
Your proposal to reach the future state, the target condition.
- What alternatives could be considered?
- How will you choose among the options? What decision criteria?
How your recommended countermeasures will impact the root cause to
change the current situation and achieve the target.
Proposed Countermeasure(s):
Implementation Plan:
Lean Six Sigma Tool - A3
Copyright 2014 GoLeanSixSigma.com. All Rights Reserved.
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Other Triggers for Ongoing Risk Assessment
• Could changes in the SPD introduce new hazards or raise the risk from low to high
• Review the assessment on a regular basis to ensure there are no changes
• Establish triggers for a review• SPD construction plans
• Work flow / process change
• Purchase of new instruments, equipment, etc.
• Hiring of new employees in training
• Relocation of services / decentralization of services
• Introduction of new chemicals (disinfectants, detergents, sterilants)
• Revision in manufacturer’s written instructions for a device, equipment in use
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Record Keeping
• Maintain record of risk assessment based on facility policies and
procedures
• Process for determining risk
• Action plans / control measures appropriate to the identified risks
• Measures of success
• Federal / state / local regulations may dictate time for these records
• Demonstrate prioritization of identified risks / hazards and was thorough
• Assessed all work areas
© 3M 2017. All Rights Reserved
Summary
Regular risk assessment should be completed for sterile processing as part of the infection
prevention risk assessment.
Risk assessment is not a one time activity but an important part of the continuous quality
improvement program.
Risk assessment means going beyond the obvious.
A comprehensive risk assessment is a key part of an overall sterilization risk analysis.
Risk assessment is not done in a vacuum but with a multi-disciplinary team.
Multiple sources are available to assist with determining what should be included in the risk
assessment.
Once risk assessment is completed, manage the risk by prioritizing based on high, medium or
low risk and focus mitigation efforts.
Continuously audit the changed process to monitor for unintended consequences and to ensure
any further changes will be included in future assessments.
© 3M 2017. All Rights Reserved
It always seems impossible until it’s done.
Nelson Mandela
3M Health Care AcademySM
© 3M 2016. All Rights Reserved 54
3M Health Care AcademySM
Additional Questions?
3M Health Care AcademySM
© 3M 2016. All Rights Reserved 55
References• The Joint Commission. Hospital Accreditation Standards. January 2017.
• Challenging Standards January to June 2016. Joint Commission Online. August 31, 2016
• The Joint Commission. Improving Patient and Worker Safety: Opportunities for Synergy, Collaboration and Innovation. Oakbrook Terrace, IL: The Joint Commission, Nov 2012. https://www.jointcommission.org/improving_patient_worker_safety/ (accessed January 18, 2017)
• ANSI/AAMI ST79ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• http://www.ihi.org (accessed January 18, 2017)
• CDC HAN 0382 Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. September 11, 2015. https://emergency.cdc.gov/han/han00382.asp (accessed January 18, 2017)
• CDC HAN 0383 - 9/29/2015 - CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. https://emergency.cdc.gov/han/han00383.asp (accessed January 18, 2017)
• Alfa, M.J., et al. (2006). American Journal of Infection Control, 34(9), 561-570.
• Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg. Alexandra M. Dirlam-Langlay, Cori L. Ofstead, Natalie J. Mueller, Pritish K. Tosh, Todd H. Baron, Harry P. Wetzler. American Journal of Infection Control 2013 Dec;41(12):1188-94.
3M Health Care AcademySM
© 3M 2016. All Rights Reserved 56
References• The Joint Commission: The Source, February 2010 Volume 8, Issue 2
• Young, Martha Top 10 Risk in Sterile Processing. AAMI Horizons Spring 2012
• Center for Medicare & Medicaid Services. Center for Clinical Standards and Quality/Survey & Certification Group. Draft Pilot Hospital Infection Control Worksheet. Released November 18, 2016.
• The Joint Commission Safer Matrix https://www.jointcommission.org/webinar_replay_refresh_safer_matrix/ (accessed January 18, 2017)
• The Joint Commission Resources. Using the Risk Assessment to Set Goals and Develop the Infection Prevention and Control Plan.Chapter 3
• Manuele, F.A. (2005, May). Risk assessment and hierarchies of control. Professional Safety, 50(5), 33-39. www.asse.org
• Lean Six Sigma A3 Tool. GoLeanSixSigma.com (accessed January 18, 2017)
• Rutala W, Weber, D et. al. CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/hicpac/Disinfection_Sterilization/5_0cleaning.html (accessed January 18, 2017)
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