Risk Assessment in the Sterile Processing Department:...

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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



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

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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


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


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


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


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


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)

https://www.jointcommission.org/improving_patient_worker_safety/


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


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


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


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/


http://www.ihi.org/


Risk Assessment

Success depends upon previous preparation and without such preparation there is sure to be failure.

Confucius


Risk Assessment

• PATIENT SAFETY

• EMPLOYEE SAFETY

• VISITOR SAFETY


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


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


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)

https://emergency.cdc.gov/han/han00382.asp


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)



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)



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 ----


The Outbreaks: In the news but not new…..There is a well documented history of outbreaks


“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….


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.


Risk assessment means …

GOING BEYOND THE OBVIOUS!


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


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


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


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



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.





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.



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




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


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


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

https://www.jointcommission.org/webinar_replay_refresh_safer_matrix/


Decision Making

Manuele, F.A. (2005, May). Risk assessment and hierarchies of control. Professional Safety, 50(5), 33-39. www.asse.org


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


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


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


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


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.


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


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


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.


It always seems impossible until it’s done.

Nelson Mandela




Additional Questions?



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.


http://www.ihi.org/





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)

https://www.jointcommission.org/webinar_replay_refresh_safer_matrix/

http://www.asse.org/

http://www.cdc.gov/hicpac/Disinfection_Sterilization/5_0cleaning.html


THANK YOU!



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