NJAASC in Partnership with NJDOH Welcomes you to the ...

The use of this presentation or the presentation material is strictly prohibited without the expressed written permission of the author. Neither video or audio recording of the program is permitted.

Non-Solicitation Disclaimer: NJAASC maintains a strict non-solicitation policy at our conferences, meet-ings, and events in order for attendees to feel welcome and to provide a distraction-free environment. Accordingly, other than our registered event Vendors and Sponsors, NJAASC does not allow solicitation of any kind at any of our conferences, meetings, and events (except exchanging business cards). Also, other than our registered event Vendors and Sponsors, for the purpose of promoting their own products and services only, NJAASC does not allow future solicitation of attendees after any of our conferences, meetings, and events including, but not limited to, the solicitation of other conferences, meetings or events (unless the attendee specifically invited future contact). NJAASC prohibits the use of its attendee lists and similar information for solicitation purposes without the express written permission of NJAASC.

Any person or organization found to be violating NJAASC’s non-solicitation policy may be expelled from the conference, meeting, or event without refund of registration fees. Egregious or multiple violations of NJAASC’s non-solicitation policy may result in disqualification from future conferences, meetings, and events at the discretion of NJAASC.

If you do not agree to the foregoing, please do not enter the conference, meeting, or event.

NJAASC in Partnership with NJDOH Welcomes you to the Inaugural Infection

Control Conference

Galloping Hill Country ClubKenilworth, NJ

Tuesday, February 26, 2019

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8:00 - 8:30 AMBreakfast, networking and visit the vendors

8:30 AMOpening RemarksJeff Shanton, President, NJAASC & Stefanie Mozgai, BA, RN, CPM, Assistant Commissioner NJDOH, Health Facilities Survey and Field Operations

8:30 - 10:00 AMSurveys and Outbreaks, and Prevention, Oh My!Stefanie Mozgai, BA, RN, CPM, Assistant Commissioner NJDOH, Health Facilities Survey and Field Operations

Infection Control Deficiencies and Reporting of BreachesLouise A. Steska, MSN, RN, NJDOHThis presentation will review the survey process for the Ambulatory Surgery Centers (ASCs.) It will also present the common Infection Control deficiencies that are cited by the surveyors as well as examples of reporting breaches.

Infection Control Breaches and Patient NotificationJason Mehr, MPH, CIC, State HAI CoordinatorBreaches in infection control can occur in any healthcare practice. However, disease transmission risk is not the same in every scenario. This presentation will discuss the categories of infection control breaches and what the response is from Communicable Disease Service including recommendations for patient notification and bloodborne pathogen testing.

Proactive Approaches to Infection Prevention and ControlJessica Arias, BSN, RN, CIC, Infection Preventionist, Infection Control Assessment and Response (ICAR) Team Leader, NJDOHInfection prevention and control deficiencies are not uncommon on federal, state, and accrediting surveys. With the threat of

emerging infectious diseases to our nation, proactive approaches and facility preparedness are imperative. This presentation will explore what resources are available to mitigate gaps and enhance infection prevention and control programs throughout New Jersey Ambulatory Surgery Centers.

Q & A- Questions submitted in advance and taken from the floor.

Ask the Department – Submit your questions for the Department to us in advance to: [email protected]

10:00 - 11:00 AMPitfalls and Vulnerabilities in High Level Disinfection and Sterilization; Report on AAMI ChangesNancy Chobin, RN, AAS, ACSP, CSPM, CFER, President, Sterile Processing University, LLCThis session will review the most common processing errors, why they occur and how to prevent them from occurring.

11:00 - 11:15 AMBreak & Networking with Vendors

11:15 - 12:15 PMHigh Level (Equipment) and Low Level (Environmental Surface) DisinfectionRenee Fusco, RN, CIC, Advanced Infection Control Concepts

12:15 - 12:45 PMLegal Ramifications of an Infection Control BreachJohn Fanburg, Esq., Managing Member and Chair Health Care Law Practice Group, Brach EichlerThe Legal Report and Regulatory update. What ASCs need to know.

12:45 - 1:30 PMLunch & networking, and visit with vendors

Program Schedule

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Program Schedule1:30 - 2:30 PMCompetencies for Sterilization Reprocessing Staff & Physical Plant in a Sterile Decontamination RoomAl Spath, Jr., MPA, BA, CHL, CRCST, IAHCSMM, Instructor & SME, SPD Management Consulting, LLCPreparing for a Survey: what are the design considerations and staff competencies needed in SPD according to best practices.

2:30 - 3:00 PMThe Role of Anesthesia and Infection ControlDr. Monte Goldstein, MD, Medical Director Virtua Joint Venture ASC’s, AAAASF/CMS SurveyorInfection prevention in the operating room anesthesia work area: This session is designed to update participants on current concepts and guidelines designed to decrease microbial cross contamination and disease transmission by members of the anesthesia care team and related clinicians.

3:00 - 3:15 PMBreak

3:15 - 4:00 PMResponsibilities of the Administrator, Medical Director and Ownership in Infection ControlMeg Stagliano, RN, BSN, MBA, Seashore Surgical InstituteYour Leadership Team’s Role in Infection Control in the ASC: The session will review the responsibilities of the governing body, medical director, director of nursing and administrator in infection prevention and control.

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Jessica Arias, BSN, RN, CIC is the full-time Infection Preventionist, Infection Control Assessment Response Team Lead with New Jersey Department of Health, Communicable Disease Service. In her 14 years in healthcare, Jessica has practiced in a variety of settings including acute psychiatric, correctional, post-acute, and public health as a certified aide, registered nurse, occupational health professional, or as the infection preventionist. Jessica serves as the Legislative Director in the professional organization of APIC; local Southern New Jersey Chapter 11. She holds a Bachelor of Science in Nursing degree from Wilmington University, and is board Certified in Infection Prevention and Control.

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, President and CEO of Sterile Processing University, LLC, (2006) a SPD consulting company. My website provides on-line SPD/Endoscopy education and continuing education as well as textbooks on sterile processing, management of SPD and endoscopy processing, (www.SPDCEUS.com).

Registered Nurse since 1966 licensed in New York and New Jersey. Experience in Operating Room, Central Sterile Supply (39 years) and Materials Management. Have developed over 15 surgical case cart systems and designed twelve Central Service Departments in the U.S. and Canada. Consulted in over 260 hospitals, medical device manufacturers, legal firms and healthcare systems and surgery centers in the US. Consultant for the military services (Navy and Army). Member of AAMI (serve on 10 Committees), AORN, SGNA. Legal consultant on matters relating to cleaning, disinfection and/or sterilization.

John D. Fanburg, Esq is Managing Member and Chair of Health Law for Brach Eichler, LLC. John Fanburg has more than 30 years of experience in health and hospital law, with an emphasis on corporate, transactional, and regulatory matters for physicians and health care institutions. A recognized leader in health law, John is known for excellence in transactions, perseverance in deal-making and strength in corporate and regulatory matters.

Renee Fusco, RN, CIC, Renee’s experience as an infection prevention and control professional began in 1997, including management of home health and hospital-wide infection prevention and control programs, as well as consulting services for ambulatory care settings. Hospital-wide infection prevention and control program management experiences have included Inspira Health Network - Woodbury (formerly Underwood-Memorial Hospital) and Deborah Heart and Lung Center. Renee has maintained certification through the Certification Board for Infection Control (CBIC) since 2000 and has been self-employed as an infection prevention consultant since 2005. Prior experiences in her 30-year nursing career include direct patient care and management roles in acute care, long term care, rehabilitation and home health care settings.

Renee has been an active member of the Southern New Jersey chapter of The Association for Professionals in Infection Control and Epidemiology (APIC) since 1998 and has served the chapter as Nominating and Awards Committee Chairperson, Chapter Treasurer and Product Support Director. She was awarded the Chapter Leadership Award in 2011. Renee is also the facilitator of curriculum and manuals for the Northeastern Infection Control Educators, a group which plans and presents a 5-day basic course for infection prevention and control twice each year and presents 4 lectures at each course.

Speaker Bios

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Speaker BiosRenee has also served on the planning committee of the annual joint Northern / Southern NJ APIC/ NJDOH/IDSNJ conference, served as a working group member for development of the 2008 Guidelines to Prevent and Control Methicillin-resistant Staphylococcus aureus Transmission in New Jersey General Hospitals, and co-authored an article published in The American Journal of Infection Control in 2005, entitled Multihospital Surveillance of Nosocomial Methicillin-resistant Staphylococcus aureus,Vancomycin-resistant

Monte Jay Goldstein, M.D., is the Medical Director for Ramapo Valley Surgical Center, a 3 room multi-specialty surgical center in Bergen County, where he also serves as Chief of Anesthesia.

He is the Chief Anesthesiologist for the Jandee Division of Envision Healthcare. He is also the Chief of Anesthesiology for The Robert Zubowski Center for Plastic and Reconstructive Surgery.

Dr. Goldstein has been a CMS and AAAASF surgical and procedural facility surveyor since 2007 and is an educator for the CMS Surveyor Training Program. In February of 2015 he was appointed to both the AAAASF Standards Committee and the Investigative Committee, of which he currently serves as chairperson.

Since 2015, Dr. Goldstein has served as Administrative Director for ASC Development and Clinical Operations, Partnerships & Business Development at Virtua.

Dr. Goldstein is a Graduate of Downstate Medical center and received his anesthesia training at NYU/Bellevue Medical Center. He completed fellowships in both cardiac and obstetrical anesthesia. He is a member of multiple professional organization including the NJAASC, American Society of Anesthesiologists (ASA) and Society for Ambulatory Anesthesia (SAMBA).

Jason Mehr, MPH, CIC is the New Jersey’s Department of Health Healthcare Associated Infection (HAI) Coordinator. He completed his undergraduate education at Bucknell University in 2009 and received his Master of Public Health degree from Drexel University in 2012 with a concentration in epidemiology. While at Drexel he worked at the Philadelphia Department of Public Health investigating foodborne and vector-borne disease outbreaks. After graduation, Jason completed a two year CDC/CSTE Applied Epidemiology Fellowship with a focus on HAIs at the New Jersey Department of Health’s (NJDOH) Communicable Disease Service. Throughout his time at NJDOH, Jason has developed an ongoing working knowledge of HAI outbreaks, reporting, and prevention strategies. He is certified in infection control and prevention.

Stefanie Mozgai, BA, RA, CPM is the Assistant Commissioner of the Division of Health Facilities Survey and Field Operations of the New Jersey Department of Health. As an 18 year veteran of the Department, Stefanie is responsible for ensuring compliance with State and Federal requirements and the overall management of the survey and certification process of over 2000 Licensed and Certified facilities including Hospitals, Ambulatory Care, and Long Term Care Facilities.

Stefanie, a Certified Public Manager, earned a Degree in Nursing from Essex County College and a Bachelor of Arts Degree from Moravian College in Bethlehem Pennsylvania.

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Speaker BiosShe has participated in the 2007-2008 Patient Safety Improvement Corps: An AHRQ/VA Partnership and was featured on the DoH web site “Meet the Department’s Nurses.” Stefanie represents the Department, meeting with the Home Health and Hospice Work Group, the New Jersey Ambulatory Surgery Association, and Long Term Care Associations on a regular basis. In conjunction with the State HAI Coordinator, she chairs the Department’s internal infection control committee, a multi-disciplinary workgroup that focuses on facility outbreaks and other timely issues.

Stefanie works closely with her partners in the Department’s Division of Public Health Infrastructure, Laboratories, and Emergency Preparedness. She assisted in the development of an electronic reporting mechanism that rapidly collects and disseminates information between Licensed healthcare facilities and the Department which is used during public health emergencies for streamlined communications. She also serves as the Treasurer of the Association for Health Facility Survey Agencies.

Al Spath Jr, MPA, BA, CHL, CRCST, IAHCSMM Al has worked in the Healthcare profession for over 35 years of which 26 years were in the Sterile Processing field. He is currently an approved IAHCSMM instructor teaching the sterile processing course for the last 12 years. He was also one of the authors for IAHCSMM’s 8th edition of the Sterile Technician text book.

He is the co-owner of SP Management Consulting LLC providing the following services: sterilization audits and assessments, sterilization staff competencies and materials management.

He is currently the past president of the New Jersey Healthcare Central Service Association actively serving since 2004. He was one of many instrumental with working with Tony Monaco in requiring/mandating that anyone working in sterile processing must be certified.

Meg Stagliano, RN, BSN, MBA is the Chief Executive Officer at Seashore Surgical Institute, a state licensed, CMS certified, AAAHC accredited ambulatory surgery center in Brick New Jersey. Mrs. Stagliano has been a registered nurse for over 20 years working in various leadership roles for the majority of her career. Meg received her Executive MBA in Health Systems Management. Meg has a successful track record as a top performer consistently adding value in the areas of Financial Planning and Analysis, Operations Management and Team Building. Meg is currently the Vice President of the NJAASC.

Louise Steska, MSN, RN, has been with the New Jersey Department of Health, Health Facility Survey & Field Operations division for ten years. During this time, she spent many years as a surveyor inspecting ambulatory surgery centers. In January of last year, she became the Program Manager of the Acute Care Program.

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The use of this presentation or the presentation material is strictly prohibited without the expressed written permission of the author. Neither video or audio recording of the program is permitted.

Non-Solicitation Disclaimer: NJAASC maintains a strict non-solicitation policy at our conferences, meet-ings, and events in order for attendees to feel welcome and to provide a distraction-free environment. Accordingly, other than our registered event Vendors and Sponsors, NJAASC does not allow solicitation of any kind at any of our conferences, meetings, and events (except exchanging business cards). Also, other than our registered event Vendors and Sponsors, for the purpose of promoting their own products and services only, NJAASC does not allow future solicitation of attendees after any of our conferences, meetings, and events including, but not limited to, the solicitation of other conferences, meetings or events (unless the attendee specifically invited future contact). NJAASC prohibits the use of its attendee lists and similar information for solicitation purposes without the express written permission of NJAASC.

Any person or organization found to be violating NJAASC’s non-solicitation policy may be expelled from the conference, meeting, or event without refund of registration fees. Egregious or multiple violations of NJAASC’s non-solicitation policy may result in disqualification from future conferences, meetings, and events at the discretion of NJAASC.

If you do not agree to the foregoing, please do not enter the conference, meeting, or event.

Session Handouts

Inaugural Infection Control Conference

Galloping Hill Country ClubKenilworth, NJ

Tuesday, February 26, 2019

8 1

Ambulatory Surgery Center Survey Process

Infection Control Deficiencies Reporting of Breaches

Louise Steska MSN, RNProgram Manager

Acute Care Survey Health Facility Survey

&Field Operations

ASCs in New Jersey

• ASCs can be licensed in accordance with

N.J.A.C. 8:43 A

• Medicare Certified ASCs must be in compliance with the Federal Conditions for Coverage outlined in 42 CFR 416.25-52

Conditions for Coverage

• There are 14 Conditions for Coverage for ASCs in 42 CFR 416.25-52

CfC

• Must be in compliance at all times

• 45 Days to correct if not in compliance

• If not in compliance after 45 days, DOH may recommend termination of provider number

CfCs

• Conditions and Standards

• Conditions out of compliance because of many standards not met

• Conditions out of compliance because of a severe deficient practice

Standard Level Deficiencies

• Written report will be issued

• Facility submits acceptable Plan of Correction

• Not in jeopardy of losing provider number

Slides: Louise Steska

9 2

Types of Surveys

• State Licensure Surveys

• Federal Recertification Surveys

• Validation Surveys

• Complaint Investigations

SURVEY PROCESS: Survey Team

• Usually two nurse surveyors

• One pharmacist

• One sanitarian/nurse

• One building inspector

SURVEY PROCESS: Length of Survey

• Typically staff are on site two consecutive days for a Federal recertification/validation, one day for a State survey.

• Depends on the number of surveyors.

• Pharmacist or Building Inspector may survey after the team

SURVEY PROCESS: Entrance Conference

• Survey staff will interview DON or Administrator and ask for:

• Policies and procedures, infection control, and QA information

• List of patients who recently received services

• Medical Records• Employee files including health

information and inservice records

SURVEY PROCESS: Physician/Employee Files

• We will review:

• Staff education/orientation• Credentials/Privileges• Licenses• Health information

SURVEY PROCESS: Exit Conference

• The survey staff can give you a brief overview of some of the issues.

• Because each surveyor reviews different records, it is difficult to tell you exactly which deficiencies exist, if any.


10 3

Federal ASC survey protocol

• Primary Investigation Methods include:

• ASC staff and patient interviews

• Tour of the facility

• Observation of procedure

• Clinical record reviews

Survey Process – Complaint Investigations

• Usually one surveyor for one day

• Focuses on the specific complaint(s) issue as opposed to a broad overview

• Documentation requested is similar to standard survey process

• May result in a full Federal survey or State survey if significant issues are identified

Immediate Jeopardy Situations

• Inability to treat malignant hyperthermia• Multiple use of single dose vials• Multiple use of multi dose vials opened in

an immediate patient care area• Issue with sterilization and processing• Issues with lack of credentialing

Common Federal Deficiencies

• In FY 2018, DOH conducted 46 recertification surveys

• Common deficiencies included Infection Control, Administration of Drugs, Form and Content of record, Physical environment

DoH Top Ten FY 18

• Q 242 Infection Control Program*• Q 241 Sanitary Environment*• Q 181 Administration of Drugs*• Q 240 Infection Control*• Q 141 Organization and Staffing*• Q 162 Form and Content of Record• Q 261 Admission Assessment• Q 105 Emergency Equipment • Q 262 Pre-Surgical Assessment• Q 101 Physical Environment*

*Also on CMS Top Ten

CMS Top Ten FY 18

• Q 241 Sanitary Environment• Q 181 Administration of Drugs• Q 242 Infection Control Program• Q 162 Form and Content of Record• Q 101 Physical Environment• Q 104 Safety from Fire• Q 141 Organization and Staffing• Q 240 Infection Control • Q 040 Governing body and Management• Q 100 Environment


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•Q240, Q241 & Q242 Infection Control Program

•Common deficiencies included failing to implement nationally recognized infection control guidelines, failure to follow manufacturer’s instructions for use

Infection Control

• Review processing of instrumentation

• Review storage/handling of instrumentation

• Review Manufacturer’s Instruction for Use

• State: CDC/AAMI guidelines

• Federal: Nationally recognized standard(s) that facility is following


• Q 181 Administration of Drugs

• Common deficiencies included multi use of single dose vials, multi use of multi dose vials that were opened in an immediate patient care area, and lack of controlled drug accountability.


• Q 101 Physical Environment

• Common deficiency is failing to provide a functional and sanitary environment.

Plans of Correction

Plans of Correction

• State PoCs are due ten business days from receipt of the deficiency report

• Federal PoCs are due ten calendar days from receipt of the deficiency report

• There must be one PoC for each report. State and Federal cannot be combined


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Plans of Correction

• You may request an extension to the PoC due date if needed

• Please contact our office

Examples of Infection Control Breaches

• Likelihood of blood exposure• Using the same needle for more than one person• Using the syringe, pen or injection device for more

than one individual• Reusing a needle or syringe which has already been

used• Using the same lancing/finger stick device for more

than one person• Reprocessing of colonoscope performed incorrectly• Reuse or reprocessing of biopsy needles that are

single use items

THANK YOU

[email protected]


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2/18/2019

1

PROACTIVE APPROACHES TO INFECTION PREVENTION AND

CONTROL

Jessica Arias, BSN, RN, CIC Infection Preventionist

Infection Control Assessment and Response (ICAR) Team LeadCommunicable Disease Service

New Jersey Department of Health

EBOLA OR OTHER EMERGING

INFECTIOUS D ISEASES

• Public Health Emergency

• Detect, Protect, Respond

• Enhance preparedness and response

https://www.phe.gov/Preparedness/responders/ebola/Pages/Ebola-Preparedness-Considerations-for-OutpatientAmbulatory-Care-Settings.aspx

2

INFECTION CONTROL ASSESSMENT & RESPONSE (ICAR) PROGRAM

• Partnering with healthcare facilities throughout NJ

• 170 assessments to date

• Increase infection prevention competency and practice

• Enhance surveillance and reporting capacity

3

37 Acute Care 32 Hemodialysis

71 Long-term Care

30 Outpatient

WHERE WE’VE BEEN

4

COMPETENCY BASED TRAINING

• CDC definitions

• Healthcare Personnel (HCP) Infection Prevention (IP) Competency

• HCP IP Competency-Based Training

• Competency Assessment

• Audit

• Feedback

https://www.cdc.gov/hai/prevent/infection-control-assessment-tools.html5

0

10

20

30

40

50

60

70

80

90

100

InfectionControl

Program andInfrastructure

InfectionControl

Training andCompetency

HealthcarePersonnel

Safety

Surveillance andDisease

Reporting

Hand Hygiene PersonalProtectiveEquipment

Injection Safety RespiratoryHygiene

Point-of-CareTesting

EnvironmentalCleaning

DeviceReprocessing

Perc

ent

(%)

Outpatient Domains

Outpatient ICAR Tool: Percent Adherence (%) by Domain

Percent "No" Percent "Yes"

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Slides: Jessica Arias

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2

PERSONNEL PROTECTIVE EQUIPMENT

(PPE)

0

10

20

30

40

50

60

70

80

90

100

Training upon hire? Training annually? Training with newequipment?

Returndemonstration?

Audit? Feedback?

Outpatient ICAR Tool: Personal Protective Equipment (PPE) Percent Adherence (%)


• 54% did not require demonstration of competency with selection and use of PPE following each training

• 65% did not routinely audit (monitored and documented) adherence to proper PPE selection and use

• 62% did not provide audit feedback to healthcare personnel

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0

10

20

30

40

50

60

70

80

90

100

Outpatient ICAR Tool: Device Reprocessing Percent Adherence (%)

Percent "No" Percent "Yes" Percent "N/A"

DEVICE REPROCESSING

• 24% did not receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices

• 29% were not required to demonstrate competency with reprocessing procedures (i.e., correct technique is observed by trainer) following each training.

• 52% did not routinely audit (monitored and documented) or feedback adherence to reprocessing procedures. 8

INJECTION SAFETY

0

10

20

30

40

50

60

70

80

90

100

Training upon hire? Training annually? Training with newequipment?

Returndemonstration?

Audit? Feedback?

Outpatient ICAR Tool: Personal Protective Equipment (PPE) Percent Adherence (%)


• 50% did not require demonstration of competency with safe injection practices following each training

• 60% did not routinely audit (monitored and documented) adherence to safe injection practices

• 65% did not provide audit feedback to healthcare personnel

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RESOURCES

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CDC’S ICAR TOOL & GUIDE TO IP FOR OUTPATIENT SETTINGS

https://www.cdc.gov/hai/prevent/infection-control-assessment-tools.htmlhttps://www.cdc.gov/HAI/settings/outpatient/outpatient-care-guidelines.html

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HEALTHCARE-ASSOCIATED INFECTIONS:

ICAR

https://www.nj.gov/health/cd/12


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ICAR VIDEO LEADER GUIDE

• Stimulate discussion

• Self-evaluation

• Engaging

• Q&A

• Additional resources

• Recently updated

https://www.nj.gov/health/cd/documents/topics/hai/icar_video_discussion_oct_2017.pdf13

https://www.nj.gov/health/cd/topics/hai.shtml14

INJECTION SAFETY & DRUG DIVERSION

• Draft drug diversion policy templates

• Table top exercises

• Facilitator guide

• Scenarios

• Slides

http://www.oneandonlycampaign.org/partner/new-jersey15

https://www.nj.gov/health/cd/documents/topics/hai/guidance_resources_for_ip_partners.pdf16

TABLE OF CONTENTS

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Background Public health partners

An introduction to the basics

Policies and procedures

Data and surveillance

Information technology

Communicable diseases and

infectious organisms

Networking and professional development

Healthcare-associated infection

prevention

Closing Resource List Appendix

DATA & SURVEILLANCE

• Process vs. outcome

• Audit tools and forms

• APIC/CDC QUOT-https://www.cdc.gov/infectioncontrol/pdf/QUOTS/Ambulatory-Care-Suite-P.pdf

• AORN-https://aornguidelines.org/tool/filter?gboscontainerid=166

• Reporting

• National Healthcare Safety Network (NHSN)

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4

PUBLIC HEALTH PARTNERS

• Local health department

• Community resources

• Sharps disposal

• Medication drop-off

• Immunizations

• Clinics

• Educational brochures

19

NEW JERSEY DEPARTMENT OF HEALTH

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NJ ADMINISTRATIVE CODE

• LexisNexis- Free online public access

• Title 8. Health

• Chapter 43A. Manual of Standards for Licensing Ambulatory Care Facilities

• Subchapter 14. Infection Prevention and Control Services

https://www.state.nj.us/oal/rules/accessp/21

ELECTRONIC CODE OF FEDERAL REGULATIONS (E-CFR)

Electronic Code of Federal Regulations (e-CFR): https://www.ecfr.gov22

ELECTRONIC CODE OF FEDERAL REGULATIONS (E-CFR)

•Electronic Code of Federal Regulations (e-CFR): https://www.ecfr.gov

•Title 42: Public Health > Chapter IV > Subchapter B > Part 416

23

SURVEYOR TRAINING

• CMS Survey and Certification Group- Integrated Surveyor Training Website: https://surveyortraining.cms.hhs.gov/

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S URVE YO R IN F E CT IO N CO N TRO L WO RK S HE E T

25

RESOURCES

• Guidance for Surveyors: Ambulatory Surgical Centers: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_l_ambulatory.pdf

• CMS S&C: 15-43-ASC Advanced Copy – Update to ASC Infection Control Worksheet: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-43.pdf

• Infection Control Assessment Tools: https://www.cdc.gov/hai/prevent/infection-control-assessment-tools.html

• CDC Guide to Infection Prevention for Outpatient Settings: https://www.cdc.gov/hai/settings/outpatient/outpatient-care-guidelines.html

• APIC Observation Tools Library: http://ipcobservationtools.site.apic.org/observation-tools-library/

• AORN Audit Tool Reference Center: https://aornguidelines.org/tool/filter?gboscontainerid=166

26

THANK YOU

Jessica Arias, BSN, RN, CIC on behalf of the ICAR team

[email protected] 609-826-5964


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1

N A N C Y C H O B I N , R N , A A S , A C S P , C S P M , C F E R PR E S I D E N T , S T E R I L E P R O C E S S I N G

U N I V E R S I T Y , L L CC O P Y R I G H T 2 0 1 9

Pitfalls and Vulnerabilities in Disinfection and Sterilization

Objectives

Review common processing errors in disinfection and sterilization.

Discuss the need for auditing and monitoring disinfection and sterilization activities.

Identify methods to prevent processing errors.

Focus

JC has increasingly found non-compliance with standard IC.02.02.01 – requires organizations to reduce the risk of infections associated with medical equipment, devices and supplies.

The 2009 non-compliance rate was 21%. During the first half of 2016 the non-

compliance rate tripled to 59%.

Patient Safety

Most common citation is “performing intermediate and high level disinfection of medical equipment, devices and supplies”.

Covers disinfection of endoscopes as well as sterilization of other reusable devices.

In first half of 2016 Nearly half of all HCF were cited with findings such as

failure to adhere to the IFU Not following recommended practices or guidelines Lack of documentation related to staff competency

and lack of trained oversight.

Vulnerabilities

Who has the clinical expertise for the high level disinfectionand sterilization practices?

Is the Nurse Manager or designee educated in AAMI and NJSDH standards?

Orientation Guide Detailed

Staff certified Certification current?

Continuing Education provided routinely and documented? Topics relevant to SPD practices.

Competencies

Annual Competencies for SPD staff Who performed them? Specific? Who performed competency

assessment on person who performs the competencies?

Slides: Nancy Chobin

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2/18/2019

2

Major Vulnerability

Clinical Managers in ASCs not knowledgeable in all AAMI standards and SPD practices.

Depends on SPD staff to know what to do and do it correctly.

No monitoring of processes/practices. Yet, responsible for the safety of their patients. Get certified, attend SPD courses to keep updated. Contract with a SPD professional to review your practices

annually.

Administration of SPD Area

Dress code not in compliance with AAMI standards (revised) All facial hair covered (except eyebrows); no jewelry, nails no loner

than ¼” from tip, no artificial nails or nail polish Arms covered using warm-up jacket in prep area to keep fallout from

bare arms getting into sets Shoes worn in the area should be clean, closed (i.e., no open toes

or other areas), have non-skid soles, and be sturdy enough to prevent injury if an item drops on the foot.

Personnel should not wear jewelry (e.g., rings, watches, bracelets) on the hands or wrists. Earrings must be contained in the head cover.

Personal electronic devices should not be brought into the processing areas. Exceptions should be noted in the organization’s policies.

Decontamination Pitfalls

Outside shipping cartons in area Supplies other than cleaning supplies and implements stored

in area No direct access to IFUs; IFUs not current or dated Computerized IFUs not verified for accuracy; no back-up

plan if system is down No process to continually update No one verifying the IFU information Equipment and cleaning implements needed to comply with

the IFU not available (i.e. ultrasonic cleaner, washer).


Not performing cleaning verification tests of mechanical cleaning equipment DAILY

Not measuring detergents to ensure correct dilution

No source of critical water for final rinse Using Nitrogen, compressed air, “computer

air” or hair dryers to dry items.

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.


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Water level not marked in sink – or if tape used not ingood condition

Not monitoring temp. of enzyme detergent if required Not using a 3 sink method for manual cleaning No separate hand wash sink All chemicals used (including “wipes” are used in

accordance with IFUs and staff knowledgeable inexposure time for all chemicals used

Pre-Treatment of Instruments

Gross soil removed in OR or treatment area Replaced in original container or basket Soils kept moist by one of 3 methods: Cover instruments with a moist towel; place in biohazard bag Place instruments inside a package designed to maintain

humid conditions Use an enzymatic spray, gel, or foam

All transport cart/bins/bags labeled as biohazard when they leave the OR room

Unacceptable

Decontamination

No emergency eyewash within 10 second travel time – tested weekly Hands free operation, stay open feature, water temp. should be 60-

100oF. Provide 0.4 gallons water/minute. Flushes both eyes at thesame time.

Not documenting testing and water temperature Eyewash located on decontam sink No separate handwash sink Reusable cleaning implements cleaned after each use and

disinfected/sterilized at least daily. Have IFUs to do so? Soiled transport containers do not have IFUs for decontamination

(disinfection or sterilization) Decontaminated after each use

Preparation/Packaging Pitfalls

Copies of Manufacturers’ IFUs not available and staff not referencing them

Copies of IFUs for all sterilization products used: BIs, CI, packaging materials, rigid containers, etc. available and staff knowledgeable

Magnifying lamps available at all workstations –staff using them to inspect all instrumentation

Paper-plastic pouches Limited to -2 small, light weight items Jaws open and kept open

# 1 Deficiency - Jaws Closed


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Sterilization Pitfalls

Sterilizers clean (inside and out) – being cleaned per the IFU; documented

Sterilizer carts/rails clean Emergency eyewash within 10 second travel time

of Sterrad or other chemicals (HLD) IFUs for sterilization not available or being

followed Sterilizing items in wrong temperature


QA testing of sterilizers BIs and CIs and packaging materials are not validated

for use in the cycle type (gravity or pre0vac) or temperature of the sterilizer in use.

Qualification testing being performed incorrectly; should be 3 BIS followed by 3 Bowie-Dick tests.

Incomplete BI documentation Incomplete or generalized documentation on

sterilization logs (e.g. 4 OR peel packs)


Purchasing/using sterilizer with cycle temp. of 273oF.

99% of all devices validated for sterilization at 270oF or 275oF.

Placing items in the 273 deg cycle is using the device off label.

Not knowing if sterilizer is gravity displacement or pulse vacuum.


Implants – not being processed with BI test pack containing a Type 5 chemical integrator Quarantined until result of BI known Will implant be released before BI known? Use of Early release form

ALL implants traced to the patient?


Not documenting the temperature in incubators with a thermometer, thermometer missing or broken

Lot control label is not legible Event related statement not visible


Running items requiring extended cycles with other items

Staff unable to interpret ALL printouts Printouts not signed at end of cycle if all parameters

met Printout is not legible (legal document) Items allowed to cool after sterilization and before

handling? Using thermometer gun? Recall procedure in place; staff knowledgeable in

process


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Infrared Thermometer Gun

IUSS (Flash Sterilization)

IUSS container must be used If Riley vented daily; maintained per IFU Open pan method should not be used

IUSS container tested as required (container testing) IUSS container cleaned after each use and documented IUSS log contains all documented information QA testing of IUSS sterilizers performed E.g. Bowie-Dick BI testing – frequency BI testing of each cycle type (gravity/pre-vacuum) IUSS used

Assorted Immediate-Use “Flash” Containers

IUSS Cycles

The pre-vacuum IUSS cycle is tested using convention BI test pack in an empty sterilizer

If gravity IUSS cycle used contact the container mfr for guidance on BI testing of this cycle

Sterile Storage

Sterile items stored to protect from damage No outside shipping cartons in area No crushed/damaged packages on shelves No outdated supplies Wrapped sets can only be stacked if the

packaging mfr provides information

Manual High Level Disinfection

Items being processed in HLD have been validated for processing in the HLD (need IFUs for all devices processed in HLD)

Staff competencies performed for all users of HLD initially and annually

If glutaraldehyde, employee monitoring performed? Below 0.5ppm ceiling limit?

Correct PPE being used? Staff monitoring and documenting the temp of the

solution? All items being HLD documented on a log form?


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Process Improvement

No PI Plan for Sterile ProcessingNo auditsNo monthly report to Infection

ControlNo one is “minding the store”

Laryngoscope Handles and Blades

Must be cleaned and HLD or sterilized per the manufacturer’s IFUs

Issue if multiple vendors’ handles and blades Can sterilize unwrapped and place in zip lock bag; place

“CLEAN NOT STERILE” label over zip. Can test bulb without compromising the blade

Handles also must be HLD or sterilized per IFUs Stored in a way that would prevent contamination.

Examples of compliant storage include, but are not limited to, a peel pack post steam sterilization, or containment within a closed plastic bag. (JC)

Flexible Endoscopes -Pitfalls

How scopes transported to processing room? IFUs in room for ALL scopes in use? Staff competencies performed General scope processing Scope specific Chemicals used (HLDs) Ancillary equipment (e.g. assisted flushing devices) AER

Who performs the competencies?

Scopes - Pitfalls

Point of Use cleaning (in room) initiated when scope removed from patient.

Document the time the POU cleaning performed and send with scope

Initiate manual cleaning within 1 hour of POU cleaning; otherwise delayed reprocessing procedures may be required.

Manufacturer’s instructions for use of foam tip protectors require single-use only and that the distal tip of the endoscope be left uncovered.

Flexible Endoscopes

Leak testing performed per manufacturer? Testing documented?

Leak tester validated daily for accuracy? If using automated flushing device (e.g. Scope

Buddy) Documents volume test daily Documents decontamination of tubing daily and unit

monthly or as recommended by the mfr.

Scopes visually inspected for cleanliness before HLD performed – lighted magnification

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)


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HEPA Filtered Storage/Drying Cabinet


If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either Designed/intended by the cabinet mfr for horizontal storage

of flexible scopes Of sufficient height, width and depth to allow flexible scopes

to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet


CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Miscellaneous

There is a preventive maintenance (PM) program for all processing equipmentEquipment is serviced in

accordance with the manufacturer’s recommendations for PM


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SUMMARY

The standards and guidelines that direct safe sterile processing practices apply to ALL locations where sterile processing activities take place.

The staff, equipment and equipment needed to comply with IFUs must be provided.

Staff training and competencies are required. There are on line courses and certification specifically for ASC technicians.

SUMMARY

Technology has dictated that sterilization and HLD practices are highly technical.

Need to ensure that these practices are reviewed by a competent consultant with a background in these areas (FDA) and knowledgeable in all AAMI standards.

We must ensure patients are receiving patient safe items each and every time.

The End

QUESTIONS???????????????????

References

Association for the Advancement of MedicalInstrumentation. “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities”, ST-79, 2017.

Centers for Disease Control. Guides for Disinfection and Sterilization in Healthcare Facilities, 2008.

Centers for Medicare and Medicaid Survey Guidelines.

Joint Commission Survey Tool. Basics of Sterile Processing textbook, 6th edition.


26

A Crash Course in Principles of

Surface and Medical Device

Cleaning & Disinfection in

Healthcare

Prepared and Presented By:

Renee Fusco, RN, CIC

Objectives

Review the applicable guidelines and standards for

cleaning, low-level disinfection and high-level

disinfection

Discuss the differences between low-level and

high-level disinfection - methods, chemicals and

tools for effective processes

Review the key steps for cleaning and disinfection

of flexible endoscopes

Highlight current “hot topics” in cleaning &

disinfection

2015 CDC Health Advisory

Immediate need for healthcare facilities to review procedures for cleaning, disinfection and sterilizing reusable medical devices

Manufacturer Instructions

Training & Competency

Regular Audits

Policies and Procedures Based on

Current Guidelines & Standards

GUIDELINES AND STANDARDS FOR CLEANING AND

DISINFECTION PRACTICES

AAMI - Association for the Advancement of Medical Instrumentation

SGNA – Society of Gastroenterology Nurses and Associates

CDC - Centers for Disease Control and Prevention

GUIDELINES AND STANDARDS FOR CLEANING AND

DISINFECTION PRACTICES

APIC – Association for Professionals in Infection Control

CMS- The Centers for Medicare and Medicaid

ACCREDITATION - TJC, AAAHC & AAAASF

NJDOH Regulations

All AAMI standards incorporated into NJ Standards for Licensure

All Category IA, IB, IC CDC guidelines incorporated into NJ Standards for Licensure

Slides: Renee Fusco

27

NJDOH Regulations - IP

Develop policies & procedures based on guidelines & standards

Review & revise at least every 3 years

Employ qualified, trained individuals

Document competency on hire and annually (at a minimum)

Document continuing education

Maintain documentation of processes

Definitions

CLEANING – removal of soils, using a soap or detergent and water, by scrubbing & washing or vacuuming of infectious agents and organic matter from surfaces where infectious agents may survive and / or multiply

Some items require only cleaning but some require cleaning followed by disinfection or sterilization

Definitions

Disinfection - a process that kills / destroys pathogens & other microorganisms on inanimate objects by physical or chemical means

Medical Device - Instrument, apparatus, material, or other article, intended by the manufacturer to be used for human beings for diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury or handicap; also for investigation, replacement, or modification of the anatomy or of a physiological process

Classification of Medical Devices

E.H. Spaulding Classification

How an object will be disinfected depends

on the object’s intended use (framework

developed in 1968)

Non-critical

Semi-critical

Critical

NONCRITICAL - medical devices that

touch only intact skin require low-level

disinfection

Two Categories of

Non-critical Devices

Non-critcal

environmental

surfaces include bed

rails, bedside tables,

patient furniture and

floors

Non-critical patient

care items include

thermomters, blood

pressure cuffs,

crutches and

computers

Classification of Medical Devices

SEMI-CRITICAL-medical devices that touch mucous membranes or non-intact skin require high-level disinfection (HLD)

CRITICAL-medical devices which enter normally sterile tissue or the vascular system require sterilization.

Slides: Renee Fusco

28

Slides: Renee Fusco

LEVELS OF DISINFECTION

LOW LEVEL DISINFECTION - kills most bacteria, some viruses, and some fungi but cannot be relied upon to kill organisms such as MTB, bacterial spores or prions

INTERMEDIATE LEVEL DISINFECTION -inactivates MTB, vegetative bacteria, most viruses and most fungi but it does not kill bacterial spores or prions

Chemicals Regulated by the EPA

Use for non-critical equipment or environmental surfaces

LEVELS OF DISINFECTION

HIGH LEVEL DISINFECTION –

can be expected to destroy all microorganisms, with the exception of some bacterial spores and Prions

Chemicals regulated by the FDA

Use for semi-critical devices

Environmental Cleaning

The entire environment

must be considered when

developing processes.

IP program should

include collaboration

between different groups

involved in order to

ensure the processes &

environment are safe and

well maintained

CLEANING & DISINFECTION

PROCEDURES

Responsibility should be clearly defined, including who performs the

cleaning, where, and how frequently

Protocols must be clearly written to reflect each device manufacturer instructions for use (IFU)

Educational programs / competency verified upon hire and at least annually

Environmental Cleaning

Policies & Procedures must reflect current guidelines & regulatory requirements for the type of facility and services provided

Practice must reflect Policies and be documented and monitored

IP committee selects/approves products to be used, based on manufacturer IFU, intended use and potential for blood/ body fluid contamination

Between-case CleaningCleaning and disinfecting the OR / Procedure

room between patients throughout the day

ALL contaminated equipment &

environmental surfaces must be cleaned &

disinfected after each use

This step takes time but is very important!

prevents the spread of microbes from one

patient to the next

Limits the accumulation of bioburden /

employee exposure

29

Slides: Renee FuscoTerminal Cleaning

Terminal cleaning and disinfection of the

OR and procedural areas should be

performed at the end of the day every day

when the area is in use

Use checklists to monitor and document

Methods are available to verify cleaning

ATP testing & fluorescent markers

Direct observation

Are the necessary products &tools

available?

Non-critical Device Cleaning

NJ DOH, CDC, AAMI, AORNAll re-usable patient care equipment must be

cleaned and disinfected prior to use for another

patient – these devices all have IFU too!

CLEANING vs. DISINFECTION

Clean to remove any visible AND invisible soil

Prepares the surface of an item so there is DIRECT contact with the disinfectant

Must read and follow label instructions for the cleaning/disinfectant wipes –

1-step process vs. 2-step process

Wet contact (dwell) time

Let it air dry

IMPORTANCE OF THOROUGH

and TIMELY CLEANING

Soil and blood/body fluids can harbor and protect harmful microorganisms resulting in the growth of biofilms

May inactivate chemical disinfectants

Can prevent adequate disinfection and sterilization of the device

WHAT IS BIOFILM?

Accumulated biomass of bacteria and extracellular material that is tightly adhered to a surface and cannot be removed easily.

Prevents antimicrobial agents such as detergents, disinfectants, sterilantsfrom direct contact required for eliminating microorganisms

Management of Blood &

Body Fluid ContaminationBlood and other potentially infectious

materials should be promptly cleaned and

disinfected

Use protective gloves and other PPE

appropriate for the task

Place contaminated items in red bag,

sharps container or linen receptacle

Must first clean/absorb blood/fluid, THEN

disinfect with EPA-registered disinfectant

with effectiveness for blood-borne

pathogens

30

Slides: Renee FuscoAREAS WHERE CLEANING

SHOULD BE PERFORMED

Should limit cross contamination

Follow established traffic patterns

Adhere to manufacturer IFU

Proper ventilation / air exchanges per hour – depends on chemicals in use

For some devices, at the point of use but for others, must transport to designated area

PPE Requirements

Gloves at a minimum (point of use

cleaning for environment/equipment)

For more in depth cleaning/disinfection:

Impervious gown,

Head cover,

Dedicated shoes /shoe covers

Fluid-resistant face shield or mask

and eye protection.

Soiled Utility Area Requirements

Eyewash station must meet ANSI standards

Hands-free stay open feature

0.4 gallons of water/minute

Within 10 seconds travel time of the use area

Weekly test/flush documented

Hand washing sink ideal / waterless hand hygiene products available

Adequate counter space, lighting

Manufacturer Instructions

No device should be reprocessed without written manufacturer’s instructions( IFU)

Need to be available to staff in the area where devices are cleaned / disinfected

Update reference annually

Patient and device safety issue

Ideal Detergent Qualities

Effective cleaning agents

Enzymatic action

Non-abrasive

Low foaming

Free rinsing

Biodegradable/non toxic

Rapid soil dispersion

Neutral pH for most instruments

Water Temperature

Monitor water temperature to ensure enzymatic effectiveness

Many detergents require temps <140oF

31

Slides: Renee FuscoPRECLEANING

For many devices this is the only step that can be performed in the OR / procedure room

Follow manufactures IFU

AFTER PRECLEANING transport to decontamination area for manual cleaning if necessary

CLEANING METHODS

Manual – all device manufacturers must provide IFU for manual cleaning

Automated Cleaning – only if permitted by manufacturer IFU

Ultrasonic

Washer-Disinfector

Combination cleaning/HLD

High Level Disinfectants (HLD)

Used for semi-critical medical devices (e.g. Ultrasound, Rectal and TEE probes and Flexible Endoscopes)

Do not use on environmental surfaces

Regulated by the FDA

Process must be documented

HIGH LEVEL DISINFECTANTS

Glutaraldehyde

Ortho-phthaldehyde (OPA)

Hydrogen Peroxide

Peracetic Acid (PA)

Hydrogen peroxide + Peracetic Acid

Accelerated Hydrogen Peroxide

Hypochlorite

Safety Considerations

Employees need full PPE when working with HLD’s - impervious gown, face protection, butyl or nitrile rubber gloves (no vinyl/neoprene)

Must follow manufacturer IFU

Some have ventilation requirements

Glutaraldehyde exposure - ceiling limits exist

Can use fume hoods

Neutralization pads for under container

4 Key Requirements to Achieve

High Level Disinfection:

Minimum Effective Concentration of the disinfectant

Contact with all internal and external surfaces of the device

For a sufficient period of time (per manufacturer’s IFU)

Within the manufacturer’s specified temperature range

32

Slides: Renee FuscoHIGH LEVEL DISINFECTANTS

HLD’s must be monitored for minimum effective concentration (MEC)

Recommend using test kit supplied by the disinfectant manufacturer

AAMI recommendation to test before each use and document results

Most test strips require QC of the strips when container is first opened –document results

Minimum Effective Concentration

Test Strips for HLDs

Time & Temperature Monitoring

HLD must be within

recommended temperature

range for HLD to take place

For Manual HLD:

Document temperature

before each use

Document time in and time

out of solution

Flexible Endoscope Processing

Current standard is HLD; sterilization not required (CDC) unless otherwise stated by manufacturer

Recent outbreaks related to inadequate reprocessing have lead to new recommendations - may be moving toward sterilization

Until then…must follow manufactures IFU, SGNA, CDC, AAMI and/or AORN recommended practices

AAMI ST91 and SGNA

New emphasis on training and documentation of competency

Certification recommended by ST91

Monitor compliance with all policies

Tracking scope and all accessories (valves, caps) to the patient

Verification of cleaning

Proper transport and storage

33

Slides: Renee FuscoEndoscope Processing Area

Cleaning area should be separate from HLD/sterilization area

Cross contamination of scopes can result – must flow from soiled to clean

Must follow specific scope manufacturer’s instructions for cleaning

Detergents

Size - specific brushes

Suction device connectors

Key Steps in Processing Scopes

Pre-cleaning at bedside

Proper transportation

Leak testing

Manual cleaning & Rinsing

Cleaning Verification

High Level Disinfection & Rinsing

Dry / flush with alcohol / dry

Proper transportation & storage

Sinks

Must have proper

depth and width to

accommodate

scopes (some are 6

feet long)

Recommend

marking with a

clearly visible fill line

Clean/disinfect after

each use

Cleaning

Detergents must be used only once (for one scope) and discarded

Cleaning brushes and sponges should be used for one scope and discarded (if single use) or reprocessed if reusable

Proper size brushes (diameter and length)

Automated Flushing Devices

Eliminated manual

flushing with

syringes

Requires thorough

training

Daily/monthly QC &

decontamination

Not to be used with

HLD, only

detergents

Cleaning Verification Tools

Visualization devices

e.g. borescopes

Chemical indicators to

detect residual

protein, blood or ATP

Some devices

validated for use

inside automated

endoscope

reprocessors (AER)

34

Slides: Renee FuscoAutomated Disinfection (AER)

Must follow manufacturer’s IFU; may require

special adapters that are scope specific

If AER has more than one chamber, must be

labeled and track scopes processed in each

chamber

AER with cleaning function still requires

bedside pre-clean & manual cleaning

Verify if accessories can be processed in

AER; some require manual soak or sterilize

Must have a manual reprocessing policy in

place, in the event of AER failure

Proper Drying, ID and Storage

Scopes should be flushed with alcohol after disinfection & fully dried

Must be a method to identify the scope has been cleaned/HLD

Tag or printout

date processed

employee(s) who cleaned/disinfected

Properly hung in designated & ventilated cabinet / tip hanging freely

Recent Outbreaks

Transmission of Carbapenem-Resistant Enterobacteriaceae and related “superbugs” during GI endoscopy with no breach in protocol identified

Duodenoscopes implicated

Elevator channel could not be properly cleaned, even when manufacturer’s instructions were followed

Additional Steps Currently

Recommended - DuodenoscopesPeriodic microbiologic surveillance PLUS one of the following:

Ethylene oxide sterilization after HLD

Repeat HLD (2 cycles)

HLD with scope quarantine until culture-negative

Liquid chemical sterilant processing system using peracetic acid

Watch for new guidance from CDC/FDA

Hot topic: HPV Resistance

One study concluded OPA and other HLD’s failed to inactivate human papillomavirus on trans-vaginal US probes

Hydrogen Peroxide mist and hypochlorite more effective but did not completely eliminate mycobacteria & spores

CDC has requested additional studies, no change in recommendations for now

Reducing Risk Where The

Rubber Meets The RoadOrganize The Team

Evaluate Existing Protocols

Review Guidelines and Standards

Align Policy and Procedure with Guidelines

and Standards

Empower the Team

Standardize the Process and Educate Staff

Monitor the Process, Document and Evaluate

Results

Repeat Until You Get It Right

35

Slides: Renee FuscoOur Patients Are Counting on Us

To Get This Right EVERY TIME

Safe Care is Competent Care

References Centers for Disease Control Guideline for

Disinfection and Sterilization, 2008

ANSI/AAMI ST 91 – Association for the Advancement

of Medical Instrumentation: Flexible and semi-rigid

endoscope processing in health care facilities, 2015

Multi-society Guideline for Gastrointestinal

Endoscope Reprocessing, 2017

Society of Gastroenterology Nurses and Associates

(SGNA) Standards for Infection Prevention in Flexible

Endoscope Reprocessing - 2018

•

Available at:

•

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1

Infection Control from the Top Down

Meg Stagliano RN BSN MBA

So……

Who Owns Infection Control ?

Short Answer

• Everyone who works for the Ambulatory Surgery Center

The Long Answer

• Requires delineation of responsibilities related to Infection Prevention and Control from the top of the organizational chart down to the front line.

Generic Organizational Structure

Responsibilities by Title

Slides: Meg Stagliano

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2/18/2019

2

ASC Ownership/ Governing Body

• Identify an Administrator to manage the surgical center

• Insure resources are available for the provision of an infection prevention and control plan and program.

• Receives and review reports from the Infection Control Committee as presented by the Administrator on a quarterly basis regarding the status of the infection prevention and control plan and program.

ASC Ownership/ Governing Body

• Provide feedback through the Administrator and DON to the Infection Control Committee related to

• Last quarterly results

• Suggestions and directives for new directions the facility needs to focus infection prevention and control resources

Administrator

• The responsibilities of the Administrator related to infection control are outlined in • New Jersey Department of Health and Senior Services Publication

• Standards for Licensure of Ambulatory Care Facilities

• 8:43A -14.1 Administrator’s Responsibilities

8:43A -14.1 Administrator’s Responsibilities

• The administrator or designee shall ensure the development and implementation of an infection prevention and control program.

8:43A -14.1 Administrator’s Responsibilities

• The administrator shall designate an infection control professional who shall be responsible for the direction, provision and quality of the infection prevention and control services.

• The designated person shall be responsible for, but not limited to, developing and maintaining written objectives, policies and procedures, an organizational plan and a quality improvement program for the infection prevention and control service.

• The infection control professional may be a consultant; however there must be a health care professional on site that is responsible for the day to day activities related to infection control.

Administrator Responsibilities

• Assigns the appropriate people to fill the roles:

• Infection Control Professional

• Infection Preventionist (healthcare professional onsite daily)


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Medical Director

• Oversees the functions and practices of the medical staff

• Holds membership on the Infection Control Committee

• Actively participates in designing Infection Control Plan and Program

• Provides oversight and insight into infection control practices of the medical staff

• Responsible for communicating Infection Control Committee Results to Medical Staff

Director of Nursing

• The Director of Nursing (DON) is a registered nurse who is responsible for the management and flow of the clinical environment.

• The DON maybe designated with the responsibility for ensuring the development and implementation of an Infection Prevention and Control Program.

• The DON is an active member of the Infection Control Committee

Director of Nursing

• Participates in development of policies and procedures related to infection prevention and control

• Coordinates involvement other areas to develop policies and procedures related to infection control i.e. Sterile Processing Department

Infection Control Professional

• Qualifications:• The Infection Control Professional (ICP)shall have education or training

in surveillance, prevention and control of nosocomial infections

• The ICP shall be certified in infection control within five years of beginning practice of infection control and shall maintain certification through the Certification Board of Infection Control (CBIC)


• Provides Infection Control Risk Assessment

• Provides input and guidance into the development of the Infection Prevention and Control Plan and Program

• Assists in developing goals for the facility related to Infection Prevention and Control


• Assists in development of policy and procedures related to Infection Prevention and Control

• Completes a biannual inspection of facility

• Active member of the Infection Control Committee


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4

Onsite Infection Preventionist

• DON or designee

• Individual is assigned the responsibility for ensuring the infection prevention and control plan and program is being adhered to on a daily basis.

• Reports Infection Control Results to the Infection Control Committee


• Monitoring Responsibilities• Surgical Site Infections

• Hand Hygiene

• Infection Control Environmental Rounding

• Monitors identified via risk assessment

• Facility driven monitors


• Staff Education• New hire infection prevention and control education

• Ongoing staff education

• Development of Infection Control Education identified through state survey and accreditation survey


• Reporting Responsibilities

• Formulates the monthly reports related to the monitors

• Reports significant findings to the DON and Administrator

• Reports findings on quarterly basis to the Infection Control Committee

Staff Responsibilities

• HAND HYGIENE

• Vigilance to monitor environment for breaches in infection control

• Follow set protocols and procedures for safe patient handling and cleaning equipment between patients

• Reporting Concerns to Infection Preventionist

Infection Control Committee

• Facility must establish an Infection Control Committee

• Committee is comprised of the following at minimum• Medical Director

• Infection Control Professional

• Administrator

• DON


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5


• Responsible to the Governing Body

• Reports to the Quality Improvement Committee as instructed by the Governing Body

• Functions in accordance with NJAC 8:43A-14.2


• Meets a minimum of quarterly

• The committee shall devise and recommend to the Governing Body, measures for reporting, analyzing and controlling infections throughout the center. It shall have whatever powers are necessary to implement an effective program to prevent and control infections.


• The committee oversees:• Number of infections in ASC

• housekeeping services

• approves cleaning solutions

• MSDS sheets

• laundry services

Infection Control Information Flow

Questions


41

2/18/2019

1

Presented by

Al Spath Jr, MPA, BA, CHL, CSCRT, IAHCSMM Instructor & SMESP Management Consulting LLC

FIRST ANNUAL INFECTION CONTROL & NEW JERSEY DEPARTMENT OF HEALTH CONFERENCE February 26, 2019

Preparing For Licensure or Accreditation

Who are the surveyors (NJDOHSS, CMS, TJC, AAAHC & AAASF)?

What are they looking for in the sterile processing department (SPD)?

What are the best practices facilities should follow?

What are the requirements for facilities to use when designing a Sterile Processing Department (SPD)?

What are the requirements (competencies) of staff working in SPD?

Objectives

Objective

It’s all about patient safety!

Risk reduction and process improvement is the heart and soul of most surveys

Patient Safety

In the last 30-plus years, healthcare has had a major shift from the acute inpatient hospital setting to ambulatory settings. Today, more than 70-75% of surgical procedures are performed in outpatient settings such as freestanding or hospital-based ambulatory surgery centers (ASC), physician offices, and other dedicated settings.

Every patient has the right to efficient and safe care in any setting. Established “evidence-based best practices” for reprocessing should be consistently followed.

Facilities should ensure that the validated manufacturer’s IFUs are available and constantly followed and that the staff reprocessing these devices are competent in their duties.

It only takes “one mistake’ to make a big change in a patient’s life. Remember, safety isn’t expensive—it’s priceless!

Surveyors

Regulatory

New Jersey Department of Health & Senior Services (NJDOHSS) Licensure

Occupational Safety & Health Administration (OSHA)

Centers for Medicare & Medicaid (CMS)

Centers for Disease Control & Prevention (CDC)

Accreditation Organizations

The Joint Commission (TJC)

Accreditation Association for Ambulatory Health Care (AAAHC)

American Association for Accreditation of AmbulatorySurgery Facilities, Inc. (AAASF)

Infection & Prevention Control ServicesSubchapter 14

8:43A-14.4. Sterilization of patient care items Methods for processing reusable medical devices shall conform with the following or revised or

later editions, if in effect, incorporated herein by reference:

1. The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Good Hospital Practice: Steam Sterilization and Sterility Assurance," ST 46; (now ST79)

2. The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate Use," ST 37;

3. The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Safe Use and Handling of Gultaraldehyde-based Products in Health Care Facilities," ST 58;

NJDOHSS Standards for Licensure of Ambulatory Care Facilities

Chapter 43A. Title 8

Slides: Al Spath, Jr.

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4. The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Guidelines for the Selection and use of Reusable Rigid Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care Facilities," ST 33;

5. The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Steam Sterilization and Sterility Assurance Using Table Top Sterilizers in Office-Based, Ambulatory Care, Medical, Surgical and Dental Facilities," January 1998; ST-42R;

6. The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings," ST 35;

7. The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness," October 1998, ST 41R; and

8. Society of Gastroenterology Nurses and Associates (SGNA), "Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes," (2000).

Regulatory

Occupational Safety & Health Administration (OSHA) Blood Borne Pathogen Standard (29 CFR

1910.1030) Hazard Communication Standard (29 CFR

1910.1200) Eyewash Standard, 29 CFR 1910.151 & American

National Standards Institute (ANSI Z358.1)

Centers for Medicare & Medicaid (CMS) Reimbursement for Medicare or Medicaid patients

Centers for Disease Control & Prevention (CDC) Guidelines for Decontamination and Sterilization

in Healthcare Facilities 2008

Accreditation Organizations

The Joint Commission (TJC)Accreditation Association for Ambulatory Health Care (AAAHC)American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAASF)

Focuses on the quality and safety of care, treatment, and services for the patient

Uses national recognized best practices during their survey

Overall it improves risk management and risk reduction and helps organize and strengthen patient safety efforts and creates a culture of patient safety

What are Surveyors looking for?

Physical Design Considerations

Temperature & Humidity parameters Ventilation: Airflow(negative or

positive air) and how many exchanges in each Area

What do you do if it is out of compliance?

Proper documentation Utility systems risks Eye wash station

Education and Training

Credentials of staff (certified) & verification

Training & education records Are staff that reprocess medical devices

competent? Are competency assessments performed? Who performs the orientation,

competency assessment, education or training for the facility

What are Surveyors Looking for?

Instructions for Use

Are facilities following the manufacturers’ instructions for use (IFU) for each type of reusable device, piece of equipment and/or chemical disinfectants used

Are they readily available for staff & surveyors

Are they being reviewed frequently and updated

Infection Prevention & Control

What are the risks of infections associated with the use of medical equipment, devices and supplies

Are their standardized practices to minimize infection risks related to them

What practice is being followed Are there written policies &

procedures

Focus on Quality Care and Patient Safety.

Two important challenges

Does the facility meet the standards on: Physical Design of the sterile

processing department (SPD)

Staff qualifications (knowledge, skills & abilities (KSA’s)

Facilities need to follow the evidence-based best practices for sterile processing

Evidence-based Best Practices

ST79:2017: Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI

ST91:2015: Flexible and semi-rigid endoscope processing in health care facilities, ANSI/AAMI

ST58:2013: Chemical sterilization and high-level disinfection in health care facilities, ANSI/AAMI

Guidelines for Perioperative Practice. Denver, CO, AORN

CDC Guideline for Decontamination and Sterilization in Healthcare Facilities 2008

Society of Gastroenterology Nurses and Associates (SGNA), "Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes," (2012)

These documents reflect the most current research and expert opinions resulting in best practices, so it is critical that the most current editions are obtained. It is essential that all reprocessing policies and procedures be developed and referenced using the most current published recommended standards and guidelines.


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AAMI ST79, Section 3: Design Considerations

This section provides guidance for the design and maintenance of the workplace to facilitate effective and efficient processing, promote personnel safety and standardization of procedures, minimize environmental contamination, and maintain the sterility of processed items. Centralized processing (i.e., decontamination, preparation and packaging & sterilization) is in one location.

The physical design of the sterile processing department/area should support safe patient care, workplace safety, and security.

Design Considerations for Sterile Processing Areas

Functional workflow patterns Traffic control Electrical systems Steam for sterile processing

Steam qualitySteam purity

Utility monitoring & alarm systems Heating, ventilation, and air conditioning (HVAC) operating

parameters Ceilings, floors, walls, doors

Design Criteria

Special area requirements and restrictions Decontamination area Preparation area Sterile storage Breakout area Emergency eyewash/shower requirements

Housekeeping Lighting Handwashing sinks

Design criteria

Knowledge, Skills & Abilities(KSA’s)

Knowledge, Skills, Abilities, Education and Experience are critical to survive in today’s dynamic and complex Environment, it is necessary to be prepared, KSA’s & education and experience become absolutely critical to do so.

Qualified and educated staff are needed to meet the new changes in Sterile Processing.

Knowledge, Skills, and Abilities (KSAs) – The attributes required to perform a job

Knowledge: a body of information applied directly to the performance of a function. Basic understanding of sterile processing. (the why’s)

Skills: an observable competence to perform a learned activity. Learned through training and education. (the what’s)

Abilities: competence to perform an observable behavior. Being able to do something. (the how’s)

Why’s, What’s and How’s(KSA’s)

To succeed on the job, staff need to demonstrate the right mix of skills, knowledge, and on-the-job abilities

Have an understanding of the following: Medical terminology, anatomy, physiology, microbiology Regulations & standards that govern sterile processing Infection prevention Point of use transporting Cleaning and decontamination Disinfection Surgical instrumentation (identification and care & handling) Assembly & packaging Point of use processing (IUSS-flash) Sterilization (low & high temperature)

Staff


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Monitoring & recordkeeping Quality Assurance Sterile storage & transport Inventory control management Patient care equipment Safety & risk management Information technology Oral & written communication skills Policies & Procedures Manufacturers instructions for use (IFU’s) Safety data sheets

Is Your Staff Qualified

Certification

Certification: association/industry recognition attained by individuals with educational and/or work experience requirements who successfully complete an examination process demonstrating their knowledge of pertinent, job- related subject matter

Certification in SPD helps develop Basic level of understanding and knowledge, Consistencies and standardization. Adds a Professional element to the facility,

and Builds self-esteem, confidence and authority.

Two are two organizations that offer international certification for Sterile Processing.

The Certification Board for Sterile Processing and Distribution, Inc. (CBSPD) www.sterileprocessing.org

The International Association of Healthcare Central Service Materiel Management (IAHCSMM) www.iahcsmm.org

Competency may be described as a combination of observable and measurable knowledge, skills, abilities and personal attributes that constitute a staff’s performance. The ultimate goal is that the staff can demonstrate the required attributes to deliver safe, quality care for the patient.

Achieving competence means that we understand why we do what we do. That's not the same thing as just doing what we’re told. Competent staff are prepared to make informed decisions because they know where to find the answers to "How do I do this?" or "Why should I do it this way?”

Competency assessment is an ongoing process in which knowledge and skills are continually built. This is particularly important in today’s fast paced dynamic world. Being able to understand current capabilities and develop new ones is critical to stay ahead of the curve.

What is Competency?

When determining competency requirements, consideration should be given to the needs of the facility’s patient population, the types of procedures conducted, conditions or diseases treated, and the kinds of equipment it uses. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.

Sterilization and decontamination duties should only be performed by competent staff with demonstrated knowledge and documented competences in all aspects of reprocessing: decontamination, preparation, packaging, sterilization, sterile storage, and handling of sterile items.

Competency Assessment

Competencies should be documented and performed at least annually.

Competencies should be established by the facilities. A competency-base job description.

The person performing the competency assessment should be as qualified as the staff that they are assessing. A Subject Matter Expert (SME).

When performing a staff competency assessment, you can validate by observation, demonstration and/or interview. Does the staff meet expectations, needs improvement or non-applicable.

Competency Assessment


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Know Your Survey Standards

Surveys can be announced or unannounced. Each visit may be different and may not have the same focus. Therefore, the best way to ensure a good survey is to know and consistently follow your State and Federal regulations as well as any accreditation standards. Ensure staff are trained and educated according to current evidence-based process guidelines and work closely with your IP to ensure the environment operates within standards.

If these suggestions are followed, then your SPD should pass with flying colors.

Summary

References

ST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2017

ST58-The Association for the Advancement of Medical Instrumentation (AAMI) requirements, "Safe Use and Handling of Gultaraldehyde-based Products in Health Care Facilities," ST 58;

ST91:2015: Flexible and semi-rigid endoscope processing in health care facilities, ANSI/AAMI

CDC Guideline for Decontamination and Sterilization in Healthcare Facilities 2008 Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile

Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014 Hubbard, Cynthia Association for the Advancement of Medical Instrumentation.

“Building for the Future”

SHC © 26


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Infection Control in the Operating Room‐

A Primer for the Anesthesia Provider

Monte J. Goldstein, MDFebruary 26thth, 2019

• Medical Director at Ramapo Valley Surgical Center• AAAASF/CMS Surveyor• AAAASF Education/ Standards Committee• AAAASF Investigations Committee Chairperson• Virtua‐ Administrative Director for ASC Development & Clinical Operations

• Anesthesia Chief‐Envision Healthcare‐Jandee Division

• Anesthesia Chief at the Robert Zubowski Center for Plastic and Reconstructive Surgery

• Orbis International‐Medical Advisory Board

Disclosures

Infection Control in the Operating Room for the Anesthesia Provider

First Things First


First Things First:• 2016 SHEA Network survey found only 35.6% of healthcare institutions had infection prevention and control policies specific to anesthesia practice in the OR.

• International respondents were more likely than US to have specific anesthesia related policies.

• 97.5% reported that the expectation was anesthesia personnel would be compliant with all infection related institutional policies.


Surveys to ASA, AANA, AAAA members revealed:• Infection prevention and control policies specific to anesthesia care in the OR are not universal in the US

• Anesthesia work areas are NOT cleaned and disinfected between every patient and/or case

• Many anesthesia practices still remain problematic from an infection control standpoint.


Most Problematic Practices:

• Multi‐dose vials used for > one (1) patient• Single‐use vials used for > one (1) patient• Less then 100% use of gloves for airway management• Failure to perform proper Hand Hygiene (HH) at various times

including after removing gloves and entry into anesthesia carts and drawers

Slides: Dr. Goldstein

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A growing body of literature indicates contamination in the anesthesia work area results in transmission of healthcare‐associated infections, and increases the risk of infection‐ related patient morbidity and mortality.

• Anesthesia Carts • Stopcocks• Laryngeal masks• Laryngeal blades• Touchscreens• Keyboards and Computer Mice• Providers Hands

*.


Hand HygieneWhich activities in anesthesia care should always result in hand hygiene (HH)?Recommendation: HH ideally should be performed according to the WHO five (5) Moments for Hand Hygiene:

• Before performing any aseptic task such as insertion of invasive lines, drawing medications, spiking of IV bags, performing regional anesthetics

• Before donning and after removing gloves• Whenever hands are soiled and/or contaminated (oropharyngeal secretions)• Before touching the contents of the anesthesia cart• When entering and exiting the OR


Hand Hygiene

Recommendation: Alcohol Based Hand Rubs (ABHR) • Increasing access to Alcohol Based Hand Rubs (ABHR) leads to an increase in the

number of times HH is performed during any surgical procedure.• Wearable ABHR dispensers decreases contamination rate of intravenous tubing

in the OR• Wearables also correlated with an 8‐fold increase in the number of times HH

was performed compared to OR’s with only wall mounted dispensers.


Hand HygieneRecommendation: Alcohol Based Hand Rub (ABHR) Dispensers


Hand HygieneRecommendation: Alcohol Based Hand Rubs ( ABHR)‐Locations

• Entrances to the OR• Near anesthesia providers INSIDE the OR to promote frequent HH• Filling of ABHR should be performed and charted by designated personnel• Wearable ABHR dispensers with automatic reminders• Be mindful of applicable national and local fire safety standards and code‐

NFPA 101 Life Safety Code stipulates a 1.2L maximum/dispenser 122cm (48inch) horizontal separation and 2.5cm (1 inch) from ignition source


Hand Hygiene


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Hand HygieneRecommendation: Anesthesia providers should consider wearing double gloves during airway management and should remove outer gloves immediately after airway manipulation. Inner gloves should be removed as soon as possible afterwards, and HH should be performed.

• Providers hands are often contaminated with airway secretions while providing airway management and intubation.

• Providers often unable to perform HH during critical airway management moments leading to cross contamination of the anesthesia work area


Hand Hygiene


Hand Hygiene‐Double Glove Technique


Hand HygieneRecommendation: Anesthesia providers should change gloves and perform HH between doffing and donning every time.

• When HH not possible and or feasible , the use of ABHR on gloved hands should be considered.

• Used extensively during recent Ebola outbreaks• May make identification of “clean” hands more difficult


Laryngoscopes and Video Laryngoscopes

• All standard reusable direct and/or video laryngoscope handles and blades MUST undergo, at a minimum, high level disinfection prior to use. Sterilization is preferable.

• Facilities must have on hand, and follow, manufacturers IFU!• Storage of handles and blades must be in appropriate

packaging.



Recommendation: Handles that are not able to undergo high‐level disinfection according to manufacturers instructions should NOT be used.

• May require complete disassembly which is costly and impractical.

• Apply same principles to ALL supraglottic airway masks (LMA’s).


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Semi‐Critical Equipment

Anything that will contact a mucous membrane or other body surface:

• Must have undergone high level disinfection• Must have no exposure to previous patient or “dirty environment”• Anesthesia breathing circuits• Exposed items must be discarded after each case


Laryngoscopes, Video Laryngoscopes and Semi‐Critical Equipment







Recommendation: Facilities should consider switching all airway management to single use disposable airway devices.

• Cost per use may actually be less then reusable devises• Environmental concerns being addressed by return/recycle

programs




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Disinfection of anesthesia machine and anesthesia work area

Recommendation: All high‐touch surfaces on the anesthesia machine AND anesthesia work area should be cleaned with an EPA‐approved hospital/medical grade disinfectant based on manufactures' instructions for use.

• Machines, keyboards, mice, monitors, carts, and other ancillary equipment are complex and not designed well for cleaning.

• Consider disposable covers whenever possible


Disinfection of anesthesia machine and anesthesia work areaFacilities must prioritize cleaning of specific components that are most likely to be contaminated. This includes monitoring equipment such as:

Reusable BP cuffs Twitch monitor Pulse oximeter probes All sensors/cablesECG leads



Anesthesia components that are most likely to be contaminated include:Work surface Pressure limiting valveGas flow valves IV standsVaporizer dials Fluid warmersSupply cart Keyboard/mouse



Infection Control in the Operating Room for the Anesthesia ProviderMedication and injection practices

Injection Ports:

• Anesthesia providers should ONLY use disinfected ports for intravenous access.

• Ports may be disinfected by scrubbing with a sterile alcohol‐based disinfectant immediately prior to EACH use ( 15 secs?)

• Use of sterile isopropyl alcohol containing caps that cover injection ports continuously.



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Rubber stoppers:

• Anesthesia providers MUST wipe all medication vials’ rubber stopper and necks of ampules with 70% alcohol prior to any vial/ampule access and medication withdrawal


Medication Syringe Recapping:

• Needleless syringes should be capped when used to administer multiple medication doses to the same patient. The sterile cap should completely cover the Luer connector on the syringe.

• Recapping used needles should be discouraged.


Injectable drug and intravenous solution expiration times:

• United States Pharmacopia (USP) Chapter 797 recommends that the use of provider prepared sterile injectable drugs commence within one (1) hour of preparation.

• May be used until the end of the case• Consider use of commercial or hospital pharmacy prefilled syringes


Injectable drug and intravenous solution expiration times:

• Anesthesia practitioners should minimize the time between spiking of IV bags and patient administration.

• Administration should commence as soon as possible. NJDOH and CMS One (1) hour)? Despite lack of literature.



• Single‐dose medication vials and flushes should be used whenever possible.

• If multi‐dose medication vials must be used, they should be used for only one (1) patient and access with a new sterile syringe and needle for each entry.*

• Syringes and needles are SINGLE PATIENT DEVICES ONLY!!!!!!!


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Infection Control in the Operating Room for the Anesthesia ProviderKeyboards, mice, and touchscreens

Recommendation: Facilities should require cleaning and disinfection of computer keyboards, mice, and all touchscreens after EACH anesthesia case using hospital grade disinfectants.

• Consider use of commercial grade plastic keyboard shields and/or sealed medical grade keyboards and mice.

Infection Control in the Operating Room for the Anesthesia ProviderKeyboards, mice, and touchscreens

Infection Control in the Operating Room for the Anesthesia ProviderImplementation‐ Setup for Success

• Facilities should conduct regular monitoring and evaluation of anesthesia personnel infection control practices.

• Improvement efforts should be collaborative with ALL staff and include input from frontline anesthesia providers and leadership.

• Goals and expectations should be CLEAR and measured.


• Feedback should focus on methods to improve adherence rather than place blame.

• Consider Checklists• Success is dependent on leadership! It’s on us!



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Thank You!

[email protected]


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