APIC Implementation Guide:

Infection Preventionist’s
Guide to the OR

About APIC
The Association for Professionals in Infection Control and Epidemiology (APIC) is the leading
professional association for infection preventionists (IPs) with more than 15,000 members. Our
mission is to create a safer world through the prevention of infection. APIC advances its mission
through patient safety, implementation science, competencies and certification, advocacy, and data
standardization.
About the Sponsor
For more than 100 years, the Johnson & Johnson Medical Devices
Companies (JJMDC) have focused on advancing technologies, products,
and services to enhance patient care and bring greater precision to every
aspect of surgery. As an APIC Strategic Partner and a proud sponsor
of APIC’S Infection Preventionist’s Guide to the OR, JJMDC remains
committed to providing the infection prevention community with the
knowledge and tools to address risks for infection in the perioperative
setting. Thank you to APIC, the authors, and the contributors for
developing this comprehensive resource to help bring us closer to a
world without infection.

About the Implementation Guide Series

APIC Implementation Guides help infection preventionists apply current scientific knowledge and best practices to
achieve targeted outcomes and enhance patient safety. This series reflects APIC’s commitment to implementation
science and focus on the utilization of infection prevention research. Topic-specific information is presented in an
easy-to-understand and use format that includes numerous examples and tools.
Visit www.apic.org/implementationguides to learn more and to access all of the titles in the Implementation
Guide series.

Printed in the United States of America

First edition, December 2015
ISBN: 978-1-933013-76-3
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© 2018, Association for Professionals in Infection Control and Epidemiology, Inc. (APIC).
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TABLE OF CONTENTS
Guide Overview.........................................................................7 SECTION 4. The Sterile Processing Department,
Purpose High-Level Disinfection, and Sterilization.......................... 42

Introduction The SPD Environment and Basics

References Figure 5: Attire and PPE Requirements for the Sterile
Processing Department
SECTION 1. IP Role in Perioperative Settings...................... 9 Point-of-Use Precleaning
Building Partnerships with Perioperative Teams Decontamination
Engaging Surgeon and Perioperative Leaders in Use of SSI Data Instrument/Item Prep
Figure 1: Quality Metrics Data Systems Compared Verification of Cleaning
Acting as a Change Agent to Support Surgical Assembly/Packaging
Infection Prevention
Sterilization
Application of Regulatory and Accreditation Requirements to
Loading and Running the Sterilizer
Perioperative Care
Immediate-Use Steam Sterilization (IUSS)
The IP Role in Policy Review and Surveys
Cooling and Recordkeeping
Implementation Strategies for the IP
Sterile Storage
Tools and Resources
Monitoring the Sterilization Process
References
Loaned Instrument Considerations
SECTION 2. Preventing Surgical Site Infections................. 18 Special Considerations: Toxic Anterior Segment
Sterile Technique Syndrome (TASS) and Creutzfeldt-Jakob Disease (CJD)
OR Attire High-Level Disinfection
Statement on Head and Ear Coverings Figure 6: High-Level Disinfectants and Kill Times
Causes and Prevention of SSIs Flexible Endoscope Reprocessing
Figure 2: Comparison of SSI Prevention Guidelines 2016-2017 Impact of Biofilms on High-Level
Disinfection of Flexible Endoscopes
Preventing Other Healthcare-Associated Infections
Length of Storage of Endoscopes
Implementation Strategies for the IP
Other Semi-Critical Devices
Tools and Resources
Implementation Strategies for the IP
References
Tools and Resources
SECTION 3. Understanding the OR Environment.............. 30 References
Standards for HVAC
SECTION 5. Epidemiology and Pathogenesis
OR Air and Infection Risk: Air Quality
of Surgical Site Infections..................................................... 59
Air Flow and Air Pressure
The Scope and Cost of SSIs
OR Temperature
Procedure-Specific Risks
Handling Humidity Issues
Figure 7: SSI Rates for Open and Robotic Procedures
Figure 3: Risk Assessment for Lower OR Humidity Levels
Primary Organisms Associated with SSIs
HVAC Variance and Risk Assessment
Implementation Strategies for the IP
Foot Traffic and Door Openings
Tools and Resources
Figure 4: Traffic Restriction by Area/Unit
References
OR Design Features for Cleanability
Implementation Strategies for the IP
Tools and Resources
References
SECTION 6. SSI Surveillance: Definitions, Methods, SECTION 9. Connecting the Dots: Turning Data
Outcomes, and Reporting..................................................... 63 into Action............................................................................... 80
SSI Definitions Getting Started: Transmitting Outcome Data—Not Infections
SSI Wound Class Engagement and Leader Champions
Duration of Surgical Procedure Figure 11: 4 E’s: An Action-oriented Implementation Model
Classification of Wound Closure Using Outcome Data to Improve Performance:
Figure 8: Wound-Closure Types From SSI Rates to SIRs

SSI Case Finding Figure 12: SSI Data as Reported to NHSN

for Two Procedure Types
Implementation Strategies for the IP
Figure 13: Four Steps to Determining Statistical Significance
Tools and Resources
Figure 14: Macro Snapshot of SIRs by Select Procedure Groups
References
Figure 15: Analysis for a Group of Hospitals
SECTION 7. Audit and Feedback.......................................... 68 Figure 16: Real-Time Analysis through the NHSN Component
Bundles: The Sum is Greater Than the Parts
IP Observations of Surgical Cases
Figure 17: Core Elements of SSI Prevention Bundles
Environmental Infection Prevention Audit in the OR
Figure 18: Procedure-specific SSI Prevention Bundle Elements
Figure 9: Cleaning Frequencies For OR and Procedure Rooms
Figure 19: Use of Enhanced Recovery after Surgery (ERAS)
Implementation Strategies for the IP
Protocols
Tools and Resources
Figure 20: Perioperative Environment-Related Interventions
References
Bundle Implementation: Two Case Studies:
Hospital Corporation of America (HCA),
SECTION 8. Risk Management...............................................73
Michigan Surgical Quality Collaborative (MSQC)
Root-Cause Analysis for SSI Figure 21: MSQC Study: SSI Rate by Number
Sterilizer Failure and Recall of Instruments of Bundle Elements Employed
Recall of Contaminated Products and Tissue Implants Implementation Strategies for the IP
Assessing Patient Risk after Gaps in Sterilization Processes Tools and Resources
Figure 10: Protocol for Exposure Investigation after a Failure References
of Disinfection and Sterilization Procedures
Operating Room Noise
The Role of Communication
Implementation Strategies for the IP
Tools and Resources
References
Acknowledgments
Accomplishing this comprehensive update required input and expertise from a broad array of experts from
practice and research settings. The Association for Professionals in Infection Control and Epidemiology gratefully
acknowledges the following individuals for their valuable contributions:

Scientific Advisory Group Contributing Authors

Linda Greene, RN, MPS, CIC, FAPIC Sue Barnes
Highland Hospital, Affiliate University
Charles Edmiston, Jr., PhD, CIC, FIDSA, FSHEA, FAPIC
of Rochester Medical Center
Department of Surgery (Division of Vascular Surgery),
Rochester, NY
Medical College of Wisconsin
Russell Olmsted, MPH, CIC, FAPIC Milwaukee, WI
Trinity Health
Linda Greene
Livonia, MI
Heather Hohenberger, MSN, RN, CIC, CNOR, CPHQ, FAPIC
Amber Wood, MSN, RN, CNOR, CIC, FAPIC
Indiana University Health Hospitals (Arnett, White, Frankfort)
Association of perioperative Registered Nurses
Lafayette, IN
Denver, CO
Kathleen McMullen, MPH, CIC, FAPIC
Managing Editor
Christian Hospital and Northwest Healthcare
Sue Barnes, RN, CIC, FAPIC Florissant, MO
Independent Clinical Infection Prevention Consultant
Frank Myers III, MA, CIC, FAPIC
San Mateo, CA
University of California San Diego Health
San Diego, CA
Russell Olmsted
Jennifer Spivey, MSN, RN, CNOR, CIC, FAPIC
St. Vincent, Inc.
Indianapolis, IN
Amber Wood

Reviewers APIC Editorial and Production Services

Kathy Arias, MS, MT(ASCP), SM(AAM), CIC, FAPIC Charu Malik, PhD
Arias Infection Control Consulting, LLC Vice President, Education, Research, and Special Projects
Crownsville, MD Washington, DC
Ramona Conner, MSN, RN, CNOR, FAAN Colin Richardson
Association of perioperative Registered Nurses Associate Director, Special Projects and Development
Denver, CO Washington, DC
Michelle Farber, RN, CIC Cover Design
Infection Preventionist Consultant
McGregor, MN Sarah Vickers, Art Director, APIC
Washington, DC
Text Design and Layout
Project Design Company
Washington, DC
Printing
HBP
Alexandria, VA
Declarations of Conflicts of Interest
Only individuals who have made declarations of potential conflicts have been listed here.

△△Sue Barnes reports consulting for: Aerobiotix, AORN, Applied Silver, Clorox, Denise Graham and Associates,
Infection Prevention Partners, Infection Control Today, Elyptol, IDSA, Ethicon, Nanosonics, and Nozin

△△Charles Edmiston reports consultation work for the Wisconsin Division of Public Health, membership to the
Scientific Committee-Aerobiotix, and membership to Speaker’s Bureau-Ethicon

△△Linda Greene reports honorarium from New Jersey Healthcare Association, Florida Healthcare Association for
work on educational activities; honorarium for participation in Steering Committee, Duke Network (federal SSI
reduction grant)

△△Russell Olmsted reports personal fees from Ethicon, Inc., Premier Inc., and Medscape Public Health
△△Amber Wood reports being employed by AORN as Senior Perioperative Practice Specialist

APIC: IP’s Guide to the OR

  Guide Overview | 7

GUIDE OVERVIEW

Purpose
The purpose of this guide is to prepare and support Infection Preventionists (IPs) as they engage and collaborate
with the entire Surgery Suite, Sterile Processing department (SPD), critical support services—such as Environmental
Services, Facility Engineering and Value Analysis—and supply chain in efforts to eliminate preventable surgical
site infections (SSIs) and other healthcare-associated infections (HAIs). This engagement will, of course, primarily
involve perioperative nurses and those technicians, surgeons, and anesthesia professionals who provide and oversee
perioperative care.

Introduction 2 to 5 percent of patients undergoing inpatient surgery.

Annual incidence of SSIs in the United States is between
Effective infection prevention in the perioperative
160,000 and 300,000, and annual attributable cost
setting calls for expertise in teamwork, relationship
ranges from $3.5 billion to $10 billion. On average,
development, and communication. In addition, an
an SSI increases a hospital length of stay by 9.7 days.
understanding of aseptic technique, procedure-specific
In addition, the Guidelines reports that approximately
SSI risk, disinfection and sterilization, and effective
50 percent of SSIs are preventable when evidence-based
methods for case finding; expertise in the analysis
prevention strategies are employed.1
and communication of outcomes; and knowledge
of improvement science are essential to the mission The Centers for Disease Control and Prevention Guideline
of preventing SSI. for the Prevention of Surgical Site Infection, 2017 points
to the rising need for such strategies: “The human
IPs advocate for optimal surgical infection prevention and financial costs of treating SSIs are increasing. The
through dissemination of both process and outcome data number of surgical procedures performed in the United
and of current and evolving evidence related to products States continues to rise, on patients with increasingly
and practices designed to reduce surgical infection risk, complex comorbidities.”2
as well as sharing findings from case observations and
A key responsibility of the IP is to support the
infection surveillance reports. Development of trust and
perioperative team in applying the most current and
collaboration with the perioperative team is important
evidence-based surgical infection prevention strategies,
to the IP’s success in the OR as collaboration is in every
as well as in tracking and communicating targeted
other department.
surgical infection rates. This guide is for new IPs or
According to the Surgical Site Infection Guidelines IPs who wish to improve their understanding of and
published in 2017 by the American College of Surgeons collaboration with perioperative team members in the
(ACS) and Surgical Infection Society (SIS), SSIs are the goal of SSI prevention. All efforts have been made to
most common and costly type of healthcare-associated highlight key concepts and strategies in guidelines most
infection (HAI), accounting for 20 percent of all recent to the publication date, including those from the
HAIs.1 Surgical site infections occur in an estimated CDC, World Health Organization (WHO),3 Wisconsin

APIC: IP’s Guide to the OR

  Guide Overview | 8

Division of Public Health (WDPH),4 and the American outcomes. Development of this Implementation Guide
College of Surgeons (ACS)/Surgical Infection Society has been a team effort by expert Infection Preventionists
(SIS). In addition, we have presented the key practices with a passion for ensuring collaboration between
relevant to HAI prevention including SSI recommended Infection Prevention and Control and Perioperative
by the Association for Professionals in Infection Control departments and professionals with a shared goal of
and Epidemiology and the Association of periOperative surgical site infection prevention. We appreciate the
Registered Nurses.5,6 great assistance of APIC staff members, in particular
It is our aim that this guide will help IPs apply science Charu Malik, PhD, Vice President, Education,
to advance SSI prevention practice and improve patient Research, and Special Projects, APIC.

REFERENCES
1. Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, 5. Association for Professionals in Infection Control and Epidemiology.
Fry DE, Itani KMF, Dellinger EP, Ko CY, Duane TM. American APIC Implementation Guides: Prevention of Central Line-
College of Surgeons/Surgical Infection Society surgical site Associated Bloodstream Infections, Hand Hygiene, Preventing
infection guidelines-2016 update. Surg Infect (Larchmt). 2017 Catheter-Associated Urinary Tract Infections, Elimination of
May/Jun;18(4):379-382. Orthopedic Surgical Site Infections, Prevention of Mediastinitis
Surgical Site Infections Following Cardiac Surgery. APIC website.
2. Berríos-Torres, S et al. for the Healthcare Infection Control Practices
Available at: https://www.APIC.org. Accessed April 30, 2018.
Advisory Committee. Centers for Disease Control and Prevention
guideline for the prevention of surgical site infection, 2017. 6. Association of periOperative Registered Nurses. AORN Guidelines
JAMA Surg August 2017;152(8):784-791. for Perioperative Practice. Denver, CO: AORN, Inc.; 2017.
Available from: https://www.AORN.org.
3. World Health Organization. WHO Global Guidelines for the
Prevention of Surgical Site Infection. Geneva [Switzerland]:
World Health Organization; 2016. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK401132/
4. Edmiston CE, Borlaug, G, Davis, JP, Gould, JC, Roskos, M,
Seabrook, GR. (2017, January). Wisconsin Division of Public
Health supplemental guidance for the prevention of SSI: an
evidence based perspective. Wisconsin Division of Public Health
website. January 2017. https://www.dhs.wisconsin.gov/
publications/p01715.pdf. Accessed April 30, 2018.

APIC: IP’s Guide to the OR

 9

SECTION 1

IP ROLE
IN PERIOPERATIVE SETTINGS

Building Partnerships ORs under oversight of a control desk), and restricted

with Perioperative Teams (such as inside an OR).
Efforts to improve collaboration and partnership Other essential partners to the perioperative team include
among multidisciplinary teams has been shown to clinical engineers; value analysis professionals, who
reduce adverse patient outcomes, including surgical site oversee selection, distribution and stewardship of patient
infections (SSIs) and other types of healthcare-associated care supplies, products and devices; and facility engineers,
infections (HAIs).1, 2 In the domain of perioperative care, who operate mechanical systems of heating, ventilation,
this partnership should involve the Infection Prevention and air conditioning (HVAC) and the water-distribution
and Control (IPC) department and all perioperative network. In general, the surgeon is the leader of any
team members. Increasingly in recent years, Infection perioperative team. As a result, the relationship between
Preventionists (IPs) have become trusted advisors and IPs and surgeons is especially important to a successful
core stakeholders in the perioperative team. Infection partnership between Perioperative and IPC departments.3
prevention and control is central to all patient care, Another perioperative team member important for
but particularly to care provided in the Perioperative IPs to connect with is the OR nurse-educator, who is
Department. Knowledge-sharing between the IPC fully versed on policies and procedures governing daily
and Perioperative departments ensures continual work practice by the team in the Surgery Suite. Surgical
performance improvement and the safest patient care.1 subspecialty nurse coordinators are another important
source of information and expertise; they can provide
The perioperative team includes surgeons, nurses,
assistance to the IP during case observations as well
nonlicensed technicians, Environmental Services
as help determine why infections might be occurring
technicians, sterile processing technicians, anesthesia
in a given surgical subspecialty.
providers, nurse educator(s), and others who collaborate
to ensure safe patient care throughout the perioperative The operating room and its myriad players can feel
experience. Hereafter, the terms operating room (OR) like a foreign environment to an IP whose training
and Surgery Suite will be used interchangeably. The and work experience have been outside the domain
Surgery Suite typically comprises a number of ORs with of perioperative care. Cloaked in interwoven traditions,
zones encompassing areas that are unrestricted (family- dogma, diverse cultural identities, and evidence-based
visitor waiting and other areas used by healthcare practices, the OR can present simultaneously as a state-
personnel), semi-restricted (corridor outside individual of-the-art enclave where heroic lifesaving technologies

APIC: IP’s Guide to the OR

 Section 1 IP Role in Perioperative Settings | 10

improve patient outcome and an intimidating separateness of the Surgery Suite. This is sometimes
environment to outsiders unfamiliar with this “turf.” referred to as a “silo effect.” Over time, developing
IPs who thrive in the OR environment exhibit a genuine respect and trust among IPs and perioperative team
curiosity about individual practices among the various members can counter this silo effect. In addition,
surgical team members, a respect for the diversity of knowledge-sharing can enhance prevention efforts for
personalities that co-exist within the cloistered enclave, surgical, bloodstream, urinary, and respiratory tract
and a willingness to integrate themselves into the daily infections, thereby improving patient outcomes.5
OR routine. By embracing this strategy, an IP can Key values that Infection Preventionists bring to
function as an “agent of change” and a valued resource the operating room a command of HAI prevention
by all perioperative team members. and control literature, grading of scientific evidence,
Any IP who enters the OR environment will, in the evaluation and selection of products and devices to
short-term, be on a steep learning curve: becoming support SSI prevention, implementation science,
familiar with the processes and procedures that and subject-matter expertise to identify selective
encompass aseptic technique sterile instrument interventional strategies that should be included in
reprocessing, terminal room cleaning during surgical care bundles. In addition, IPs can keep surgical
room change-over, appropriate surgical attire, and leadership and perioperative staff apprised of SSI data
management of patients with multidrug-resistant and trends, which are best offered as opportunities for
organisms (MDRO) as well as learning about innovative collaborative resolution and performance improvement.
surgical procedures and technologies that play a role Finally, understanding specific surgical procedures and
in improving patient outcomes. innovative technologies can be complex. Fortunately,
It is important to recognize that both worlds— most surgeons are natural teachers and enjoy describing
perioperative services and infection prevention— in great detail how their surgeries are performed.
are clinically dynamic. Just as surgical techniques, Surgeons can be especially helpful in determining root
instruments, and procedures are constantly evolving, causes of a surgical infection, identifying what risk
so too is the body of knowledge and evidence regarding factors were present, naming possible exacerbating
products and practices designed to reduce the risk of SSIs, co-morbidities, and developing strategies that might
central line-associated and catheter-related bloodstream be beneficial in preventing further adverse events. This
infections (CLABSI, CRBSI), catheter-associated process of briefings and debriefings offers an excellent
urinary tract infections (CAUTI), ventilator-associated opportunity for improving teamwork and opening up
pneumonia (VAP) and healthcare-associated pneumonia lines of communication.
(HAP). Within their specific areas of expertise, surgeons,
anesthesia providers, perioperative nurses, and ancillary Engaging Surgeon and Perioperative
staff should serve as clinical expert resources for IPs. Leaders in Use of SSI Data
Similarly, and also with regard to their areas of expertise, Surgical site infection has emerged as a leading outcome
IPs should serve in the same role for the perioperative measure of surgical quality. For instance, SSI data from
team.3 Indeed, sharing their expert clinical knowledge the Centers for Disease Control and Prevention’s National
best mitigates surgical infection risks. Knowledge-sharing Healthcare Safety Network (NHSN) for colon procedures
can also lead to a more robust exchange of ideas, which and abdominal hysterectomy are being used by the
can further foster a collaborative relationship, improving National Quality Forum and have been incorporated into
patient safety.4 the Centers for Medicare & Medicaid Services (CMS)
One challenge to building such collaborative Hospital Inpatient Quality Reporting program. These
partnerships lies in the physical and environmental data are reported publicly on the CMS Hospital Compare

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 Section 1 IP Role in Perioperative Settings | 11

website and are tied to payment determinations in the A second study, by Memorial Sloan Kettering Cancer
CMS Hospital Acquired Conditions (HAC) and Value- Center, suggests that NSQIP SSI rates, when used in
Based Purchasing programs.6 conjunction with an in-house surgical secondary event
(SSE) database, resulted in excellent concordance.9
Surgeons and others have questioned the accuracy of the
The authors reported that while the programs are
NHSN data and the sufficiency of the risk adjustment
complementary, the SSE program is a prospective
methods. An audit of this process by the New York State
real-time collection database that facilitates real-time
Department of Health, published in 2009, found a
intervention in response to adverse outcomes.
10.9 percent false-positive rate and a 39.6 percent false-
negative rate for colon surgery.7 A separate study, published in 2016, queried three
databases: Vizient, a large, member-driven, performance-
Many hospitals use the American College of Surgeons
improvement company, NHSN, and NSQIP. The study
National Surgical Quality Improvement Program
compared SSI rates following surgery for gynecologic
(NSQIP) in addition to the mandated NHSN
malignancy. The Vizient database included only those
reporting system. NSQIP uses hierarchical multivariable
cases that occurred during the same hospital admission
logistic regression modeling for hospital performance
and had the broadest inclusion criteria. The authors
adjustment; it accounts for clusters of patients within
reported a wide variation in the rates of deep incisional
hospitals, in theory reducing false-positive rates through
and organ-space SSIs among the three databases
multiple sampling. In a recent analysis of 16 hospitals,
(p<0.001).10 These findings, while suggesting a significant
11 of which were academic centers, the mean colon SSI
level of disharmony among current reporting systems,
rates were 5.7 percent for NHSN and 13.5 percent for
should come as no surprise to anyone knowledgeable
NSQIP. The authors concluded that colon SSI rates for
about the pitfalls of SSI surveillance.
NHSN and NSQIP could not be used interchangeably
to evaluate hospital performance, because in most cases It is important for IPs at hospitals that participate in
the NSQIP rate would result in the hospital being NSQIP to understand the similarities and differences
deemed an outlier.8 between both systems and to collaborate and utilize
information in identifying improvement opportunities.

FIGURE 1
QUALITY METRICS DATA SYSTEMS COMPARED

National Healthcare Safety Network (NHSN) National Surgical Quality Improvement Program (NSQIP)

Data are used for public reporting Data are used for internal quality
Provides comparison data based upon U.S. experience
Provides comparison data based upon other National Surgical
in hospitals reporting to National Healthcare Safety
Quality Improvement Program (NSQIP) hospitals
Network (NHSN)
Standardized SSI definitions per CDC NHSN Standardized SSI definitions similar to CDC NHSN
Uses sampling methodology: 40 cases per 8-day cycle
100 percent of denominators of eligible procedures
minimum (some hospitals may elect to review all cases)
Variety of case-finding methodologies Standardized case-finding methodologies
Review potential SSI for 30 days postsurgery; 90 days with All cases followed for 30 days, including orthopedic joint
implantables and implantables
Used for reporting and calculating SSI rates and standardized In addition to SSI data, provides information on other
infection ratios. Analytical functions are available to the user. complications such as respiratory, cardiac; mortality numbers

APIC: IP’s Guide to the OR

 Section 1 IP Role in Perioperative Settings | 12

As a part of the multidisciplinary team, IPs deliver from SSI surveillance is to include these team members
meaningful data to the perioperative team, including in clinical case reviews if a patient develops an SSI or
communicating any trends noted during HAI other HAI following a surgical procedure. For example,
surveillance. This is true not only for SSI data, but if a urinary catheter was inserted intra-operatively
also CLABSIs and CAUTIs, which may be traced and the patient develops a CAUTI within 3 to 7 days
back to the OR if the devices were placed, “accessed, after insertion, the team/individual who inserted
and manipulated” in the perioperative department. the catheter should be a part of the review team.
However, since NHSN definitions require that any HAI Another approach that can encourage perioperative
be attributed to the unit where the patient first meets engagement: The IP can provide SSI data stratified by
infection criteria, and not to the location of probable teams that oversee care of various NHSN procedure
causation, teasing out the location of causation involves groups, such as joint arthroplasty, spine. SSI data
additional work on the part of the IPC department. stratified by procedure groups is the operating room
Otherwise, it may be common to hear phrases from the equivalent of nursing-unit-based HAI data. Providing
perioperative team such as: “I never see infection data, surgical-specialty-specific SSI data shows the IPC
so I guess we don’t have a problem,” “HAI data are too department’s investment in ensuring improvement in
broad—it doesn’t show me if we have a problem in patient care and can support the relationship between
the OR,” or “The data we get never show the infection the OR team and the IPC department.
attributable to the OR.”
Perioperative staff have an intrinsic desire to provide safe Acting as a Change Agent to Support
patient care, and they rely on the infection prevention Surgical Infection Prevention
team to communicate meaningful infection data to The primary role of the IP in the operating room is
identify improvement opportunities. Aseptic skill during to support all efforts to optimize SSI prevention. This
placement of invasive devices such as vascular access and work may involve providing evidence updates and
urinary catheters can lessen risk of infection once the information on current practices as well new products.
patient leaves the perioperative care environment. It also commonly involves offering to provide an outside
The introduction of the standardized infection ratio view via direct observation of cases. In addition, this
(SIR) in the NHSN surveillance reporting system work may include summarizing both best practices
opened a new door for infection-data reporting in and opportunities to improve infection prevention
healthcare. As are the NSQIP data reporting structures, efforts, based on a comparison with the most recent SSI
the SIR is a statistical measurement used to report and Prevention Guidelines and practices recommended by
track the observed number of infections compared APIC and the Association of periOperative Registered
with the expected number of infections.11,12 While the Nurses (AORN).13-18
NSQIP database calculates rates using a risk-adjusted To effectively execute the role, an IP must be able to
model, the SIR uses a logistic regression model and engage with the perioperative team, as the complexity
specific exclusion criteria. The SSI/SIR data commonly inherent in the OR requires effective inter-professional
shared with the perioperative team currently are for collaboration.19 Indeed, an effective partnership between
colorectal and abdominal hysterectomy procedures. the Perioperative and IPC departments is critical for
With the July 2017 changes in NHSN calculations and evaluation and introduction of new infection prevention
definitions, SSI/SIRs can now be reported for a broader products and practices in the real world.20 The blended
range of NHSN–defined surgical procedure groups. insights of the two departments foster performance
One important technique to engage the surgeon and improvement by hardwiring new products and practices
perioperative team in understanding and using findings demonstrated as effective in peer-reviewed literature.21,22

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 Section 1 IP Role in Perioperative Settings | 13

IPs may also benefit from leveraging change- the Centers for Medicare & Medicaid Services (CMS),
management strategies. For example, one simple change- and the Food and Drug Administration (FDA). OSHA
management strategy is to identify a local champion regulations associated with infection prevention in the
for any recommended change in product or practice.23 perioperative space include reporting of occupational
Another strategy is use of a compelling patient story sharps injuries, because these can lead to possible
to engage the team in support of the change.24 exposure to blood-borne pathogens.
A more sophisticated example is Kotter’s 8-Step The FDA is responsible for monitoring the safety of
Change Model, developed by Harvard professor and medications and accountable for regulating surgical
entrepreneur John Kotter. It includes the following instruments, medical devices, biologics, blood products,
steps: create urgency, create a powerful coalition, create safety notices involving medical devices, and implantable
a vision for change, communicate the vision, remove product recalls due to issues including contamination.
obstacles, create short-term wins, build on the change, Resources for federal regulations can be found in the
and anchor the change in corporate culture.25 Another Federal Register or the Code of Federal Regulations. The
useful tool is the Agency for Healthcare Research and most pertinent section for IPs is the CMS Conditions
Quality’s Toolkit to Promote Safe Surgery.26 of Participation (CoP), and for ambulatory surgery
centers, Conditions for Coverage (CfCs).28 (See Tools and
Application of Regulatory and Resources: CMS CoP Infection Control Worksheet.)
Accreditation Requirements to CMS also publishes interpretive guidelines with details on
Perioperative Care survey process, expectations, and enforcement of CoPs.29
The IPC department in every healthcare facility providing All healthcare facilities, regardless of payer mix, are
surgical services should include perioperative care in the required to meet federal, state, and local regulations.
annual infection control plan. During accreditation and Healthcare organizations receiving reimbursement for
regulatory surveys, the IP may be consulted as an advisor services from CMS are required to undergo a process
to the perioperative or regulatory/accreditation team. known as certification. Certification determines whether
While not all IPC departments have a formal linkage a healthcare facility meets regulatory standards using
to the Quality department, IPs must be knowledgeable the rules in place per the CoPs.
about the differences between regulation and accreditation CoP Subpart C: Basic Hospital Functions include:
as well as ensure that the infection prevention and
control program is well integrated with the facility’s △△482.21—Condition of participation: Quality
quality assurance and performance improvement assessment and performance improvement program
(QAPI) program and initiatives. And of course, infection △△§482.25—Condition of participation:
prevention leadership is critical for response to findings Pharmaceutical services

△△§482.26—Condition of participation:
identified by accreditation/regulatory surveyors, including
assessment of annual infection prevention and control
Radiologic services
plan review.
The perioperative area is regulated by federal, state, △△§482.41—Condition of participation:
Physical environment
and local government agencies as a subset of the
healthcare facility.27 Federal regulatory agencies include △△§482.42—Condition of participation:
the Occupational Safety and Health Administration Infection control
(OSHA), the Environmental Protection Agency (EPA) ›› The Interpretive Guidelines offer additional
and the Department of Health and Human Services details, importantly: “…The hospital’s program for
(HHS). Selected agencies under HHS include the CDC, prevention, control, and investigation of infections

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 Section 1 IP Role in Perioperative Settings | 14

and communicable diseases should be conducted an IPC department’s Environmental OR checklist

in accordance with nationally recognized infection is proper storage of sterile supplies and equipment.

△△§482.42(a)(1)—Determine whether the hospital

control practices or guidelines, as well as applicable
regulations of federal or state agencies. Examples
has an active, hospital-wide infection control
of organizations that promulgate nationally
program reflecting the infection control officer
recognized infection and communicable disease
responsibilities. The IP is responsible for conducting
control guidelines and/or recommendations include
active surveillance for HAIs, mitigating the risks for
the CDC, APIC, AORN, and the Society for
development of HAIs, and routinely evaluating the
Healthcare Epidemiology of America. The U.S.
infection prevention plan.
Occupational Health and Safety Administration
also issues federal regulations applicable to infection △△§482.51—Surgical services: Surveyors will perform
control practices…” tracer activities to validate [the following:] surgical

△△§482.45—Condition of participation: Organ,

area is accessed by authorized personnel only,
there are appropriate traffic patterns, and proper
tissue, and eye procurement surgical attire is worn; maintenance of aseptic
CoP Subpart D: Optional Hospital Services include: technique; environmental cleaning between each
patient; terminal cleaning; processes for high-
△△§482.51—Condition of participation: level disinfection and sterilization of reusable
Surgical services instrumentation; appropriate storage and handling

△△§482.52—Condition of participation: of sterile supplies; temperature, humidity, and

air-pressure monitoring; and proper testing of
Anesthesia services
equipment used for patient care.30
Surgical Services CoPs specific to the infection Of note are the following interpretive guidelines in
prevention and control include: the CMS State Operations Manual for Surgical Services:
△△§482.21(a)(2)—The hospital must measure, analyze, △△“…If the hospital provides surgical services, the
and track quality indicators, including adverse services must be well-organized and provided in
patient events and other aspects of performance accordance with acceptable standards of practice.
that assess processes of care, hospital service, and If outpatient surgical services are offered, the services
operations. Perioperative areas may use SSI data must be consistent in quality with inpatient care in
as a quality indicator meeting this rule. IPs play accordance with the complexity of services offered.
an integral part in maintaining compliance since
the IPC department is responsible for infection △△“Surgical services must be consistent with needs
surveillance and reporting and for triggering the and resources. Policies governing surgical care
multidisciplinary team for SSI case review as needed. must be designed to assure the achievement and
maintenance of high standards of medical practice
△△§482.41(c) (2)—Facilities, supplies, and equipment and patient care. … Policies and procedures must
must be maintained to ensure an acceptable be written, implemented, and enforced. Surgical
level of safety and quality. Sterile supplies and Services’ policies must be in accordance with
instrumentation are frequently stored in surgical and acceptable standards of medical practice and
procedural areas. One topic commonly included in surgical patient care …”31

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Section 1 IP Role in Perioperative Settings | 15

The IP Role in Policy Review and Surveys

Guidelines from relevant professional organizations, such as AORN, American College of Surgeons (ACS)
and the federal Healthcare Infection Control Practices Advisory Committee (HICPAC), are often used as a
basis for facility policies and procedures. Surveyors typically will review facility policies to assess whether
practices observed align with policies. If there is variation from policies, this often can lead to citations or
requirements for improvement from CMS or accrediting organizations. It is essential to carefully review policies
on requirements applied to the surgeon and perioperative team. Therefore, the IP can advise the Perioperative
Care department regarding relevant guidelines and recommendations related to SSI prevention that should be
cited in support of these policies and their periodic review and revision.

The IP is a vital member of the facility survey team during certification or licensure surveys. As a content expert
in evidence-based practices, the IP can provide input during perioperative services tracer activities, respond
to surveyors’ questions directly, and develop action plans when gaps are discovered. (See Tools and Resources:
Tracer Tools for OR and SPD.)

IMPLEMENTATION STRATEGIES FOR THE IP

△△Attend perioperative staff meetings to improve connections and develop deeper mutual understanding
between Infection Prevention and Control and Perioperative departments

△△Invite perioperative nurse executives and chiefs of anesthesia and surgery to participate in developing one
or more shared goals during the annual IP Risk Assessment and Program Planning process. This Leadership
Triad team typically oversees provision of surgical care and is an essential unit with which the IP should
develop a relationship and ensure robust, ongoing, communication and collaboration.

△△Offer perioperative leadership an opportunity to review SSI and other HAI reports prior to internal
and external publication.

△△Invite perioperative team representative to present best practices, performance improvement project results,
or new product information to the Infection Prevention and Control Committee.

△△Serve as a resource for problem investigation, risk mitigation, and response when infection surveillance data
suggest a possible cluster or outbreak. The IP can also assist with strategies and decision-making in the event
of unanticipated alteration or disruption in HVAC or water quality, or of water intrusion. The IP should be
knowledgeable regarding the CMS water-management requirements.

△△Ensure that the IPC department has a seat on the Surgery Quality of Care Committee, and vice versa.
△△Work collaboratively with OR nursing staff and surgeons to reduce traffic.
△△Identify a perioperative team champion (e.g., surgeon, nurse, or anesthesia provider) for any new product
or practice.

△△Use a patient story to engage a champion or the whole department. See Tools and Resources for a collection
of patient stories.

△△Consider use of Kotter’s 8-Step Change Model when suggesting practice/product changes
(see Tools and Resources).

△△Include the perioperative space in the annual infection control plan.

△△Be prepared to respond to accreditation surveyors regarding perioperative services during the infection
control and prevention plan review, how current practice meets regulatory standards, any process-
improvement work in reducing SSIs, and documentation of routine tracer activity in the perioperative space.

△△Be familiar with the details of the CMS CoPs and state licensure rules where perioperative services and
infection prevention overlap.

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 Section 1 IP Role in Perioperative Settings | 16

TOOLS AND RESOURCES

△△CMS Conditions of Participation (CoP) Infection Control Worksheet—Items and questions for interviews,
and review for on-site survey to determine compliance with Conditions of Participation; 48 pages.
Provided by APIC https://bit.ly/2jNGXt1

△△“Partnering with Perioperative Colleagues to Prevent Infections”—2017 AORN Journal guest editorial
addressing surgical team and Infection Preventionist partnership on SSI prevention, including attire,
precautions, aseptic technique, and environment. Provided by APIC https://bit.ly/2rDxJmy

△△Collection of Patient Stories—First-person accounts collected by the Consumers Union of Consumer

Reports; can be used to champion change or make the case for programs.
https://safepatientproject.org/stories

△△Kotter’s 8-Step Change Model—Scalable and adaptable process for successfully leading change; developed
by Harvard Business School professor. https://www.mindtools.com/pages/article/newPPM_82.htm

△△CMS Conditions of Participation—State Operations Manual, Appendix A, outlining survey protocol,

regulations, and interpretive guidelines for hospitals; 2008. https://go.cms.gov/2dbxAzT

△△CMS Water Management Directive—Memo on CoP requirements and regulations re Legionella and other
opportunistic waterborne pathogens. https://go.cms.gov/2r3ue6B

REFERENCES
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patient outcomes: A review. Surg Neurol Int 2014 Aug 28; SL, et al. What is the real rate of infection? J Oncology Practice
5(Suppl 7):S295303. 2016;12:e878-e881.
2. Dellinger EP. Teamwork and collaboration for prevention of surgical 11. American College of Surgeons (July 27, 2017). About
site infections. Surg Infect (Larchmt) 2016 Apr; 17(2):198-202. NSQIP. American College of Surgeons website. July 27, 2017.
https://www.facs.org/quality-programs/acs-nsqip/about.
3. Singer SJ, Molina G, Li Z, et al. Relationship between operating
Accessed April 30, 2018.
room teamwork, contextual factors, and safety checklist
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standardized infection ratio (SIR): A guide to the SIR. CDC
4. Chan TM, Gottlieb M, Quinn A, London K, Conlon LW, Ankel
website. July 2017. https://www.cdc.gov/nhsn/pdfs/ps-analysis-
F. Academic primer series: five key papers for consulting clinician
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13. Berríos-Torres, S et al. for the Healthcare Infection Control Practices
5. Epstein NE. Multidisciplinary in-hospital teams improve
Advisory Committee. Centers for Disease Control and Prevention
patient outcomes: A review. Surg Neurol Int 2014 Aug 28;
guideline for the prevention of surgical site infection, 2017. JAMA
5(Suppl 7):S295303.
Surg August 2017;152(8):784-791.
6. Centers for Medicare and Medicaid Services. HHS Medicaid
14. Edmiston C. et al. Wisconsin Division of Public Health
program; payment adjusted for provider-preventable conditions.
supplemental guidance for the prevention of SSI: an evidence based
Final rule. Fed Regist 2011;76:32816-32838.
perspective. Wisconsin Division of Public Health website. January
7. Haley VB, Van Antwerpen C, Tserenpuntsag B, et al. Use of 2017. https://www.dhs.wisconsin.gov/publications/p01715.pdf.
administrative data in efficient auditing of hospital acquired surgical Accessed April 30, 2018.
site infections, New York State 2009-2010. Infect Control Hosp
15. World Health Organization. WHO Global Guidelines for the
Epidemiol 2012; 33:565-571.
Prevention of Surgical Site Infection. Geneva [Switzerland]: World
8. Ju MH, Ko CY, Hall BL, Bosk CL, Bilimoria KY, Wick EC. A Health Organization; 2016. Available from: https://www.ncbi.nlm.
comparison of 2 surgical infection monitoring systems. JAMA Surg nih.gov/books/NBK401132/
2015;150:51-57.
9. Selby LV, Sjoberg DD, Cassella D, Sovel M, Weiser MR, Sepkowitz
K, et al. Comparing surgical infections in the national improvement
project and an institutional database. J Surg Res 2015;196:416-420.

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 Section 1 IP Role in Perioperative Settings | 17

16. Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, 24. Houston TK, Cherrington A, Coley HL, Robinson KM, Trobaugh
Fry DE, Itani KMF, Dellinger EP, Ko CY, Duane TM. American JA, Williams JH, Foster PH, Ford DE, Gerber BS, Shewchuk RM,
College of Surgeons/Surgical Infection Society surgical site Allison JJ. The art and science of patient storytelling- harnessing
infection guidelines-2016 update. Surg Infect (Larchmt) 2017 narrative communication for behavioral interventions: the ACCE
May/Jun;18(4):379-382. project. J Health Commun 2011 Aug;16(7):686-97.
17. Association of periOperative Registered Nurses. AORN guidelines 25. Burden M. Using a change model to reduce the risk of surgical site
for perioperative practice. Denver, CO: AORN, Inc.; 2017. infection. Br J Nurs 2016 Sep 22;25(17):949-955.
Available from: www.AORN.org
26. Agency for Healthcare Research and Quality. AHRQ toolkit to
18. Association for Professionals in Infection Control and Epidemiology. promote safe surgery. AHRQ website. 2017. https://www.ahrq.gov/
APIC Implementation Guides: Prevention of Central Line- professionals/quality-patient-safety/hais/tools/surgery/index.
Associated Bloodstream Infections, Hand Hygiene, Preventing html Accessed April 9, 2018.
Catheter-Associated Urinary Tract Infections, Elimination of
27. Brown, D.S. Q Solutions: Regulation, Accreditation, and
Orthopedic Surgical Site Infections, Prevention of Mediastinitis
Continuous Readiness (3rd ed.). Glenview, OH: NAHQ; 2013.
Surgical Site Infections.
28. Center for Medicare & Medicaid Services. CMS Conditions
Following Cardiac Surgery. APIC website. Available at: of Participation. CMS website. 2008. https://www.cms.gov/
https://www.APIC.org. Accessed April 30, 2018 Regulations-and-Guidance/Guidance/Transmittals/downloads/
R37SOMA.pdf. Accessed April 30, 2018.
19. Jones NJ, Villavaso CD. An inter-professional team approach to
decreasing surgical site infection after coronary artery bypass graft 29. Centers for Medicare & Medicaid Services. State operations
surgery. Crit Care Nurs Clin North Am 2017 Mar;29(1):1-13. manual, appendix A - survey protocol, regulations and interpretive
guidelines for hospitals. Rev. 151, 11-20-15. CMS website.
20. Bohnenkamp S, Pelton N, Rishel CJ, Kurtin S. Implementing
2015. https://www.cms.gov/Regulations-and-Guidance/Guidance/
evidence-based practice using an interprofessional team approach:
Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.
part two. Oncol Nurs Forum 2014 Sep;41(5):548-50.
html. Accessed April 30, 2018.
21. Grossman S, Bautista C. Collaboration yields cost-effective,
30. Brown, D.S. Q Solutions: Regulation, Accreditation, and Continuous
evidence-based nursing protocols. Orthop Nurs 2002
Readiness (3rd ed.). Glenview, OH: NAHQ; 2013.
May-Jun;21(3):30-6.
31. Centers for Medicare & Medicaid Services. State operations
22. Lassiter S. Preventing infection: collaboration between surgical
manual, appendix A - survey protocol, regulations and interpretive
team members and infection preventionists. AORN J 2011
guidelines for hospitals. Rev. 151, 11-20-15. CMS website.
Feb;93(2):287-90.
2015. https://www.cms.gov/Regulations-and-Guidance/
23. Gagliardi AR, Eskicioglu C, McKenzie M, Fenech D, Nathens Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/
A, McLeod R. Identifying opportunities for quality improvement CMS1201984.html. Accessed April 30, 2018.
in surgical site infection prevention. Am J Infect Control 2009
Jun;37(5):398-402.

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 18

SECTION 2

PREVENTING SURGICAL
SITE INFECTIONS

Sterile Technique1-4
Important terms
Sterile technique is the foundation for prevention of
Sterile technique: The use of specific actions and
surgical site infections (SSIs). The following list contains
activities to prevent contamination and maintain
the primary principles of sterile technique. sterility of identified areas during a surgical or

△△Hand hygiene should be performed before and after other invasive procedure.

patient contact, before performing a clean or sterile Aseptic technique: Methods by which
task, after risk for blood or body fluid exposure, contamination with microorganisms is prevented.
after contact with patient surroundings, when hands
are visibly soiled, before and after eating, and after
using the restroom. published SSI prevention guidelines concur that
skin preparation solutions containing alcohol plus
△△Surgical hand antisepsis should be performed before another antiseptic (e.g., iodine, chlorhexidine)
donning sterile gowns and gloves for operative and provide the most effective immediate and sustained
other invasive procedures. antimicrobial effect.5-8 Correct application and

△△Personnel should wear a clean surgical mask

drying of the product is required to ensure optimal
antimicrobial efficacy and mitigate risk of fires
that covers the mouth and nose and is secured associated with alcohol-containing skin preparations.
in a manner to prevent venting when open
sterile supplies are present and when preparing, △△A sterile field should be prepared for patients
performing, or assisting with surgery and other undergoing surgical or other invasive procedures.
invasive procedures. Perioperative team members should place sterile

△△Preoperative patient skin antisepsis minimizes the

drapes on the patient, furniture, and equipment in
the sterile field and should handle them in a manner
number of microorganisms on the patient’s skin that prevents contamination. Only the top surface
prior to incision and should be performed. Hair of a sterile, draped area should be considered sterile.
removal at the surgical site should be performed Items that fall below the sterile area should be
only in select clinical situations. Skin antiseptic considered contaminated.
products should be purchased in single-use
containers. Only preoperative skin antiseptics △△Only sterile items should come in contact with
that meet Food and Drug Administration (FDA) the sterile field. Perioperative team members
requirements should be used. The four most recently should inspect sterile items for proper processing,

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Section 2 Preventing Surgical Site Infections | 19

packaging, and package integrity immediately before △△The number and movement of individuals involved
presentation to the sterile field. Prior to opening, in an operative or other invasive procedure should
the package or rigid sterilization container should be be kept to a minimum.

△△All members of the perioperative team are

inspected for seal integrity, holes, or intact filter (rigid
containers). Sterile packs should also be inspected
responsible for monitoring the sterile field.
for expiration dates; manufacturers have shelf-life
Breaks in sterile technique should be immediately
parameters for specific sterile wraps and dust covers
communicated and remedied.
of hospital sterilized packs. Humidity levels in sterile
storage supplies areas also affect shelf life of sterile
items. Packs should also be checked for dampness
△△Any reprocessed instruments on which tissue (bone,
hair, etc.) or debris is found should be considered
because high humidity levels can compromise contaminated and immediately removed from the
integrity. Chemical indicators (external and internal) sterile field, then returned for repeat reprocessing
should be inspected for appropriate change indicating to the Sterile Processing department (SPD). The
exposure to sterilization conditions. perioperative team should conduct a risk assessment

△△Medication Management is an important activity in to determine any further corrective action.

the perioperative setting. Infectious outbreak–related The role of the Infection Preventionist (IP) relative
perioperative breaches have occurred in medication to sterile technique should include observation during
preparation or administration in the perioperative cases and collaborating with perioperative leadership
setting. Medications and solutions are to be visually in planning performance improvement efforts when
inspected immediately before transfer to the sterile trends in breaches of sterile technique are noted.
field and are not to be used if the expiration date
has passed or if there is any indication that the OR Attire
medication or solution has been compromised
(e.g., discoloration, particulate formation). Stoppers Personnel entering the semi-restricted and restricted
should not be removed from vials for the purpose of (operating room, or OR) areas of the Surgery Suite
pouring medications unless specifically designed by should wear clean surgical attire, laundered in a
the manufacturer for such for removal and pouring. healthcare-accredited laundry in accordance with facility
Sterile transfer devices (e.g., sterile vial spike, filter policy. Personnel should don clean scrub attire daily.
straw, plastic catheter) should be used. Scrub attire that has been penetrated by blood, body

△△The sterile field should:

fluids, or other potentially infectious materials must be
removed immediately or as soon as possible and replaced
›› Be prepared in the location where it will be used, with clean attire. When extensive contamination of
and should not be moved the body occurs, the healthcare worker should take a
›› Be prepared as close as possible to the time of use shower or bath before donning fresh attire. Personnel
›› Never be left unattended. Once the sterile field should change into street clothes whenever they go
is opened, a member of the perioperative team outside of the building. The Occupational Safety and
should monitor at all times. Health Administration (OSHA) requires that PPE not
permit blood, body fluids, or other potentially infectious
△△Scrubbed team members should remain close to materials to pass through or reach the employee’s
the sterile field and touch only sterile areas or items. clothing, skin, eyes, or other mucous membranes under
Unscrubbed personnel should face the sterile field normal conditions of use.
on approach, should not walk between sterile fields
or scrubbed persons, and should maintain a distance When in the restricted areas, personnel who are
of at least 12 inches from the sterile field and nonscrubbed should cover their arms completely,
scrubbed persons at all times. such as with a long-sleeved scrub top or jacket. While

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 Section 2 Preventing Surgical Site Infections | 20

preparing and packaging items in the clean assembly and be secured in a manner that prevents venting at
section of the sterile processing area, the perioperative the sides of the mask. Masks should be changed when
or sterile processing team member should wear scrub soiled or wet and should be removed and discarded by
attire that covers the arms. handling only the mask ties. Masks should not be left
dangling around the neck. Hand hygiene should be
Surgical masks worn in the perioperative setting serve
performed after removal of masks.9
two purposes. First, they help protect the patient
and environment from microbial contamination by As stated earlier in this Implementation Guide,
organisms carried in the provider’s mouth or nose. practice issues where consensus is lacking and
Second, they provide protection for the wearer from peer-reviewed evidence is not definitive should
exposure to blood, body fluids, or other potentially be addressed by the Surgery Leadership Triad
infectious materials. Surgical masks in combination (perioperative nurse executive leader and chiefs of
with eye-protection devices such as goggles, glasses surgery and anesthesia) in consultation with the IPC
with solid side shields, or chin-length face shields must team. A notable, recent example of this involves the
be worn whenever splashes, spray, spatter, or droplets element of attire related to covering scalp and facial
of blood, body fluids, or other potentially infectious hair. Currently, the Association of periOperative
materials may be generated, and eye, nose, or mouth Registered Nurses (AORN) publication, Guideline for
contamination can be reasonably anticipated. A mask Surgical Attire, and the American College of Surgeons
should be worn where open sterile supplies are present. (ACS) Statement on surgical attire differ in the
The surgical mask should cover the mouth and nose amount of hair covering recommended.

A Statement from the Meeting of ACS, AORN, ASA, APIC, AST, and TJC

The American College of Surgeons (ACS), the American Society of Anesthesiologists (ASA), the Association
of peri-Operative Registered Nurses (AORN), the Association for Professionals in Infection Control
and Epidemiology (APIC), the Association of Surgical Technologists (AST), the Council on Surgical and
Perioperative Safety (CSPS); and The Joint Commission (TJC) met on February 27, 2018, to review and discuss
the literature related to recommendations for operating room (OR) attire, specifically ear and hair covering.

Over the past two years, as recommendations were implemented, it became increasingly apparent that
in practice, covering the ears is not practical for surgeons and anesthesiologists and in many cases
counterproductive to their ability to perform optimally in the OR.  Furthermore, in reassessing the strength
of the evidence for this narrowly defined recommendation, the group concluded the following:

△△Evidence-based recommendations on surgical attire developed for perioperative policies and procedures
are best created collaboratively, with a multi-disciplinary team representing surgery, anesthesia, nursing,
and infection prevention.

△△The requirement for ear coverage is not supported by sufficient evidence.

△△At present, available scientific evidence does not demonstrate any association between the type of hat
or extent of hair coverage and SSI rates. One recent study* on head coverings (disposable bouffant or
skullcap, cloth cap), identified that the commonly available disposable bouffant hat is the least effective
barrier to transmission of particles.

△△Other issues regarding areas of surgical attire need further evaluation.

*Markel TA, Gormley T, Greeley D, Ostojic J, Wise A, Rajala J, Bharadwaj R, Wagner J. Hats Off: A Study of Different Operating Room Headgear
Assessed by Environmental Quality Indicators. JACS 225(5): 573-581, 2017.

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 Section 2 Preventing Surgical Site Infections | 21

On February 27, 2018, APIC met with the ACS, AORN, professional organizations (e.g., the American
the American Society of Anesthesiologists, the Association Medical Association, American College of Surgeons,
of Surgical Technologists, and The Joint Commission Association of periOperative Registered Nurses,
to discuss the state of the evidence on surgical attire, Association for Professionals in Infection Control
specifically ear and head coverings. The group concluded and Epidemiology, etc.).”
through its review that at present, the evidence does not Note that the language above does not prescribe that
indicate the ideal amount of hair and scalp coverage or only one of organizations listed in the examples be used
best type of material for the head covering, nor does the to establish acceptable standards and policies. Therefore,
evidence indicate any association with head covering and the Leadership Triad is in the best position to identify
SSI rates. Furthermore, there is insufficient evidence to findings on which to base such policies.
require ear covering.
The AORN Guideline for Sterile Technique recommends:
The type of head covering will vary by individual “Scrubbed team members should wear two pairs of
practitioners in the amount of hair and scalp covered. surgical gloves, one over the other, during surgical and
Regulatory and accreditation agencies have cited providers other invasive procedures with the potential for exposure
for noncompliance. However, it is important to clarify if to blood, body fluids, or other potentially infectious
this noncompliance tracks to the facility’s policies or to materials. When double gloves are worn, a perforation
the cited source. The IPs will find themselves at the nexus indicator system should be used.”11 Use of an indicator
of this issue, as the primary rationale for covering scalp glove under a standard glove can help identify when
and facial hair is to prevent contamination of the surgical glove perforation has occurred. The 2016 SSI prevention
site. Issues tangential to a proscriptive requirement of guidelines from the American College of Surgeons and
all who enter the restricted area include enforcement Surgical Infection Society (ACS/SIS) concurs with this
of facility policy against need for a high-functioning recommendation, not only for the protection of the
collaborative perioperative team. The pathway toward surgical team, but for the patient as well.12
consensus is for the IP to participate in deliberations with
The benefits of double-gloving were first documented
the Surgery Leadership Triad and advise on development
in 1992 by a surgical team at the Medical College of
and revision of policy and work practices.
Wisconsin. The team found that by double-gloving,
The Centers for Medicare & Medicaid Services released surgeons were protected from blood contamination
the following Interpretive Guidance in its Surgical in the OR.13 In addition to this benefit, several other
Services Conditions of Participation (CoP) number studies have documented the efficacy of double-gloving
42 CFR 482.5110: in preventing transference of bacteria from surgeons’

△△“If the hospital provides surgical services, the hands through microperforations in the gloves to the
wound bed.
services must be well organized and provided in
accordance with acceptable standards of practice. If Mechanical stressors within the OR can lead to glove
outpatient surgical services are offered the services perforation and glove-barrier failure. Glove failure rates
must be consistent in quality with inpatient care in of 22 to 61 percent have been observed during various
accordance with the complexity of services offered… types of surgical procedures.14 While glove perforation
△△“Acceptable standards of practice include during laparoscopic surgery appears to occur at a
low frequency, glove perforation during orthopedic
maintaining compliance with applicable federal
and state laws, regulations, and guidelines governing procedures approaches 50 percent, increasing the risk of
surgical services or surgical service locations, blood exposure of the surgical team and of transference
as well as any standards and recommendations of bacteria from surgical team to the patient wound.15,16
promoted by or established by nationally recognized Double-gloving by anesthesia providers as well can

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 Section 2 Preventing Surgical Site Infections | 22

help protect the patient by reducing environmental Causes and Prevention of SSIs
contamination, because frequent contact with upper
The fundamental strategy for preventing SSIs involves
airway secretions and blood and body fluids can lead
reducing the vulnerability of the surgical wound to
to the potential contamination of anesthesia provider
contamination. This can be accomplished by selective
gloves and subsequently their surroundings (e.g., the
evidence-based practices, such as skin antisepsis.
laryngoscope, anesthesia machine, keyboards, stopcocks,
Other strategies include administering a prophylactic
and IV tubing). This contamination can involve both
antibiotic for certain cases per guidelines, use of an
skin commensal microbial populations and MDROs.
innovative wound protector to reduce wound-edge
A recent study has suggested that when an anesthesia
contamination during abdominal procedures, use of
provider wears two sets of gloves during laryngoscopy
isolation technique (changing of gloves and instrument
and intubation and removes the outer set immediately
sets prior to skin closure for extensive intra-abdominal
after intubation, contamination of the intraoperative
procedures), and enhancing the immune integrity of
environment can be significantly reduced (p<0.001).17
the patient through normothermia, glycemic control,
In addition to double-gloving, care must be taken and smoking cessation.18-21
to prevent percutaneous injury from other sources.
Effective SSI risk reduction should be viewed as
Successful strategies to prevent such injuries may include
a four-pronged approach, mitigating risk in the
blunt-tip suture needles, neutral zone, and engineered
pre-admission, pre-operative, intra-operative,
sharps injury prevention.
and postoperative periods.
SSI RISK FACTORS In the pre-admission period, a minimum of two (night
before, morning of surgery) showers/cleansings using
An SSI can occur through one or more of these a standardized process with 4 percent chlorhexidine
interrelated risk factors:
gluconate (CHG) aqueous soap or 2 percent CHG-
△△primarily
Microbial-related factors, which center
around bacterial virulence and
impregnated, no-rinse cloths has been shown to be an
antimicrobial resistance effective risk reduction strategy when combined with

△△Host-related factors, including multiple

comorbidities (e.g., obesity, diabetes, history
a number of other SSI prevention strategies.22 While the
surface of the skin can never be rendered sterile, use of
of corticosteroid therapy) a standardized evidence-based antiseptic preadmission
△△Intra-operative risk factors, which include
perioperative team factors, operative technique,
shower/bath will result in several log reductions of typical
Gram-positive and Gram-negative surgical wound
organizational and management factors, and
pathogens, including methicillin-resistant Staphylococcus
the operating room environment

△△Postoperative
aureus (MRSA) and other drug-resistant bacteria.23
care-related factors, such as
inadequate postoperative wound management, The 2017 guidance from AORN and the federal
which can adversely impact outcomes once a Healthcare Infection Control Practices Advisory
patient leaves the operating room.
Committee (HICPAC) recommend use of soap or an
antiseptic for pre-operative cleansing. The rationale for
this option is absence of definitive evidence that antiseptic
cleansing as a single intervention can lessen risk of SSIs.

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 Section 2 Preventing Surgical Site Infections | 23

Intra-operative contamination leading to a postoperative The mechanistic risk of infection in the postoperative
SSI can occur by a variety of mechanisms, including:24 period can be associated with failure to adequately

△△Dispersion of microbial aerosols within the vicinity

manage the surgical wound, leading to possible
wound contamination and/or dehiscence. The sterile
of the surgical wound during the intra-operative
dressing should remain intact for 48 hours if there is
period (exacerbated by excessive room traffic, which
can disrupt microbes) no evidence of infection. In the absence of excessive
discharge, members of the postoperative care team
△△Contaminated OR air, alteration in OR air should refrain from repeatedly lifting the edges of
differential (positive pressure), reduced velocity the dressing to observe the incision within the first
(air changes), or excessive humidity 48 hours, since this can lead to possible wound
△△Contamination of the wound bed by endogenous contamination and delayed healing. There is some, but
host flora originating from the sebaceous glands not conclusive, evidence of advantage of antimicrobial
at the time of surgical incision dressings over regular occlusive or gauze dressings.
△△Insertion of a contaminated biomedical device However, further studies are warranted as new wound
or use of surgical instruments that have been care technologies become available.
inadequately cleaned or sterilized
Successful prevention of SSIs involves many moving
△△Contamination of the fascial or subcuticular tissues parts and people—starting with the patient—including
by the hands of surgical team members during the surgical team and the consultative assistance of
bowel manipulation/resection the IP and the Infection Prevention and Control
△△Failure to adequately irrigate the surgical wound prior department. By keeping pace with the constantly
to closure or use of contaminated irrigation solution evolving products and practices designed to prevent
△△Failure to deliver the correct weight-based surgical infections, the IP and the IPC department
antimicrobial prophylaxis or neglecting to re- dose can provide this information to the perioperative team
the patient during surgical procedures lasting more during the surgical case observation process, during
than 3 hours committee meetings, and during informal interactions
△△Any inadvertent break in aseptic technique by with surgical team members.
a member of the surgical team

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 Section 2 Preventing Surgical Site Infections | 24 Section 2 Preventing Surgical Site Infections | 25

2016-2017 Evidence-Based SSI Guidelines

FIGURE 2
Intervention Details and rationale CDC Wisconsin
COMPARISON OF SSI PREVENTION KEY WHO ACS/SIS
HICPAC DPH
GUIDELINES 2016-2017 CDC: IA, IB, IC, II, NR (no recommendation); with IA as strongest Ortho and
Pre-op nasal screen for MSSA, MRSA Yes Strong
The four most recent evidence- recommendation. Nasal screening
cardiac

based SSI prevention guidelines and decolonization Mupirocin x 5 days Yes Strong Yes
Wisconsin DPH: Yes means support, No means don’t support, and NR;
come from the CDC, the Wisconsin with Yes as strongest. Antiseptic (alcohol or PVI) immediately pre-op Yes
Division of Public Health, the Hair removal
WHO: Strong, Conditional, and NR; with Strong as strongest. by clipping
Remove hair only when necessary—and by clipper vs. razor Strong Yes
World Health Organization, and
the American College of Surgeons/ ACS/SIS: Yes means support, No means don’t support, and NR; with Use skin prep containing alcohol plus PVI or CHG IA Yes Strong Yes
Surgical Infection Society. Yes as strongest. Alcohol plus iodine or alcohol plus CHG IA Yes
Alcohol-based skin
Green shading highlights where these antiseptic agent Alcohol plus iodine
guidelines concur. Alcohol plus CHG
Prep mucous membranes (e.g., genital) to ensure
2016-2017 Evidence-Based SSI Guidelines Yes
bactericidal effect
Intervention Details and rationale Mucous membrane
CDC Wisconsin
WHO ACS/SIS surgical prep CHG
HICPAC DPH
PVI
Scrub with either alcohol-based brushless product or
Surgical hand For patients with normal pulmonary function undergoing
antimicrobial solution with brush, to reduce resident and Strong
scrub general anesthesia with endotracheal intubation, administer
transient hand flora.
an increased fraction of inspired oxygen (FiO2) both
Wear long sleeves, masks, gloves to cover all skin and hair to Supplemental O2 intraoperatively and post-extubation in the immediate IA Yes Strong Yes
reduce shedding of skin scales, hair, and respiratory aerosols to Yes postoperative period. To optimize tissue oxygen delivery,
Surgical team attire reduce risk of wound contamination. maintain perioperative normothermia and adequate volume
Double-glove for surgeon to reduce risk of migration of replacement; data strongest for colorectal surgery.
NR Yes
bacterial through microperforations Minimally invasive
To minimal incision size and reduced operative time Yes
Consistent engineering controls (positive pressure, 20 ACH, surgery
humidity, temperature, HEPA) and traffic control to reduce risk Yes Yes Wound edge To protect subcuticular tissue from contamination for
OR air quality of implant contamination Yes Conditional Yes
protector abdominal procedures
Laminar air flow NR To eliminate any contaminants introduced during case Yes
Blood loss Balanced Yes, PVI –
Eliminate the immunosuppressive effect of blood transfusion NR Surgical irrigation
prevention approach Antiseptic (PVI, chlorhexidine) irrigation II (PVI) 0.85%; CHG Conditional
prior to closure
Improve tissue granulocytic cell function and wound healing Yes, – 0.05%
Glycemic control by maintaining a mean perioperative blood glucose level <200 IA alternative Conditional Yes Antibiotic irrigation NR Do not use Do not use
mg/dl in diabetic and nondiabetic surgical patients Ha1c <6.7
Sterile glove
Normothermia Diminish blood loss, increase O2 tissue perfusion IA Yes Conditional Yes To reduce risk of sound contamination, for colorectal, selective
change prior to Yes NR Yes
OB/GYN, orthopedic and other device-related procedures
Enhance nutritional status with oral or enteral multiple nutrient- wound closure
Nutritional support Conditional
enhanced nutritional formulas. Dedicated sterile To reduce wound contamination, for colorectal, selective OB/
PAB for clean contaminated, contaminated and dirty cases, Strong instrument tray for GYN, orthopedic and other device related procedures to reduce Yes NR Yes
in addition to high-risk clean cases within 60 minutes prior to (within 120 wound closure risk of instrument contamination for fascia and skin closure
IB Yes Yes
incision to ensure bactericidal concentration of the agents is minutes of Yes, use
established in the serum and tissues when the incision is made incision) Yes, multiple
for the Yes, clean
Prophylactic evidence-
Adjust the PAB dose based on the patient’s weight in obese prevention and clean-
antibiotic (PAB) IB Yes Yes Antimicrobial based meta-
and morbidly obese patients To reduce SSI risk in selective surgical patients II of SSI contaminated
(triclosan) sutures analysis
regardless abdominal
Re-dose for prolonged cases to ensure adequate tissue documents
NR Yes Yes of surgical procedures
concentration as IA
procedure
Administer NO further doses after incision is closed IA Yes Strong Yes
To reduce post-operative contamination of would prior to
NR Yes Conditional
Oral antibiotic / wound edges healing
Bowel prep prior to colorectal surgical procedures both oral
mechanical bowel Yes Strong Yes Aseptic post-op
antibiotic and mechanical to reduce wound contamination Aseptic Yes
prep dressing
Antiseptic-impregnated Do not use
For reduction of resident and transient skin flora IB Yes Conditional No
Pre-op patient Negative-pressure wound dressing Conditional Yes
With bland soap IB Conditional
bathing
With CHG Yes Sources: Centers for Disease Control and Prevention5, Wisconsin Division of Public Health6, World Health Organization7, American College
of Surgeons/Surgical Infection Society8

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 Section 2 Preventing Surgical Site Infections | 26

The appendix from the 2017 guidelines from the and prompt removal of urinary catheters can mitigate risk
Centers for Disease Control and Prevention (CDC) of urinary tract infection.27
also provides a review of specific recommendations
Peripheral and central catheter-associated bloodstream
for orthopedic surgery, as well as re-addressing 1999
infections are also a risk for those who require a vascular
recommendations such as airflow and ventilation.
access device.27 Infection can result from introduction
of organisms during catheter insertion or during
Preventing Other Healthcare-
maintenance of the device while in place. Prevention
Associated Infections
focuses on aseptic technique during insertion and
Adverse outcomes after a surgical procedure can measures to eliminate contamination while the catheter
include not only SSIs but also CAUTI, CLABSI, and is in place. In the operating room, this includes use
postoperative pneumonia. APIC Implementation Guides of closed (versus open) stop cocks, scrubbing the hub
provide a prescribed evidence-based approach to the prior to injection of any medication, and/or use of hub
prevention of these HAI.25 Additionally, collaborative protector/disinfection caps.28,29
strategies have proven to be effective in reducing both
Postoperative pneumonia, meanwhile, is a risk for any
SSIs and device-associated HAIs. Three key examples
patient who receives general anesthesia. This is due
are The Joint Commission’s Surgical Care Improvement
to the process of intubation and extubation, and the
Project (SCIP), Enhanced Recovery After Surgery
associated risk of aspiration of secretions containing
(ERAS), and Fast-Track Surgery (FTS) protocols.26
oral bacteria into the lungs. Prevention focuses on hand
Care should be taken when patients require a urinary hygiene for anesthesia providers performing intubation
catheter. In surgery, as elsewhere in healthcare, a CAUTI and extubation and while providing ventilation during
can develop as a result of contamination during insertion the surgical procedure. Prevention may also include
or while the catheter is in place. Prevention focuses preoperative oral rinsing with an antiseptic solution, such
on aseptic insertion technique as well as measures to as chlorhexidine, and postoperative incentive spirometry
eliminate contamination while the catheter is in place, and early ambulation.30 These collaborative approaches
such as keeping the urine bag off the floor and below the to perioperative care have been proven to reduce lengths
level of the bladder. There is evidence that awareness of of stay and postoperative HAIs.

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Section 2 Preventing Surgical Site Infections | 27

IMPLEMENTATION STRATEGIES FOR THE IP

△△Offer to provide infection prevention–related educational/in-service sessions for staff.

△△Coordinate with the perioperative team for IPs to observe surgical cases.
△△Collaborate to develop an observation checklist (with surgical, nursing, and anesthesia input) to ensure
agreement and engagement regarding the observation process, including when and how observation
summaries should be shared.

△△Regularly engage perioperative team members, including surgeons, to get input on the greatest
opportunities for reducing SSIs and other HAIs.

△△Include perioperative staff in clinical case reviews when a patient develops an SSI.
△△Provide actionable infection data to OR teams and collaborate on root-cause analysis.
△△Consider developing an Infection Prevention Resource Nurse program to support career-ladder
development for perioperative nurses interested in learning more about SSI prevention.

△△Formally recognize and acknowledge best practices in SSI prevention on the part of perioperative teams
and team members (e.g., a letter to the local executive team).

△△Look beyond the obvious causes of SSIs (e.g., inadequate antimicrobial prophylaxis, obesity, diabetes,
hyperglycemia, hypothermia, and surgical technique), remaining inquisitive in order to determine the root
cause of each surgical infection.

△△Identify a perioperative team champion (e.g., surgeon, nurse, or anesthesia provider) for any new product
or practice.

△△Use a patient story to engage a champion, or the whole department. See Tools and Resources for a
collection of patient stories.

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 Section 2 Preventing Surgical Site Infections | 28

TOOLS AND RESOURCES

△△APIC Implementation Guides—Practical, evidence-based strategies for surveillance and the elimination
of infection, each with online tools and resources; 12 publications. https://bit.ly/2wwIGw1

△△7S SSI Prevention Bundle—A seven-step approach to preventing surgical site infections, developed
by IP consultant Maureen Spencer, RN, BSN, MEd, CIC, FAPIC. https://bit.ly/2Kgb73w

△△HAI Prevention Plus Measures Toolkit (SSI Prevention chapter) AN IP resource when assessing/expanding
infection prevention programs, with “plus measures,” or those supported by less than category 1 evidence,
developed by Sue Barnes, RN, CIC, FAPIC, independent clinical consultant, infection prevention and control.
https://bit.ly/2wxX4Er

△△“Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection,
2017”—Updated evidence-based recommendations for prevention of SSI from the CDC. Provided by APIC
https://bit.ly/2IgUPXh

△△“Global Guidelines for the Prevention of Surgical Site Infection”—WHO guidelines for the prevention
of surgical site infection, published November 2016. Provided by APIC https://bit.ly/2wxm4M2

△△American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016
Update—Full text of article with guidelines for prevention, detection, and management of surgical site
infections, published 2016. Provided by APIC https://bit.ly/2rDlzdx

△△“Wisconsin Division of Public Health Supplemental Guidance for the Prevention of Surgical Site
Infections: An Evidence-Based Perspective”—25-page book of prevention recommendations, published
2017. Provided by APIC https://bit.ly/2IcpuJp

△△2017 HICPAC-CDC Guideline for Prevention of Surgical Site Infection: What the IP Needs to Know—
Open-access, three-page article from APIC’s Prevention Strategist magazine, breaking down the guidelines
and summarizing top points and action items for IPs. Provided by APIC https://bit.ly/2wFT2d6

△△APIC Position Paper on safe injection practices—Recommendations for injection, infusion, medication vial,
and point-of-care testing practices; 2016. https://bit.ly/2KfuCcs

△△ACS Paper on sharps safety—Statement from the American College of Surgeons on practices for sharps
injury reduction; 2016. https://bit.ly/2rGT5Rd

△△CDC safe injection practices—Collection of guidelines, slide presentations, FAQs, and publications on
injection safety. https://www.cdc.gov/injectionsafety/index.html

△△SSI Template Review—Checklist for reviewing a surgical site infection incident, from Highland Hospital,
University of Rochester Medical Center. Provided by APIC https://bit.ly/2ryQGrG

REFERENCES:
1. Rothrock, J. Alexander’s Care of the Patient in Surgery, 14th ed. 5. Berríos-Torres, S et al. for the Healthcare Infection Control Practices
St. Louis, MO: Elsevier Mosby; 2011. Advisory Committee. Centers for Disease Control and Prevention
guideline for the prevention of surgical site infection, 2017. JAMA
2. Association of periOperative Registered Nurses. AORN Guidelines
Surg August 2017;152(8):784-791.
for Perioperative Practice. Denver, CO: AORN, Inc.; 2017.
Available from: https://www.AORN.org. 6. Edmiston C. et al. Wisconsin Division of Public Health supplemental
guidance for the prevention of SSI: an evidence based perspective.
3. Phillips, NF, Berry, EC. Berry & Kohn’s Operating Room Wisconsin Division of Public Health website. January 2017.
Technique, 11th ed. St. Louis, MO: Elsevier; 2007. https://www.dhs.wisconsin.gov/publications/p01715.pdf.
4. Dalstrom DJ, et al. Time-dependent contamination of opened Accessed April 30, 2018.
sterile operating-room trays. J Bone Joint Surg Am 2008;90:1022-5. 7. World Health Organization. WHO Global Guidelines for the
Prevention of Surgical Site Infection. Geneva [Switzerland]:
World Health Organization; 2016. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK401132/

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 Section 2 Preventing Surgical Site Infections | 29

8. Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, 21. Thomsen T, Tønnesen H, Møller AM. Effect of preoperative smoking
Fry DE, Itani KMF, Dellinger EP, Ko CY, Duane TM. American cessation interventions on postoperative complications and smoking
College of Surgeons/Surgical Infection Society surgical site cessation. British Journal of Surgery 2009;96:451-461.
infection guidelines-2016 update. Surg Infect (Larchmt) 2017 22. Edmiston CE, Krepel C, Spencer M, Lee CJ, Malinowski M, Brown
May/Jun;18(4):379-382. KR, Rossi PR, Lewis BL, Seabrook GR. Evidence for preadmission
9. Association of periOperative Registered Nurses. AORN Guideline for showering regimen to achieve maximal antiseptic skin surface
Surgical Attire. In: Association of periOperative Registered Nurses. concentrations of chlorhexidine gluconate, 4% in surgical patients.
AORN Guidelines for Perioperative Practice. Denver, CO: AORN, JAMA Surg 2015;150:1027-332.
Inc.; 2017. p. 105-128. 23. Edmiston CE, Krepel CJ, Spencer, M, Ferraz AA, Seabrook GR,
10. Center for Medicare & Medicaid Services. Interpretive guidance Lee CJ, Lewis BD, Brown KR, Rossi PR, Malinowski M, Edmiston
from CMS in its surgical services CoP # 42 CFR 482.51. CMS SE, Ferraz EM, Leaper D. Preadmission application of 2%
website. 2017. https://www.cms.gov/Regulations-and-Guidance/ chlorhexidine gluconate (CHG): enhancing patient compliance while
Guidance/Manuals/downloads/som107ap_a_hospitals.pdf. maximizing skin surface concentrations. Infect Control Hosp Epidemiol
Accessed April 30, 2018. 2016;37:254-259.
11. Association of periOperative Registered Nurses. Sterile technique. 24. Edmiston CE, Seabrook GR, Cambria RA, Brown KR, Lewis BD,
In: Association of periOperative Registered Nurses. AORN Guidelines Sommers JR, Krepel CJ, Wilson PJ, Sinski S, Towne JB. Molecular
for Perioperative Practice. Denver, CO: AORN, Inc.; 2017. epidemiology of microbial contamination in the operating room
12. Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, environment: is there a risk for infections? Surgery 2005;138:572-588.
et al. American College of Surgeons and Surgical Infection Society: 25. Association for Professionals in Infection Control and Epidemiology.
surgical site infection guidelines-2016 update. J Am Coll Surg APIC Implementation Guides: Prevention of Central Line-Associated
2017;224:59-74. Bloodstream Infections, Hand Hygiene, Preventing Catheter-
13. Birnbach DJ, Rosen LF, Fitzpatrick M, Carling P, Arheart KL, Associated Urinary Tract Infections, Elimination of Orthopedic
Munoz-Price S. Double gloves: a randomized trial to evaluate Surgical Site Infections, Prevention of Mediastinitis Surgical Site
a simple strategy to reduce contamination in the operating room. Infections Following Cardiac Surgery. APIC website. Available at:
Anesth Analg 2015 Apr;120(4):848-52. https://www.APIC.org. Accessed April 30, 2018

14. Quebbeman EJ, Telford GL, Wadsworth K, Hubbard S, Goodman 26. Grant MC, Yang D, Wu CL, Makary MA, Wick EC. Impact
H, Gottlieb MS. Double gloving: protecting surgeons from blood of enhanced recovery after surgery and fast track surgery pathways
contamination in the operating room. Arch Surg 1992;127:213-217. on healthcare-associated infections: results from a systematic review
and meta-analysis. Ann Surg 2017 Jan;265(1):68-79.
15. Thomas-Copeland J. Do surgical personnel really need to double
glove? AORN J 2009; 89:322-328. 27. Okrainec A, et al. Compliance with urinary catheter removal
guidelines leads to improved outcome in enhanced recovery after
16. Yinusa W, Li YH, Chow W, Ho WY, Leong JC. Glove punctures surgery patients. J Gastrointest Surg (2017) 21:1309–1317.
in orthopedic surgery. Int Orthop 2004;28:36-39.
28. Cole DC1, Baslanti TO, Gravenstein NL. Leaving more than your
17. Birnbach DJ, Rosen LF, Fitzpatrick M, Carling P, Arheart KL, fingerprint on the intravenous line: a prospective study on propofol
Munoz-Price S. Double gloves: a randomized trial to evaluate a simple anesthesia and implications of stopcock contamination. Anesth Analg
strategy to reduce contamination in the operating room. Anesth 2015 Apr;120(4):861-7.
Analg 2015 Apr;120(4):848-52.
29. Kamboj M1, Blair R1, Bell N1, Son C1, Huang YT2, Dowling M3,
18. Anderson DJ, Podgorny K, Berríos-Torres SI, Bratzler D, Dellinger Lipitz-Snyderman A4, Eagan J1, Sepkowitz K1. Use of disinfection
EP, Greene, L, et al. Strategies to prevent surgical site infections in cap to reduce central-line-associated bloodstream infection and blood
acute care hospitals: 2014 update. Infect Control Hosp Epidemiol 2014 culture contamination among hematology-oncology patients. Infect
35: 605-627. Control Hosp Epidemiol 2015 Dec;36(12):1401-8.
19. Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, 30. Lin YJ1, Xu L2, Huang XZ2, Jiang F2, Li SL2, Lin F2, Ye QY2,
et al. American College of Surgeons and Surgical Infection Society: Chen ML2, Lin JL2. Reduced occurrence of ventilator-associated
surgical site infection guidelines-2016 update. J Am Coll Surg pneumonia after cardiac surgery using preoperative 0.2%
2017;224:59-74. chlorhexidine oral rinse: results from a single-centre single-blinded
20. Edmiston C. et al. Wisconsin Division of Public Health supplemental randomized trial. J Hosp Infect 2015 Dec;91(4):362-6.
guidance for the prevention of SSI: an evidence based perspective.
Wisconsin Division of Public Health website. January 2017.
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Accessed April 30, 2018.

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 30

SECTION 3

UNDERSTANDING
THE OR ENVIRONMENT
The operating room (OR) is a space designed for of the infrastructure were not functioning according to
conducting surgical procedures. Typically, a number design. It is a persistent challenge that among facilities
of ORs are organized into a suite of three major zones: investigating outbreaks or elevated surgical site infection
unrestricted, semi-restricted, and restricted. Surgical (SSI) rates, the operating room is routinely considered
procedures are routinely conducted in many different as a potential source, despite the paucity of evidence
spaces in acute care and outpatient settings. Surgery suggesting that it is a risk factor when compared to all
occurs in areas including intensive care units, trauma other variables.2
rooms, interventional radiology suites, MRI rooms, and
Many years of experience and thought have gone into
physician offices. Additionally, for maximum capacity,
the design of operating rooms in order to optimize
facilities may license operating room space. These spaces
surgical team functioning and patient outcomes.
(e.g., the cardiac catheterization lab) are never, however,
Knowledge and practices have been codified in a series
used as operating room suites.
of building codes and design standards, which direct
This Implementation Guide addresses only those spaces how new operating rooms are built.3 For example, if an
designed to be and functioning as operating rooms. operating room has a design standard to operate between
This includes not only ORs but also a newer generation 65° and 72°F, the operating room heating, ventilation,
called “hybrid operating rooms,” which combine the and air conditioning (HVAC) system must be built to
operating room with another service (e.g., MRI). Hybrid maintain a temperature in that range. Additionally, a
operating rooms allow for more complex surgeries and design standard or building code for new construction
provide access to useful technologies while maintaining or renovation applies only to the edition and year
the protective environment of the OR. As far as possible, enforced by the Authority Having Jurisdiction (AHJ)
operating/surgical cystoscopy rooms, operating rooms in the state in which this OR/Surgery Suite is located.
class b & c, and delivery rooms licensed for cesarean This means, for instance, that an operating room built in
sections are regarded as equivalent. In addition, this 1970 and remodeled in 1994 need comply only with the
section focuses on elements in the OR that have a direct building code for 1994, unless regulations explicitly state
impact on infection risk. that all operating rooms must be upgraded to any newer
The operating room environment has been identified standards. A given operating room cannot be held to the
by some as a risk factor for infection for patients newest code and standards. However, once the operating
undergoing surgical procedures.1 However, a review of room or Surgery Suite is built and commissioned for
the literature finds that in such events, certain elements use, it transitions to the domain of operational aspects.

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 Section 3 Understanding the OR Environment | 31

When there is a variance in the HVAC performance For maintaining temperature and humidity levels once
parameters, the Association of periOperative Registered a space has been occupied, the most-often cited clinical
Nurses (AORN) recommends that the perioperative team, practice guidelines are the AORN Guideline for a Safe
including the IP, perform a risk assessment to determine Environment of Care, Part 210 and the Association for
whether any corrective measures should be taken.4 Design the Advancement of Medical Instrumentation (AAMI)
standards are not developed using the same level of guide ST79: Comprehensive Guide to Steam Sterilization
scientific review as practice guidelines. Expert experience and Sterility Assurance in Health Care Facilities.11
and economics, however, play a large role.
OR Air and Infection Risk: Air Quality
Design standards for operating rooms address several
factors: those related to air, such as air-pressure Air is known to contain particles on which
relationships, temperature, and relative humidity; microorganisms can reside. There is evidence to suggest
those of the space itself, such as traffic and door and that these airborne contaminants can cause SSIs.12,13
ceiling design; and cleanability. The HVAC standards Recent studies using a model prototype that mimics
cover the source of the air, filtration and flow of the air, conditions during surgery on a human have found
and the relationship between the air supplied to the notable differences between ORs in deposition and
room and the air exhausted from the room. Ranges for clearance of particles and bacteria. Interestingly, these
temperature and humidity also are provided. Structural studies demonstrated that the mayo stand or back table
design that impacts traffic patterns and plumbing (e.g., used to stage sterile instruments was contaminated
clinical flush sinks) are determined. Cleanable surfaces with high levels of particulates and microbes during
are essential to an operating room, and standards around the procedure. Such investigations provide important
this speak not only to the surface design but also to the perspective regarding sources of airborne contamination
materials used in the space.5-7 in the OR.14
The air source in the OR must, therefore, be as free as
Standards for HVAC possible from microorganisms. The established standard
Air quality, air flow, air pressure, temperature, and for operating rooms requires 20 air changes/hour, of
humidity in the rooms that make up the Surgery Suite which at least four come from outdoor air.15
are interrelated—and all tied to the function and design Fungi are routinely present in air from the outside
of the HVAC system. environment, so this source air is filtered and
For the OR and the Sterile Processing department conditioned prior to supplying the OR. The filters for
(SPD), the standard for HVAC system design and supply air are rated on a minimum efficiency reporting
construction most often cited by surveyors is ANSI/ value scale, or MERV. The higher the MERV, the more
ASHRAE/ASHE Standard 170-2013: Ventilation of efficient the filter. Recommended MERV ratings for the
Health Care Facilities, known as ASHRAE 170.8 These OR are included in the FGI guidelines.16
standards were developed by the American National When a HEPA (high-efficiency particulate air) filter,
Standards Institute (ANSI), the American Society of typically of MERV rating 17 to 20, is used, air is
Heating, Refrigerating, and Air-Conditioning Engineers often referred to as “ultra-clean.” In published studies,
(ASHRAE), and the American Society for Healthcare ultra-clean air has been reported to achieve less than
Engineering (ASHE). The guidance was incorporated 10 colony-forming units per meter cubed (CFU/
as part of the 2014 Facility Guidelines Institute (FGI) m3) of bacteria. In order to determine whether a
Guidelines for Design and Construction of Hospitals and given operating room ventilation system is achieving a
Outpatient Facilities.9 certain range of CFU, air sampling must be performed.

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 Section 3 Understanding the OR Environment | 32

Unfortunately, the United States has not established rationale for this design is to have clean air enter high,
a standard method for testing OR air quality.17 and contaminated air exit by the feet, thus moving clean,
In today’s operating rooms, implants are being placed filtered air toward the operative field. If the design were
by those in many surgical specialties, including plastics, reversed, clean air from the floor, likely contaminated,
spine, general (e.g., hernia mesh), OB-GYN (e.g., would be directed upward to be exhausted, and could
pelvic floor mesh), and cardiac (e.g., pacemakers, potentially contaminate the surgical field. When this
stents, valves, and IADs). While orthopedic surgeons directional airflow meets certain specifications, it is
are typically sensitive to the potential patient risk considered “unidirectional airflow.”
posed by implants, other surgical services are often less Unidirectional airflow also requires that air move at
informed. The risk of contamination by bacteria-laden the same speed and in the same direction, with no or
particles increases during implant procedures because minimal crossover of air streams (a condition also called
the patient’s immune system is primarily focused on “laminar”). HEPA refers to the efficiency of air filtration
the implant (foreign body) rather than on any bacteria. of circulating particulates. Laminar airflow (LAF)
In addition, there is the matter of bacteria possibly specifications include “a canopy of approximately 18
contaminating the implant and adhering to it. Bacteria inches high and approximately 10 feet square attached
multiply more slowly on implant surfaces, which further to the ceiling [and] containing a full diffuser to focus
slows the body’s recognition of the contamination.18 and direct the filtered air plenum downward over the
This phenomenon has been reported regarding vascular wound site and the immediate surgical team [at] a
grafts, where infection symptoms can be delayed for up downward air speed of approximately 75 feet per minute
to months after the surgery.19,20 with a circulation rate of approximately 450 changes per
Consequently, SSIs involving an implant can result from hour.” By contrast, turbulent airflow creates swirls and
even a minimal microbial inoculum.21,22 In nonimplant eddies that deposit particles on surfaces randomly and
surgeries, an SSI typically results from bacterial unpredictably.28,29
contamination of not less than 100,000 CFU; but Another important factor in OR air and SSI infection
with an implant, the inoculum resulting in an SSI risk is air pressure. The standard air-pressure differential
can be as low as 100 CFU.18,23,24 for operating rooms is positive pressure: A positive
At present, microbial contamination of air in the OR is an pressure environment means air flows out of the OR and
under-appreciated factor in selective biomedical device- into surrounding rooms. This is generally accomplished
associated infections. The stringent air quality standards by supplying more air to a room than is exhausted from
enforced among the pharmaceutical and computer the room, forcing supplemental air out.
industries may prove useful as models. A recent report has The standard approach to measuring a room’s air-
suggested that future consideration be given to research pressure status is to measure supply against exhaust.
into OR air quality by testing the feasibility of HVAC- This approach does not account, however, for the
implemented designs according to ASHRAE 170 using surrounding area’s pressure, which, if insufficient, can
both simulated surgical procedures and equipment that result in air flowing back into a positive-pressure room.
mirrors activity during a typical device-related surgical The logic of positive pressure reducing SSIs is as follows:
procedure, such as a total joint arthroplasty.25-27 If air can carry bacteria and fungi, then maintaining a
pressure difference that prevents additional bacteria from
Air Flow and Air Pressure entering the room should reduce SSI risk. This logic is
Air flow plays a role in air quality. ORs are typically also put into place in “clean room” environments such
designed so that air flows into the top area of the room as compounding pharmacies. The 1999 SSI prevention
and is exhausted at the bottom of the room. The guideline from the Centers for Disease Control and

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 Section 3 Understanding the OR Environment | 33

Prevention (CDC) lists the recommendation as The normal protection of the surgical field was disrupted
a category IB and cites only one paper.30 by the fan’s exhaust air, meaning that the room’s
Positive pressure is addressed in the 2017 CDC ventilation design was disturbed by the machine; and
guideline supplemental with a statement that the the air did not flow from outside the room but from
issue was readdressed as a re-emphasis of several 1999 inside the room, so a positive-pressure environment
recommendations and asserting the importance of OR offered no protection to the patients.35 These incidents
ventilation. In addition, a comprehensive literature make clear that issues such as local air disruptions caused
review in the 600-page supplemental addresses laminar by equipment cooling fans should be more carefully
flow. The CDC Environmental Infection Control considered in the OR environment.
Guidelines repeats the single paper as the sole citation Efficacy of complete air changes is also dependent on
on patient outcomes.31 That paper looked solely avoiding blockage of return air grills in the OR. Often,
at orthopedic procedures. While the authors saw a equipment placed in front of such grills results in
reduction of SSIs as the purity of the air in the OR inadvertent disruption of proper functioning.
increased, they had simultaneously made other changes
to their surgical approach, such as increased use of When a patient is known to have active tuberculosis
prophylactic antibiotics to prevent SSIs in orthopedic (TB), OR ventilation systems must be adjusted. Indeed,
surgery.32 There is a need for much more rigorous studies operating rooms have been identified as an area where
on the current recommendations regarding air quality in tuberculosis can be acquired if air pressure is positive
the OR environment.33 instead of negative as directed by CDC.36 To mitigate
the risk of TB from known or suspected cases, some
Thus, while national design guidelines agree that ORs
institutions require OR use of a portable HEPA filter.
should be positive-pressure environments, no outcome
One study demonstrated that the room airflow was
data support that such interventions provide any
disrupted by the HEPA filter, thereby potentially
reductions in SSI rates. This should not be surprising,
increasing the SSI risk to the patient—and, additionally,
given that the patient’s own microbiome and the
providing no protection for those outside the OR.37
surgeon’s microbiome would be expected to comprise
the vast majority of organisms present at the surgical An HVAC system requires significant consumption
field during surgery. When quantitative counts of of energy during the course of the scheduled surgery
the patient’s own microbiome and the surgeons are shifts. The ASHRAE 170 standard does permit “set-
conducted, one can easily see the numbers of pathogens back” of the HVAC when the OR is not in use. This
measured in the air are dwarfed by comparison. technique reduces energy consumption but maintains
That isn’t to say that airflow patterns are completely the proper pressure relationship, i.e., the OR has
irrelevant to surgical infection risk. Indeed, one recent positive pressure with respect to the adjacent areas
outbreak demonstrated that contaminated air does and corridor. The ASHRAE 170 standard includes the
pose a risk to patients undergoing surgery.34 In an M. following guidance:
chimaera outbreak in open-heart surgical patients,
several factors associated with OR air appear to have
△△“…Design of the ventilation system shall provide
air movement that is generally from clean to less-
led to the SSI cases. The first: The specific make and clean areas. If any form of variable-air-volume
model of the heater/cooler machines were contaminated or load-shedding system is used for energy
before arriving at the facility. Second, the cooling fan conservation, it shall not compromise the pressure
blew directly over the surgical field machine exhaust balancing relationships or the minimum air
containing the pathogen. This compounded the risk: changes required…”

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 Section 3 Understanding the OR Environment | 34

OR Temperature Handling Humidity Issues

Temperature in the OR is another factor considered when Temperature and humidity combined can pose a
discussing infection risk. Although temperature variations real infection risk to patients. Cold air can enter the
are sometimes cited as infection control failures during OR through the HVAC system at temperatures well
accreditation surveys, evidence suggesting a relationship below the design temperatures so that it can cool the
between ambient room temperature in the OR and room to an acceptable range. However, if such cool
infections is weak to nonexistent. Overt sweating by air combines with high humidity, condensation can
the surgical team with dispersal onto the operating field result. Condensation can form on walls and other
would of course increase the risk of wound contamination surfaces, increasing contamination risk. Current
and infection. The temperature point at which a surgeon guidance prescribes 20 to 60 percent relative humidity
sweats is driven by a number of variables including but for operating rooms.40 Issues around humidity largely
not limited to physical fitness, weight, age, the amount of echo those around temperature; thus, the Joint Interim
exertion during the procedure, heat given off by surgical Guidance addresses both. Low humidity may impair
lights, the body’s ability to dissipate heat, and hormonal some bacteria’s ability to reproduce over long periods
state. Design standards for operating rooms recommend a of time, though this has not been shown to be relevant
temperature of 68° to 75° F, but also allow for flexibility.38 in regard to SSI. Low humidity can, however, increase
fire risk, which can be a true threat in the OR.
The ASHRAE 170 standard states: “Surgeons or surgical
procedures may require room temperatures, ventilation To reiterate, although humidity poses no infection risk
rates, humidity ranges, and/or distribution methods that to the patient, it can pose other risks. Low and high
exceed the minimum indicated ranges.” A suggested humidity can impair the accuracy of measurements
reason for lower OR temperatures is the common taken using electrical conductivity. Over a long period
misconception that lower temperatures retard microbial of time, low humidity can deteriorate the wrap used
growth. This ignores that some bacteria are psychrophilic on sterile items and compromise the sterility. Although
(prefer cold), some are thermophilic (prefer higher such deterioration would not be caused by a 1-minute
temperatures), and some are mesophilic (prefer normal variance outside the recommended humidity ranges,
temperature ranges). Most pathogenic bacteria are the exact duration needed to compromise the wrap
mesophilic, but some within this category can replicate is not known. As sterile wrap during its journey to a
well at temperatures within the range of 68° to 75°.39 healthcare facility is exposed numerous times to areas
of uncontrolled humidity, that variance time is generally
Cooling patients during long surgeries in which critical
considered to be more than the 1-minute variance.
organs like the heart or brain are at risk of hypoxia
has been shown to improve outcomes. Such cooling Attempts to mitigate humidity variance using mobile
is generally done using cooling devices or blankets. dehumidifiers creates a greater risk of infection than the
For burn patients with more than 20 percent of skin variance itself. Dehumidifiers and humidifiers disrupt
surface damaged, hypothermia is a known risk. In airflow patterns and, like air conditioners, draw air in
most cases, mechanical devices are used to warm the much closer to the ground, releasing air at roughly the
patient. However, if the patient’s wounds and surgery are same height as the sterile field. Moreover, these devices
extensive enough, it may not be possible to employ such frequently are not filtering the released air, leading to
devices. In such cases, OR room temperatures can be set increased circulating contaminants and associated surgical
to exceed 100°F. The impact on the surgeon and team of infection risk. Pressure differentials can be assessed using
extremely high room temperatures can be mitigated by a tissue test: Hold a tissue at the edge of the OR door and
the use of cooling vests. observe how it moves; this will reveal whether air pressure

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 Section 3 Understanding the OR Environment | 35

is positive or negative. Operating rooms should have locations and cross-referenced the 2008 ASHRAE
positive pressure (i.e., the OR should be positive relative Standard 170 Ventilation of Health Care Facilities, with
to the exterior hallway) and SPD decontamination Addendum D, and the 2013 version of the standard
process rooms should have negative pressure. has also been incorporated into the 2014 edition of the
FGI Guidelines for Design and Construction of Hospitals
The American Hospital Association in collaboration
and Outpatient Facilities. The [ASHE] and [AORN]
with ASHE and the Association for Healthcare Resource
also support the ASHRAE standard, as does The Joint
and Materials Management (AHRMM) released New
Commission. Use of a 20 percent rather than a 30 percent
Guidance on Humidity Levels in the Operating Room in
minimum RH is becoming increasingly desirable from a
early 2015.41 This communication had two goals: Ensure
facilities management perspective.”
patients are protected through the safe and effective use
of equipment and products during surgery; and eliminate The Joint Commission FAQ states: “Organizations should
the potential waste of resources used for installation, determine the appropriate temperature and humidity
energy, and ongoing maintenance that do not improve (and ventilation) parameters based on the design
patient outcomes. It reads in part: “At the request of a criteria at the time of construction (see also the note
number of healthcare delivery organizations, ASHRAE in EC.02.05.01 EP 15). For new, renovated, or altered
investigated and revised its international standard for spaces, organizations that use The Joint Commission for
HVAC design parameters in 2010 (Addendum D to the deemed status purposes must use ASHRAE 170-2008
2008 version). The environmental room humidity (RH) as referenced in NFPA 99-2012, Chapter 9, effective
for anesthetizing locations, including operating rooms, July 5, 2016. This document is included in the 2010
was changed to expand the minimum end of the range FGI Guidelines for Design and Construction of Health
from 30 percent to 20 percent RH. The upper limit Care Facilities. Organizations that do not use The Joint
remains at 60 percent RH. The 2012 edition of National Commission for deemed status purposes would use
Fire Protection Association (NFPA) 99 eliminated direct ASHRAE 170-2013 as referenced in the 2014 FGI
references to humidity requirements for anesthetizing Guidelines for new, renovated, or altered spaces.”42

FIGURE 3
RISK ASSESSMENT FOR LOWER OR HUMIDITY LEVELS43
Following are questions proposed for risk assessment in preparation for lower OR humidity levels.43
1. What is the desired minimum humidity range in the OR? What is the actual level of humidity the HVAC system is able to
achieve and maintain in a variety of weather conditions?
2. Have you assessed humidity-level data over a sufficient time to know whether, when, and for how long the humidity falls below
30 percent due to environmental conditions with all seasonal variations? The method of assessment should be conducted in
consultation with facilities engineers.
3. Have you determined what the information for use (IFU) says about humidity levels for each item in the existing inventory
of supplies and equipment used in the OR?
4. What are the likely risks of using equipment that calls for a humidity level of 30 percent or higher (which may be especially
prevalent with older electro-medical equipment)? What are the potential impacts on performance?
5. Request data from manufacturers documenting the variance of time (excursion data) that products can be out of range before
their package integrity or performances are impacted. Learn and understand how integrity and performance are affected when
supplies and equipment are stored and used out of range. Note: These data may not be available from all manufacturers as of
the date of this communication.
6. For any planned new supplies and equipment, what are the anticipated recommended humidity levels for storage and use?
7. Using all of the available information, have you done an overall assessment to determine whether the benefits of lowering the
humidity-level threshold below 30 percent override the potential risks?
8. If the decision is made to maintain humidity levels below 30 percent, consider moving supplies that call for humidity levels of
30 percent or higher to a humidity-controlled closet. Note: Supplies that currently require minimum RH levels of 30 percent
or higher are used throughout a healthcare facility (e.g., EKG electrodes). While this risk assessment is specific to the OR, the
same process should be considered for other areas where RH levels are going below 30 percent by design or effect.

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 Section 3 Understanding the OR Environment | 36

HVAC Variance and Risk Assessment below) from the prescribed range. A small variance for
a short period of time may not be of clinical concern,
Newer HVAC monitoring technologies, including
whereas a large variance for a longer period may have
systems that monitor the air and humidity in the
clinical significance. Therefore, a multidisciplinary team
OR minute by minute, have resulted in an increase
should perform a risk assessment when any component
in regulatory agencies’ citations for variances outside
of the HVAC falls outside the prescribed range.
a hospital’s own defined OR temperature ranges. In
response to this, a joint HVAC task force was convened The AORN guideline provides recommendations that
on April 29, 2015, for the purpose of achieving may be taken based on risk assessment:
consistency among the professional guidelines related △△Reschedule or redirect procedures to areas
to HVAC parameters for the operating room, SPD, and of the Surgery Suite where the HVAC system
endoscopy suites in U.S. healthcare facilities. The task is functioning within parameters
force included representatives from APIC and AORN as △△Delay elective procedures
well as those from AAMI, ASHRAE, ASHE, FGI, The
Joint Commission, Centers for Medicare and Medicaid
△△Limit surgical procedures to emergency
procedures only
Services (CMS), Kaiser Permanente, and International
△△Close the affected OR
△△Take no action
Association of Healthcare Central Service Materiel
Management (IAHCSMM). It met in Annapolis,
Maryland, to work toward the goal of harmonizing the To restore the Surgery Suite to full functionality after
HVAC guidance in the various standards and guidelines. the HVAC system variance has been corrected, measures
may include:
The task force recognized that achieving consensus
among task force members, drafting proposed changes △△Terminal cleaning when there is evidence of
to the various guidelines, gaining approval from the contamination on surfaces
respective organizations, and final publication of revised △△Reprocessing or discarding any supplies with
guidelines all take time. Therefore, on September 21, packaging that may have been compromised
2015, the task force issued Joint Interim Guidance: △△Inventorying discarded, damaged supplies
HVAC in the Operating Room and Sterile Processing for insurance-claim purposes and to obtain
Department. The guidance was intended to inform replacements
regulatory bodies of the quality of data around The Joint Interim Guidance was created not only to avoid
infections and temperature and to assist hospitals unnecessary citations, but also to avoid temperature
in creating policies that result in fewer citations.44 and humidity variations that put patients at risk.44 For
Healthcare organizations are challenged to meet a example, there have been reports of facilities bringing
number of conflicting and sometimes unclear HVAC portable air conditioning units into the operating room in
standards and guidelines established by a variety of order to maintain temperatures within design standards.
professional organizations. Misunderstandings about Such disruption of the airflow and differentials in the OR
critical differences between building and engineering can put patients at risk of infection.
design standards and clinical practice guidelines have
Perioperative team members in collaboration with
led to a great deal of confusion and even conflict in the
multidisciplinary team members, including IPs,
healthcare community.
should perform a risk assessment if any of the HVAC
The Joint Interim Guidance recommendations include parameters fall out of range for an extended period.
a facility risk assessment and establishment of acceptable There is no association claimed between low humidity
duration of temperature variation (and humidity, see and surgical site infections. However high-humidity

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 Section 3 Understanding the OR Environment | 37

levels that are out of range for extended periods may A 2005 study looked at multiple nasopharyngeal
require IP intervention. Action steps include: cultures taken from members of the surgery team
(surgeons, anesthesiologist, nurses, residents, and
1. Assemble the multidisciplinary team (OR nurse,
IP, facility engineer, SPD representative, surgeon, fellows) over the course of 75 peripheral vascular
etc.) and carry out a risk assessment. procedures. Using pulse-field gel electrophoresis
(PFGE), the authors observed on multiple occasions
2. Based upon risk assessment, actions may include direct clonality between isolates recovered from ambient
movement of cases to unaffected areas, delay of air sampling and strains cultured from members of the
elective procedures, limiting cases to emergencies,
surgical team, including the circulating nurses who
closing the OR, or no action.
exited and entered the room several times during cases.49
3. Once restorative measures have been taken,
The 2017 update of the CDC SSI Prevention
actions may include terminal cleaning if
evidence of contamination on surfaces, guidelines, however, assesses the impact of OR
discarding compromised supplies, and ensuring traffic on bacterial counts in air and not on infection
inventory of damaged supplies or equipment rates. For this reason, limitation of traffic was given
for claim purposes. only a category II recommendation (suggested for
implementation and supported by suggestive clinical
Foot Traffic and Door Openings or epidemiological studies or theoretical rationale).50
The operating room is not a sterile environment. The Currently, only small, uncontrolled studies support
microbial burden in the ambient air is complex and that reduced OR traffic may reduce SSI risk.51 New
diverse, often including the presence of multidrug- technology, however, makes it possible to automate
resistant organisms (MDROs) within the immediate counts of entries and exits, allowing for more accurate
vicinity of the surgical wound. The rationale for readings. Where such counts have been done, findings
minimizing traffic in the OR includes the conclusion clearly challenge accepted opinion. A large, multi-
in the 1999 CDC SSI Prevention guideline that center study of many surgeries, adjusted for patient
“the microbial level in operating room air is directly acuity (using NHSNs model), found no association
proportional to the number of people moving about between increased room entries and SSIs.52
in the room; therefore, efforts should be made to
When addressing quality of air, disruption of
minimize personnel traffic during operations.”45
airflow, control of ventilation, and maintenance
Findings from a 2012 study in orthopedic trauma
of positive airflow in the OR suite, it is important
implant surgery were consistent with this conclusion,
to include a discussion of traffic patterns. Research
reporting a positive correlation between airborne
microbial recovery (CFU/m3) and increased traffic supports the idea that disruption of airflow during
flow, exacerbating the risk of implant contamination.46 the surgical procedure may increase risk of surgical
site microbial contamination.53
The impact of multiple door openings was also studied
in cardiac surgery; investigators noted a trend among Decreasing the number of times OR doors are opened
patients who developed SSIs toward increased frequency during a procedure has also been the focus of published
of door openings.47 In addition, a recent quality improvement projects focusing in part on improved
initiative (QI) looked at the volume of OR traffic that communication of ORs with the front desk. The
occurred in selective surgical services, reporting in AORN Guideline for a Safe Environment of Care, Part
baseline analysis that average door openings ranged from 2 addresses the designation of level of restriction and
33 per hour in general surgery to a high of 54 per hour traffic patterns based on environmental controls for
in cardiac surgery.48 infection prevention.54

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 Section 3 Understanding the OR Environment | 38

FIGURE 4
TRAFFIC RESTRICTION BY AREA/UNIT54
Unit/area Level of restriction
Postanesthesia care unit Unrestricted or semi-restricted
Endoscopy suite Unrestricted
Pain clinic/procedure room Unrestricted
Locker room/administrative office/waiting room Unrestricted
Sterile processing area Semi-restricted
Equipment and sterile supply storage Semi-restricted
Sterile processing decontamination area Semi-restricted
Operating room Restricted
Invasive procedure room Restricted
Preoperative/postoperative patient-care area Unrestricted
Reprinted with permission from Guidelines for Perioperative Practice. Copyright ©2017, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO
80231. All rights reserved.

OR Design Features for Cleanability

The OR environment requires surfaces that are smooth, cleanable, nonabsorptive, and capable of withstanding
cleaners and disinfectant solutions. There should be no cracks and crevices where dirt can become trapped.55
Ideally, the ceiling should be solid, with no ledges or crevices. However, the recently published FGI guideline
allows for drop ceilings that are gasketed; a design needed particularly where access to spaces above the
ceiling is necessary, such as in hybrid ORs.
Texture on areas such as steps and floors helps reduce slips and falls but may make surfaces harder to clean.
Surfaces may become damaged through wear and exposure to disinfectants; areas should be routinely
inspected for cracks or chips and repaired quickly. Porous material cannot be cleaned easily, if at all.
New disinfectants can adversely affect some materials; care must always be taken when changing
disinfectants.56 For example, stainless steel performs well with most healthcare disinfectants. With concern over
C. difficile, some institutions have implemented bleach cleaning of ORs. However, bleach may cause pitting on
stainless steel, rendering it uncleanable and unusable. Other materials (e.g., vinyl) can rip or wear in ways that
create environmental reservoirs for microorganisms.57 In addition, there is little evidence that the OR is a source
of exposure to C. difficile endospores. Nonbleach sporicidal disinfectants available for the OR can be used
on high-frequency-touch surfaces, but necessarily on floors, except for spot disinfection. Typically, floors are
cleaned and disinfected at the end of the procedures scheduled for the day/shift. Most facilities use a one-step
surface disinfectant, quaternary ammonium compound, for this process.
The FDA has issued Safety Notices recommending that integrity of mattresses, and by inference positioning
pads in the OR, be assessed during routine cleaning and disinfection. If damage to the cover is identified, the
mattress should be replaced.
Among the most challenging surface areas to clean: Electronic equipment. Touch screens can degrade from
contact with hospital disinfectants. Manufacturers’ instructions may not be helpful—some recommend these
surfaces be cleaned with water rather than disinfected. Some facilities have added coatings or films to touch
screens to permit damage-free disinfecting.58
Floor design should factor in how operating rooms are cleaned. For example, items that rest on the OR floor
should be designed so that water cannot pool beneath them and to allow for full floor cleaning. Items in contact
with the floor should be impervious to water damage.
While use of technology in the OR has increased, the ability to clean the space has not. Computers, audio cables,
medical gas lines, and increased lighting all are now routinely suspended from the ceiling, and new technologies
further complicate cleaning. Take, for example, hybrid ORs that include an MRI. These spaces are confined and
require special approaches or equipment to ensure the area is properly cleaned to minimize SSI risk.59

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 Section 3 Understanding the OR Environment | 39

IMPLEMENTATION STRATEGIES FOR THE IP

△△Incorporate assessment of environmental factors in routine OR site visits.

△△Ensure environmental factors are included in SSI root-cause analysis template.
△△Use cleaning grids.

TOOLS AND RESOURCES

△△FGI Guideline for OR Design 2018—Facility Guidelines Institute publication with definitions of new surgical
spaces, sizes, and requirements for scrub sinks and hand-washing facilities; available for purchase.
https://bit.ly/2I8unTR

△△Joint Interim Guidance: HVAC in the Operating Room and Sterile Processing Department—3-page 2015
guidance prepared by American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE),
the American Society for Healthcare Engineering (ASHE), the Association for the Advancement of Medical
Instrumentation (AAMI), the Association for Professionals in Infection Control and Epidemiology (APIC), the
Association of periOperative Registered Nurses (AORN), and the Facility Guidelines Institute (FGI).
https://bit.ly/2IapVUu

REFERENCES
1. Spagnolo AM, Ottria G, Amicizia D, Perdelli F, Cristina ML. 8. American National Standards Institute/ American Society of
Operating theatre quality and prevention of surgical site infections. Heating, Refrigerating, and Air-Conditioning Engineers / American
J Prev Med Hyg 2013 Sep;54(3):131-7. Society of Health Care Engineering. Standard 170-2013—
Ventilation of health care facilities.
2. Cristina M, et al. Operating room environment and surgical
site infections in arthroplasty Procedures. J Prev Med Hyg 9. Facility Guidelines Institute. 2014 Guidelines for Design and
2016;57(3):E142-E148. Construction of Hospitals and Outpatient Facilities. Available from:
https://www.fgiguidelines.org/guidelines/2014-fgi-guidelines/
3. Mora M, Mahnert A, Koskinen K, et al. Microorganisms in
confined habitats: microbial monitoring and control of intensive 10. Burlingame B, Davidson J, Denholm B, Fearon M, Giarrizzo-
care units, operating rooms, cleanrooms and the international space Wilson S, Johnstone EM, Link T, Ogg MJ, Spruce L, Spry C, Van
station. Front Microb 2016;7:1573. Wicklin SA, Wood A. Guideline for safe environment of care, part
2. In: Conner R, ed. AORN Guidelines for Perioperative Practice,
4. Burlingame B, Davidson J, Denholm B, Fearon M, Giarrizzo-
Vol. 1. AORN website. doi:10.6015/​psrp.17.01.269. 2018.
Wilson S, Johnstone EM, Link T, Ogg MJ, Spruce L, Spry C, Van
Accessed April 30, 2018.
Wicklin SA, Wood A. Guideline for safe environment of care, part
2. In: Conner R, ed. AORN Guidelines for Perioperative Practice, 11. American National Standards Institute/Association for the
Vol. 1. AORN website. doi:10.6015/​psrp.17.01.269. 2018. Advancement of Medical Instrumentation. ST 79:2017—
Accessed April 30, 2018. Comprehensive guide to steam sterilization and sterility assurance
in health care facilities. ANSI website. 2017. http://my.aami.org/
5. Sehulster LM, Chinn RYW, Arduino MJ, Carpenter J, Donlan R,
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April 30, 2018.
S, Juranek D, Cleveland J. Guidelines for environmental infection
control in health-care facilities. Recommendations from CDC and 12. Fridkin SK, Kremer FB, Bland LA, Padhye A, McNeil MM, Jarvis
the Healthcare Infection Control Practices Advisory Committee WR. Acremonium kiliense endophthalmitis that occurred after
(HICPAC). Chicago IL; American Society for Healthcare cataract extraction in an ambulatory surgical center and was traced
Engineering/American Hospital Association; 2004. to an environmental reservoir. Clin Infect Dis 1996 Feb;22(2):222-7
6. Memarzadeh F. The environment of care and healthcare-associated 13. Williamson D, Howden B, Stinear, T. Mycobacterium chimaera
infections: an engineering perspective. Chicago, IL: ASHE; 2011. spread from heating and cooling units in heart surgery. N Engl
J Med 2017; 376: 600-602.
7. Ayliffe GA. Role of the environment of the operating suite in
surgical wound infection. Rev Infect Dis 1991;13(Suppl 10):S800-4. 14. Spagnolo A, et al. Operating theatre quality and prevention
of surgical site infections. J Prev Med Hyg 2013;54(3):131-137.

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15. American National Standards Institute/ American Society of 31. Sehulster LM, Chinn RYW, Arduino MJ, Carpenter J, Donlan R,
Heating, Refrigerating, and Air-Conditioning Engineers / American Ashford D, Besser R, Fields B, McNeil MM, Whitney C, Wong
Society of Health Care Engineering. Standard 170-2013— S, Juranek D, Cleveland J. Guidelines for environmental infection
Ventilation of health care facilities. control in health-care facilities. Recommendations from CDC and
the Healthcare Infection Control Practices Advisory Committee
16. Facility Guidelines Institute. 2014 Guidelines for Design and
(HICPAC). Chicago IL; American Society for Healthcare
Construction of Hospitals and Outpatient Facilities. Available from:
Engineering/American Hospital Association; 2004
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32. Lidwell OM. Clean air at operation and subsequent sepsis in the
17. Evans RP. Current concepts for clean air and total joint arthroplasty:
joint. Clin Orthop 1986;211:91-102
laminar airflow and ultraviolet radiation: a systematic review. Clin
Orthop Related Res 2011;469(4):945-953. 33. Pittet D, Ducel G. Infectious risk factors related to operating rooms.
Infect Control Hosp Epidemiol 1994;15:456–462.
18. Edmiston CE. Prosthetic device infections in surgery. In: Nichols,
R.L. and Nyhus, L.M. (eds). Update Surgical Sepsis. Philadelphia: 34. Perkins KM, Lawsin A, Hasan NA, et al. Notes from the Field.
J.B. Lippincott Co.; 1993. Mycobacterium chimaera contamination of heater-cooler devices
used in cardiac surgery — United States. MMWR 2016;65:1117-
19. Hasanadka R, Seabrook GR, Edmiston CE. Vascular graft
1118. DOI: https://www.cdc.gov/mmwr/volumes/65/wr/
infections. In: Rello J, Vanes J, Kollef M, eds. Critical Care
mm6540a6.htm.
Infectious Diseases, 2nd ed. Boston: Kluwer Academic Publishers;
2001. 35. Sommerstein R, Rüegg C, Kohler P, Bloemberg G, Kuster SP, Sax H.
Transmission of Mycobacterium chimaera from heater-cooler units
20. Edmiston CE, McBride A, Leaper D. Surgical site infections
during cardiac surgery despite an ultraclean air ventilation system.
associated with microbial biofilms. In: Donelli C (ed). Biofilm-
Emerg Infect Dis 2016 Jun;22(6)1008-1013.
Based Healthcare-Associated Infections, Advances in Experimental
Medicine and Biology series (AEMB), Berlin [Germany]: 36. Centers for Disease Control and Prevention. Guidelines for
Springer; 2015. Preventing the Transmission of Mycobacterium tuberculosis in
Health-Care Settings, 2005. MMWR 2005;54(No. RR-17)
21. Sawan SP, Manivannan G. In: Sawan SP, Manivannan G, eds.
Antimicrobial/Anti-Infective Materials: Principles, Applications 37. Olmsted RN. Pilot study of directional airflow and containment
and Devices. Lancaster, LA: Technomic Publishing Company, Inc., of airborne particles in the size of Mycobacterium tuberculosis
2000. in an operating room. Am J Infect Control 2008;36(4):260-267
22. Petrova OE, Sauer K. Sticky situations: key components that control 38. American National Standards Institute/ American Society of
bacterial surface attachment. J Bacteriol 2012;194:2413-2425. Heating, Refrigerating, and Air-Conditioning Engineers / American
Society of Health Care Engineering. Standard 170-2013—
23. Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections.
Ventilation of health care facilities.
N Eng J Med 2004; 35:1645–1654.
39. Memarzadeh F. The environment of care and healthcare-associated
24. Gomez-Alonso, A et al. Study of the efficacy of Coated VICRYL
infections: an engineering perspective. Chicago, IL: ASHE; 2011.
Plus® Antibacterial suture in two animal models of general surgery.
J Infect 2007 January;54:82-88. 40. American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE), American Society for Healthcare
25. Parvizi J, Barnes S, Shohat N, Edmiston CE. Environment of care:
Engineering (ASHE), Association for the Advancement of Medical
Is it time to reassess microbial contamination of the operating
Instrumentation (AAMI), Association for Professionals in Infection
room air as a risk factor for surgical site infection in total joint
Control and Epidemiology (APIC), Association of periOperative
arthroplasty? Am J Infect Control 2012;45:1267-1272
Registered Nurses (AORN), Facility Guidelines Institute (FGI). Joint
26. Gormley T, et al. Cost-benefit analysis of different air change rates interim guidance: HVAC in the operating room and sterile processing
in an operating room environment. Am J Infect Control 2017 Dec department. September 21, 2015. http://apic.org/Resource_/
1;45(12):1318-1323. TinyMceFileManager/Implementation_Guides/PosStat-Safety-
HVAC-Interim-Guidance.pdf. Accessed April 30, 2018.
27. Gormley T, et al. Methodology for analyzing environmental quality
indicators in a dynamic operating room environment. Am J Infect 41. American National Standards Institute/ American Society of
Control 2017 April 1;45(4):354-9. Heating, Refrigerating, and Air-Conditioning Engineers / American
Society of Health Care Engineering. Standard 170-2013—
28. Facility Guidelines Institute. 2014 Guidelines for Design and Ventilation of health care facilities.
Construction of Hospitals and Outpatient Facilities. Available from:
https://www.fgiguidelines.org/guidelines/2014-fgi-guidelines/ 42. The Joint Commission. Temperature and Humidity - Monitoring
Requirements for Sterile Supply Storage Areas. The Joint
29. Memarzedeh F. Role of air changes per hour (ACH) in possible Commission website. n.d. https://www.jointcommission.org/
transmission of airborne infections. Build Simul 2012;5:15-28. standards_information/jcfaqdetails.aspx?StandardsFAQId=1498.
30. Mangram A, Horan T, Pearson M, Silver L, Jarvis W. Guideline Accessed April 30, 2018
for Prevention of Surgical Site Infection, 1999. Infect Control Hosp
Epidemiol 1999;20(4):247-280. doi:10.1086/501620

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43. Association of Surgical Technologists. Guidelines for best 51. American College of Surgeons. Minimizing operating room
practices for humidity in the operating room. AST website. traffic may improve patient safety by lowering rates of surgical site
Approved April 10, 2015, revised June 2017. http://www. infections. ACS website. July 18, 2016. https://www.facs.org/
ast.org/uploadedFiles/Main_Site/Content/About_Us/ media/press-releases/2016/nsqip-ssi-071816. Accessed April 30,
ASTGuidelinesHumidityintheOR.pdf Accessed April 30, 2018. 2018.
44. American Society of Heating, Refrigerating and Air-Conditioning 52. Abeles, SR, Myers F, El-Kareh R, Marmor, R, Kovryga Kornick,
Engineers (ASHRAE), American Society for Healthcare M, Gohil, SK, Cohen, SH, Mahr, N, Nichols, A, Garritson, S,
Engineering (ASHE), Association for the Advancement of Medical Liu, C, Rubin, Z, Trout, A, Allyn, PR, Torriani, FJ. (2016, May).
Instrumentation (AAMI), Association for Professionals in Infection No Significant Correlation between OR Traffic and Surgical Site
Control and Epidemiology (APIC), Association of periOperative Infections in a Multicenter Study. Poster session presented at Society
Registered Nurses (AORN), Facility Guidelines Institute (FGI). Joint for Healthcare Epidemiology of America Conference, Atlanta, GA.
interim guidance: HVAC in the operating room and sterile processing
53. Spagnolo AM, Ottria G, Amicizia D, Perdelli F, Cristina ML.
department. September 21, 2015. http://apic.org/Resource_/
Operating theatre quality and prevention of surgical site infections.
TinyMceFileManager/Implementation_Guides/PosStat-Safety-
J Prev Med Hyg 2013 Sep;54(3):131-7.
HVAC-Interim-Guidance.pdf. Accessed April 30, 2018.
54. Burlingame B, Davidson J, Denholm B, Fearon M, Giarrizzo-
45. Mangram A, Horan T, Pearson M, Silver L, Jarvis W. Guideline
Wilson S, Johnstone EM, Link T, Ogg MJ, Spruce L, Spry C, Van
for Prevention of Surgical Site Infection, 1999. Infect Control Hosp
Wicklin SA, Wood A. Guideline for safe environment of care, part
Epidemiol 1999;20(4):247-280. doi:10.1086/501620
2. In: Conner R, ed. AORN Guidelines for Perioperative Practice,
46. Andersson, AE. Traffic flow in the operating room: an explorative Vol. 1. AORN website. doi:10.6015/​psrp.17.01.269. 2018.
and descriptive study on air quality during orthopedic trauma Accessed April 30, 2018.
implant surgery. J Infect Control 2012;40(8):750-755.
55. Lybert L. Porous and Non-Porous Hard Surfaces. Health Facilities
47. Sastry S, Rahman R, Yassin MH. Cardiac implantable electronic Manag July 6, 2016.
device infection: from an infection prevention perspective. Adv Prev
56. Rutala WA, Weber DJ. Selection of the Ideal Disinfectant. Infect
Med 2015:357087.
Cont Hosp Epidemiol 2014;35(7); 855-865.
48. Lynch R, et al. Measurement of Foot Traffic in the Operating
57. Bradbury S, et al. Potential bloodborne pathogen exposure from
Room: Implications for Infection Control. Am J Med Qual 2009
occult mattress damage. Am J Infect Cont 2014;42(4);421-422.
January-February;(24-1):45-52
58. Pal S, Juyal D, Adekhandi S, et al. Mobile phones: Reservoirs for the
49. Edmiston CE Jr, Seabrook GR, Cambria RA, Brown KR, Lewis BD,
transmission of nosocomial pathogens. Adv Biomed Res 2015;4:144.
Sommers JR, Krepel CJ, Wilson PJ, Sinski S, Towne JB. Molecular
epidemiology of microbial contamination in the operating 59. Mora M, Mahnert A, Koskinen K, et al. Microorganisms in
room environment: Is there a risk for infection? Surgery 2005 confined habitats: microbial monitoring and control of intensive
Oct;138(4):573-9. care units, operating rooms, cleanrooms and the international space
station. Front Microb 2016;7:1573.
50. Berríos-Torres S, et al. for the Healthcare Infection Control Practices
Advisory Committee Centers for Disease Control and Prevention
Guideline for the Prevention of Surgical Site Infection, 2017. JAMA
Surg August 2017;152(8):784-791.

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 42

SECTION 4

THE STERILE PROCESSING

DEPARTMENT, HIGH-LEVEL
DISINFECTION, AND STERILIZATION

The SPD Environment and Basics not followed, a risk assessment should be completed
to justify the practice.
The Sterile Processing department (SPD) is defined as
a service within the hospital in which medical/surgical The major areas of the SPD are decontamination,
supplies and equipment, both sterile and nonsterile, high-level disinfecting (HLD), assembly/packaging,
are cleaned, prepared, processed, stored, and issued sterilization, and sterile storage. SPD should be
for patient care. The effectiveness of an SPD relies on considered a semi-restricted space. Surgical attire
expert execution of processes, facility design, resources is recommended in all these areas, but personal
(including equipment and personnel), education protection equipment (PPE) is required only in the
and training, quality control, and documentation of decontamination area, where exposure to blood and
processes. Professional guidelines, including those from other potentially infectious materials (OPIM) is likely.
the Association of periOperative Registered Nurses In addition, jewelry on hands and wrists is prohibited.
(AORN) and the Association for the Advancement Ideally, SPD areas should be separated via physical
of Medical Instrumentation (AAMI), direct SPD barriers. This may not be possible in all facilities,
protocols.1-5 The SPD leadership should have access however. The highest-priority separation is that
to these guidelines, be familiar with their contents, between the decontamination area and “clean” spaces
and be able to speak to discrepancies between their (e.g., assembly/packaging, sterilization). Isolating
facility’s process and these recommendations. Every the decontamination area decreases the chances for
facility should maintain policies for all elements of cross-contamination to other areas of the SPD. The
decontamination, disinfection, sterilization, and storage traffic flow of items through SPD should be from
as performed within SPD. contaminated areas to increasingly cleaner ones.
All SPD staff should have easy access to manufacturer’s Surfaces in the department—including countertops,
IFUs for every instrument processed as well as for cabinets, floors, doors, walls, and ceilings—should
machines, products, solutions, and chemicals used. be smooth, made of cleanable materials, and durable
Indeed, the importance of the IFUs cannot be enough to withstand frequent use and application
overstated. When any questions arise, these documents of disinfectant solutions. Lighting should be adequate
should be consulted to ensure compliance. IF IFUs are to facilitate the attention to detail required for

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 43

instrument reprocessing. Hand hygiene stations, with ASHE Standard 170-2013 provides guidance regarding
soap and water and waterless alcohol hand sanitizer, HVAC parameters, including temperature and humidity
should be readily available throughout the department. for the various areas within the SPD. Facility Guidelines
All personnel should comply with the facility’s hand Institute (FGI) Guidelines for Design and Construction
hygiene policies. of Hospitals and Outpatient Facilities, 2014 provides
The AAMI and AORN guidelines provide clinical standards to be used when constructing or completing
practice recommendations for SPD.1,3 ANSI/ASHRAE/ major renovations in SPD.6-7

FIGURE 5
ATTIRE AND PPE REQUIREMENTS FOR THE STERILE PROCESSING DEPARTMENT5

Eye Masks or Face

Work Area Scrubs Head Covers Gloves* Gowns#
Protection+ Shields±
Decontamination X X X X X X
Preparation and Packaging X X
Sterilization Processing X X
Sterile Storage X X
*Gloves should be waterproof, general-purpose utility, or heavy-duty.
#
Gowns must be liquid-resistant with sleeves.
Eye protection includes goggles/eyeglasses with side shields or chin-length face shields.
+

±
Masks should be fluid-resistant.
Other protective equipment (such as shoe covers) may be worn as needed. The type and characteristics will depend on the task and degree
of anticipated exposure.

Source: Occupational Safety & Health Administration. US Department of Labor. Toxic and hazardous substances. Appendix A: bloodborne pathogens.
29 CFR 1910.1030. Fed Regist 1991;56(235):64004-64182. Effective December 6, 1991.
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051 Accessed April 25, 2012
Reprinted with permission from Guideline for Sterilization. Copyright (c)2017, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.

Point-of-Use Precleaning Biofilm can form on many types of surfaces, including

Instruments should be cleaned and decontaminated as medical and surgical instruments. The risk of formation
soon as possible after use. To prevent biofilm formation, is greatest for surfaces that are moist and in regular
preparation for decontamination of instruments should contact with water. Biofilm may contain multiple types
begin at the point of use. Point-of-use preparation for of microorganisms, including bacteria, yeast and fungi.
decontamination can be accomplished by removing Biofilm is created as bacterial colonies grow, secreting
gross soil, flushing or suctioning lumens, and immersion a protective gel that is very difficult to penetrate with
of instruments in sterile water. During the procedure, detergent and water. Bacteria within biofilms can be
the scrub person should remove gross soil from up to 1,000 times more resistant to cleaning agents
instruments by wiping the surfaces with a sterile surgical than are their counterparts outside a biofilm colony.
sponge moistened with sterile water. Instruments that Consequently, it is easier to clean devices before biofilm
cannot be cleaned immediately should be treated with forms.8 Biofilm development on endoscopes can result
an instrument cleaner according to the device and the from failure to adequately wipe down the scope and/
instrument cleaner manufacturers’ written IFU. or thoroughly flush the internal channels with an

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 44

enzymatic detergent at the point of use; a failure to Decontamination

adequately brush all internal surfaces prior to HLD
Decontamination refers to cleaning or removal of
or sterilization; or internal surface defects within the
foreign material, such as soil, tissue, and blood.16
lumens of the various scope channels.9-11 Such defects
This process reduces the bioburden on an item prior
can be caused by wear and tear over time or be minute
to disinfection or sterilization. Decontamination is
structural flaws emerging during manufacturing.12
typically accomplished using water with detergents
Flaws in instrument design can increase risk of
and/or enzymatic products. Manual decontamination
biofilm formation, as well. For example, cleaning the
has two essential components: friction and fluidics.
side‑viewing duodenoscopes is challenging: A design
Friction means rubbing or scrubbing the soiled area
flaw provides a place under the elevator mechanism
with a brush. Fluidics is the use of fluids under pressure
or within the sheath housing the elevator cable where
to remove soil and debris from internal channels
organic debris can be trapped. See Tools and Resources
after brushing, or when the design does not allow the
for the Food and Drug Administration guidance
passage of a brush through a channel. It is important
document on culturing and sampling of these scopes.
to note that neither of these processes ensures complete
Contaminated instruments should be transported as cleaning of intricate devices.
soon as possible to the decontamination room of the
Automated cleaning is a good adjunct to manual
SPD for reprocessing. Spray enzymatic products cannot
cleaning. Two common types are ultrasonic cleaning,
be applied during a surgical case, but may be applied
and washers or washer/disinfectors. Ultrasonic cleaning
after the surgical case, and prior to transporting. Hinged
uses a process of cavitation to loosen soil, which can be
instruments should be in an open position. Soiled
particularly useful for delicate instruments. Automated
instruments must be transported to the decontamination
washers and washer/disinfectors can be likened to a
area in a closed container or enclosed transport cart.
residential dishwasher, where large volumes of water
The container or cart must be:
and disinfectants are applied, often in conjunction with
△△Leakproof high-heat drying cycles.17,18

△△Puncture resistant The correct flow of instruments and items within

the decontamination area is critical to prevent cross-
△△Large enough to contain all contents transmission. The area should have a dedicated entry
△△Labeled with a fluorescent orange or red label door for contaminated instruments, separate from the
door through which reprocessed instruments exit. Pass-
containing a biohazard legend
through windows are commonly employed to make it
Both precleaning at point of use and thorough cleaning
easier to get manually cleaned instruments from the
in SPD is critical before high-level disinfection or
decontamination area or room into the assembly and
sterilization. If soiled material becomes dried onto
packing area prior to sterilization. All doors and pass-
the item, the process of soil removal becomes much
through windows should remain closed when not in use.
more difficult. Precleaning at point of use is critical to
In addition, the ventilation system should be designed
preventing this, especially if the item will sit for more than
so that air flows into the decontamination area (i.e.,
1 hour prior to comprehensive SPD cleaning. Include
negative pressure).
SPD staff in design of the precleaning process, so they are
prepared to properly treat the instruments afterward.13-15 Personal protective equipment is required for much
of the work done in the decontamination area. This
should include a liquid-resistant gown with sleeves,
utility gloves that extend beyond the gown sleeve,

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 45

and a fluid‑resistant mask and eye protection. Personal how to obtain the correct size and type of brush. It is
protective equipment should be readily available in the critical to obtain the correct brush for each item, and
area, and there should be a dedicated place to put on for SPD personnel to be able to speak to the process
and remove PPE. Convenient access to regular trash of determining which brush to use. Brushes should
containers, regulated waste (blood and body substances) be checked for visible soil and damage after each use,
containers, and hampers for soiled linens (including and reusable brushes should be reprocessed and dried
reusable PPE) are also needed. Emergency eye wash and for storage.
shower stations should be easily accessible within 10 If ultrasonic cleaning is used, it is important to ensure
seconds of contact with any hazardous chemical. Finally, that gross soil is removed prior to placing instruments
care should be taken to prevent sharps injuries, and food in the machine. The cleaning solution that is used
and drink should not be kept in this area.19,20 should be labeled for ultrasonic use, and it should be
Sinks in the decontamination area ideally have three changed after each load. As always, the manufacturer’s
sections: for soaking, cleaning, and rinsing. Sinks should recommendations must be followed for proper loading
be large enough to accommodate trays and baskets of of instruments and items, for daily cleaning of the
instruments, and deep enough to allow enough water machine, for performance verification, and for degassing
and/or detergent to cover the instruments. Evaluate of the machine.
the decontamination area for ergonomic quality: Look When automated washers are used, it should be as the
at height and placement of sinks, attached counters or last step of the cleaning process in decontamination.
workspaces, adequate space to perform the required Manufacturer’s IFUs must be followed, including how
tasks, and anti-fatigue flooring or mats. to load items (avoidance of overloading is critical),
cycle selection, and how to maintain all working
Instrument/Item Prep
parts of the equipment, including any connectors. IPs
As instruments enter the SPD, additional pre-treatment should be mindful that water quality is an important
(or other methods to ensure bioburden remains moist) is issue in sterilizers and automated washers. Water can
advisable if instruments will not be immediately cleaned. contain contaminants that are organic or inorganic,
At the beginning of processing, instruments should and microorganisms can survive and even multiply in
be separated based on cleaning method (e.g., hand water. Poor water quality can reduce the efficiency and
wash/delicate). Instruments should be disassembled as life of equipment and can contribute to infections and
much as possible and jointed or channeled instruments toxic reactions.
should be opened. It is important to ensure that the Reusable containers, such as rigid container systems and
solution used for presoaking and cleaning is approved transportation carts, should be regularly inspected for
by the device or instrument manufacturer. In addition, damage, including breaks in gaskets and malfunctioning
the solution manufacturer’s requirements should be latching mechanisms. Processing of rigid containers (for
followed, including dilution, temperature, and contact cleaning and disinfection) and transport carts should
time. If an automatic dilution device is used, it should follow the manufacturer IFUs. In general, filters and
be routinely verified and calibrated. The solution should filter holders, valves, and interior baskets should be
be clean before use and may require changing after every removed and processed separately.
use. Thorough rinsing after presoaking and cleaning is
also necessary to ensure removal of all solutions. Following cleaning, items are typically rinsed in critical
water (although each manufacturer’s IFU should
Any brushes that are used should be designed for that be consulted). Items should be inspected for damage
specific purpose. Instruments that require brushing at the end of the cleaning process prior to assembly
(such as those with lumens) will have instructions on and packaging.21

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 46

Verification of Cleaning well labeled. Labeling should be done with a material

designed for this use, and labels should remain securely
Verification of cleaning starts with a visual inspection
attached to the package. The label should indicate:
of the device for damage or remaining visible soil.
sterilizer used, the cycle number, load control record
Magnifiers can assist with this process. Methods for
number, date of sterilization, and the worker responsible
verification of soil removal, such as ATP testing or
for prep and packaging. The outside of opaque container
microbiologic sampling, may be used. If used, the
systems should have a short description of the contents,
processes for testing should be approved by the facility
and a full description of all contents should be attainable
and rigorously followed. Verification of cleaning
also includes monitoring of the parameters of the via the load control record number. The expiration date
cleaning process. For example, automated washers and or statement of event-based expiration should also be
ultrasonic machines often provide a digital readout or visible on the external container.
printout. These records should be reviewed to ensure Policies and procedures regarding selection and use
all parameters are met. In addition, the documentation of packaging systems should include:

△△Pre-purchase evaluation
should be maintained. There are a variety of additional
verification methods, such as use of coupons
contaminated with proteins, which should be used △△Assembly of devices within packaging systems
only with facility-approved testing procedures.
All mechanical equipment should be properly
△△Weight limitations
maintained according to manufacturers’ IFUs, along with △△Product testing
documentation of routine preventive, and other types of
maintenance. After non-routine maintenance, cleaning
△△Labeling
verification should be completed prior to use.16-20 △△Placement and positioning of packages within
the sterilizer

△△Storage requirements pre- and post-sterilization

Assembly/Packaging
In the assembly and packaging area, clean instruments
should be thoroughly dried, inspected, and assembled △△Shelf life
into packaging for sterilization. If there is concern about
the cleanliness of any item, or contamination of an
△△Use of internal and external sterilization monitors
item occurs in this area, the item should be returned △△Wrapping requirements and technique
to decontamination for repeat cleaning. The ventilation
of this and the other clean areas (i.e., sterilization, sterile
△△Use of peel pouches
storage) should be designed so that air flows out of △△Maintenance of packaging materials, peel pouches,
the overall area (positive pressure), although pressure rigid container systems, and heat sealers
gradients between these areas can be neutral. Instruments and other items that are prepared for
Assembly requires that each instrument be positioned sterilization must be packaged so that their sterility
in the packaging to allow the sterilant to contact all can be maintained to the point of use. Materials and
surfaces. Every item and instrument should be opened, techniques used for packaging must allow the sterilant to
unlatched, and disassembled to allow contact to all contact the device during the sterilization process as well
surfaces. Items that could hold water should be placed as protect the device from contamination during storage
on their sides, and heavy items should be placed below and handling before it is used. Types of packaging may
lighter and more delicate ones. In the end, a set should include textiles or nonwoven disposable materials, pouch
not weigh more than 25 pounds. Packages should be packaging, or rigid container systems.

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 47

The package should be closed in a way that any Loading and Running the Sterilizer
tampering would be obvious. Closures should not
Items should be carefully loaded into the sterilizer.
inhibit sterilization or package shape and integrity.
The sterilizer manufacturer’s IFU for loading must be
Paper-plastic pouches (commonly called “peel packs”)
closely followed. Different sterilizers require different
should be used for small items that are used as singular
load configurations and have specific specifications. Peel
items (and generally not as part of a surgical procedure).
pouches should stand on edge with the paper of one
Ensure the items fit completely inside the pouch,
package facing the plastic of the next. Holding racks are
and that the seals of the pouch are smoothly closed.
recommended to assist with proper loading of peel packs.
Double pouching may be allowable, based on the pouch
Instrument sets should be placed level. Rigid containers
manufacturer’s IFUs.
should be placed lower on the rack than wrapped items or
Odd-shape or heavy items may require items to be peel pouches. All items and packs loaded in the sterilizer
packaged by wrapping the item with the textile or at the same time should require the same cycle parameters.
nonwoven disposable material referenced above. There are several “standard” cycles recommended by
However, this method should be minimized whenever manufacturers. All SPD staff should be able to speak
possible due to the risk of integrity-failure associated to the sterilizer parameters as well as the need for any
with wrapped instruments. Every wrapper should be adjustments among the parameters used. It’s important
examined for holes and tears prior to use. Reusable to recognize that some items require nonstandard or
wraps are permissible, assuming they are well extended cycles. Validation of these types of cycles is
maintained and laundered between uses. The material extremely difficult, and use of these items should be
should completely cover the item enclosed, and it should evaluated by the facility using a risk assessment.19,20
be applied to allow sterility maintenance while opening
(e.g., envelope-fold or square-fold technique). The Immediate-Use Steam Sterilization
packaging material selected must also permit the device (IUSS)
to be removed aseptically. 16-20 Immediate-use steam sterilization (IUSS), historically
referred to as flashing or flash sterilization, should be used
Sterilization only when no other method is possible or when there
Critical items that enter sterile tissue or the vascular is insufficient time to process by the preferred wrapped
system must be sterile. Examples of items that require or container method intended for terminal sterilization.
sterilization include surgical instruments and ultrasound It can be used, for instance, if there is a hole in a wrap
probes used in sterile body cavities. immediately prior to surgery for nonimplantable
instruments, if specialized equipment is needed for
There are three common sterilization processes:
back-to-back surgical cases, or if a specialized instrument
△△Heat: Steam sterilization is the preferred method. is dropped during an operation. It should not serve as a
substitute for sufficient instrument inventory. Instruments
△△Gas: Items that are heat sensitive are typically sterilized through IUSS cannot be stored for future use;
sterilized by ethylene oxide or hydrogen they must be used immediately. Terminal sterilization of
peroxide vapor.
reusable surgical instrumentation is always the preferred
△△Liquid Chemical: The same chemicals used in method of preparing instruments for surgery.
high-level disinfection can render an item sterile, The IUSS method can be used under
but the contact time is much longer (3 to 12 hours). the following conditions:
The disadvantage of the liquid chemical sterilization
process is that items cannot be wrapped to maintain △△Device manufacturer’s written instructions include
sterility (and must be rinsed).19,20 instructions for IUSS

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 48

△△Manufacturer’s written instructions for cleaning, △△Devices or loads that have not been validated
cycle type, exposure times, temperature settings, with the specific cycle employed

△△Devices that are sold sterile and intended for

and drying times (if recommended) are available
and followed
single-use only22
△△Items are placed in a containment device that has
been validated for IUSS, cleared by the FDA for this Cooling and Recordkeeping
purpose, and works in a manner that allows steam
After sterilization, items should be cooled to room
to contact all instrument surfaces
temperature before they are handled, in order to prevent
△△Containment device manufacturer’s written IFUs condensation. ANSI/AAMI ST79, Comprehensive Guide
are followed to Steam Sterilization and Sterility Assurance in Health
△△Measures are taken to prevent contamination during Care Facilities, states that a 30-minute minimum cool-
down time is recommended; however, it could require 2
transfer to the sterile field
hours or more for sterilized items to cool enough prior
△△Items subjected to IUSS are used immediately and to being handled. Items should be cooled in the sterilizer
not stored for later use or held from one procedure (or on the cart used in the sterilizer), and not transferred
to another to other racks or shelves for cooling. There should be a
IUSS is the process of sterilization of a surgical dedicated area to allow for holding of items away from
instrument through the use of a shorter, abbreviated traffic, air conditioning, and cooling vents.19,20
cycle, with no drying time before the instrument is
After cooling items, inspect them to ensure that
used for patient care. The instrument must first be
packaging is intact, external indicators of sterilization
cleaned according to IFUs, then placed in an autoclave
are there, and no moisture is present. If there is
designated for IUSS. The same monitoring and
any failure on these points or other concern with
documentation of sterilization processes are required
integrity of packaging, then the items should be
no matter where the sterilizer is located.
returned to decontamination and the process
IUSS cycles last generally either 3 or 10 minutes, restarted. Recordkeeping is necessary for every run
depending on the nature of the device being sterilized of the sterilizer. Recordkeeping should include the
and the type of cycle indicated, with minimal or no sterilization date, sterilizer number, the cycle number
dry time and no cool down. This makes the cycle-time (sequential number of times the sterilizer is run in a
shorter than that for wrapped or terminally sterilized day), the load control record numbers (which point
items. Time constraints may result in pressure on to a detailed list of all items run in that sterilization
personnel to eliminate or modify one or more steps in cycle), the exposure time and temperature (if printouts
the cleaning and sterilization process, which could result are provided by the sterilizer, they should be used for
in retained contamination and associated SSI risk. this documentation), the name of the person operating
IUSS should not be performed on the the sterilizer, and the results of any testing. Results
following devices:22 of testing can include biological testing, Bowie-Dick
testing, and response of a chemical indicator (CI)
△△Implants, except in a documented emergency placed in a process-challenge device. If there are
situation when no other option is available negative or questionable chemical indicator results,
△△Postprocedure decontamination of instruments used these should also be recorded. These records should
on patients who may have Creutzfeldt-Jakob disease then be retained for the duration established by
or similar disorders facility policy.

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 49

All sterilization equipment should be properly principles should apply to all areas where sterile stock is
maintained according to IFUs, with documentation of stored, as well as to commercial products as well.
routine preventive and all other types of maintenance.
In addition, extreme care should be taken to maintain
After nonroutine maintenance, sterilization verification
package integrity whenever an item has been handled
should be completed prior to instrument use.19,20
or transported. Containers should remain level when
stored, handled, and transported.16,17
Sterile Storage
As its name indicates, the sterile storage area is used for Monitoring the Sterilization Process
storage of clean and sterile items. The sterile storage area
Physical, chemical, and biological monitors should be
should be designed to protect items from damage and
used to oversee the sterilization processes. They should
contamination. Open or wire shelving is appropriate,
be used for routine load release, routine sterilizer efficacy
unless the area has high levels of traffic, in which case
testing, and sterilizer qualification testing (e.g., after
closed carts are preferable. Items should be at least 8 to
installation, relocation, malfunction, major repair, and
10 inches from the floor, and all storage shelves should
sterilization process failure). These monitors are used
have solid bottoms to protect items from dust and
in a variety of ways and places and will be evaluated
debris. Items should be at least 18 inches below ceiling
by sterilization personnel at the end of the process as
or sprinkler heads and 2 inches from exterior walls.
well as by any healthcare workers who open the item at
In general, there should be plenty of space and minimal the point of use. If there is concern about any process
stacking to ensure package integrity. (Refer to the monitor, the item should not be used, management
wrapping manufacturer’s instructions for allowance of should be notified, and an investigation should be
stacking of wrapped instruments.) Sterile items should undertaken to remedy any problems.
not be stored near water sources.
The first type of monitor is a physical monitor. Physical
External shipping containers and web-based cardboard monitors include a sterilizer’s time, temperature, and
should be considered contaminated. Contents should pressure. The sterilizer will produce this information,
be removed before transporting to the clean areas of the usually via printout or electronic display. The sterilizer
SPD or OR. operator should verify that the physical monitor
Shelf life of sterilized items is event-related: It is indicates that the necessary parameters have been met
dependent on packaging material, storage conditions, and should retain the cycle information as required by
transport, and handling. An event must occur to the facility policy.
compromise package content sterility. Events that may
The second type of monitor is a chemical indicator.
compromise the sterility of a package include:
A chemical indicator is a device used to monitor the
△△Multiple instances of handling that leads to seal attainment of one or more critical parameters required
breakage or loss of package integrity for sterilization. A characteristic color or other visual

△△Moisture penetration
change indicates a defined level of exposure, based on
the type of the chemical indicator used.22
△△Exposure to airborne contaminants There are six types of chemical indicators. Type 1 is
Use the FIFO technique: First In, First Out. “Older” a process indicator, which is placed on the outside of
items should be used prior to those freshly sterilized. individual containers or packs and provides a visual
Even though event-related sterility principles are used, indication that an item has been exposed to the
it is still necessary to ensure stock is arranged on shelves sterilization process. The Bowie-Dick is an example of
so that the oldest stock is used first. These stock rotation a Type 2 indicator, which tests for air leaks, adequate air

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 50

removal, and steam penetration in steam sterilization. △△Ozone sterilizers: Geobacillus stearothermophilus
△△Dry-heat sterilizers: Bacillus atrophaeus
Bowie-Dick tests should be run daily for all steam
sterilizers. Types 3 and 4 test only some of the process
variables and have little use in healthcare. Type 5, also The biological indicator is placed within a process-
referred to as an integrating indicator, is designed to control device and incubated after the sterilization cycle
react to all of the critical process variables. Type 6 is an is complete. After the manufacturer’s recommended
emulating indicator, and it reacts to all critical process incubation time has passed, the indicator is evaluated
variables for specific sterilization processes. for growth (showing whether the sterilization process
has succeeded or failed). A biological indicator should
A type 5 or 6 chemical indicator should be placed inside
be used for routine load release, routine sterilizer efficacy
each container or package. Multiple indicators may be
monitoring, sterilizer qualification testing, and periodic
placed in packages, depending on the manufacturer’s
product quality assurance testing. A biological indicator
IFUs, and evaluated by the staff member who opens the
should be run with every sterilization load that contains
item at the point of use. These indicators are specific
an implant. When used for implant loads, the biological
to the sterilization cycle and should be selected based
incubation should be completed prior to use of the
on the cycle required for the items being sterilized.
implant on a patient.23-27
A type 5 or 6 indicator will also be placed within a
process-control device that is evaluated at the end of the
Loaned Instrument Considerations
sterilization load (prior to releasing the items for use).
Sterility assurance related to loaned instruments should
The final type of monitor is a biological indicator.
begin at the point at which the healthcare organization
Biological indicators are composed of very hearty
assumes responsibility for the items. If an item was
bacterial spores and provide clear indication that the
reprocessed at another institution prior to delivery,
sterilization cycle was adequate to kill organisms.
the item should be considered contaminated and
Biological indicator should be selected specific to the
delivered directly to the SPD for decontamination and
sterilization method:
sterilization. A deadline for receipt by SPD should be
△△Steam sterilizers: Geobacillus stearothermophilus made—usually 24 to 48 hours prior to the case—to

△△Ethylene oxide sterilizers: Bacillus atrophaeus

allow proper processing. Late receipt of instruments
should not result in IUSS. A record of loaned
△△Low-temperature hydrogen peroxide gas plasma instruments should be kept, and the facility should have
sterilizers: Geobacillus stearothermophilus access to the IFUs for each loaned instrument.28-32

△△Hydrogen-peroxide vapor sterilizer: Geobacillus

stearothermophilus

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Special Considerations

Toxic Anterior Segment Syndrome (TASS)

TASS is a rare ophthalmologic condition associated with inadequate or improper instrument processing. It is
caused when a chemical agent enters the anterior chamber of the eye, causing an inflammatory reaction. It is
commonly associated with cataract surgery, but it can occur subsequent to any anterior eye surgery.33,34 If TASS
is not treated properly, the inflammatory response can result in severe visual impairment. The root cause of
TASS has been found to be associated with selective elements of instrument reprocessing including:34

△△Residual detergent left on instruments

△△Insufficient rinsing of instruments
△△Dried organic debris and residues of ophthalmic viscoelastic material remaining on instruments
△△Insufficiently dried lumens
The American Society of Cataract and Refractive Surgery has published Recommended Practices for Cleaning
and Sterilizing Intraocular Surgery Instruments.35

Creutzfeldt-Jakob Disease (CJD)

CJD is a rare, degenerative, fatal brain disorder caused by an abnormal “infectious” protein. It belongs to a
family of human and animal diseases known as the transmissible spongiform encephalopathies (TSEs). Prions
are difficult to kill and are resistant to common strategies for disinfection and sterilization. Instruments that
have come in contact with selective tissues from high-risk surgical patients (e.g., brain, spinal cord, and eyes)
require segregation (quarantine) from other surgical instruments and must be adequately decontaminated to
reduce the transmission of these particles to other patients. Neurosurgical instruments pose the greatest risk,
because they can be contaminated with a large burden of infectious proteins.36 The World Health Organization
(WHO) has published guidelines for the inactivation of these resistant particles. If disposable instruments are
not used, WHO recommends one of the following reprocessing protocols:37

△△Immerse the instrument in a covered pan containing 1N sodium hydroxide (NaOH) and heat in a gravity
displacement autoclave at 121°C for 30 minutes; clean; rinse in water; and subject to routine sterilization.

△△Immerse the instrument in 1N NaOH or sodium hypochlorite (20,000 ppm available chlorine) for 1 hour;
transfer instruments to water; heat in a gravity displacement autoclave at 121°C for 1 hour; clean; and subject
to routine sterilization.

△△Immerse the instrument in 1N NaOH or sodium hypochlorite (20,000 ppm available chlorine) for 1 hour;
remove and rinse in water; transfer to an open pan and heat in a gravity displacement (121°C) or porous load
(134°C) autoclave for 1 hour; clean; and subject to routine sterilization.

△△Heat-sensitive reusable instruments and surfaces that come in contact with high- infectivity and low-
infectivity tissues can be decontaminated by flooding with or soaking in 2N NaOH or undiluted sodium
hypochlorite for 1 hour and then rinsed with water. To minimize drying of tissues and body fluids on the
surgical instruments, the devices should be kept moist until cleaned and decontaminated.
In suspected or confirmed cases of CJD, all disposable instruments, materials, and wastes that come in contact
with high-infectivity tissues (e.g., brain, spinal cord, and eyes) and low-infectivity tissues (e.g., cerebrospinal
fluid, kidneys, liver, lungs, lymph nodes, spleen, and placenta) of suspected or confirmed TSE patients should
be disposed of by incineration. Management of suspected or confirmed cases requires close communication
among the surgeon, OR nursing, and the IP to ensure that a comprehensive CJD policy is developed and in
place for managing suspected or confirmed cases.

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 52

High-Level Disinfection endocavitary probes (rectal and vaginal), respiratory

therapy, and anesthesia equipment. SPD staff may be
The high-level disinfection (HLD) process involves
responsible for performing high-level disinfection on
elimination of all microorganisms (mycobacteria, medical devices used in hospital or outpatient clinics,
fungi, viruses, and bacteria) in or on a device, with emergency rooms, OB/GYN clinics, operating rooms,
the exception of high numbers of bacterial spores. special procedures rooms, and endoscopy suites. HLD
Devices processed by HLD include endoscopes (GI, can involve heat, pasteurization (65° to 77°C for 30
bronchoscopes, and laryngoscopes), laryngoscope blades, minutes), or more typically, chemical disinfection.

FIGURE 6
HIGH-LEVEL DISINFECTANTS AND KILL TIMES
The following table lists common chemicals used for high-level disinfection along with estimated kill times.38,39

HLD Method Duration

>2 percent glutaraldehyde 20 to 45 minutes
0.55 percent ortho-phthalaldehyde (OPA) 12 minutes
1.12 percent GLUT/1.93 percent phenol 20 minutes
7.5 percent hydrogen peroxide (HP) 30 minutes
7.35 percent HP/0.23 percent peracetic acid (PA) 15 minutes
1.0 percent HP/0.08 percent PA 25 minutes
400 to 500 ppm chlorine 10 minutes
2.0 percent HP 8 minutes
3.4 percent GLUT/26 percent isopropanol 10 minutes

While these chemical disinfectants have proven to be As noncritical (low-level) disinfection rarely applies
effective for HLD, several of the selective agents have been to items used in the OR, it will not be discussed further
documented to cause skin, eye, and respiratory irritation; in this guide.
contact dermatitis; and anaphylactic irritation in bladder
Flexible Endoscope Reprocessing
cancer patients. All require the use of personal protective
equipment (PPE)i.e., long-sleeve impervious gown, Flexible endoscopes, categorized as semi-critical items,
protective eyewear, mask, gloves, and cap). require high-level disinfection at a minimum. They
can be processed manually or by using an automated
The determination of level of disinfection or sterilization
endoscope reprocessor (AER).40 For manual reprocessing
required for any instrument is determined by the
at point of use, the flexible endoscope must be
Spaulding criteria, a classification scheme using the degree
immediately wiped down and placed in a basin with
of infection risk and the intended use of the object to
detergent or enzymatic cleaner, which must then be
determine how items should be reprocessed. Spaulding
suctioned through all channels until the fluid is clear.
criteria uses three categories:
The scope must then be placed in a covered container
△△Critical: Items that enter sterile tissue, which must and transported to the reprocessing area. In the
be sterilized reprocessing area, the endoscope must be leak-tested;
△△Semicritical: Items that contact mucous membranes, manually brushed on all internal and external surfaces;
which require at least high-level disinfection all channels flushed with detergent cleaning fluid;
△△Noncritical: Items that come in contact with intact thoroughly rinsed in clean water; then immersed with
skin, which require low-level disinfection38,39 accessories in high-level disinfectant, to fill all channels
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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 53

and ports. Following HLD the scope and channels must area/decontamination room in a closed container and
be thoroughly rinsed, purged with air, flushed with labeled as biohazardous. An advantage of automated
70 to 80 percent alcohol (refer to manufacturer IFU), reprocessing of endoscopes is reduced operator exposure
and stored in a vertical position in a well-ventilated to chemicals, and reduced operator error. However, there
and dust-free area/cabinet. Wet or inadequately dried have been several documented cross transmissions of
endoscopes pose an increased risk of contamination and multidrug-resistant pathogens following reprocessing
have been associated with transmission of waterborne with AER.43,44 These failures in HLD were found to be
microorganisms and infection; it is important that scopes related to improper manual cleaning, improper use of
be thoroughly dried. AER, inability or failure to clean the suction channel,
The 2018 Guidelines for Perioperative Practice recommend and mechanical or design flaws in the flexible endoscope.
that scopes be stored in a drying cabinet. Drying cabinets Impact of Biofilms on High-Level Disinfection
for endoscope storage are defined as a cabinet equipped of Flexible Endoscopes
with a drying system that continually blows pressurized,
As with other instruments, biofilm formation is a
HEPA-filtered air through the endoscope’s channels
challenge in the reprocessing of flexible endoscopes.45
and while also circulating HEPA-filtered air around the
Biofilm development on or in flexible endoscopes can
exterior of the endoscopes. If a drying cabinet is not
be associated with the following:
available, the guidelines recommend that scopes be stored
in a cabinet that is HEPA filtered with positive pressure. △△Failure to adequately wipe down the scope and/or
thoroughly flush the channels with an enzymatic
The distal end of the endoscope should not touch the
detergent at the point of use
floor or bottom of the storage cabinet, nor should the
distal end rest on a soft surface such as a towel or synthetic △△Failure to adequate brush all internal and external
“bumper” since these surfaces can become contaminated surfaces prior to HLD
over time.41,42
△△Development of internal surface defects within the
For automated endoscope reprocessing, the scope must lumens of the various scope channels

△△Design flaws in the endoscope

also be wiped down at point of use with an enzymatic 46-48
detergent, which must then be suctioned through all
channels, after which the scope must be transported Biofilm-forming Gram-negative bacteria such as
in closed container to the cleaning/decontamination Pseudomonas aeruginosa and other multidrug-resistant
area in the SPD. Prior to placing in the AER, the scope pathogens have been implicated in biliary tract infection
must be leak-tested (some AERs include this step during following ERCP.49 Endoscope contamination involving
reprocessing) and manually brushed and cleaned. The mature biofilms are difficult to resolve, even following
HLD solution concentration must be checked and high-level disinfection, and can result in patient infection.
recorded, and the scope and accessories connected to Consequently, enhanced guidelines emphasize the
the AER. Following the HLD cycle, the scope channel(s) importance of adequate precleaning at point of use,
must be flushed with alcohol and compressed air, and incorporating the following steps:50
the scope must be stored in a vertical position to facilitate
drying and prevent tip contamination. The automated △△Prepare fresh cleaning solution for each endoscope
reprocessing steps must follow all manufacturer’s △△Wipe exterior surfaces with a soft, lint-free cloth
recommendations, including validating HLD or sponge saturated with the solution
concentration and cycle time.
△△Suction the cleaning solution through the channels
When transporting a “dirty” scope from the procedure of the device by placing the distal end in the
area, the instrument must be safely moved to the cleaning cleaning solution

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 54

△△Alternate suctioning the channels with cleaning safe, data are insufficient to provide a maximal duration
solution and air, finishing with air for use of appropriately cleaned, reprocessed, dried, and

△△Discard the cleaning solution and cloth or sponge stored flexible endoscopes.”
after each endoscope A 2015 article in Gastrointestinal Endoscopy aimed

△△Visually inspect the endoscope for damage

to demonstrate whether duodenoscopes, gastroscopes,
and colonoscopes could be stored for as long as 21
This visual inspection is critical to determine if any days without microbial colonization by potential
residual debris remains on the surface of the device or if pathogens. In light of conflicting recommendations,
damage has occurred to the external or internal surfaces. organizations should do a thorough risk assessment
A recent study documented microbial recovery from including careful consideration of turnover and risk of
60 percent of endoscopes following use of automated potential contamination. Through this process, many
reprocessing machines. In the study, visual inspection organizations have set specific time frames, usually
via borescope documented internal surface irregularities reprocessing within 14 to 21 days. Scopes should be
that could sequester microbial contamination following labeled with the date they underwent HLD.
HLD. It was the authors’ opinion that rigorous Other Semi-Critical Devices
reprocessing practices may not be adequate to ensure
that “patient-ready” endoscopes are free of residual Vaginal and rectal (endocavitary) probes and
contamination, underscoring the need for both visual laryngoscopes are designated as semi- critical devices,
inspections and a biochemical-based verification test to requiring at least high-level disinfection between patient
ensure more comprehensive reprocessing.51 However, uses. The precleaning, cleaning and disinfecting process
the use of a borescope is not currently recommended by must be performed per the device manufacturer’s
recommendations and current published guidelines.53
any regulatory or professional guidelines. It is important
Human papilloma virus (HPV) has been reported
to recognize that endoscopic equipment has a finite
to contaminate both endovaginal and endorectal
life expectancy, and continuous wear and tear will
ultrasound probes.54,55
compromise the internal/external integrity of the device.
In light of current outbreaks, a systematic maintenance Guidelines from the American Institute of Ultrasound
schedule and/or strategy for replacement of aged in Medicine recommends the following steps to reduce
equipment should be implemented to decrease the risk the risk of microbial cross-transmission between
of endoscope-associated bacterial transmission.52 patients: single-use sheath or condom applied to the
probe prior to use; thorough cleaning after each use;
Length of Storage of Endoscopes
HLD after cleaning.56 When determining which method
How long can endoscopes be stored after reprocessing? and solution to use for HLD, it is important to note
Insufficient data exist. Concern about possible microbial that current studies conclude that glutaraldehyde and
colonization has led to various recommendations orthophthaladehyde (OPA) demonstrate little virucidal
for reprocessing intervals among institutions, with activity against HPV types 16 and 18.57 Sonication of
many as short as 5 days. The Multisociety Guideline on the probe in an H2O2 system has been demonstrated to
Reprocessing Flexible GI Endoscopes (https://www.ncbi. provide strong virucidal activity resulting in a 5.2 to 7.4
nlm.nih.gov/pubmed/28069113) notes that this is an log10 reduction in viral loads for HPV types 16 and 18.
unresolved issue: “Although reuse of endoscopes within Furthermore, a sonicated H2O2 system provides HLD
10 to 14 days of high-level disinfection appears to be of both the probe and probe handle.57

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IMPLEMENTATION STRATEGIES FOR THE IP

△△Review and become familiar with SPD policies and related professional guidelines (AORN, AAMI).
△△Review and become familiar with ANSI/ASHRAE/ASHE Standard 170-2013 regarding HVAC, temperature,
and humidity parameters for SPD.

△△Review and become familiar with FGI guidelines for design of SPD.
△△Request SPD manager’s input during the annual IPC risk assessment process relative to SPD processes,
any recalls, and/or issues related to inadequate inventory or instrument reprocessing.

△△Use a checklist to help guide site visits to the SPD and other areas where instruments used for invasive
procedures are reprocessed; review and be familiar with these processes to support best practices during
site visits. A sample endoscopy review checklist is in Tools and Resources for this section.

△△Collaborate with perioperative leadership to advocate for minimizing IUSS by reviewing reasons for use
of IUSS and promoting adequate inventory of surgical instrumentation with the support of the Infection
Control Committee.

△△Promote measures that help ensure that all personnel that use reusable medical devices and that
instruments adhere to the facility’s protocols for reprocessing and handling these items.

TOOLS AND RESOURCES

△△CDC Guideline for Disinfection and Sterilization in Healthcare Facilities—Link to 161-page print document,
summary, and updates. https://bit.ly/2FcAEHI

△△Point-of-Use Pre-Cleaning Surgical Instruments—Step-by-step instructions and references on proper

care and handling of instruments and devices which must be transported for sterilization or high-level
disinfection, from Highland Hospital, University of Rochester Medical Center. Provided by APIC
https://bit.ly/2I81AyJ

△△“AORN Guideline Summary: Cleaning and Care of Surgical Instruments”—Comprehensive list

of recommendations and key points for action for cleaning and care of surgical instruments.
Provided by APIC https://bit.ly/2IeFKWk

△△“AORN Guideline Summary: Processing Flexible Endoscopes”—Recommendations and key points for
perioperative, endoscopy, and sterile-processing personnel for processing all types of reusable flexible
endoscopes and accessories. Provided by APIC https://bit.ly/2IbJmwx

△△SPD Tracer Observation Form—The Joint Commission key survey assessment tool for the Sterile Processing
Department, with questions on instruments, practices, training. Can also be adapted. https://bit.ly/2KcP0Lg

△△FDA guidance on scopes—Duodenoscope Surveillance Sampling & Culturing: Reducing the Risk of Infection;
57-page report with protocols; 2018. Provided by APIC https://bit.ly/2G8w6m5

△△BSWH Endoscopy Audit Tool—Excel scoring tool for high-level disinfection of GI endoscopes, created
by Teri Mauldin, MBA, BSN, RN, ACM, CIC, Manager, Infection Prevention and Control Centralized
Surveillance, Baylor Scott & White Health. Provided by APIC https://bit.ly/2rGVfjN

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 56

REFERENCES
1. American National Standards Institute/Association for the 13. American National Standards Institute/Association for the
Advancement of Medical Instrumentation. ST 79:2017— Advancement of Medical Instrumentation. ST 58:2013—Chemical
Comprehensive guide to steam sterilization and sterility assurance sterilization and high-level disinfection in health care facilities. ANSI
in health care facilities. ANSI website. 2017. http://my.aami.org/ website. 2013. http://my.aami.org/aamiresources/previewfiles/
aamiresources/previewfiles/1709_ST79Preview.pdf. Accessed ST58_1308_preview.pdf Accessed April 30, 2018.
April 30, 2018.
14. Rutala WA, Weber DJ. Healthcare Infection Control Practice
2. American National Standards Institute/Association for the Advisory Committee (HICPAC). Guidelines for disinfection and
Advancement of Medical Instrumentation. ST 58:2013—Chemical sterilization in healthcare facilities. CDC website. 2008. https://
sterilization and high-level disinfection in health care facilities. ANSI www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-
website. 2013. http://my.aami.org/aamiresources/previewfiles/ guidelines.pdf Accessed April 30, 2018.
ST58_1308_preview.pdf Accessed April 30, 2018.
15. Association of periOperative Registered Nurses. Guideline for
3. Rutala WA, Weber DJ. Healthcare Infection Control Practice cleaning and care of surgical instruments. AORN website. January
Advisory Committee (HICPAC). Guidelines for disinfection 2017. http://www.aornstandards.org/content/1/SEC36.extract.
and sterilization in healthcare facilities. CDC website. 2008. https:// Accessed April 30, 2018.
www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-
16. Jinadatha C, Bridges A. Cleaning, Disinfection, and Sterilization.
guidelines.pdf Accessed April 30, 2018.
In: APIC Text Online, 2018. http://text.apic.org/toc/basic-
4. Association of periOperative Registered Nurses. Guideline for principles-of-infection-prevention-practice/cleaning-
cleaning and care of surgical instruments. AORN website. January disinfection-and-sterilization. Accessed April 2018. Subscription
2017. http://www.aornstandards.org/content/1/SEC36.extract. required.
Accessed April 30, 2018.
17. Rutala WA, Weber DJ. Healthcare Infection Control Practice
5. Association of periOperative Registered Nurses. Guideline Advisory Committee (HICPAC). Guidelines for disinfection
for sterilization. AORN website. January 2017. http://www. and sterilization in healthcare facilities. CDC website. 2008.
aornstandards.org/content/1/SEC38.extract. Accessed https://www.cdc.gov/infectioncontrol/pdf/guidelines/
April 30, 2018. disinfection-guidelines.pdf Accessed April 30, 2018.
6. American National Standards Institute, American Society of 18. Association of periOperative Registered Nurses. Guideline for
Heating, Refrigerating and Air-Conditioning Engineers, American cleaning and care of surgical instruments. In: AORN. Guidelines for
Society for Healthcare Engineering. ANSI website. 2017. Perioperative Practice. Denver, CO: AORN, Inc.; 2017. p. 815-850.
7. Facilities Guideline Institute. Guidelines for design and construction 19. American National Standards Institute/Association for the
of hospitals and outpatient facilities, 2018. FGI website. 2018. Advancement of Medical Instrumentation. ST 79:2017—
Available at: https://www.fgiguidelines.org/guidelines/ Comprehensive guide to steam sterilization and sterility assurance
purchase-the-guidelines/read-only-copy/ in health care facilities. ANSI website. 2017. http://my.aami.org/
aamiresources/previewfiles/1709_ST79Preview.pdf. Accessed
8. Roberts CG. The role of biofilms in reprocessing medical devices.
April 30, 2018.
Am J Infect Control 2013;41:S77-80.
20. American National Standards Institute/Association for the
9. Epstein L, Hunter JC, Arwady MA, Stein L, Gribogiannis M, et al.
Advancement of Medical Instrumentation. ST 58:2013—Chemical
New Delhi metallo-beta- lactamase producing carbapenem-resistant
sterilization and high-level disinfection in health care facilities. ANSI
Escherichia coli associated with exposure to duodenoscopes. JAMA
website. 2013. http://my.aami.org/aamiresources/previewfiles/
2014;312:1447-1455.
ST58_1308_preview.pdf Accessed April 30, 2018.
10. Smith Z, Oh Y, Saeian K, Edmiston CE, Khan AH, Massey BT,
21. Association for the Advancement of Medical Instrumentation.
Dua KS. Transmission of carbapenem resistant Enterobacteriaceae
Technical information report 34: water for the reprocessing of
during ERCP: time to revisit the current reprocessing guidelines. In
medical devices. Atlanta, GA: Association for the Advancement
Press: Gastrointestinal Endoscopy 2015;81:1041-5.
of Medical Instrumentation; 2014.
11. Ofstead CL, Wetzler HP, Heymann OL, Johnson EA, Eiland JE,
22. Association of PeriOperative Registered Nurses. AORN guideline
Shaw MJ. Longitudinal assessment of reprocessing effectiveness
for sterilization and guideline for packaging. In: Guidelines for
for colonoscopes and gastroscopes: results of visual inspections,
Perioperative Practice. Denver, CO: AORN, Inc.; 2017. p. 865-892.
biochemical markers, and microbial cultures. A, J Infect Control
2017;45:e26-e33. 23. American National Standards Institute/Association for the
Advancement of Medical Instrumentation. ST 79:2017—
12. Kenters N, Huijskens EGW, Meier C, Voss A. Infectious diseases
Comprehensive guide to steam sterilization and sterility assurance
linked to cross- contamination of flexible endoscopes. Endoscopy Int
in health care facilities. ANSI website. 2017. http://my.aami.org/
Open 2015;3(4):E259- E265.
aamiresources/previewfiles/1709_ST79Preview.pdf. Accessed
April 30, 2018.

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 57

24. American National Standards Institute/Association for the 37. World Health Organization. WHO infection control guidelines
Advancement of Medical Instrumentation. ST 58:2013—Chemical for transmissible spongiform encephalopathies: Report of a WHO
sterilization and high-level disinfection in health care facilities. ANSI consultation, Geneva, Switzerland, March 23-26, 1999. http://
website. 2013. http://my.aami.org/aamiresources/previewfiles/ www.who.int/csr/resources/publications/bse/whocdscsraph2003.
ST58_1308_preview.pdf Accessed April 30, 2018. pdf. Accessed April 30, 2018.
25. Rutala WA, Weber DJ. Disinfection and sterilization: An overview. 38. Jinadatha C, Bridges A. Cleaning, Disinfection, and Sterilization.
Am J Infect Control 2013; 41:S2-S5 In: APIC Text Online, 2018. http://text.apic.org/toc/basic-
principles-of-infection-prevention-practice/cleaning-
26. Association of periOperative Registered Nurses. AORN Guideline
disinfection-and-sterilization. Accessed April 2018. Subscription
for Cleaning and Care of Surgical Instruments. In: Guidelines for
required.
Perioperative Practice. Denver, CO: AORN, Inc.; 2017. p. 815-850.
39. Rutala WA, Weber DJ. Healthcare Infection Control Practice
27. Association of PeriOperative Registered Nurses. AORN guideline
Advisory Committee (HICPAC). Guidelines for disinfection
for sterilization. In: Guidelines for Perioperative Practice. Denver,
and sterilization in healthcare facilities. CDC website. 2008.
CO: AORN, Inc.; 2017. p. 865-892.
https://www.cdc.gov/infectioncontrol/pdf/guidelines/
28. American National Standards Institute/Association for the disinfection-guidelines.pdf Accessed April 30, 2018.
Advancement of Medical Instrumentation. ST 79:2017—
40. Rutala WA, Weber DJ. Healthcare Infection Control Practice
Comprehensive guide to steam sterilization and sterility assurance
Advisory Committee (HICPAC). Guidelines for disinfection
in health care facilities. ANSI website. 2017. http://my.aami.org/
and sterilization in healthcare facilities. CDC website. 2008.
aamiresources/previewfiles/1709_ST79Preview.pdf. Accessed
https://www.cdc.gov/infectioncontrol/pdf/guidelines/
April 30, 2018.
disinfection-guidelines.pdf Accessed April 30, 2018.
29. American National Standards Institute/Association for the
41. Society of Gastroenterology Nurses and Associates. Standards
Advancement of Medical Instrumentation. ST 58:2013—Chemical
of infection prevention in reprocessing flexible endoscopes.
sterilization and high-level disinfection in health care facilities. ANSI
Chicago, IL: SGNA; 2015. p. 1-31.
website. 2013. http://my.aami.org/aamiresources/previewfiles/
ST58_1308_preview.pdf Accessed April 30, 2018. 42. Association of PeriOperative Registered Nurses. AORN guideline
for processing flexible endoscopes. In: Guidelines for Perioperative
30. Rutala WA, Weber DJ. Healthcare Infection Control Practice
Practice. Denver, CO: AORN, Inc.; 2017. p. 717-800.
Advisory Committee (HICPAC). Guidelines for disinfection
and sterilization in healthcare facilities. CDC website. 2008. 43. Epstein L, Hunter JC, Arwady MA, Stein L, Gribogiannis M, et al.
https://www.cdc.gov/infectioncontrol/pdf/guidelines/ New Delhi metallo-beta-lactamase producing carbapenem-resistant
disinfection-guidelines.pdf Accessed April 30, 2018. Escherichia coli associated with exposure to duodenoscopes. JAMA
2014;312:1447-1455.
31. Association of PeriOperative Registered Nurses. AORN guideline
for cleaning and care of surgical instruments. In: Guidelines for 44. Smith Z, Oh Y, Saeian K, Edmiston CE, Khan AH, Massey BT,
Perioperative Practice. Denver, CO: AORN, Inc.; 2017. p. 815-850. Dua KS. Transmission of carbapenem resistant Enterobacteriaceae
during ERCP: time to revisit the current reprocessing guidelines.
32. Association of PeriOperative Registered Nurses. AORN guideline
In Press: Gastrointest Endoscopy 2015;81:1041-5.
for sterilization. In: Guidelines for Perioperative Practice. Denver,
CO: AORN, Inc.; 2017. p. 865-892. 45. Roberts CG. The role of biofilms in reprocessing medical devices.
Am J Infect Control 2013;41:S77-80.
33. Cetinkaya S, Dadaci Z, Aksoy H, Acir NO, Yener HI, Kadioglu E.
Toxic anterior-segment syndrome (TASS). Clinical Ophthalmology 46. Putnam K. Preventing biofilm formation in flexible endoscopes.
(Auckland, NZ). 2014;8:2065-2069. AORN J 2016;103:7-8.
34. Johnston J. Toxic anterior segment syndrome—more than sterility 47. Smith Z, Oh Y, Saeian K, Edmiston CE, Khan AH, Massey BT,
meets the eye. AORN J 2006 Dec;84(6):969-84. Dua KS. Transmission of carbapenem resistant Enterobacteriaceae
during ERCP: time to revisit the current reprocessing guidelines.
35. American Society of Cataract and Refractive Surgery, American
In Press: Gastrointest Endoscopy 2015;81:1041-5.
Society of Ophthalmic Registered Nurses. Recommended practices
for cleaning and sterilizing intraocular surgery instruments. J 48. Ofstead CL, Wetzler HP, Heymann OL, Johnson EA, Eiland JE,
Cataract Refract Surg 2007;33:1095-1100. Shaw MJ. Longitudinal assessment of reprocessing effectiveness
for colonoscopes and gastroscopes: Results of visual inspections,
36. Belay ED, Blase J, Sehulster LM, Maddox RA, Schonberger LB.
biochemical markers, and microbial cultures. A, J Infect Control
Management of neurosurgical instruments and patients exposed to
2017;45:e26-e33.
Creutzfeldt-Jakob Disease. Infection control and hospital epidemiology.
2013;34(12):1272-1280. 49. Nelson DB, Muscarella LF. Current issues in endoscope reprocessing
and infection control during gastrointestinal endoscopy. World J of
Gastroenterol 2006;12(25):3953-3964.

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 Section 4 The Sterile Processing Department, High-Level Disinfection, and Sterilization | 58

50. Centers for Disease Control and Prevention. Interim protocol 54. Casalegno JS, Carval KLB, Eibach D, Valdeyron ML, Lamblin G,
for healthcare facilities regarding surveillance for bacterial Jacquemoud H, et al. High risk HPV contamination of endocavity
contamination of duodenoscopes after reprocessing. Atlanta, GA: vaginal ultrasound probes: an underestimated route of nosocomial
Department of Health and Human Services; 2015. p. 1-5. infection? PLOS one 2012;7:e48137.
51. Qiu L, Zhou Z, Liu Q, Ni Y, Zhao F, Cheng H. Investigating 55. Combs CA, Fishman A. A proposal to reduce the risk of
the failure of repeated standard cleaning and disinfection of a transmission of human papilloma virus via transvaginal ultrasound.
Pseudomonas aeruginosa-infected pancreatic and biliary endoscope. Am J Obstet Gynecol 2016;215:63-67.
Am J Infect Control 2015;43:e43-e46.
56. American Institute of Ultrasound Medicine. Guidelines for
52. Smith Z, Oh Y, Saeian K, Edmiston CE, Khan AH, Massey BT, cleaning and preparing external- and internal-use ultrasound
Dua KS. Transmission of carbapenem resistant Enterobacteriaceae probes between patients, safe handling, and use of ultrasound
during ERCP: time to revisit the current reprocessing guidelines. coupling gel. AIUM website. May 16, 2017. http://www.aium.org/
In Press: Gastrointest Endoscopy 2015;81:1041-5. officialStatements/57. Accessed April 30, 2018.
53. Rutala WA, Weber DJ. Healthcare Infection Control Practice 57. Ryndock E, Robison R, Meyers C. Susceptibility of HPV17 and
Advisory Committee (HICPAC). Guidelines for disinfection 18 to high-level disinfectants indicated for semi-critical ultrasound
and sterilization in healthcare facilities. CDC website. 2008. probes. J Med Virology 2016;88:1076-1080.
https://www.cdc.gov/infectioncontrol/pdf/guidelines/
disinfection-guidelines.pdf Accessed April 30, 2018.

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 59

SECTION 5

EPIDEMIOLOGY AND PATHOGENESIS

OF SURGICAL SITE INFECTIONS

The Scope and Cost of SSIs the program in future years. As a result, a failure to
mitigate SSI risk will have a significant impact on
In the United States, surgical site infections (SSIs)
future hospital reimbursements.5
are a common postoperative complication associated
with significant morbidity and mortality. A multi-state
Procedure-Specific Risks
point-prevalence survey published in 2014 ranked SSI
as the number one healthcare-associated infection (HAI) The National Healthcare Safety Network (NHSN)
occurring in U.S. acute care facilities.1 Approximately calculates the surgical site infection standardized
160,000 to 300,000 SSIs occur annually in the United infection ratio (SSI SIR) for facilities that enroll
States.2 It is estimated that there is a 2- to 11-fold in NHSN as acute care or critical access hospitals.
increased risk of mortality associated with SSIs. This Three SSI SIR models are available for inpatient adult
risk is modulated by the selective surgical procedure; procedures and two models for inpatient pediatric
preoperative, intra-operative, and postoperative care procedures.6 Studies support the continual enhancement
processes provided; and comorbidity patient risk factors. of procedure-specific risk adjustment to make more
The national costs incurred are significant: SSIs now effective inter-hospital comparisons.
rank as the costliest of all HAIs. Indeed, the annual fiscal In one study, for example, the overall SSI rate for colon
burden has been estimated at between $4 billion and procedures was 19.2 percent, but specific procedures
$10 billion.3 ranged from 7.6 percent (lap colectomy) to 52.5 percent
It has been suggested that 60 percent of SSIs could be (open colectomy with or without other bowel surgery
prevented if practitioners and healthcare institutions plus colostomy).7 In addition, the study showed that
consistently employed all evidence-based infection colon surgeries combined with other surgeries had a
prevention practices.4 In 2015, the Hospital-Acquired higher infection rate (29.3 percent) compared to the
Condition (HAC) Reduction Program, which was overall rate. Moreover, teaching hospitals have been
mandated by the Affordable Care Act, required that found to perform a disproportionately greater number
Centers for Medicare & Medicaid Services (CMS) of surgical procedure types.7
reduce payments by 1 percent for hospitals that rank Although it has long been known that emergency
among the lowest-performing 25 percent with regard procedures are associated with a higher SSI rate than
to HACs. In 2016, SSIs after abdominal hysterectomies scheduled surgeries, one study suggests that seven
and colon-related surgical procedures were added types of procedures represent the majority of costs and
to the list of HACs, and there is an expectation that patient harms (including SSI) among all emergency
SSIs after other surgical procedures will be added to general surgery (EGS) procedures.8 The study examined

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 Section 5 Epidemiology and Pathogenesis of Surgical Site Infections | 60

a large sample of EGS procedures, representing directs that “robotic assistance is considered equivalent
approximately 500,000 cases per year. The authors to use of a scope for NHSN SSI surveillance.” However,
concluded that partial colectomy, small-bowel resection, it is difficult to understand how the two can be
cholecystectomy, operative management of peptic ulcer considered in the same category. Although robot-assisted
disease, lysis of peritoneal adhesions, appendectomy, and surgery has evolved over the years for the purpose of
laparotomy make up 80 percent of all EGS procedures, providing a less invasive and safer approach to a number
80.3 percent of deaths, 78.9 percent of complications, of surgical procedures, there are mixed reviews re safety.
and 80.2 percent of inpatient costs nationwide. Studies offer a variety of conclusions, including that
There is no separate NHSN category for robotic surgical there is not enough evidence of benefits to support its
procedures at the present time. The NHSN SSI module significantly higher costs.9

FIGURE 7
SSI RATES FOR OPEN AND ROBOTIC PROCEDURES
A study that analyzed outcomes from 273 robot-assisted procedures found a 5.9 percent SSI rate.10 The study also
found that the patients with SSIs had a longer duration of procedure than those without an SSI. The study compared
nationally reported SSIs after open procedures to SSIs after robotic procedures. It concluded that the increased
incidence of SSIs after some types of robot-assisted surgeries compared with rates after traditional open surgeries
may be related to the learning curve associated with use of the robot.10

Open SSI rate Robotic SSI rate

Prostate and GU 0.85/100 procedures 5.74/100 procedures
GYN 1.72/100 procedures 10.00/100 procedures
COLO 5.88/100 procedures 33.33/100 procedures
Herniorrhaphy 1.62/100 procedures 37.50/100 procedures

Primary Organisms Associated with SSIs (54 percent).13 Meanwhile, a retrospective cohort
comparative study of 389 instrumented spine surgery
Most sources agree that the most common organisms
procedures concluded that Pseudomonas was the most
found to cause SSIs include Staphylococcus aureus,
common organism causing SSIs.14 Possible reservoirs
coagulase-negative staphylococci, Pseudomonas,
for these organisms include the skin, nose, and hair of
Enterococcus spp., and Escherichia coli.11,12 Some studies patients and surgical team members, a contaminated
suggest pathogen specificity based on procedure. For environment, contaminated instruments and
instance, one recent study retrospectively analyzed more equipment (e.g., ortho-pneumatic tourniquets), and
than 900 head and facial plastic surgery SSI cases and bowel contamination. Introduction of the organisms
found that the majority of causative organisms were can occur during surgery or after surgery before the
Pseudomonas aeruginosa and Klebsiella pneumoniae wound has healed.

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 Section 5 Epidemiology and Pathogenesis of Surgical Site Infections | 61

IMPLEMENTATION STRATEGIES FOR THE IP

△△Compare your facility/organization SSI prevention practices with Table 1; meet with your perioperative nurse
executive to share the comparison and evidence supporting any practices not currently in place. Suggest
that you schedule a meeting with the medical director of the OR to present the same opportunity for
improvement in SSI prevention.

△△Offer to lead a multidisciplinary Perioperative Tracer based on an actual or fictionalized SSI case during
a staff meeting or other time. See Tools and Resources: Operating Room Tracer Observation Form.

△△Know the epidemiology of SSIs in your organization and provide information on this to the OR personnel
and surgeons (i.e., identify and collect/report data on organisms associated with SSIs in your facility).

TOOLS AND RESOURCES

△△CDC/NHSN Classifications for SSI Diagram—Visual aid using cross-section of abdominal wall to help
determine SSI classification. Provided by APIC https://bit.ly/2I8ghlq

△△Article on procedure-specific SSI incidence—“Procedure-specific Surgical Site Incidence Varies widely

within Certain National Healthcare Safety Network Surgical Groups,” Saeed MJ, Dubberke ER, Fraser
VJ, Olsen MA. Procedure-specific surgical site infection incidence varies widely within certain National
Healthcare Safety Network surgery groups. Am J Infect Control 2015 June;43(6):6 17-23. doi: 10.1016/j.
ajic.2015.02.012. Provided by APIC https://bit.ly/2I65ZlI

△△Operating Room Tracer Observation Form—The Joint Commissions key survey assessment tool to check
OR equipment use and storage, attire, space, and processes. Provided by APIC https://bit.ly/2wyjvJL

△△NHSN procedure manual—37-page module on handling an SSI event; 2018. Provided by APIC
https://bit.ly/2rA9IwQ

REFERENCES
1. Magill SS, Edwards JR, Bamberg W, et al. Multistate point- 6. Centers of Disease Control and Prevention. NHSN procedure
prevalence survey of health care–associated infections. NEJM manual, surgical site infection event. CDC website. January 2018.
2014;370(13):1198-1208. doi:10.1056/NEJMoa1306801. https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf.
Accessed April 30, 2018.
2. Anderson DJ, Podgorny K, and Berrios-Torres SI, et al. Strategies to
prevent surgical site infections in acute care hospitals: 2014 update. 7. Saeed MJ, Dubberke ER, Fraser VJ, Olsen MA. Procedure-specific
Infect Control Hosp Epidemiol 2014; 35:605-627. surgical site infection incidence varies widely within certain national
healthcare safety network surgery groups. Am J Infect Control.
3. Jenks PJ, Laurent M, McQuarry S, Watkins R. Clinical and
2015;43:617-623.
economic burden of surgical site infection (SSI) and predicted
financial consequences of elimination of SSI from an English 8. John W. Scott, MD, MPH; Olubode A. Olufajo, MD, MPH;
hospital. J Hosp Infect 2014 Jan;86(1):24-33. Gabriel A. Brat, MD; John A. Rose, MD, MPH; Cheryl K.
Zogg, MSPH, MHS; Adil H. Haider, MD, MPH; Ali Salim,
4. Berríos-Torres, S et al. for the Healthcare Infection Control Practices
MD; Joaquim M. Havens, MD. Use of national burden
Advisory Committee. Centers for Disease Control and Prevention
to define operative emergency general surgery. JAMA Surg
guideline for the prevention of surgical site infection, 2017. JAMA
2016;151(6):e160480.
Surg August 2017;152(8):784-791.
9. Broholm M, Onsberg Hansen I, Rosenberg J. Limited evidence
5. Kandilov A, Coomer N, Dalton K. The impact of hospital-acquired
for robot-assisted surgery: a systematic review and meta-analysis
conditions on medicare program payments. Medicare Medicaid Res
of randomized controlled trials. Surg Laparosc Endosc Percutan Tech
Rev 2014; 4(4): mmrr2014-004-04- a01.
2016 Apr;26(2):117-23.

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 Section 5 Epidemiology and Pathogenesis of Surgical Site Infections | 62

10. Hermsen ED, Hinze T, Sayles H, Sholtz L, Rupp ME. Incidence

of surgical site infection associated with robotic surgery. Infect
Control Hosp Epidemiol 2010 Aug;31(8):822-7.
11. Owens CD, Stoessel K. Surgical site infections: epidemiology,
microbiology and prevention. J Hosp Infect 2008 Nov;70 Suppl
2:3-10.
12. Johns Hopkins Medicine. Health library: Surgical site
infections. Johns Hopkins Medicine website. n.d. http://www.
hopkinsmedicine.org/healthlibrary/conditions/surgical_care/
surgical_site_infections_134,144/. Accessed April 30, 2018.
13. Wang G, Zhang S. The risk factors, etiology, and drug resistance
of infection after plastic surgery, and corresponding measures.
Minerva Chir 2017 Feb 23.
14. Hey HW, Thiam DW, Koh ZS, Thambiah JS, Kumar N, Lau LL,
Liu KG, Wong HK. Is intraoperative local vancomycin powder
the answer to surgical site infections in spine surgery? Spine
(Phila Pa 1976) 2017 Feb 15;42(4):267-274.

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 63

SECTION 6

SSI SURVEILLANCE:
DEFINITIONS, METHODS,
OUTCOMES, AND REPORTING
Surgical site infection (SSI) surveillance is a critical SSI Wound Class
component of any infection prevention and control
Surgical wound classification (also called the wound
program. Whether SSI surveillance is manual or
class) is an assessment of the degree of contamination of
automated, its goal is to quantify surgical infection
a surgical wound and is intended to assist in stratifying
risk, assess outcomes in patients undergoing specific
the patient’s risk for developing an infection. Wounds
operations, and identify and implement measures to
are categorized in one of four classes:
reduce risk of infection. This information is typically
shared on a regular basis with stakeholders—including △△Class I, Clean: An uninfected operative wound
surgeons, perioperative nurses, and executives—as in which no inflammation is encountered and the
a means of assessing the effectiveness of infection respiratory, alimentary, genital, or uninfected urinary
prevention efforts, as well as to identify opportunities tracts are not entered. In addition, clean wounds
for improvement. are primarily closed and, if necessary, drained with
closed drainage. Most operative incisional wounds
SSI Definitions that follow nonpenetrating (blunt) trauma should
be included in this category.
The Centers for Disease Control and Prevention (CDC)
has developed and maintains the surveillance definition △△Class II, Clean-Contaminated: Operative wounds
for SSI events, protocols for reporting SSI events to the in which the respiratory, alimentary, genital,
or urinary tracts are entered under controlled
National Healthcare Safety Network (NHSN), and
conditions and without unusual contamination.
training materials for enrolled NHSN users.1 IPs can
Operations involving the biliary tract, appendix,
face challenges in collecting procedure denominator data vagina, and oropharynx are included in this
and SSI event data if surveillance is performed manually. category, provided no evidence of infection or major
Fortunately, as electronic medical records are increasingly break in technique is encountered.
used in place of paper records, automated electronic
capture of denominator data, as well as screening for △△Class III, Contaminated: Open, fresh, accidental
infections, can be accomplished using “homegrown” tools wounds. This category also includes operations with
(e.g., Excel) or infection-surveillance software. major breaks in sterile technique (e.g., open cardiac
massage) or gross spillage from the gastrointestinal
tract and incisions in which acute, nonpurulent

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 Section 6 SSI Surveillance: Definitions, Methods, Outcomes, and Reporting | 64

inflammation is encountered, including necrotic Duration of Surgical Procedure

tissue without evidence of purulent drainage
(e.g., dry gangrene). The duration of the operative procedure is defined by
the Association of Anesthesia Clinical Directors (AACD)
△△Class IV, Dirty or Infected: Includes old traumatic as the interval in hours and minutes between the
wounds with retained devitalized tissue and those procedure/surgery start time and the procedure/surgery
that involve existing clinical infection or perforated finish time.
viscera. This definition suggests that the organisms
causing postoperative infection were present in the △△Procedure/Surgery Start Time: Time when
operative field before the operation.2,3 the procedure is begun (e.g., incision for a
surgical procedure).
The literature has demonstrated that there are
interprofessional variations in wound classification. One △△Procedure/Surgery Finish: Time when all
study of 11 pediatric facilities found that documentation instrument and sponge counts are completed and
of wound classification by registered nurse (RN) verified as correct, all postoperative radiologic
circulators and surgeons was in agreement for only studies to be done in the operating room are
56 percent of procedures. The researchers found that complete, wound is closed and all dressings and
nurses underclassified wound classification in 84 percent drains are secure, and the physicians/surgeons have
completed all procedure-related activities on the
of the procedures.2 A second study, of pediatric
patient. Perioperative personnel entering data for
general surgery procedures, found similar results when
these times in the data source should follow the
comparing wound classifications by RN circulators, AACD definitions. This is typically done by the
surgeons, and National Surgical Quality Improvement RN circulator documenting the times in the intra-
Program (NSQIP) reviewers.3 The researchers observed operative record. Although the AACD defines the
52 percent agreement among the classifications, and RN start times for positioning and prepping the patient
circulators were most likely to underclassify the wounds. for the procedure, the AACD definitions do not
Perioperative personnel must validate the wound clearly address whether injection of local anesthesia
prior to the surgical procedure is included in this
classification data by comparing the SSI denominator data
definition. Because of this, the RN circulator may
source (often the RN circulator’s documentation on the
document the start time as the injection of local
intra-operative record through an electronic health record) anesthesia before the incision has been made.
with the surgeon’s postoperative note. The reliability of The end of the surgical procedure is a busy time
the wound classification documentation may be improved for the RN circulator, which makes real-time
by intra-operative use of a standardized decision tool, with documentation challenging. Documenting surgery
the perioperative nurse assigning the wound classification start-times earlier than the actual incision time and
at the end of the procedure in consultation with the surgery finish-times later may falsely lengthen the
surgeon and including the wound classification in the time that a wound was open, which may reduce the
surgical debrief to facilitate team communication. accuracy of SSI risk adjustment.

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Section 6 SSI Surveillance: Definitions, Methods, Outcomes, and Reporting | 65

Classification of Wound Closure

Classification of the type of surgical wound closure has been the topic of one of the most frequently asked
questions regarding SSI event protocol. Wound closure is classified as either primary or nonprimary:

△△Primary closure: Closure of the skin layer during the original surgery, regardless of the presence of wires,
wicks, drains, or other devices or objects extruding through the incision. This category includes surgeries
where the skin is closed by any means. If any portion of the incision is closed at the skin level, by any manner,
a designation of primary closure should be assigned to the surgery.

△△Nonprimary closure: Closure of the surgical wound in a way that leaves the skin layer completely open
following surgery. For surgeries with nonprimary closure, the deep-tissue layers may be closed by some means
(with the skin level left open), or both the deep and superficial layers may be left completely open. An example
of a surgery with nonprimary closure would be a laparotomy in which the incision was closed to the level of
the deep-tissue layers (sometimes called fascial layers or deep fascia) but the skin level was left open. Another
example would be an open abdominal case in which the abdomen is left completely open after surgery. Wounds
with nonprimary closure may or may not be described as “packed” with gauze or another material and may or
may not be covered with plastic dressing, wound vacuum, or other synthetic devices or materials.2,3
Wound-closure documentation is challenging and requires collaboration among the perioperative team, who
are visualizing the wound. The electronic health record may need to be modified to capture this data element
in a field that can be abstracted for the denominator data report. Providing a visual tool to the perioperative RN
documenting this data element may facilitate the correct classification of wound-closure type.

FIGURE 8
WOUND-CLOSURE TYPES
A visual can help in classification of wound-closure types, a frequent topic in SSI event protocol.

Source: Centers for Disease Control and Prevention, National Healthcare Safety Network. Surveillance for surgical site infection (SSI) event
resources and procedure-associated module. CDC website. January 2018. https://www.cdc.gov/nhsn/acute-care-hospital/ssi/index.html and
http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf.

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 Section 6 SSI Surveillance: Definitions, Methods, Outcomes, and Reporting | 66

SSI Case Finding using electronic medical records and algorithms. The
more accurate and comprehensive methods for case-
Detection of SSIs is challenging in part because
finding will provide a more robust SSI surveillance
infections generally develop after discharge. This is
program and improve identification of outbreaks.
always true for patients undergoing outpatient surgical
Alternatively, taking a bare-bones (e.g., surgeon self-
procedures. The patient may present with an infection
report) approach to SSI case-finding may lead to missed
to their primary physician, at urgent care, or at
SSI events, a failure to identify outbreaks in a timely
another hospital, and they may or may not report the
fashion, and potential regulatory consequences upon
infection to the surgeon or healthcare facility where the
validation of SSI data by the Centers for Medicaid
surgery was done. In the event that a patient receives
& Medicare Services (CMS). Automated and semi-
postoperative care at the hospital where the surgery took
automated infection-detection products are now
place, the IP will have a better opportunity to capture all
available. Infection-surveillance data mining software
surgical infections that occur.
programs typically automate certain aspects of infection
According to the CDC, post-discharge surveillance surveillance, such as denominator data collation.
may include: These systems are being used with more frequency

△△Review of medical records or surgery-clinic patent as electronic medical records replace paper-based
records in most healthcare facilities. These programs,
records (including Admission, Readmission,
Emergency department notes, and OR logs; lab, as well as homegrown fully automated surgical-
x-ray, and other diagnostic test reports; and nurse infection detection tools, can reduce burden the on
and physician notes) valuable IP resources that might otherwise be spent
in front of a computer. The results of peer-reviewed
△△Visiting the ICU and wards to talk to primary- studies have demonstrated that adopting electronic
care staff surveillance software yields considerable dividends
△△Mail or telephone surgeon surveys in IP staff time relating to data collection and case-
finding while maintaining high levels of sensitivity and
△△Mail or telephone patient surveys (although patients specificity. This has the potential to enable reinvestment
may have difficulty assessing their infections) of Infection Preventionist (IP) time in infection
These processes do not take into account systems that prevention activities, to make more efficient use of
completely or partially automate infection detection often constrained expert IP resources.4

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 Section 6 SSI Surveillance: Definitions, Methods, Outcomes, and Reporting | 67

IMPLEMENTATION STRATEGIES FOR THE IP

△△Provide a visual tool, such as Figure 8, to the perioperative RN documenting this data element to facilitate
the correct classification of wound closure type.

△△When possible, automate surgical denominator collation and surgical infection case-finding and reporting
to NHSN, in order to dedicate the majority of IP resources in infection prevention and control activities.

△△Consider developing a business case supporting installation of infection control data-mining software or
IT development of homegrown tool to collate denominator data and screen medical records for surgical
infection triggers.

TOOLS AND RESOURCES

△△NHSN procedure manual—37-page module on handling an SSI event; 2018. https://bit.ly/2rA9IwQ

△△APIC HAI Cost Calculator—Insert data for custom report on costs associated with HAIs and savings
realized by preventing them; available for open access from APIC. Provided by APIC https://bit.ly/2rKFuat

△△Days between Infections Calculator—Excel tool gives number of days free of infections; from Kaiser
Permanente. Provided by APIC https://bit.ly/2KfIOlE

△△AHRQ Toolkit for Safe Surgery—Agency for Healthcare Research and Quality toolkit based on the
organization’s Comprehensive Unit-based Safety Program (CUSP); two complementary guides and 15
instructional modules. https://bit.ly/2wAUzkG

△△APIC Text: Surveillance Chapter—Guidance for implementing an SSI surveillance program, and major
components of an effective surveillance program; subscription required. https://bit.ly/2wwQwpr

REFERENCES
1. Centers for Disease Control and Prevention, National Healthcare 3. Snyder RA, Johnson L, Tice J, et al. Wound classification in
Safety Network. Surveillance for surgical site infection (SSI) pediatric general surgery: significant variation exists among
event resources and procedure-associated module. CDC providers. J Am Coll Surg 2013;217(5):819-826.
website. January 2018. https://www.cdc.gov/nhsn/acute-care-
4. Russo PL, Shaban RZ, MacBeth D, Carter A, Mitchell BG. The
hospital/ssi/index.html and http://www.cdc.gov/nhsn/pdfs/
impact of electronic healthcare associated infection surveillance
pscmanual/9pscssicurrent.pdf. Accessed April 30, 2018.
software on infection prevention resources: a systematic review of
2. Levy SM, Lally KP, Blakely ML, et al. Surgical wound the literature. J Hosp Infect 2017 Sep 8;pii:S0195-6701(17)30491-7.
misclassification: a multicenter evaluation. J Am Coll Surg
2015;220(3):323-329.

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SECTION 7

AUDIT AND FEEDBACK

IP Observations of Surgical Cases Entering the domain of the operating room (OR) for the
first time can be daunting for the novice IP. Setting the
Case observation by the Infection Preventionist
stage with some foundational steps, such as touring the
(IP) can help identify areas to improve surgical site
OR and observing an entire surgical patient journey, can
infection (SSI) prevention and afford an opportunity
support success in subsequent case observations. Surgical
for knowledge-sharing between Infection Prevention
case observations can be enriching for the IP and can
and Control (IPC) and Perioperative departments
provide a valuable opportunity for IPs to partner with
relative to SSI prevention. A critical first step is to ensure
perioperative colleagues in identifying opportunities to
support of the perioperative team regarding the plan for
reduce surgical and device-associated infection risks.2
IP case observations, including agreement on what will
be observed and the method and process for sharing A number of useful checklists that include infection
information after the observations. In some instances, prevention measures have been created by organizations
it may be convenient to have an immediate debrief with including The Joint Commission (TJC), the America
the perioperative manager after each case observation. Hospital Association (AHA), and the Health Research
In others, a written summary and/or presentation at Educational Trust (HRET).3 Any one of these might be
the OR committee meeting may be preferable. Advance a useful starting point for development of an infection
planning is important: When all parties are not included prevention observation checklist, which can serve to
in the process, auditing can have a negative impact on support compliance with standards and evidence-based
the function of the team.1 practices.4 The checklist can be developed for use with
a mobile device or simply as a paper tool on a clipboard.
To guide the IP’s observations, develop a checklist that
supports the goals of both teams (perioperative and Following are categories that might be included.
infection prevention). The list can include items not See Tools and Resources at the end of this section
directly related to SSI prevention, but which nonetheless for a sample OR Observation checklist.
assist the perioperative team—such as assessment of △△Attire
Universal Protocol for preventing wrong site, wrong
procedure, and wrong person surgery. Findings from
△△Environment (including traffic during cases, i.e.,
the number of people in the room and number
observations guided by an infection prevention of door openings)
△△Skin prep application per product
checklist can encourage the sharing of critical case-
related information, flag knowledge gaps, help prioritize
findings based on risk, and enhance team cohesion.1 △△Sterile technique

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 Section 7 Audit and Feedback | 69

△△Hand hygiene by nonscrubbed members of the team Through the relationships built with members of the

△△Instrument handling and reprocessing

multidisciplinary team, the IP acts as a trusted consultant,
advisor, and teammate to those with direct accountability
△△Catheter-associated bloodstream infection for practice changes impacting patient outcomes.
prevention practices Ensuring changes in practice is the responsibility of the

△△Catheter-associated urinary tract infection

perioperative management and leadership, who have
direct responsibility and accountability for those staff
prevention practices
working within the perioperative area.
△△Healthcare-associated pneumonia
prevention practices Environmental Infection Prevention
Audit in the OR
Alternative or additional checklists might be considered
for focused observations addressing specific workstreams An environmental infection prevention audit in the
such as surgical instrument reprocessing or specific OR should be designed to identify issues or concerns
prevention measures such as operating room traffic, that could create patient infection risk. The audit
compliance with surgical attire, or anesthesia practices. might be focused only on infection prevention issues/
Before undertaking a focused assessment, the IP should concerns, or it could be a component of a more
review any related perioperative policies and procedures. comprehensive safety audit. Either way, it should
A request for a focused assessment sometimes results optimally be multidisciplinary. Members in addition
from a concern by perioperative nursing leadership, to an IP may include perioperative leadership,
physicians, or another staff member, or rises after perioperative staff, Sterile Processing department (SPD)
an adverse event. The facility’s Risk Management staff, and representatives from facilities maintenance,
department may also request a focused assessment after Environmental Services (EVS), quality/regulatory/
a root-cause analysis is performed and infection risk accreditation, and executive leadership.
is identified. Alternatively, the IPC department may The IP can provide input on principles of surgical
initiate a recommendation for a focused assessment in infection prevention such as adequacy of hand-sanitizer
response to an upward trend in surgical infection for dispensers, ensuring that supplies are stored behind
a particular procedure type. Real-time auditing and closed doors, traffic control and closure of operating
sharing observations can support an environment of room doors during procedures, etc. EVS representatives
continuous learning, compliance, and synergy, which can weigh in regarding prescribed procedures for
has been reported to result in a safer OR.5 operating room cleaning6-9.

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 Section 7 Audit and Feedback | 70

FIGURE 9
CLEANING FREQUENCIES FOR OR AND PROCEDURE ROOMS10

Every patient Every patient, if used Enhanced If soiled

Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2017, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO
80231. All rights reserved.

Facilities and maintenance, meanwhile, can identify Documentation of the environmental audit should
issues related to the building and infrastructure. be completed in a short period of time (e.g., 2 days)
Quality/regulatory/accreditation’s role would involve after rounding within the perioperative area. The
communicating any concerns with federal, state, or documentation in the environmental audit is meant
local regulatory compliance. The executive leader can to be a useful feedback tool for continuous process
help remove barriers as needed. The benefit in having improvement of the perioperative practice.
multiple parties performing environmental rounds is the
synergy created when the team works together.

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Section 7 Audit and Feedback | 71

IMPLEMENTATION STRATEGIES FOR THE IP

△△Work with representatives from perioperative nursing, surgeons, and anesthesia providers to collaboratively
create the OR case-observation checklist.

△△Consider limiting the OR case-observation checklist to items that can be observed during a case, to simplify
the process.

△△Ask for input: The perioperative team may have items to include in the checklist beyond SSI prevention
(e.g., the team may have suggestions helpful for other performance-improvement projects).

△△When developing the checklist, collaborate with perioperative leaders to leverage clinical support offered
by vendors, such as information regarding proper use of products for skin prep.

△△an
Frame the surgical case-observation project as a method for identifying best practices and leveraging
outside pair of eyes to identify opportunities for improvement.

△△Communicate with perioperative leaders in advance of any case observation to determine the preferred
method for debriefing/reporting observations.

△△When planning the observation project, consider inviting perioperative staff (including surgeons and
anesthesia providers) to identify procedures as candidates for observation—particularly those that have the
highest risk for infection and morbidity from SSI/HAI.

△△Prepare for observation, such as by watching a YouTube video in advance of the type of case scheduled,
with an eye toward considering any procedure-specific infection risk.

△△Change into scrubs before observing case (i.e., no bunny suits).

△△Plan to attend the morning huddle if possible, for introduction to the team before entering the OR.
△△Share a mobile number with the OR manager prior to case observation, in order to communicate if needed
during the case (i.e., to avoid leaving the room).

△△Consider asking the perioperative manager for an introduction to the perioperative team in the room on the
day of the observation—introduce yourself—to share the purpose of the observation and reiterate that you
intend to remain silent (unless questions are asked) to avoid causing distraction.

△△Inopened
order to observe all aspects of the case, take your position in the OR in time to see the instrument set(s)
and the room prepped and to identify an out-of-the-way observation spot.

△△Do not leave the room during the surgical case to avoid unnecessary door opening(s) and associated
increased infection risk.

△△Prepare a written summary of observations, including best practices identified and any perceived
opportunities for improvement, to share with the perioperative team.

△△Before your observation, review perioperative departmental policies and infection prevention policies
pertinent to the operating room. This is also a good opportunity to review the most recent evidence-based
best practice guidelines, which should be reflected in the perioperative policies. Evidence-based guidelines
would include those from the Association for Professionals in Infection Control and Epidemiology (APIC),
the Association of periOperative Registered Nurses (AORN), the Association for the Advancement of
Medical Instrumentation (AAMI), the Society of Gastroenterology Nurses and Associates (SGNA), and the
International Association of Healthcare Central Service Materiel Management (IAHCSMM).

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 Section 7 Audit and Feedback | 72

TOOLS AND RESOURCES

△△OR Case Observation Tool for IPs—Checklist for Sterile Processing processes and practices.
Provided by APIC https://bit.ly/2IeLgbu

△△OR Cleaning Guidelines—Chart outlining the who, what, and when of cleaning responsibilities, from
Highland Hospital, University of Rochester Medical Center Provided by APIC https://bit.ly/2jQZhRW

REFERENCES
1. Oliveira AC, Gama CS. [Evaluation of adherence to measures for 6. Munoz-Price LS, Birnbach DJ, Lubarsky DA, et al. Decreasing
the prevention of surgical site infections by the surgical team]. Rev operating room environmental pathogen contamination through
Esc Enferm USP 2015 Oct;49(5):767-74. improved cleaning practice. Infect Control Hosp Epidemiol
2012;33(9):897-904.
2. Russ S, Rout S, Sevdalis N, Moorthy K, Darzi A, Vincent C.
Do safety checklists improve teamwork and communication 7. Jefferson J, Whelan R, Dick B, Carling P. A novel technique for
in the operating room? A systematic review. Ann Surg 2013 identifying opportunities to improve environmental hygiene in the
Dec;258(6):856-71. operating room. AORN J 2011;93(3):358-364.
3. American Hospital Association/Health Research & Educational 8. Dancer SJ. The role of environmental cleaning in the control of
Trust. Surgical site infections change package. Health Research & hospital-acquired infection. J Hosp Infect 2009;73(4):378-385.
Educational Trust/Hospital Improvement Innovation Network
9. Otter JA, Yezli S, French GL. The role played by contaminated
website. April 17, 2017. http://www.hret-hiin.org/Resources/
surfaces in the transmission of nosocomial pathogens. Infect Control
ssi/17/surgical-site-infections-change-package.pdf. Accessed April
Hosp Epidemiol 2011;32(7):687-699.
30, 2018.
10. Association of periOperative Registered Nurses. AORN guideline
4. Anderson, D.J. et al. Strategies to prevent surgical site infections
for environmental cleaning. In: Guidelines for perioperative
in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol
practice. Denver, CO: AORN, Inc.; 2017. p. 7-28.
2014;35(6),605-627.
5. Russ S, Rout S, Sevdalis N, Moorthy K, Darzi A, Vincent C.
Do safety checklists improve teamwork and communication
in the operating room? A systematic review. Ann Surg 2013
Dec;258(6):856-71.

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 73

SECTION 8

RISK MANAGEMENT
Risk management is defined as the process by which an Root-Cause Analysis for SSI
organization introduces specific measures to minimize
Surgical site infection (SSI) is one of the most significant
or eliminate unacceptable risks associated with its
complications a patient can experience. SSI can result in
operations. Risk mitigation measures can be directed
morbidity, functional dependence, and death. Surgical
toward reducing the severity of risk consequences,
site infections are also associated with additional
reducing the probability of a risk materializing, or
costs—those resulting from extended hospital stay
reducing an organization’s exposure to that risk.
as well as increased total healthcare, social, and labor
In the perioperative setting, numerous aspects of surgical costs.2 Many hospitals routinely perform a root-cause
care can involve infection risk.1 To help mitigate these analysis in response to every SSI. What is required by
risks, an Infection Preventionist (IP) can collaborate the Centers for Medicare & Medicaid Services (CMS)
with the Risk Management, Perioperative, and Sterile and accrediting agencies is an RCA or similar analysis
Processing departments to perform root-cause analysis for events including any SSI that results in permanent
(RCA) after surgical infection as well as to assess patient disability or death.3 The Risk Management or Quality
infection risk after human, system, and mechanical department typically coordinates any RCA. For RCAs
failures related to the patient’s surgical journey. involving contaminated instruments or implants and/
or surgical and other healthcare associated infections
Whether facing an operating room hallway flooded from
(HAIs), IPs must be included.
a burst ceiling water pipe, out-of-control temperature
and humidity variations, or contaminated instruments The goal of the RCA is to identify any preventable
opened on the sterile field, an IP must be able to provide system issue that may have contributed to the
expert input during root-cause analysis and development infection and plan for remediation strategies to prevent
of a risk mitigation plan to reduce the risk of recurrence. recurrence. Depending on the findings of the RCA
The IP will need expertise in researching the topic at and local protocols, a decision regarding disclosure to
hand using key evidence-based guidelines and peer- the patient and their family is made. Each facility will
reviewed literature. This section will address the critical- operationalize disclosure and transparency within the
thinking skills required to understand the issues and scope of its organizational guidelines. The Infection
provide sound evidence-based practice recommendations Prevention and Control (IPC) department is encouraged
to mitigate infection risk. to collaborate with the perioperative team to compare
evidence-based SSI prevention measures during all

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 Section 8 Risk Management | 74

periods of the surgical journey (preoperative, intra- screw-plate sets), it could be necessary to release an
operative, and postoperative) to the care provided to implantable device before the BI results are known.
the patient in question, to determine any causes and In this case, the release of the device before the BI
contributing factors. Steps to the RCA process include: results are known should be documented; the BI result
1) identify and define the effect (infection); 2) identify obtained later should also be documented. It is critical
the main causes contributing to the infection; 3) that this documentation be fully traceable to the patient.
identify factors that may contribute (becoming more Emergency situations should be defined in written
detailed with identification of more factors); 4) make policy and procedures developed in consultation with
recommendations to prevent future occurrences, and IPC, the surgeon, and Risk Management. Steps should
widely share.4 be taken to reduce the frequency of emergency release
of implantable items. For example, periodic reviews
Sterilizer Failure and Recall of the exception forms and implant logs could reveal
of Instruments consistent patterns of events that are leading to the need
The Perioperative and Sterile Processing departments for emergency release and that could be corrected.7-9
should have well-defined policies based on national In the event of a faulty sterilizer, the underlying
standards to provide direction in the event of a failed problem must be corrected. After a major repair of any
mechanical or chemical indicator in a sterilizer. Multiple type of steam sterilizer or utilities connected to the
types of human and equipment errors can result in a sterilizer, three consecutive test cycles with a Process
sterilization failure. The AAMI ST-79 Comprehensive Challenge Device (PCD) containing a BI should be
Guide to Steam Sterilization and Sterility Assurance in run, one right after the other, in an otherwise empty
Healthcare Facilities data provide some examples5,6:
chamber for sterilizers larger than 2 cubic feet and
△△Improper use or placement of biological indicator for IUSS cycles, and in a fully loaded chamber for
(BI) or interpretation of BI results, incorrect table-top sterilizers. After a major repair to a dynamic-
documentation of BI, or improper chemical air-removal sterilizer, three immediately consecutive
indicator selection for the load Bowie-Dick test cycles should then be run in an empty

△△Improper choice of packages, wraps, or containers chamber and the test sheets examined. The test results
should be obtained (i.e., the BI should be incubated
for sterilization
according to the BI manufacturer’s written IFUs) and
△△Improper loading of the sterilizer, such as stacking be determined to be satisfactory before the sterilizer
items improperly, using improper tray weights, or is returned to service.6 Infection Preventionists should
stacking packages of improper densities work with the Sterile Processing department (SPD)
△△Equipment failure, including poor steam quality, to ensure any such events are reported on a regular
wet steam, improper pressure, clogged ventilation basis to the Infection Control Committee.
lines, or improper calibrations and steam pressure
Recall of Contaminated Products
An experienced, knowledgeable sterile processing
and Tissue Implants
professional will review the sterilizer chart or printout
at the end of the sterilization cycle, as well as examine Notices of product recalls and alerts from the Food and
results of other indicators that have been used to Drug Administration (FDA) and the Centers for Disease
monitor the sterilization process. A recalled load should Control and Prevention (CDC) provide information
be quarantined until the results of the BI testing are regarding contamination of pharmaceuticals, medical
available. When documented medical exceptions devices, and hospital supplies. Typically, a hospital has
dictate (e.g., the need for trauma-related orthopedic a department or committee responsible for oversight

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 Section 8 Risk Management | 75

of product evaluation. Such a committee usually also provide implant device tracking cards.12 The cards must
coordinates oversight of any required product recall. be completed by the implanting facility and returned to
A representative from the IPC department should be the manufacturer. If an implantable device does not have
included on the Product Evaluation Committee; it is implant tracking documents in its packaging, the device
important for IPs to be aware of any contaminated is not required to be logged or tracked by the FDA.
products that may have been used on the local patient Notification of an adverse event triggering a tissue-
population in order to monitor for resulting HAI. For implant recall may be received by the donor facility
instance, a recall was announced by the FDA on Jan or by the tissue/implant recipient. For example, the
5, 2011, by Triad Group, of all lots of alcohol prep donor facility may notify an organization of a suspected
pads, swabs, and swabsticks. The recall was due to infectious disease associated with a particular tissue
contamination with Bacillus cereus; the recalled material source. The organization would then need to promptly
resulted in at least one case of sepsis in 2012.10 identify and notify all recipients and quarantine any
Infection Preventionists can receive information implicated tissue not yet implanted. Alternatively, a
regarding relevant recalls and alerts from the local patient’s physician might notify the IP of a postoperative
Product Evaluation Committee, as well as from FDA infection associated with the tissue implant. Procedures
and APIC online groups and notifications. The Joint and records should allow the organization to determine
Commission’s Patient Care Standards of performance the tissue’s unique identifier and enable reporting of the
provides guidance on tissue implants and the traceability event to the source facility. In addition, records should
of records.11 These standards guide facilities in tracing facilitate an investigation to determine whether the
postoperative infection is related to the organization’s
a chain of events or creating an audit trail for both
storage or handling processes (e.g., use of sterile
reporting and investigational purposes. Records should
reconstitution supplies, operating room procedures,
permit bidirectional tracing of any tissue in order to:
storage temperatures, expiration dates, and so forth).12
△△Report potential disease transmission to the
recipient, after notification by the donor Assessing Patient Risk after Gaps
source facility in Sterilization Processes

△△Report adverse patient reactions to the donor Errors and gaps in disinfection and sterilization processes
source facility can result in patient infection. Failure to follow evidence-
based guidelines or mechanical failure can cause such
△△Investigate the chain of events (e.g., who handled events. The risk of patient harm after such an error
the tissue, how it was transported, how it was or gap is identified must be assessed, and so must the
stored and processed, and the dates and times
need for patient notification. This process is typically
of these activities).
multidisciplinary and should involve the IPC department.
For any tissue or medical implant device designated The 2007 peer-reviewed article by William Rutala cited
as requiring tracking under the FDA’s Medical Device in the references is a good source of guidance on how to
Rule, the manufacturer of that product is required to assess patient risk after these events.13

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 Section 8 Risk Management | 76

FIGURE 10
PROTOCOL FOR EXPOSURE INVESTIGATION AFTER A FAILURE OF DISINFECTION
AND STERILIZATION PROCEDURES

1. Confirm disinfection or sterilization reprocessing failure

2. Impound any improperly disinfected/sterilized items
3. Do not use the questionable disinfection/sterilization unit (e.g., sterilizer, automated endoscope reprocessor) until proper
functioning can be assured
4. Inform key stakeholders
5. Conduct a complete and thorough evaluation of the cause of the disinfection/sterilization failure
6. Prepare a line listing of potentially exposed patients
7. Assess whether disinfection/sterilization failure increases patient risk for infection
8. Inform expanded list of stakeholders of the reprocessing issue
9. Develop a hypothesis for the disinfection/sterilization failure and initiate corrective action
10. Develop a method to assess potential adverse patient events
11. Consider notification of state and federal authorities
12. Consider patient notification
13. Develop long-term follow-up plan
14. Perform after-action report

Source: Rutala W, Weber D. How to Assess Risk of Disease Transmission to Patients When There Is a Failure to Follow Recommended Disinfection
and Sterilization Guidelines. Infect Cont Hosp Epidemiol February 2007;(28)2.

Operating Room Noise distraction. Investigators in the United Kingdom

have published a paper concluding that excessive
Florence Nightingale wrote in 1959 that “unnecessary
noise levels result in a lapse in concentration that
noise is the most cruel absence of care which can be
can adversely impact compliance to fastidious aseptic
inflicted either on sick or on well.”14 More recently, the
technique, especially during wound closure. The
role noise plays both in the operating room (OR) and in
authors hypothesize that poor concentration caused by
development of postoperative complications has received
high levels of noise may affect one’s ability to perform
increased attention. Noise levels in the operating room
adequate aseptic closure, increasing the risk of the
have been found to exceed the limits established by
patient developing an SSI.17
federal regulatory agencies, exceeding in some cases 40
dBA.15 Excessive noise in the OR has been associated As we delve further into the continually changing tasks,
with increased stress, fatigue, distraction, and ineffective technology, and people that make up the operating
communication, all of which can lead to medical errors. room environment, we are likely to encounter a myriad
A 2015 publication has suggested excessive noise can of new risk factors with the potential to play a role in the
lead to miscommunication of critical information in etiology of SSIs. While we tend to focus on the obvious
what is viewed as a “high-stakes environment.”16 players (e.g., inadequate antimicrobial prophylaxis, skin
Many of the tasks that occur during the course of decolonization, patient obesity, diabetes, hyperglycemia,
surgery are performed in conjunction with other team hypothermia, and surgical technique), an inquisitive
members, and complex tasks require a higher level mind can be a person’s greatest resource when the root
of focused attention that can be influenced by noise cause of an SSI is not immediately apparent.

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Section 8 Risk Management | 77

The Role of Communication

The ability to influence, serve as a role model, demonstrate accountability and integrity, and communicate
the value of infection prevention to a diverse audience are all required for IP leadership competency.
Communication (verbal and written) has been suggested as the most critical element of successful leadership,
and certainly this is true in the OR. Effective communication must take into account the informational needs
of the audience, their cultural background, and their knowledge of the subject. Being concise, accurate, and
timely in communicating critical information is a skill taught in conjunction with the science of safety—and it
is a valuable competency for IPs. The art of influence and persuasion is also directly linked to communication
competencies.18

The Institute for Healthcare Improvement (IHI) offers a good tool to facilitate communication of critical
information: the SBAR.19 It has been shown to be powerful in improving the effectiveness of communication
in healthcare. It is easy to use and easily adaptable to the IP’s need to provide clear and concise messaging.
Following are the key components of the SBAR:

△△S: Situation—Clearly and briefly define the situation or problem.

△△B: Background—Provide clear, relevant background information that relates to the situation.
△△A:(Add
Assessment—A statement of your professional conclusion: What did you find/What do you think?
evidence-based resources here.)

△△R: Recommendation—Action requested/recommendation: What you want.

IMPLEMENTATION STRATEGIES FOR THE IP

△△Work with the SPD to ensure that sterilizer failures and instrument recalls are included as part of a routine
report to the Infection Control Committee and that notification of the Infection Prevention and Control
department is immediate, in order to identify any associated HAI.

△△Participate in the multidisciplinary assessment of patient risk and of need for patient notification after any
failure in disinfection or sterilization of instruments.

△△Be part of the local Product Evaluation or Value Analysis committee to provide consultation during follow-
up in response to product recalls because of contamination.

△△Employ the SBAR tool when communicating critical information with the OR team.
△△Join online groups and notification lists to ensure you receive rapid notification of product recalls
and contamination:
›› http://www.fda.gov/Safety/MedWatch/default.htm
›› http://community.apic.org/home

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TOOLS AND RESOURCES

△△“Steam Sterilization Process Failures and Recalls: Taking the Correct Actions”— Self-Study Series
sponsored by 3M. 2009 self-study article and quiz including actions for monitor failure, checklist, and
decision tree for investigations; by Rose Seavey RN, BS, MBA, CNOR, CRCST, CSPDT. Provided by APIC
https://bit.ly/2I9axaX

△△“Guidance for Performing Root Cause Analysis (RCA) with Performance Improvement Projects (PIPs)—
CMS QAPI 12-page guide for performing root-cause analysis, including 7-step process, templates for
Performance Improvement Projects and corrective action. Provided by APIC https://bit.ly/2wweJwj

△△“How to Assess Risk of Disease Transmission to Patients When There Is a Failure to Follow Recommended
Disinfection and Sterilization Guidelines”—2007 Infection Control and Hospital Epidemiology article from
William A. Rutala, PhD, MPH, with investigation protocol, sample communications tools, and guidelines for
assessing and interpreting risk. Provided by APIC https://bit.ly/2KhgOyf

△△Listservs for notification of product recalls due to contamination—FDA MedWatch Adverse Event
Reporting Program; APIC My APIC community forums home. https://bit.ly/2sTaOXb

△△SBAR Tool—Guide to framework for communication between members of the health care team
about a patient’s condition; from Institute for Healthcare Improvement; log-in required for access.
https://bit.ly/2iZNwMg

△△“Infection prevention in anesthesia practice: A tool to assess risk and compliance”— 2013 article in AJIC,
by S. Dolan, et al, includes anesthesia infection prevention assessment tool designed covering issues such
as policies, hand hygiene, environment, workflow, and disinfection; APIC members can access through AJIC
website, https://bit.ly/2KfL9wW

REFERENCES
1. InvestorWords. Risk mitigation defined. www.investorwords. 6. American National Standards Institute/Association for the
com/19332/risk_mitigation.html. Accessed April 30, 2018. Advancement of Medical Instrumentation. ST 79:2017—
Comprehensive guide to steam sterilization and sterility
2. Pyrek, K. Infection prevention and control, state of industry report.
assurance in health care facilities. ANSI website. 2017.
Infect Control Today June 2017.
7. Tissue Implants, Patient Care Standards Chapter 2017, https://
3. Sentinel Event Alert January 22, 2003 Issue 28 - January 22,
www.jointcommission.org/standards_information/jcfaqdetails.
2003 Infection control related sentinel events https://www.
aspx?StandardsFAQId=797.
jointcommission.org/assets/1/18/SEA_28.pdf
8. Stoulzenberger, T, Immediate-Use Steam Sterilization: Best Practices.
4. National Center for Patient Safety. VHA National Patient Safety
Infect Control Today 2011 Dec;15(12):40-44.
Improvement Handbook. VHA website. March 2011. https://www.
va.gov/vhapublications/ViewPublication.asp?pub_ID=2389. 9. American Society of Heating, Refrigerating and Air-Conditioning
Accessed April 30, 2018. Spath PL, ed. Error Reduction in Health Engineers (ASHRAE), American Society for Healthcare
Care: A Systems Approach to Improving Patient Safety, 2nd ed. Engineering (ASHE), Association for the Advancement of Medical
San Francisco: Jossey-Bass; 2011. Stratis Health and Minnesota Instrumentation (AAMI), Association for Professionals in Infection
Department of Health. Adverse Health Events Measurement Control and Epidemiology (APIC), Association of periOperative
Guide. Stratis Health website. Revised December 2015. http:// Registered Nurses (AORN), Facility Guidelines Institute (FGI). Joint
www.stratishealth.org/documents/MN_AE_Health_Events_ interim guidance: HVAC in the operating room and sterile processing
Measurement_Guide.pdf. Accessed April 30, 2018. department. September 21, 2015. http://apic.org/Resource_/
TinyMceFileManager/Implementation_Guides/PosStat-Safety-
5. American National Standards Institute/Association for the
HVAC-Interim-Guidance.pdf. Accessed April 30, 2018.
Advancement of Medical Instrumentation. ST 58:2013—Chemical
sterilization and high-level disinfection in health care facilities. ANSI
website. 2013.

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 Section 8 Risk Management | 79

10. Dolan SA, Littlehorn C, Glodé MP, Dowell E, Xavier K, Nyquist 14. Nightingale F. What it is, and what it is not. Notes on Nursing, First
AC, Todd JK. Association of Bacillus cereus infection with American Edition. New York: D. Appleton and Company; 1860.
contaminated alcohol prep pads. Infect Control Hosp Epidemiol
15. Katz J. Noise in the Operating Room. Anesthesiology 2014
2012 Jul;33(7):666-71.
Oct;121(4).
11. Tissue Implants, Patient Care Standards Chapter 2017,
16. Dholakia S, Jeans JP, Kalid U, Dholakia S, D’Souza C, Nemeth K.
https://www.jointcommission.org/standards_information/
The association of noise and surgical-site infection in day case hernia
jcfaqdetails.aspx?StandardsFAQId=797.
repair. Surgery 2015;157:1153-1156.
12. U.S. Food and Drug Administration, Center for Devices and
17. Way JT, Long A, Weihlings J, Ritchie R, Jones R, Bush M, et al.
Radiological Health. Overview of medical devices. FDA website.
Effect of noise on auditory processing in the operating room. J Am
March 27, 2018. https://www.fda.gov/MedicalDevices/
Coll Surg 2013;216:933-938.
DeviceRegulationandGuidance/Overview/default.htm.
Accessed April 30, 2018. 18. Spitzberg BH. (Re)introducing communication competence to the
health professions. J Public Health Res 2013;2(3):e23.
13. Rutala WA, Weber DJ. How to assess risk of disease transmission to
patients when there is a failure to follow recommended disinfection 19. Institute for Healthcare Improvement. The SBAR Toolkit.
and sterilization guidelines. Infect Control Hosp Epidemiol 2007 IHI website. n.d. http://www.ihi.org/resources/Pages/Tools/
Feb;28(2). SBARToolkit.aspx. Accessed April 30, 2018.

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 80

SECTION 9

CONNECTING THE DOTS:

TURNING DATA INTO ACTION
In her book There is Magic in Collaboration, Terri and perioperative team so that these can be used to
Goodman, PhD, RN, CNOR writes: “patient safety improve performance, safety, and quality of care has
is a team effort … no single caregiver or department power and efficacy. The Infection Preventionist (IP)
can ensure safe and effective outcomes independently. is the provider of process and outcome data to the
Relationships based on mutual understanding and perioperative team. This team, in turn, is supported by
respect also pave the way for effective collaborative a broad range of colleagues, including Sterile Processing
efforts and improved patient outcomes.”1 department (SPD) personnel, Environmental Services
Her words provide an excellent foundation for this section technicians, the facility engineer (who oversees HVAC
of the Implementation Guide. This section will review the operations), and the clinical engineer.
use of outcome data—as well as the related and important
elements of performance improvement, structure, and Getting Started: Transmitting Outcome
process—in preventing surgical complications. Data—Not Infections
The Association of periOperative Registered Nurses Relationships between the IP and the perioperative
(AORN) published in 2017 a position on patient safety team are best organized under a Leadership Triad made
that identifies the essential components for providing up of the surgeon, the perioperative nursing leader,
a safe perioperative environment.2 These include and the anesthesia provider. This triad provides a
patient-centeredness, teamwork, verbal and written governance structure that can facilitate understanding
communication, infection prevention, sharps injury of surgical site infection (SSI) risk, support any needed
prevention, fall prevention, safe patient handling and structural and process changes, and share the overall
movement, correct cleaning and care of instruments, mission and vision relative to prevention of SSIs. One
a safe environment of care, fire safety, and appropriate expert observed that “personnel in the operating room
staffing levels. (OR) suite are role models for a true culture of safety.”
The practice of sharing findings from infection Quite literally, the OR suite is an environment where
surveillance and case observations with the surgeon infection prevention is a way of life.3

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 Section 9 Connecting the Dots: Turning Data into Action | 81

Engagement and Leader Champions

FIGURE 11
4 E’s: AN ACTION-ORIENTED IMPLEMENTATION MODEL
A key study, “Implementation Science: How to Jumpstart Infection Prevention,” describes this conceptual model
for supporting prevention of healthcare-associated infections (HAIs).4

Source: Agency for Healthcare Research and Quality. http://www.ahrq.gov/professionals/education/curriculum-tools/clabsitools/index.html

The first element is to “Engage” the surgeon, the Using Outcome Data to Improve
perioperative care team, and the anesthesia provider Performance: From SSI Rates to SIRs
in understanding SSI risk, associated morbidity, and
Once surgical leaders and team members are engaged,
current performance, and enlist their support in
the IP can work with them to develop an agreed-upon
optimizing prevention strategies and tactics. Having
process to share findings from the SSI surveillance
champions for infection prevention is essential
program. The Society for Healthcare Epidemiology
to successful collaboration under the 4E’s and
of America recommends the following for any
other performance improvement models. Success
surveillance program7:
in prevention of catheter-associated urinary tract
infections (CAUTI) has been demonstrated using this △△Provide ongoing feedback of SSI rates to surgical
model.5 The American College of Surgeons National and perioperative personnel and leadership.
Surgical Quality Improvement Program (NSQIP)
has also demonstrated the efficacy of a multifacility
△△Routinely audit and provide confidential feedback
on SSI rates and adherence to process measures to
collaborative in improving surgical care, as led by individual surgeons, the surgical division and/or
surgeon and perioperative nursing champions.6 department chiefs, and hospital leadership.

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△△For each type of procedure performed, provide team. Sharing outcomes with the broader perioperative
risk‑adjusted rates of SSI. team should begin with higher-level, summary outcomes

△△Anonymously benchmark procedure-specific risk- (e.g., SIRs).

adjusted rates of SSI among surgeon peers. The SIR is the outcome metric currently used by
Providing surgeon-specific SSI rates or standardized the National Healthcare Safety Network (NHSN).9
infection ratios (SIRs) can be very effective in motivating Similar to an “observed/expected” ratio used by other
practice changes. However, allowing for confidential collaboratives, “[t]he SIR is a risk-adjusted summary
feedback and anonymous benchmarking is also critical.8 measure that compares observed number of SSIs to the
Feedback must be given in a collaborative manner, predicted or expected number of SSIs. The predicted
including with support from surgeon leaders. Outcome number of infections is calculated by a logistic regression
data can also be shared with the perioperative nursing model developed by NHSN.”

FIGURE 12
SSI DATA AS REPORTED TO NHSN FOR TWO PROCEDURE TYPES
Using the example of colon and abdominal hysterectomy SIRs, this chart compares rates to predicted events,
showing, for instance, that for colon surgery (COLO), the facility is reporting more than 80 percent fewer colon
SSIs than predicted.

Source: Reports to NHSN displayed by the Centers for Medicare and Medicaid Services (CMS) on the Hospital Compare website.
https://www.medicare.gov/hospitalcompare/Data/About.html

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FIGURE 13
FOUR STEPS TO DETERMINING STATISTICAL SIGNIFICANCE
Another use of the SIR metric is to compare a particular SIR to 1.0 (SIR of 1 = number of actual infections is the same
as the number of predicted infections). For example, if the SIR for SSIs following C-section is 1.2. The question is
whether this number compared to 1.0 is statistically significant. The following figures illustrate this analysis.10

STEP 1. Enter number of SSIs observed, number expected and the SIR, 1.198.

Compare Single SIR to 1

When comparing a standardized infection ratio, the hypothesis is that the SIR
is not different from one. To perform a hypothesis test and calcluate a p-value,
enter the number of observed events and the number of expected events.
The SIR will be displayed automatically. Press calculate.

Data Source #1
Group Labels: CSEC SIR
Number Observed: 15
Number Expected: 1252
Standardized Infection Ratio: 1.198

STEP 2. Run the analysis (which yields the table below).

National Healthcare Safety Network

As of: March 7, 2011 at 3:57 PM

CSEC SIR CSEC SIR SIR SIR SIR95CI

Number Number p-value
Observed Expected
15 12.52 1.198 0.2800 0.67, 1.976

p-value = 0.2800

STEP 3. Next is interpretation. While the SIR was higher than expected at 1.198, the p-value is not less
than 0.05 (so is not statistically different from 1.0). The 95-percent confidence interval (0.67,
1.976) includes 1.0, which also confirms that the SIR is not significantly different from 1.0.

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 Section 9 Connecting the Dots: Turning Data into Action | 84

STEP 4. Follow-up: While understanding that the SIR is not statistically significantly high, the OB team
may request monthly SSI rates to monitor the impact of interventions they have employed to
prevent SSIs following C-sections. The following chart and result is an example of what might
be what is subsequently shared:

“The interventions implemented in December 2007 (larger dose and better timing of
preoperative antibiotic prophylaxis & competency training on application of preoperative
skin prep), resulted in a 36 percent reduction in the incidence of SSIs.”

CONTROL CHART - MONTHLY SSI RATES TRENDED OVER TIME

Source: Edwards JR. Analytic methods for assessing intervention effectiveness. APIC Annual Conference, Portland, OR, Session 2402. June 15, 2017.

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 Section 9 Connecting the Dots: Turning Data into Action | 85

FIGURE 14
MACRO SNAPSHOT OF SIRS BY SELECT PROCEDURE GROUPS
Standardized infection ratios can be used more broadly to determine the performance of all healthcare facilities
enrolled in the NHSN. The following table provides the 2014 SIRs for 10 NHSN surgical procedure groups compared to
the 2008 baseline data, as well as the overall performance of the greater than 2,500 hospitals that submitted data. The
SIR for hip arthroplasty in 2014, for example, was 0.78, or 22 percent lower compared to performance at the baseline.

PROCEDURE # HOSPITALS # PROCEDURES 2014 NAT’L SIR

2014 NAT’L SIR
CATEGORY REPORTING REPORTED VS. NAT’L BASELINE
green down arrow
Hip arthroplasty 1,928 291,628 22% 0.78
green down arrow
Knee arthroplasty 1,907 417,937 41% 0.59
green down arrow
Colon surgery 3,377 300,526 2% 0.98
green down arrow
Rectal surgery 329 6,561 40% 0.60
green down arrow
Abdominal hysterectomy 3,225 307,648 17% 0.83
white down arrow
Vaginal hysterectomy 822 30,961 14% 0.86
green down arrow
Coronary artery bypass graft 755 117,972 45% 0.55
green down arrow
Other cardiac surgery 379 44,713 58% 0.42
green down arrow
Peripheral vascular bypass surgery 295 8,755 30% 0.70
green down arrow
Abdominal aortic aneurysm repair 273 2,121 72% 0.28
green down arrow
These 10 procedures combined 3,618 1,528,822 17% 0.83

Source: CDC National and State Healthcare Associated Infections Progress Report, 2016.
https://www.cdc.gov/hai/surveillance/progress-report/index.html

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FIGURE 15
ANALYSIS FOR A GROUP OF HOSPITALS
More granular analysis from the macro-level view can be performed for a group of hospitals using either SSI rates
or SIRs. The Michigan Surgical Quality Collaborative (MSQC) is one example, where performance across a large
number of hospitals was shared with the aim of improving performance among all participants. The following figure
illustrates the predicted/expected (P/E) SSI ratio for abdominal hysterectomy across the 53 facilities. The number is
similar to but not identical to that seen in the NHSN data.11
The chart shows that only two hospitals had P/E ratios statistically higher than a ratio of 1.0. However, application
of the Centers for Medicare & Medicaid Services’ Hospital-Acquired Condition Reduction Program would result in
penalties for the group of ten hospitals in the upper quartile (N=12) despite the lack of a statistically higher SSI ratio
when compared to all facilities. The program results in a 1 percent reduction payment to hospitals with the highest
SIRs. The bottom quartile of hospitals will always receive a penalty. This use of outcome data highlights the need for
additional risk adjustment and shared understanding of outcome comparisons among a large group of facilities.

Analysis of SSI Rates after Hysterectomy by P/E Ratio

Source: Michigan Surgical Quality Collaborative (MSQC) in Morgan DM, et al. Surgical site infection following hysterectomy: adjusted rankings
in a regional collaborative. Am J Obstet Gynecol 2016;214:259.e1-8

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FIGURE 16
REAL-TIME ANALYSIS THROUGH THE NHSN COMPONENT
One method of tracking SSIs for two reportable procedures (colon surgery and hysterectomy) and evaluating
current performance is through the use of the NHSN Patient Safety Analysis Quick Reference Guides, including
the Guide to the SIR, at https://www.cdc.gov/nhsn/ps-analysis-resources/reference-guides.html. This option is
available to hospitals and can be used periodically to assess performance.

Source: CDC/NHSN Patient Safety Analysis Quick Reference Guides, https://www.cdc.gov/nhsn/ps-analysis-resources/reference-guides.html

Bundles: The Sum is Greater Than The concept of bundling practices to improve care
the Parts originated in 2001 with an initiative by the Voluntary
Hospital Association and the Institute for Healthcare
When outcome data show action must be taken to
Improvement (IHI) to improve patient care in the
reduce SSIs, the first approach often considered is
intensive care unit setting.12 The IHI defines a bundle as
implementing a bundle. However, there are a myriad
“a small set of evidence-based interventions for a defined
of SSI prevention bundles, composed of varying
patient segment/population and care setting that, when
combinations of interventions. Some bundles are generic
implemented together, will result in significantly better
and can be used for all surgical procedures, some are
outcomes than when implemented individually.” When
specific to a certain type of procedure, and some seem
designing a care bundle, the IHI recommends following
to include every possible intervention.
these guidelines for a successful outcome13:
Bundles are often based on a facility-specific risk
assessment and gap analysis of best practices for SSI △△Select three to five interventions supported by
prevention. Because SSIs are multifactorial, it can be strong evidence and clinician agreement for the
patient population of focus. This prevents the team
difficult to determine the exact source of the infection
from being derailed with debate over the validity of
problem. Consequently, the tendency is to implement
bundle elements.
interventions for every deficient practice observed.
This approach may lead to including in the bundle △△Select bundle elements that are relatively
interventions that have low compliance, are not independent of one another; if one of the elements
supported by evidence, are not measurable, and/or of care is not implemented for the patient, that
are not directly tied to patient care. Creating a bundle element will not affect whether other bundle
based on practices that are unsupported, controversial, elements are implemented.
unmeasurable, or simply a laundry list of tasks will
undermine the success of the bundle. Incorporating
△△Design the bundle for a defined patient population
and patient care teams that physically work together
elements supported by high-quality evidence, with high in the same location (e.g., preoperative unit,
reliability, implementation science, change management, operating room, postoperative unit). When a bundle
human factors, and efforts to enhance perioperative element crosses perioperative phases of care, develop
team communication will create a strong foundation for a bundle for each location and design standardized
bundle implementation success. hand-off communication tools.

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△△Involve an interdisciplinary perioperative team (e.g., a bundle is not intended to be a comprehensive care
surgeon, anesthesia provider, surgical assistants, protocol, nor should it become a checklist. Common
perioperative RN, scrub person, pharmacy) in the core elements of SSI bundles that apply to most
creation of the bundle to facilitate communication surgical procedures, are centered on direct patient
and teamwork. Teams may be specific to a service care interventions, and are supported by strong
line (e.g., orthopedic, cardiac, colorectal) when evidence include: antimicrobial prophylaxis, glycemic
developing procedure-specific bundles.
control, normothermia, increased fraction of inspired
△△Design descriptive bundle elements that allow for oxygenation, patient skin antisepsis with an alcohol-
local customization and clinical judgment, including based antiseptic, and preoperative patient bathing.
an “opt out” choice when an intervention is Other common bundle elements with lower levels of
clinically inappropriate. supporting evidence include: Staphylococcus aureus

△△Develop bundle elements that can be measured screening and decolonization, use of sterile technique
interventions (e.g., use of closing tray), wound dressings
using an all-or-none method (i.e., yes or no), with a
goal of 95 percent or higher compliance. (e.g., antimicrobial or antiseptic- impregnated,
standardized technique), postoperative patient education
The IHI recommends designing the bundle around on wound care, and hair-removal methods as part of
the patient and direct patient interventions. However, skin preparation (e.g., clippers, leave hair in place).14

FIGURE 17
CORE ELEMENTS OF SSI PREVENTION BUNDLES

Antimicrobial Prophylaxis* Glycemic Control*

Normothermia* Oxygenation*

S aureus Screening
Preoperative Bathing* Patient Skin Antisepsis
& Decolonization

Postoperative
Sterile Technique Wound Dressings Hair Removal
Wound Education

*Strong recommendations from CDC-HICPAC SSI Guideline.

Sources: Berríos-Torres S, et al. for the Healthcare Infection Control Practices Advisory Committee Centers for Disease Control and Prevention
Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg August 2017;152(8):784-791; Summary of SSI bundle posters presented
at APIC Annual Conference 2016.

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FIGURE 18
PROCEDURE-SPECIFIC SSI PREVENTION BUNDLE ELEMENTS
Surgical patients may benefit from procedure-specific bundles that include interventions for prevention of SSIs
based on the surgical technique and anatomical location. For example, use of mechanical and chemical bowel
preparation is a specific evidence-based intervention for colorectal surgery that would not be applicable to
orthopedic or cardiac surgical patients.

Total Joint Colorectal Cardiac Cesarean Birth

△△Nasal antiseptic △△Wound protector △△Nasal antiseptic △△Closure with suture

△△Surgical helmet △△Bowel technique protector rather than staples

systems*
△△Closing instruments △△CHG mouthwash △△Vaginal prep with

△△Laminar flow* △△Changing gown/gloves for closing △△Disposable chlorhexidine or

povidone-iodine
△△Mechanical and chemical bowel prep
telemetry leads
△△Placenta removal
△△Triclosan coated suture with traction instead

△△Changing gown/gloves for closing of manual extraction

△△Mechanical and chemical bowel prep

△△Triclosan coated suture
△△Changing gown/gloves for closing
△△Mechanical and chemical bowel prep
△△Triclosan coated suture
△△Changing gown/gloves for closing
△△Mechanical and chemical bowel prep
△△Triclosan coated suture
*Not direct patient care intervention, related to perioperative environment.

Source: Summary of SSI bundle posters presented at APIC Annual Conference 2016.

While bundles are not intended to be comprehensive a bundle, assess elements already included in other
care protocols, common bundle elements may already protocols, to avoid duplication of efforts and confusion.
be included in a patient care protocol. When designing

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FIGURE 19
USE OF ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOLS
Enhanced Recovery After Surgery (ERAS) is an evidence-based protocol for improving several surgical patient
outcomes, including prevention of SSIs.15 The ERAS guidelines are procedure-specific and include interventions
throughout the perioperative phases (i.e., preoperative, intra-operative, postoperative). For example, the ERAS
protocol for elective colorectal surgery includes elements for prevention of SSIs: antimicrobial prophylaxis
timing, skin preparation, modifications of surgical access (e.g., minimally invasive versus open), normothermia, and
elimination of peritoneal cavity drains after anastomosis.

Enhanced Recovery After Surgery (ERAS) protocol for elective colorectal surgery15

Preoperative
△△Fasting and carbohydrate needs Intraoperative
△△Thromboembolism prophylaxis △△Anesthetic protocol Postoperative
△△Nausea and vomiting
△△Antimicrobial prophylaxis* △△Surgical access* △△Eliminating drains*
△△Skin preparation* △△Avoid nasogastric intubation △△Remove urinary catheter
△△Normothermia* △△Prevent ileus
△△Fluid management △△Multimodal analgesia
△△Nutrition
△△Glucose
△△Early ambulation
*Protocol elements for prevention of surgical site infection.

Source: Hohenberger, H. & Delahanty, K. 2015. Patient-centered care – Enhanced recovery after surgery and population health management. AORN
Journal. 102(6):578-583.

Interventions for prevention of SSIs may also be The IHI does not recommend including in the bundle
embedded in a comprehensive safe surgery checklist general processes such as hand hygiene or environmental
designed to improve surgical patient outcomes, cleansing, because these mixed measures are not patient
particularly for preventing wrong-site surgery. The interventions, they are difficult to track, and they are not
World Health Organization Guideline for Safe Surgery linked back to the individual patient.
includes antibiotic prophylaxis within 1 hour before
incision and confirmation of sterilization indicators in
the surgical time-out procedure.16

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FIGURE 20
PERIOPERATIVE ENVIRONMENT-RELATED INTERVENTIONS17
In the perioperative setting, the environment is often considered as a potential factor for SSI development, with
varying degrees of evidence to support this concern. However, the evidence for environmental factors is not strongly
linked to SSI and may undermine compliance if the team does not agree on the validity of bundle elements.

HVAC Settings
(temperature, humidity, Traffic in OR
air exchanges)

Environment

Environmental Cleaning Surgical Attire

Source: SSI bundle posters presented at APIC Annual Conference 2016

Bundle Implementation: Hospital Corporation of America (HCA)18

Two Case Studies A five-year, quasi-experimental study conducted in
Successfully turning data into action will require more 20 HCA-affiliated hospitals in the United States
than implementing a bundle. Successful implementation evaluated the effectiveness of an SSI bundle for patients
of a bundle will be part of a larger approach to undergoing cardiac, hip, and knee surgery. The primary
improving patient outcomes, one that includes redesign outcome was complex SSIs (i.e., deep incisional, organ
of work processes, strategies to enhance communication, space), and adherence to the bundle was monitored. The
and an infrastructure of vigilance. Use of a bundle can SSI bundle elements included:

△△Screening patient nares in the preoperative clinic for

enhance communication and teamwork, elements found
independently to improve patient outcomes. Successful
methicillin-resistant Staphylococcus aureus (MRSA)
implementation of an SSI bundle should go hand-in-
and methicillin-susceptible Staphylococcus aureus
hand with team training and cultivation of a culture of (MSSA)
safety. Including human-factors engineering and change
management in the implementation plan will further △△When tests were positive for MRSA or MSSA,
support successful implementation. Furthermore, decolonizing patient nares and skin with
ensuring that the team has the resources they need to
implement the bundle is vital. And of course, including
△△CHG bathing daily for 5 days and mupirocin
intranasally twice daily for 5 days
frontline staff in the bundle-development process
will provide the team with critical feedback early on △△Targeted antimicrobial prophylaxis with
regarding potential barriers to adoption and resources Vancomycin for MRSA-positive patients
needed for success. The researchers reported bundle adherence of
83 percent (39 percent full, 44 percent partial) after
a 3-month phase-in period. The bundle was found to
be associated with a statistically significant decrease in
complex S aureus SSIs for hip and knee arthroplasties
and cardiac operations.
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Michigan Surgical Quality Collaborative (MSQC)19

A retrospective cohort study of 24 hospitals voluntarily △△Minimally invasive surgery
participating in the Michigan Surgical Quality
Collaborative evaluated the effectiveness of an SSI
△△Short operative duration, < 100 minutes from
incision to closure
prevention bundle for patients undergoing colorectal
surgery. The primary outcome metric was SSI. The SSI Compliance with the MSQC bundle was associated
bundle elements included: with SSI rates nearly 80 percent lower than baseline
values. The researchers found that patients who received
△△Appropriate selection of IV prophylactic antibiotics all six bundle measures had a risk-adjusted SSI rate of
△△Postoperative normothermia (temperature >98.6°F) 2.5 percent. Interestingly, as with other HAI-prevention
bundles, individual components were not as effective
△△Oral antibiotics with mechanical bowel prep as consistent use of the composite of all elements.
△△Postoperative day-one glucose ≤140 mg/dl Study author Leaper and team conclude that failure to
document the benefit of an evidence-based surgical-care
bundle is directly associated with poor compliance.20

FIGURE 21
MSQC STUDY: SSI RATE BY NUMBER OF BUNDLE ELEMENTS EMPLOYED

Risk-stratified surgical site infection (SSI) rate as a function of the number of the SSI prevention measures followed
(appropriate Surgical Care Improvement Project-2 antibiotics, postoperative normothermia, oral antibiotics with bowel
preparation, perioperative glycemic control, minimally invasive surgery, and short operative duration).

Source: Michigan Surgical Quality Collaborative (MSQC) in Morgan DM, et al. Surgical site infection following hysterectomy: adjusted rankings
in a regional collaborative. Am J Obstet Gynecol 2016;214:259.e1-8

While numerous surgical-care bundles have been the statistical advantage of using an evidence-based
published representing multiple surgical disciplines, surgical-care bundle to reduce the risk of colorectal
colorectal bundles have documented the greatest risk- infection is p<0.005.21
reduction benefit. A recent meta-analysis reported that

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IMPLEMENTATION STRATEGIES FOR THE IP

△△Provide ongoing feedback of SSI rates to surgical and perioperative personnel and leadership.
△△Routinely audit and provide confidential feedback on SSI rates and adherence to process measures
to individual surgeons, the surgical division and/or department chiefs, and hospital leadership.

△△For each type of procedure performed, provide risk-adjusted rates of SSI.

△△Anonymously benchmark procedure-specific risk-adjusted rates of SSI among surgeon peers.
△△Share data in SIR format as well as rates and be prepared to help perioperative team members
understand both.

TOOLS AND RESOURCES

△△“Advanced Analysis in National Healthcare Safety Network (NHSN) Surgical Site Infection (SSI)”—NHSN/
CDC instructions on risk adjustment for SSI/SIR calculations, including checking risk factors, interpreting
and using SIRs, ensuring data quality; resource links. Provided by APIC https://bit.ly/2KWeCNx

△△Colorectal SSI Prevention Bundle—List of guidelines and recommendations to check at office visit, pre-op,
intraoperative, and postoperative to improve SSI prevention in colorectal surgery, developed by Highland
Hospital, University of Rochester Medical Center. Provided by APIC https://bit.ly/2Ix0M64

△△“CDC Guideline for the Prevention of SSI, 2017”—CDC HICPAC Gap Analysis provides checklist of
guidelines from CDC and Healthcare Infection Control Practices Advisory Committee for different bundles
and for Joint Arthroplasty. Provided by APIC https://bit.ly/2IgUPXh

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