your endoscopy setting! salem/union hospital reprocessing in … in your... · 2015. 3. 12. ·...
TRANSCRIPT
Slide 1
Aiming Higher to Exceptional Reprocessing in Your Endoscopy Setting!
Lisa Heard, BSN RN CPN CGRNDirector, Perioperative and Endoscopy Services
North Shore Medical Center
Salem/Union Hospital
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Slide 2 Objectives
• Review potential for transmission of pathogens in
endoscopy
• Describe current guidelines and recommendations for
endoscopic reprocessing
• Discuss a quality assurance program in high level
disinfection of endoscopes
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Slide 3
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Slide 4 Transmission of Pathogens in Endoscopy
• 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, 2006)
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Slide 5 Transmission of Pathogens in Endoscopy
• CLEANR study> Factors that Contribute to Nonadherence with Endoscope Reprocessing Guidelines: A
Prospective Study Overview of Findings from the CLEANR Study
(CLinical Evaluation and Assessment of ENdoscope Reprocessing)
Ofstead, CL et al, 2010
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Slide 6 Distal Tip of Olympus Scope
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Slide 7 Brush After Removal
Brush inserted 10 cm into air water channel
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Slide 8 Endoscope Channels
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Slide 9 Transmission of Pathogens in Endoscopy
• Breeches in the news:
> February 2008
— A hepatitis C outbreak in Las Vegas is traced to an endoscopy center,
prompting tests of 50,000 patients, physicians and staff for hepatitis
and HIV
> December 2008
— At the VA Hospital in Murfreesboro, TN, the use of an incorrect
connector results in widespread patient notifications and MSNBC
coverage
> April 2009
— One patient tested positive for HIV and seven others for hepatitis C
after colonoscopies at a VA facility in Miami
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Slide 10 Transmission of Pathogens in Endoscopy
• Breeches in reprocessing protocols in the news:
> October 2011
— Widely reported that a clinic in Ottawa, Ontario has been improperly
reprocessing upper and lower GI Endoscopes for almost a decade,
requiring the notification of 6,800 patients
> April 2013
— Reported an Atlanta Ambulatory Surgery Center warns 456 patients
they may have been exposed to HIV, Hepatitis B or C due to
reprocessing errors. According to report, "the surgery center staff
cleaned the endoscopy instruments with enzymatic soap after each
use… but failed to perform the final recommended step of soaking the
equipment in a high-level disinfectant."
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Slide 11 Transmission of Pathogens in Endoscopy
• Risk for potential transmission of infectious agents during
gastrointestinal (GI) endoscopy
• Estimated frequency is low - 1 in 1.8 million procedures
• Endoscopy-related infection may occur when microorganisms are
spread or transmitted from patient to patient by contaminated
endoscopic or accessory equipments
• Concluded that proper cleaning, disinfection, and reprocessing of
endoscopes and accessories help to minimize the risk for infection
transmission
Wu, H., Shen, B., 2010
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Slide 12 Safeguards for Manual Errors in Reprocessing
• Automated processes > Scope buddy
> Endo Flush
> ASP Evotech
> Medivator Advantage
> MIT?
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Slide 13 Safeguards for Manual Reprocessing
• Invested, engaged staff
• Competent, knowledgeable trainers and leaders
• Consistent, well defined, quality assurance program
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Slide 14 Current Guidelines and Recommendations
Joint Commission
• Joint Commission Online, July 20, 2011 “Focus on sterilization and high-level disinfection processes -
…beginning in 2010, surveyors have spent additional time during
survey evaluating the cleaning, disinfection and sterilization (CDS)
processes. Earlier this year, Joint Commission surveyors received
in-depth training on sterilization processes… Within the next
several months, a similar educational module will be delivered on
HLD of endoscopes”.
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Slide 15 Current Guidelines and Recommendations
Center for Medicare and Medicaid Services (CMS)
• Equipment preprocessing is an area targeted my CMS > Centers cited for deficient practice are required to correct them
> Failure to correct risks termination of Medicare participation
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Slide 16 SGNA Resources
• Standards of Infection Control in Reprocessing of Flexible
Gastrointestinal Endoscopes
• Guideline for the Use of High Level Disinfectants and Sterilants for
Reprocessing of Flexible Gastrointestinal Endoscopes
• Reuse of Single Use Critical Medical Devices - position statement
• Statement on Reprocessing of Water Bottles Used During Endoscopy
• Statement on Reprocessing of Endoscopic Accessories and Valves
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Slide 17 SGNA's Infection Prevention Champions Program
• The goal of this program is for each facility/setting across the country
to have a Champion who acts as the link to the most up-to-date
information about infection prevention.
• SGNA has created an Infection Prevention resources and toolkit to aid
the Champion and others who seek this important information
• Must apply to become a Champion
• Champions have increased access to resources, education,guidelines
• SGNA News, Quarter 2, 2013
• www.sgna.org/InfectionPrevention.aspx
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Slide 18
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Slide 19 ASGE - Improving Quality and Safety in Your Endoscopy Unit Course
• Quality in Reprocessing and Infection Control > Infection control in endoscopy:
— Endoscopy-associated infection transmission, reprocessing guidelines, and what
to do if infection is suspected
— Safe injection practices and contact precautions
> Training in proper disinfection and reprocessing:
— Working guide to disinfection solutions and reprocessing equipment; Endoscope
reprocessor operations
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Slide 20 Certification Board for Sterile Processing and Distribution
Certified Fiberoptic Endoscope Reprocessor Exam
• Infection Control
• Reprocessing Techniques
• Standard Equipment for Endoscopic Procedures
• Chemicals
• Rules and Regulations
• Safety
• Basic Medical Competencies and Performance Standards
• Recordkeeping
• Specimen Handling
• Ethical Standards
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Slide 21 2011
Multi-Society Guideline
In-Depth Review
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Slide 22 Multi-Society Guideline 2011
• American Society for Gastrointestinal Endoscopy
• Society for Healthcare Epidemiology
• American College of Gastroenterology
• American Gastroenterological Association
• American Society of Colon and Rectal Surgeons
• Accreditation Association for Ambulatory Health Care
• Association of periOperative Registered Nurses
• Association of Professionals in Infection Control and Epidemiology
• The Joint Commission
• Society of American Gastrointestinal and Endoscopic Surgeons
• Society of Gastroenterology Nurses and Associates
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Slide 23
Category IA
Strongly recommended for implementation and strongly supported by well-designed
experimental, clinical or epidemiologic studies
Category IB
Strongly recommended for implementation and supported by some experimental, clinical or epidemiologic studies and a
strong theoretical rationale
Category IC
Required by state or federal regulations. Because of state
differences, readers should not assume that the absence of an IC
recommendation implies the absence of state regulations
Category II
Recommended for implementation and supported by suggestive clinical
or epidemiologic studies or theoretical rationale
No recommendation
Unresolved issue. Practices for which insufficient evidence or no
consensus regarding efficacy exists
Category
Recommendations
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Slide 24 Personnel
• All health care personnel in the endoscopy
suite should be trained in and adhere to
standard infection prevention and control
recommendations including those to protect
both patients and health care workers
Category IA
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Slide 25 Pre-cleaning and Transport
• After point-of-use pre-cleaning, transport the soiled
endoscope to the reprocessing area for subsequent
steps in high-level decontamination before remaining
soil dries
• During transportation, soiled endoscopes should be
contained in a manner that prevents exposure of
staff, patients or the environment to the potentially
infectious organisms
• An open container can suffice for transport to
immediately adjacent reprocessing rooms, but fully
enclosed and labeled containers or bags should be
used for transportation to distant reprocessing areas
Category II
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Slide 26 Leak Testing
• Perform pressure/leak testing after each use and
before formal reprocessing, according to manufacturer
guidelines
Category IB
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Slide 27 Manual Cleaning
• Before manual or automated high-level disinfection,
clean endoscope, valves, channels, connectors and
all detachable parts
• Disconnect and disassemble endoscope
components and immerse the endoscope and
components in an appropriate detergent that is
compatible with the endoscope
• Flush and brush all accessible channels to remove
all organic and other residues
• Repeatedly actuate the valves during cleaning to
facilitate access to all surfaces
• Clean the external surfaces and components of the
endoscope by using a soft cloth, sponge, or brushes
Category IB
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Slide 28 Manual Cleaning
• Use brushes appropriate for the size of the endoscope
channel, parts, connectors and orifices cleaning
• Cleaning items should be disposable or thoroughly
cleaned and disinfected/sterilized between uses
• Discard enzymatic detergents after each use because
these products are not microbicidal and will not retard
microbial growth
• Reusable endoscopic accessories that break the
mucosal barrier should be mechanically cleaned and
then sterilized between each patient use
Category II
Category IB
Category IA
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Slide 29 Accessories
• Ultrasonic cleaning of reusable endoscopic accessories
and endoscope components may be used to remove
soil and organic material from hard-to-clean areas
• Endoscopes and accessories that come in contact with
mucous membranes are classified as semi critical items
and should receive at least high-level disinfection after
each patient use
Category II
Category IA
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Slide 30 High Level Disinfectants
• Use a high-level disinfectant cleared by the FDA for
high-level disinfection
• The exposure time and temperature for disinfecting
semi-critical patient care equipment vary among the
FDA-cleared high-level disinfectants
Category IA
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Slide 31 High Level Disinfectants
• Select a liquid disinfectant or sterilization technology
that is compatible with the endoscope
• As newer disinfectants become available, persons or
committees responsible for selecting disinfectants for
GI endoscope reprocessing should be guided by
FDA clearance of these products and by information
in the scientific literature
Category IB
Category II
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Slide 32 High Level Disinfection Process
• Completely immerse the endoscope and its
components in the high-level disinfectant solution and
ensure that all channels are perfused
• Users should obtain and review model-specific
reprocessing protocols from both the endoscope and
the AER manufacturers and check for compatibility
Category IB
Category IB
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Slide 33 High Level Disinfection Process
• If an AER is used, place the endoscope and it’s
components in the reprocessor and attach all channel
connectors according to the AER and endoscope
manufacturers’instructions to ensure exposure of all
internal surfaces with the high-level disinfectant solution
• If an AER cycle is interrupted, high-level disinfection or
sterilization cannot be ensured; therefore, the cycle
should be repeated
Category IB
Category II
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Slide 34 High Level Disinfection Process
• After high-level disinfection, rinse the endoscope and
flush the channels with sterile, filtered or tap water to
remove the disinfectant solution
• Discard the rinse water after each use/cycle
• Flush the channels with 70% to 90% ethyl or isopropyl
alcohol and dry by using forced air
Category IA
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Slide 35 Storage
• When storing the endoscope, hang it in a vertical
position to facilitate drying (with caps, valves and
other detachable components removed, per
manufacturers instructions)
• Endoscopes should be stored in a manner that will
protect them from contamination.
Category II
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Slide 36 Hang Life
• Although reuse of endoscopes within 10 to 14 days of
high-level disinfection appears to be safe, the data are
insufficient to provide a maximal duration for use of
appropriately cleaned, reprocessed, dried, and stored
flexible endoscopes
• Per Guideline may be advisable, particularly for
instruments:> used infrequently because of low volumes or specialty applications
> used in patients at high-risk of infection such as those whose immune systems
are suppressed by medications or disease
> Used in procedures with anticipated entry to otherwise sterile regions such as
the biliary tree, pancreas and peritoneal space
No Recommendation
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Slide 37 Documentation
• Maintain a log for each procedure to assist in
an outbreak investigation
• Log must indicate the following> Patient’s name
> Medical record number (if available)
> Procedure
> Serial number or other identifier of the endoscope and AER
Category II
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Slide 38 Minimal Effective Concentration
• Perform routine testing of the liquid high-level
disinfectant to ensure at least the minimum
effective concentration of the active ingredient
• Check the solution at the beginning of each day of
use (or more frequently) and document the
results
• If the chemical indicator shows that the
concentration is less than the minimal effective
concentration, the solution should be discarded
• Discard the liquid high-level disinfectant at the end
of its reuse life regardless of the minimal effective
concentration
Category IA
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Slide 39 Personal Protective Equipment
• Personal protective
equipment (PPE) should
be readily available and
should be used to protect
workers from exposure to
chemicals, blood or other
potentially infectious
material
Category IC
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Slide 40 Outbreak Reporting
Endoscopy-related infections should be
reported to all of the following:
• Infection control at the institution
• Appropriate public health agency (state or local
health department as required by state law or
regulation)
• FDA
• Manufacturers of:> endoscope
> disinfectant/sterilant
> AER (if used)
Category IC
Category IB
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Slide 41
Instituting a Quality
Assurance Program
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Slide 42 Assess Your Practice and Environment
• Understand your baseline
> Observe practice
> Interview the reprocessing staff
> Physical space
> What resources are they using
> Education / training
> Role clarity
> Communication
> Global perspective
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Slide 43 Reprocessing Room Recommendations
• Adequate space for reprocessing activities
• Proper airflow and ventilation requirements
• Work flow patterns
• Work surfaces, lighting
• Adequate utilities - electrical support and water
• Hand washing and eye washing facilities
• Air drying capability
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Slide 44 Quality Assurance
• Elements of the QA program should include:
> Supervision
> Training
> Annual competency review
> Methods of assuring the availability of appropriate equipment and
supplies
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Slide 45 Supervision
• Supervisory personnel must be familiar with the principles and
practices of instrument reprocessing if they are to properly train and
monitor staff
• Knowledgeable supervisors also serve to impress upon peer groups
and subordinates the importance of these functions
• An individual in the endoscopy setting should be designated and
assigned to monitor compliance with the reprocessing protocol
(SGNA, 2007)
> SME trainers
— CFER certified
— Nurse and technician team
— Central Processing Department
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Slide 46 Personnel
• Decisions must be made regarding the number and category of personnel that will be responsible for instrument reprocessing.
• Only individuals, who are able to read, understand, and implement instructions … should be given the responsibility to reprocess such instruments (ASTM, 2000)
• Temporary personnel should not be allowed to clean or disinfect instruments in either a manual or an automated reprocessing system (ASTM, 2000)
• Knowledge is developed through repetition and the guidance of a preceptor
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Slide 47 Education and Training
• All staff must -
> adhere to infection control principles
> not deviate from the recommended reprocessing protocol
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Slide 48 Education and Training
• All staff must –
> Be orientated in and maintain continuing education in the following
topics:
— Standard precautions
— Personal protective equipment (PPE)
— OSHA rules on occupational exposure to blood-borne
pathogens
— Reprocessing procedures for endoscopes and accessories
— Mechanisms of disease transmission
— Maintenance of a safe work environment
— Safe handling of high level disinfectants (HLD) and sterilants
— Procedures for waste management
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Slide 49 Annual Competency
• Specific training with documented competency must be
completed at least annually:
> For new equipment introduced in facility
> New models of endoscopes
> Automatic endoscope reprocessors
• All persons must be properly trained and their
performance subject to periodic review and audit
• Annual competencies - Return demonstration
• Random Consistent audits
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Slide 50 Audit Example
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Slide 51
North Shore Medical Center
Employee Name________________________ NSMC Employee
Number_______________________
Preceptor Name(s)______________________ Dates of competency
______________________
Evaluation Method
Competency Level
A. Direct Observation E. Written Test 1. Met
B. Customer Feedback F. Verbalizes Knowledge 2. Not Met
C. Documentation Review G. Other (describe) 3. Not applicable to practice area
D. Analysis of Data
Competency:
Demonstrates the ability to competently perform endoscope cleaning
and disinfection
Evaluation
Method
Competency
Level
Competency
Evaluator’s
Signature
Date
Evaluated
Prior to competency assessment, employee must complete the following:
Demonstrated competency “Use and Testing of Cidex OPA”
Locate and describe use of Cidex OPA MSDS
A,F
Demonstrates safe handling of high level disinfectants (HDL) A
Describes and demonstrates spill containment plan F
Pours and labels Cidex OPA solution per manufacturer’s instructions.
Refers to these instructions for questions and rationale. A,F
If using a bin or GUS station, employee labels container holding Cidex
OPA with the following:
Solution name
Date opened
Expiration date
Preparer’s name
A
Labels all opened unused Cidex OPA bottles with date opened and
expiration date. A
Demonstrates testing and documentation of chemical disinfectant
minimum effective concentration (MEC) – see MEC Specific
competency
A,C
Demonstrates correct procedure for changing the high level
disinfectant(HDL) in the AER reservoir A
Demonstrates use of personal protective equipment (gloves, eye
protection, impervious gown, face shield or simple surgical mask that A
Competency: Endoscope Cleaning and High Level Disinfection
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Slide 52 Methods of Assuring the Availability of Appropriate Equipment and Supplies
• Daily Rounds
• White board
• Problem tracking tools
• Chain of Command
• Par levels
• SME
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Slide 53 Perfect World Scenario
ENDOSCOPE
REPROCESSING
RN
(CGRN / CFER)
Tech (CFER)
Subject Matter Expert
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Slide 54 Review of QA Development
• Review and understand guidelines
• Review your environment
• Identify stakeholders
• Identifying responsible trainers
• Create competencies
• Developing audit tools
• Annual review and revision
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Slide 55
Thank You!
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