hfap webinar infection control december 15, 2015 dr. daniel fieker, infectious disease donna tiberi,...

HFAP WEBINAR

Infection ControlDecember 15, 2015

Dr. Daniel Fieker, Infectious Disease

Donna Tiberi, RN, BS, MHA Standards Interpretation & Accreditation Specialist

December 15, 2015 1

Objectives • Anatomy of the Biliary System.

• Microbiology of Infection.

• Understand new interim protocols related to reduction of Bacterial Contamination of Duodenoscope and related Reprocessing procedures.

• List HFAP applicable standards related to compliance procedures.

December 15, 2015 2

CRE and ERCP

• Carbapenem Resistant Enterobacteriaceae and Endoscopic Retrograde Chlolangiopancreatography First infection associated with this device 1983

Biliary Tract Anatomy

• Liver• Gallbladder• Pancreas• Small Bowell

Bile Microbiology

• Normal Biliary Bile: No Bacteria Cultured• Gallstones-50%• Common Bile Duct Stones-50%• Cholecystitis-45%• Complete Obstruction Bile Drainage-90-100%

Enterobacteriaceae Intestinal Mico-organisms

• E Coli• Klebsiella• Serratia• Enterobacter• Proteus• Pseudomonas

Antibiotic Resistant Enterobacteriacea

• Chronically Ill Patient Population• Long Term Hospitalization• Prior Broad Spectrum Antibiotics• Urinary Catheters• Ventilator Patients

Antibiotic Resistance

• Enzyme: Beta Lactamase production disrupts the Structure of the Antibiotic and as a Result the Antibiotic is Ineffective

Antibiotics: Emerging Resistance

• Ampicillin• Cefotaxime• Cefoperazone• Aminoglycosides• Carbapenems

– Imipenem– Meropenem

Past Events

• 2009 France 12 patients infected with Drug Resistant Bacteria following ERCP

• 2012 Advocate Lutheran General Hospital 44 patients

• Past two years CDC reported 75 patients with associated infection

Outbreaks of CRE Following ERCP

• Seattle Washington (Virginia Mason Medical Center)

• Los Angeles (UCLA Medical Center)• Pittsburg PA (University of Pittsburg Medical

Center)• Park Ridge IL (Advocate Lutheran General

Hospital)• Harford CT (Hartford Hospital)

ERCP Scope Manufacturers

• Olympus• Pentax• FujiFilm

Underlying ConditionsAssociated with ERCP

• Gallstones Bile Duct Stones/• Biliary Carcinoma• Pancreatic Carcinoma• Intestinal Malignancy

Biliary Tract Anatomy

Duodenoscope

ERCP ScopeDesign Problem

Duodenoscope Surveillance

• Duodenoscope Reprocessing: Elevator Mechanism Inspection and cleaning followed by drying

• Surveillance Cultures: No established guidelines: Instrument channel and distal end of scope

• Low Concern Microorganisms: Bacillus, diptheroids, coagulase negative staphylococcus

• High concern Microorganisms: E. coli, Klebsiella, Salmonella, Shigella, Staphylococcus aureus, Enterococcus

QUESTIONS?

Please submit questions to:Dr. Dan Fieker

[email protected]

December 15, 2015 20

mailto:[email protected]

CDC ALERT

The CDC announced a “CDC HEALTH ADVISORY” on September 11, 2015, to notify all healthcare facilities (hospitals, ambulatory surgical centers, clinics, and physician offices) that utilize reusable medical devices and urged facilities immediately review their current reprocessing practices at their facility to ensure the following:

(1)Comply with all steps as directed by the device manufacturers(2)Verification of the facility’s appropriate policies and procedures are in place that are consistent with current standards and guidelines.

This CDC alert was based on infection control lapses due to non-compliance with recommended reprocessing procedures which directly affects patient safety.


CDC ALERT

The patients exposed to the to increased risk for infection was based on the facility’s failure to follow basic cleaning, disinfection, and sterilization of medical devices.

Facilities failed to follow manufacturers’ reprocessing instructions for:

1.Critical and semi-critical items2.Healthcare facilities need to review their policies and procedures to ensure that policies protect patients


CDC Recommendations

1. Health care facilities must seek expertise guidance in device reprocessing in order to immediately assess their reprocessing policy and procedures.

2. The reprocessing assessment would provide verification that the reprocessing procedure is done correctly

3. To validate that facilities allows sufficient time for reprocessing personnel to follow all steps recommended by the device manufacturer


Decontamination Process Steps1.Transport - Used supplies and equipment should be collected and taken to the Decontamination Area in the Sterile Processing Department in a way that avoids contamination of personnel or any area of the hospital. Equipment should be covered and supplies should be moved in covered carts, closed totes or containers, or closed plastic bags.

2.Attire - Personnel working in the decontamination area must wear protective clothing, such as a scrub uniform covered by a moisture-resistant barrier, shoe covers, rubber or plastic gloves, and a hair covering. When performing manual cleaning processes, when splashing can occur, personnel must wear safety goggles and a face mask.


Decontamination Process Steps(continued)

3.Sorting - sorting begins at the point of use. Handling of contaminated items should be minimized unless the user of the device is already wearing full personal protective attire, such as following care in the operating room. Where workers are wearing no or minimal protective attire, sorting of contaminated items should only include removing of disposable sharps and discarding other single-use items.

4.Soaking – soaking is only required if you have lumens or other complex designs that are filled with debris or if the devices are very bloody and cannot be rinsed or wiped at the point of use.


Decontamination Process (continued)

5.Washing Methods:

•Washer/Decontaminator •Ultrasonic Washer •Tunnel Washers •Cart Washers •Inspection •Hinged Instruments


Staff Training Recommendations04.00.05 Competency. The facility develops policies and procedures identifying those patient care and/or diagnostic procedures, which requires staff to have evidence of specific competence. Some of these may result in external or internal mechanisms for certification. Maintenance of such competence is considered in the design of these policies and procedures.

•Must provide training to all personnel who reprocess medical devices

•Must provide training at time of hire/prior to provision of services at the facility and minimum of once a year

•Whenever new devices/protocols are introduced, or any changes in the manufacturer’s instructions for use during the device’s life cycle

•Personnel must demonstrate competency with device reprocessing before they are allowed to reprocess independently


Staff Training Recommendations

5. Facilities must maintain current documentation of all personnel trainings and competencies.

6. If a facility hires a contractor for device reprocessing, the facility is required to verify that the contractor has an appropriate training program and that the training program includes the particular devices the healthcare facility uses.

7. The manufacturers’ operating and reprocessing instructions for each type of reusable device must be readily available to staff and inspectors, including instructions for use of chemical disinfectants.


Performance Monitoring

1. Facilities must document and monitor performance compliance to cleaning, disinfection, sterilization, and device storage procedures. Areas to monitor are:

2. Staff promptly clean equipment after use, and prior to disinfection or sterilization procedures

3. Follow the manufacturers’ instructions when using disinfectants such as dilution, contact time, storage, and shelf-life


Performance Monitoring

4.Monitoring sterilizer performance and documentation when using chemical and biological indicators, sterilizer cycle parameters read outs, and accurate results record keeping

5.Monitoring occurs wherever reprocessing occurs

6. Facilities should provide staff feedback from audits about their adherence to cleaning, disinfection, and sterilization procedures


07.00.00: Condition of Participation:Infection Control

The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.§482.42

The hospital’s infection control program must be:

1.Hospital-wide

2.Include all locations, all campuses, all departments and services

3.Hospitals must develop, implement, and maintain an active, hospital-wide program for the prevention, control, and investigation of infections and communicable diseases.


07.00.00 Condition of Participation:Infection Control

The hospital’s Infection Control program should be conducted in accordance with nationally recognized infection control practices or guidelines, and in accordance with all applicable regulations of other federal or state agencies.

Nationally Recognized Infection Control practices or guidelines include:

1.Centers for Disease Control and Prevention see: CDC @ http://www.cdc.gov/

2.Association for Professionals in Infection Control and Epidemiology see: APIC @ http://www.apic.org/

3.Society for Healthcare Epidemiology of America see: SHEA @ http://www.cdc.gov/HAI/pdfs/cdiff/Cohen-IDSA-SHEA-CDI-guidelines-2010.pdf

4.Association of peri Operative Registered Nurses see: AORN @ http://www.aorn.org/.

5.U.S. Occupational Health and Safety Administration (OSHA) also issues federal regulations applicable to infection control practices see: https://www.osha.gov/


http://www.cdc.gov/

http://www.apic.org/

http://www.cdc.gov/HAI/pdfs/cdiff/Cohen-IDSA-SHEA-CDI-guidelines-2010.pdf

http://www.aorn.org/

http://www.aorn.org/

https://www.osha.gov/

Infection Control Policies and Procedures

Health care facilities must have a policy and procedures for the following:

1.Policies that define adequate time for reprocessing to ensure compliance to all steps recommended by the device manufacturer to include drying, proper storage, and transport of reprocessed devices.

2.Facilities should evaluate scheduled procedures times to ensure adequate time is allowed for reprocessing

3.Protocols are available to ensure staff can readily identify devices that have been properly reprocessed and ready for patient use. Examples such as using a tagging system, or using a designated storage area. Its important to track which instruments or equipment were used on each patient.



4. Policies and procedures must clearly outline a facility’s response in the event of a recognized reprocessing error or failure.

5. Facilities should have policies and procedures outlining facility response in the event of a recognized reprocessing error or failure.

6. Assess the cause of the error or failure and the exposure event in order to determine the potential risk of infection as when, how, who and why etc. Procedures should include how patients who might have been exposed to an improperly reprocessed medical device would be identified, notified, and followed.



1. Facilities must maintain documentation records of all reprocessing activities for reprocessing of autoclaves, automated endoscope preprocessors, medical washers and washer-disinfectors, water treatment systems equipment , this includes all sterilization documentations for all physical, chemical, and biological indicator results, including high-level disinfectants use/testing and solutions replacement verification.

2. Facilities must follow the manufacturer recommendations for maintenance andrepair of medical devices used to perform reprocessing functions as well as medicaldevices that are reprocessed.

3. Facilities that contract maintenance and repair of such equipment devices must verify that the vendors are approved or certified by the manufacturer to provide those services


Mechanical Indicators 1. Sterilizers have gauges, thermometers, timers, recorders, and/or other

devices that monitor their functions.

2. Chemical Indicators -A chemical indicator on a package verifies exposure to a sterilization process.

3. Biological Indicators thumbnail -Positive assurance that sterilization conditions have been achieved can be obtained only through a biologic control test. A biologic indicator must conform with USP testing standards. A control test must be performed at least weekly in each sterilizer. Many hospitals monitor on a daily basis; others test each cycle.

4. Its extremely important to have a tracking mechanism in place to identify which equipment or instrument was used on the patient.


HFAP Standards 1. **07.02.12 -Immediate Use Steam Sterilization (IUSS) in Surgical Settings.

2. 07.02.04 -Preparing, Assembling, Wrapping, Storage of, & Distribution of Sterile Equipment & Supplies.

3. 07.02.05 -Monitoring Devices.

4. 07.02.06 -Sterilization Data Requirements.

5. 07.02.07 -Shelf Life.

6. 07.02.08 -Cold Sterilization.

7. 07.02.09 -Load Control Numbers.

8. 07.02.10 -Recall Process.

9. 07.02.11 -Environmental Requirements in Decontamination Rooms.

10. 07.03.02 -High-Risk Cleaning Procedures.


07.01.02 Infection Prevention

A. The infection control officer(S) are required to develop a system for identifying,investigating, reporting and preventing spread of infections among patients and personnel §482.42(a).

B. The Infection Control officer is required to develop, implement and evaluate measures governing the identification, investigation, reporting, prevention and control of infections and communicable diseases within the hospital, including both healthcare–associated infections and community-acquired infections.

C. Infection control policies should be specific to each department, service, and location, including off-site locations, and be evaluated and revised when indicated.


07.02.03 Decontamination of Reusable Items & Reuse of

Single Use Devices1. The hospital defines policy and procedure for reuse of single use devices.

2. The hospital must follow the FDA Reuse of Single Use Devices Guidelines

3. The hospital must develop policy and procedures for those specific reuse of single devices to outline collecting, receiving, decontaminating, cleaning, disinfecting, and sterilizing of reusable instruments.

4. It must define process for device identification and documentation of how the hospital ensures the following:

a) The device can be adequately cleaned and sterilized;b) The device will not adversely affected by reprocessing;c) The device will remain safe and effective for its intended use.d) Surveyors will review policies and procedures and interview staff to determine if is consistent

with the FDA guidelines and hospital practices


07.02.02 Required PoliciesApproved policies related to at least the following:

A.Decontamination and sterilization- policies must be specific to what decontamination & sterilization processes are performed for the equipment/devised used in your facility

A. Decontamination of reusable items and reuse of single use devices- must have a list of all reusable items and re-use of single use devices used your facility with a policy to match

C.Preparing, assembling, wrapping, storage of, and distribution of sterile equipment and supplies. A policy is required to define how the process and procedure is performed

D.Monitoring devices- must define what when how , frequency, reporting & f/up if required

E. Sterilization data requirements- A policy must outline and define all requirements


07.02.02 Required Policies(continued )

F. Shelf life- the policy should clearly define the timeframe of all sterile packaged items, items should be labeled as well

G. Cold sterilization-

H. Load control numbers- policy to define procedures and tracking documentation

I. Recall process- policy should define notification of recall, follow-up of recall, and reasonsEnvironmental requirements in Decontamination Rooms-

*All polices must be approved by the infection control committee at minimum every (3) years of when ever there are changes and must be consistent with CDC guideline, OSAH and any state or local regulation/laws.

(CDC -http://www.cdc.gov/oralhealth/infectioncontrol/faq/sterilization.htmBasics on Processing & Sterilization-http://www.urmc.rochester.edu/Sterile/basics.cfm).


30.00.09 Standards of Practice

1.Surgical services must be consistent with needs and resources. Policies and procedures that govern surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. §482.51(b)

2.Surgical disinfection and sterilization procedures are expected to be consistent with accepted standards of practice to prevent the transmission of infectious disease and protect the health and safety of patients.

3.The facility adopts criteria and practices in accordance with manufacturer’s instructions and national guidelines such as, CDC, CDC/HICPAC, AORN, AAMI, and etc.



IUSS (“Immediate Use Steam Sterilization” formerly known as flash sterilization) is utilized only for emergencies. When necessary to IUSS, the facility must follow the IUSS criteria and guidelines for sterilization.

“IUSS” must not be used for convenience purposes.



1.Must have sterilization and disinfection procedures in place. All required policies are in place and enforced. Policies reflect current practice

2.Policies and procedures are developed relating to changes or new technology and procedures. Policies are reviewed and revised as necessary, consistent with state regulations and facility policy, but no less often than triennially.


Endoscope ReprocessingEndoscope Reprocessing

The proper cleaning, disinfection, and sterilization of Olympus equipment is equally as important as their proper use. Here, you will find pertinent information related to controlling or preventing infection using Olympus products. Additionally, we provide educational videos and safety information relating to reprocessing our endoscopes.

Our goal is to keep you educated and informed on how you can provide optimal infection control and prevention in your facility.

1. Cleaning: "The first and most important step in removing the microbial burden from an endoscope. Retained debris may inactivate or interfere with the capability of the chemical solution to effectively kill and/or inactivate microorganisms." — Society of Gastroenterology Nurses and Associates, Inc. (SGNA)


Endoscope Reprocessing(continued)

Endoscope Reprocessing:

2. Disinfection: "A process that results in the killing of all vegetative bacteria, viruses, fungi, and mycobacteria, but not necessarily all bacterial spores. The Spaulding Classification identifies HLD [high-level disinfection] as the standard for medical devices that touch mucous membranes, such as endoscopes." — Association of Professionals in Infection Control and Epidemiology (APIC)

3. Sterilization: "A process that results in the complete elimination or destruction or all forms of microbial life. The Spaulding Classification identifies sterilization as the standard? for medical devices that enter the vascular system or sterile tissue, such as biopsy forceps." — Association of Professionals in Infection Control and Epidemiology (APIC)


American Gastroenterological Association Preventing Duodenoscope Infections

1. Must follow enhanced reprocessing guidelines as published recently by FDA.

2. All elevator-channel endoscopes must be treated the same, for both fine-needle aspiration (FNA) echo endoscopes (endoscopic ultrasound, or EUS) and duodenoscope.

3. Track all elevator – channel endoscopes by patients and device serial numbers for identification during respective reviews

4. Develop a two-phase infection surveillance program to track patients who have under gone a procedures with an elevator channel endoscope .

5. Recommending facilities to perform culture surveillance of all elevator – channel endoscopes

6. For all elevator-channel endoscopes facilities should conduct baseline cultures following CDC protocols, facilities must conduct an in-depth review and analysis of their reprocessing procedures/techniques .

7. Facilities must develop and implement a standardized device reprocessing staff training criteria program and confirm technicians demonstrate competency at time of hire and recommended every six months, including whenever new equipment endoscopes are introduced.

8. Facilities must contact the CDC immediately whenever it is determined that a breach, infection or suspected infection has occurred. (March 26, 2015/AGA/”How To Stop Duodenoscope Infections”)

http://www.gastro.org/news_items/2015/3/26/how-to-stop-duodenoscope-infections





Resources•CDC’s Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 available athttp://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf; and guidance from the•Association for the Advancement of Medical Instrumentation (AAMI), available athttp://www.aami.org/standards/index.aspx. Health care administrators should work with theirinfection prevention personnel and accreditation organizations to ensure that all recommendations are properly implemented to protect patients and personnel.•Problems with medical device reprocessing should be reported to the FDA's MedWatch Adverse Event Reporting program either online at https://www.accessdata.fda.gov/scripts/medwatch/, by regular mail, or by fax. Download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1-800-332- 1088 to request a reporting form, then complete and mail to address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements (see:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportIng AdverseEvents/ucm2005737.htm) should follow the reporting procedures established by their facilities.


http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf

http://www.aami.org/standards/index.aspx

https://www.accessdata.fda.gov/scripts/medwatch

http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/Report

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/Report

RESOURCES 1. Epstein L, Hunter JC, Arwady MA, et al. New Delhi Metallo-β-Lactamase Producing Carbapenem-Resistant Escherichia coli Associated with Exposure to Duodenoscopes. JAMA 2014;312:1447-1455

2. Queensland Government, Queensland Health. Endoscope Reprocessing, Section 6.4 Microbiological Testing. Available at: http://www.health.qld.gov.au/EndoscopeReprocessing/module_6/6_4.asp

3. Beilenhoff U, Neumann CS, Rey JF, Biering H, Blum R, Schmidt V and ESGE Guidelines Committee. ESGE-ESGENA guideline for quality assurance in reprocessing: microbiological surveillance testing in endoscopy. Endoscopy. 2007;39:175-81.

4. CDC / Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Available at:http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf [PDF – 950 KB]

5. Alfa MJ, Fatima I, Olson N. The adenosine triphosphate test is a rapid and reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels. Am J Infect Control 2013;41:294-53

6. Hansen D, Benner D, Hilgenhöner M, Leisebein T, Brauksiepe A, Popp W. ATP measurement as method to monitor the quality of reprocessing flexible endoscopes. Ger Med Sci. 2004;2:Doc04.

7. Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopeshttp://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm439999.htmhttp://medical.olympusamerica.com/customer-resources/cleaning-disinfection-sterilization/cds-instructions/gi-endoscope-reprocessing


http://www.health.qld.gov.au/EndoscopeReprocessing/module_6/6_4.asp

http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf%20%5BPDF%20%E2%80%93%20950%20KB%5D

Additional Article Resources

• http://www.outpatientsurgery.net/guides/infection-control/2015/inside-the-deadly-duodenoscope-outbreaks

• http://www.beckershospitalreview.com/quality/how-to-safely-reprocess-scopes-tied-to-superbug-infections-experts-weigh-in.html

• http://www.outpatientsurgery.net/guides/infection-control/2015/inside-the-deadly-duodenoscope-outbreaks

• http://www.outpatientsurgery.net/guides/infection-control/2015/can-you-spell-ssi-with-iuss

• http://www.medscape.com/viewarticle/849055?src=wnl_edit_newsal&uac=210294BY&impID=783523&faf=1


QUESTIONS?

Please submit questions to:Dr. Dan Fieker- [email protected]

and

Donna Tiberi

Standards Interpretation and Accreditations

312-202-8073

[email protected]


hfap webinar infection control december 15, 2015 dr. daniel fieker, infectious disease donna tiberi,...

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