Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR Path Trac)
Phase: NA
Conditions: Staphylococcus Aureus, Health Care Associated Infection, Health Care Worker Patient Transmission
Sponsor: Randy Loftus

Reducing Perioperative S. aureus Transmission via use of an 
Evidence-Based, Multimodal Program Driven by an 
Innovative Software Platform (OR PathTrac) 
PI: 
Randy Loftus 
IRB ID #: 201802843 
 
Project Details 
I. Project Introduction 
I.1 
Project to be reviewed by: 
IRB-01 
I.2 
Project Title: 
Reducing Perioperative S. aureus Transmission via use of an Evidence-Based, 
Multimodal Program Driven by an Innovative Software Platform (OR PathTrac) 
I.3 
Short Title (optional): 
I.4 
Provide a short summary of the purpose and procedures of the study proposed 
in this IRB application. 
• 
DO NOT include information on studies not proposed in this 
application. 
• 
Use LAY terminology only. This must be easily understandable by IRB 
community members and nonscientists. 
• 
DO NOT cut and paste technical abstracts from funding applications 
that may not be understood by a general audience. 
• 
 
The purpose of this study is to prevent the spread of S. aureus, a dangerous 
bacterium, within the operating room and between patients undergoing surgery. 
We will combine several approaches in a "bundle" of activities to achieve this 
goal. The bundle will include removal of bacterial pathogens from patient skin 
sites before surgery, from provider hands before, during, and after surgery, from 
environmental surfaces before and after terminal cleaning, and from the injection 
ports of patient intravenous catheters. We will use a new surveillance system to 
evaluate how well the bundle, and each component of the bundle, is working. 
Surveillance will identify S. aureus transmission events, and movement of S. 
aureus between reservoirs before, during, and after surgery (perioperative). 
Surveillance will map transmission events to identify actionable steps to improve 
the bundle. An infection control perioperative team will act on the surveillance 
reports to proactively address the action items, and to measure the effect of their 
efforts for the treatment group. We will compare perioperative S. aureus 
transmission events for patients receiving the bundle to perioperative S. aureus 
transmission events for patients receiving usual care. 
The goal of the study is to reduce S. aureus transmission from known reservoirs 
during the perioperative period. One known reservoir is patient skin sites. That is 
why we are decolonizing patients before surgery. Another known reservoir is 
provider hands. That is why we are providing a hand hygiene system that is 
located close to the anesthesia provider so they can wash their hands at every 
opportunity. Conventional hand washing devices on the wall or on the anesthesia 
9/20/2018

machine do not facilitate hand washing during the fast-paced OR procedures. A 
third known reservoir is intravascular devices. That is why we are using the 
HubScrub and DOCit system that allows providers to scrub the hub at every 
opportunity with only 2 turns and within 10 seconds. A fourth known reservoir is 
the operating room environment itself. We are using surveillance to deploy 
strategic targeting of high risk environments as well as to continually optimize 
every component of the bundle over the 2 years. In summary, the study 
population is the perioperative period that includes patients, providers, 
equipment, environment, and even the air into which bacteria can be aerosolized 
for the patient and the patient to follow. The goal is to show that improved basic 
measures across the board in a dangerous environment like the OR can reduce 
high risk S. aureus transmission events. 
Our primary outcome is S. aureus transmission events. The surveillance 
instrument as detailed in this proposal defines transmissions. Surveillance 
involves utilizing systematic reservoir collection kits (RDB Bioinformatics, 
Omaha, NE 68154) to collect S. aureus isolates from known reservoirs in 
perioperative environments. The OR PathTrac software (RDB Bioinformatics, 
Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and 
to identify transmission events. Transmission stories are processed by the 
software to generate transmission maps that identify improvement successes and 
failures. It also identifies actionable steps to improve the bundle. The 
perioperative infection control team then uses this information to continually 
optimize the bundle, and the software to measure the effect. 
The grant funding this research project will pay RDB Bioinformatics for the kits, 
for the analysis of the swabs for S. aureus, and for the OR PathTrac analysis on a 
fee-for-service basis. RDB Informatics is providing no funding for this study or 
in-kind support. 
I.5 
Specify your research question(s), study aims or hypotheses (do not indicate 
"see protocol") 
Surgical site infections are a subset of healthcare-associated infections (HAIs) 
that affect 3-5% of all patients undergoing surgery and are associated with a 2-
fold increase in patient morbidity and mortality, a 2-fold increase in hospital 
duration, and a 66% increase in the risk of intensive care unit (ICU) admission 
(1-4). The Centers for Disease Control (CDC) and the World Health Organization 
(WHO) consider HAIs as a devastating issue tied to antibiotic resistance and have 
highlighted three major goals for HAI prevention including the following: 1) 
Prevention of infections in patients undergoing surgery, 2) Prevention of patient-
to-patient bacterial transmission, and 3) improvement in antibiotic stewardship 
(5-7). These recommendations apply to the perioperative arena where the 
contribution of intraoperative bacterial reservoirs to bacterial transmission events 
and postoperative infection development has been confirmed (8-10). Indeed, a 
multicenter study recently demonstrated that stopcock contamination occurred in 
23% of surgical cases, was associated with increased mortality, and was linked by 
molecular typing to postoperative infection (9). Intraoperative bacterial reservoir 
isolates have also been directly linked to the causative organism of infection for 
30% of 30-day postoperative HAIs. Finally, transmission of S. aureus has been 
confirmed in up to 39% of surgical cases and has been directly linked to 
postoperative infection development(11). As such, attenuation of perioperative S. 
aureus transmission is an important target for HAI reduction. Therefore, our 
primary objective is to reduce perioperative S. aureus transmission. Our 

secondary objective is to examine the impact of reduced S. aureus transmission 
on the incidence of superficial and deep surgical site infections (SSIs). 
I.6 
Background and significance and/or Preliminary studies related to this project. 
(do not indicate "see protocol") 
We have demonstrated that intraoperative S. aureus transmission affects 39% of 
all-comers to the operating room and that transmitted pathogens can be directly 
linked to the development of SSIs (11). Individually, improvements in patient 
decolonization, provider hand hygiene, intravascular catheter design and 
handling, and environmental cleaning can reduce infection and consequently 
improve intraoperative patient safety. For example, we determined that bacterial 
contamination of intravenous stopcock sets is associated with increased patient 
mortality (8,9) and that anesthesia provider hands are an important vector for 
these high-risk events (10). At Dartmouth, this finding led to hand hygiene 
improvements that reduced stopcock contamination and postoperative HAIs (12, 
13). We documented that an improved catheter design significantly reduced 
bacterial injection as compared to conventional open lumen devices (14), and that 
a novel disinfection approach can reduce stopcock contamination and 
postoperative infections and phlebitis (15). We have mapped intraoperative 
environmental contamination (16) which has led to the development of an 
improved intraoperative environmental cleaning procedure (17). Recently, we 
made the exciting finding that different clonal lineages (MLST) of S. aureus 
differ in their pathogenicity and risk of transmission (18). For example, among 22 
different lineages that are frequently encountered in the OR, MLST 5 is 
associated with increased risk of strong biofilm formation, multidrug-resistance, 
transmission, and postoperative HAI development (18) This finding points to the 
importance of understanding the genotype of the infectious agent in order to drive 
genotype and patient-specific decolonization efforts. In addition, we found that 
methicillin-resistant S. aureus isolates are more transmissible than methicillin-
sensitive isolates, indicating that S. aureus phenotype can be used to optimize 
perioperative preventive measures focused on attenuating high-risk S. aureus 
transmission and infection development (19). In this proposal, we plan to 
combine these activities into a single multi-modal program (or “bundle”) that will 
lead to further reductions in infection and improvements in intraoperative patient 
safety. These activities will be accompanied by a real-time surveillance program 
using OR PathTrac to track transmission among reservoirs (e.g. patient, provider 
hands, stopcock, environment and equipment)(18, 19, and 21). The surveillance 
program will drive optimization of the different components of the bundle and 
allow for assessment of relative effectiveness. 
I.7 
Literature cited / references (if attaching a grant or protocol enter N/A). 
1. Vogel TR, Dombrovskiy VY, Lowry SF. Impact of Infectious Complications 
after Elective Surgery on Hospital Re-Admission and late Deaths in the U.S. 
Medicare Population. Surg Infect (Larchmt). 2012; 13:307-1 
2. Koff MD, Brown JR, Marshall EJ, O’Malley AJ, Jensen JT, Heard SO, 
Longtine K, O’Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel 
HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative 
Providers and Reduction of Postoperative Healthcare-Associated Infections: A 
Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control 
Hosp Epidemiol 2016; 37: 888-95 
3. Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact 
of surgical site infections in the 1990s: attributable mortality, excess length of 
hospitalization, and extra costs. Infect Control Hosp Epidemiol 1999; 20:725-30 
4. Boucher HW, Talbot GH, Bradley JS, Edwards JE, Gilbert D, Rice LB, Scheld 

M, Spellberg B, and Bartlett J. Bad Bugs, No Drugs: No ESKAPE! An Update 
from the Infectious Diseases Society of America. Clinical Infectious Diseases 
2009; 48:1–12 
5. World Health Organization. Antimicrobial Resistance. Global Report on 
Surveillance. WHO. 2014 
6. Centers for Disease Control and Prevention. Updated guidelines for evaluating 
public health surveillance systems: recommendations from the guidelines 
working group. MMWR 2001; 50:1-35 
7. http://www.whitehouse.gov/the-press-office/2014/09/18/fact-sheet-obama-
administration-takes-actions-combat-antibiotic-resistan 
8. Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, 
Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the 
anesthesia work area. Anesthesiology 2008; 109: 399-407 
9. Loftus RW, Brown JR, Koff MD, Reddy S, Heard SO, Patel HM, Fernandez 
PG, Beach ML, Corwin HL, Jensen JT, Kispert D, Huysman B, Dodds TM, 
Ruoff KL, Yeager MP. Multiple reservoirs contribute to intraoperative bacterial 
transmission. Anesth Analg 2012; 114: 1236-48 
10. Loftus RW, Muffly MK, Brown JR, Beach ML, Koff MD, Corwin HL, 
Surgenor SD, Kirkland KB, Yeager MP. Hand contamination of anesthesia 
providers is an important risk factor for intraoperative bacterial transmission. 
Anesth Analg 2011; 112:98-105 
11. Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, 
Heard SO, Yeager MP, Dodds TM. The epidemiology of Staphylococcus aureus 
transmission in the anesthesia work area. Anesth Analg 2015; 120: 807-18 
12. Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, 
Beach ML. Reduction in intraoperative bacterial contamination of peripheral 
intravenous tubing through the use of a novel device. Anesthesiology 2009; 
110:978-85 
13. Koff MD, Corwin HL, Beach ML, Surgenor SD, Loftus RW. Reduction in 
ventilator associated pneumonia in a mixed intensive care unit after initiation of a 
novel hand hygiene program. J Crit Care 2011; 26:489-95 
14. Loftus RW, Patel HM, Huysman BC, Kispert DP, Koff MD, Gallagher JD, 
Jensen JT, Rowlands J, Reddy S, Dodds TM, Yeager MP, Ruoff KL, Surgenor 
SD, Brown JR. Prevention of intravenous bacterial injection from health care 
provider hands: the importance of catheter design and handling. Anesth Analg 
2012; 115:1109-19 
15. Loftus RW, Brindeiro BS, Kispert DP, Patel HM, Koff MD, Jensen JT, 
Dodds TM, Yeager MP, Ruoff KL, Gallagher JD, Beach ML, Brown JR. 
Reduction in intraoperative bacterial contamination of peripheral intravenous 
tubing through the use of a passive catheter care system. Anesth Analg 2012; 
115:1315-23 
16. Rowlands J, Yeager MP, Beach M, Patel HM, Huysman BC, Loftus RW. 
Video observation to map hand contact and bacterial transmission in ORs. Am J 
Infect Control 2014; 42:698-701. 

17. Clark C, Taenzer A, Charette K, Whitty M. Decreasing contamination of the 
anesthesia environment. Am J Infect Control 2014; 42:1223-5. 
18. Loftus RW, Dexter F, Robinson AM. High Risk S. aureus Transmission in the 
Operating Room; a Call for Widespread Improvements in Perioperative Hand 
Hygiene and Patient Decolonization Practices. Am J Infect control 2018 (In 
Press). 
19. Loftus RW, Robinson AM, Dexter F. Methicillin-Resistant S. aureus has 
Greater Risk of Transmission in the OR than Methicillin-Sensitive S. aureus. Am 
J Infect Control 2018 (In Press). 
20. 1431: Microbial Contamination of Today’s Operating Room Environments. 
IARS 2018 Annual Meeting and International Science Symposium, April 28 – 
May 1, 2018. Chicago, Illinois. 
21. Hadder B, Patel HM, Loftus RW. Dynamics of intraoperative Klebsiella, 
Acinetobacter, Pseudomonas, and Enterobacter transmission. Am J Infect 
Control. 2018 Jan 25. 
II. Research Team 
II.1 
Principal Investigator 
Name 
E-mail 
College 
Randy Loftus randy-loftus@uiowa.edu Carver College of Medicine 
II
.2 
Team Members 
UI Team Members 
Name 
E-mail 
Colle
ge 
Cont
act 
Ke
y 
Pr
sn 
UI 
C
OI 
VA
MC 
COI 
Consent 
Process 
Involve
ment 
Deactiv
ated 
Randy Loftus, MD 
randy-
loftus@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
Yes Yes Ye
s 
 
No 
No 
Lauren Allan, DO, BA 
lauren-
allan@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Kiran Annam, ARNP 
kiran-
annam@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 

Raven Brenneke, BA 
raven-
brenneke@uiowa.ed
u 
Univer
sity 
Hospit
als 
Yes 
No No  
Yes 
No 
Cheryl Byrnes, Advanced 
Registered Nurse Practioner 
cheryl-
byrnes@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Nicholas Cardillo, MD 
nicholas-
cardillo@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
No No  
Yes 
No 
Brian Clark, PA-C 
brian-m-
clark@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
John Cromwell, MD 
john-
cromwell@uiowa.ed
u 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Megan Davis-de Geus, MSN 
megan-
davis@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Sundar Durgempudi Tripura, MD, 
FRCA 
sundarareddy-
durgempuditripura
@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
Yes Yes No  
Yes 
No 
Bradley Erickson, MD 
brad-
erickson@uiowa.ed
u 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Lance Evans, BA 
lance-
evans@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
Yes Yes No  
Yes 
Yes 
Mark Fisher, MD 
mark-d-
fisher@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Luis Garcia, MD 
luis-
garcia@uiowa.edu 
Carver 
Colleg
e of 
No 
Yes No  
Yes 
No 

Medic
ine 
Joshua Godding, BS 
joshua-
godding@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
Yes 
Michael Goodheart, MD 
michael-
goodheart@uiowa.e
du 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Thomas Granchi, MD 
thomas-
granchi@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
Yes 
Brent Hadder, MD 
brent-
hadder@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
Yes Yes No  
Yes 
No 
Alexia Herber, High School 
alexia-
herber@uiowa.edu 
 
No 
Yes No  
Yes 
Yes 
Jean Hogan, ARNP 
jean-
hogan@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
JoAnne Hudachek, BSN 
joanne-
hudachek@uiowa.e
du 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
No 
No 
Gretchen Kass, ARNP 
gretchen-
root@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
John Keech, MD 
john-
keech@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Prashant Khullar, MD 
prashant-
khullar@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
Yes 
Susan Kloos, BSN, RN 
susan-
kloos@uiowa.edu 
Univer
sity 
No 
Yes No  
No 
No 

Hospit
als 
Walter Lawrence, MD 
thomas-
lawrence@uiowa.ed
u 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Yasmin Lyons, DO 
yasmin-
lyons@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
Yes 
Megan McDonald, MD 
megan-e-
mcdonald@uiowa.e
du 
Carver 
Colleg
e of 
Medic
ine 
Yes Yes No  
Yes 
No 
Patrick McGonagill, MD 
patrick-
mcgonagill@uiowa.
edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Nicole Miller, BA, PA-C, BS 
nicole-
miller@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Andreea Newtson, MD 
andreea-
newtson@uiowa.ed
u 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
Yes 
Nicolas Noiseux, MD 
nicolas-
noiseux@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Brittany Parchert, BSN 
brittany-
parchert@uiowa.edu 
Univer
sity 
Hospit
als 
No 
Yes No  
No 
No 
Denise Peck, ARNP/PA 
denise-
peck@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
Yes 
Deanna Persons, BS 
deanna-
persons@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 

Andrew Pugely, MD 
andrew-
pugely@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Roseanne Rath, PA-C, MA 
roseanne-
rath@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Joan Ricks-McGillin, BSN 
joan-
ricks@uiowa.edu 
Univer
sity 
Hospit
als 
No 
Yes No  
Yes 
No 
Rebecca Rosenberg, PA 
rebecca-a-
rosenberg@uiowa.e
du 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Jonathan Rueter, PA-C 
jonathan-
rueter@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Jennifer Shanklin, MD 
jennifer-
shanklin@uiowa.ed
u 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
Yes 
Mel Sharafuddin, MD 
mel-
sharafuddin@uiowa.
edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
John Sharp, MD 
william-
sharp@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Zita Sibenaller, PHD 
zita-
sibenaller@uiowa.e
du 
Carver 
Colleg
e of 
Medic
ine 
Yes Yes No  
Yes 
No 
Lori Stout, RN, BSN 
lori-
stout@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
Yes Yes No  
Yes 
No 
Judy Swafford, RN 
judy-
swafford@uiowa.ed
u 
Univer
sity 
Hospit
als 
No 
Yes No  
No 
Yes 

Chad Tracy, MD 
chad-
tracy@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
No 
Yes No  
Yes 
No 
Alicia Walter, ADN, M.A. 
alicia-
walter@uiowa.edu 
Carver 
Colleg
e of 
Medic
ine 
Yes Yes No  
Yes 
No 
Non-UI Team Members 
Nam
e 
Institutio
n 
Locatio
n 
FW
A 
Rol
e 
DHH
S 
Contac
t 
Key 
Prs
n 
UI 
CO
I 
VAM
C COI 
Consent 
Process 
Involvemen
t 
Emai
l 
Nothing found to display. 
II.3 
The Principal Investigator of this study is: 
Faculty 
II.6 
Identify the key personnel. The system will automatically designate the PI and all 
faculty members on the project as “key personnel.” For information about other team 
members who should be designated as “key personnel” please click on the help 
information. 
Name 
Is Key Personnel 
Randy Loftus, MD 
Yes 
Lauren Allan, DO, BA 
Yes 
Kiran Annam, ARNP 
Yes 
Raven Brenneke, BA 
No 
Cheryl Byrnes, Advanced Registered Nurse Practioner 
Yes 
Nicholas Cardillo, MD 
No 
Brian Clark, PA-C 
Yes 
John Cromwell, MD 
Yes 
Megan Davis-de Geus, MSN 
Yes 
Sundar Durgempudi Tripura, MD, FRCA 
Yes 
Bradley Erickson, MD 
Yes 
Lance Evans, BA 
Yes 
Mark Fisher, MD 
Yes 
Luis Garcia, MD 
Yes 
Joshua Godding, BS 
Yes 
Michael Goodheart, MD 
Yes 
Thomas Granchi, MD 
Yes 
Brent Hadder, MD 
Yes 
Alexia Herber, High School 
Yes 
Jean Hogan, ARNP 
Yes 
JoAnne Hudachek, BSN 
Yes 
Gretchen Kass, ARNP 
Yes 
John Keech, MD 
Yes 

Prashant Khullar, MD 
Yes 
Susan Kloos, BSN, RN 
Yes 
Walter Lawrence, MD 
Yes 
Yasmin Lyons, DO 
Yes 
Megan McDonald, MD 
Yes 
Patrick McGonagill, MD 
Yes 
Nicole Miller, BA, PA-C, BS 
Yes 
Andreea Newtson, MD 
Yes 
Nicolas Noiseux, MD 
Yes 
Brittany Parchert, BSN 
Yes 
Denise Peck, ARNP/PA 
Yes 
Deanna Persons, BS 
Yes 
Andrew Pugely, MD 
Yes 
Roseanne Rath, PA-C, MA 
Yes 
Joan Ricks-McGillin, BSN 
Yes 
Rebecca Rosenberg, PA 
Yes 
Jonathan Rueter, PA-C 
Yes 
Jennifer Shanklin, MD 
Yes 
Mel Sharafuddin, MD 
Yes 
John Sharp, MD 
Yes 
Zita Sibenaller, PHD 
Yes 
Lori Stout, RN, BSN 
Yes 
Judy Swafford, RN 
Yes 
Chad Tracy, MD 
Yes 
Alicia Walter, ADN, M.A. 
Yes 
II.5 
Select research team member who is the primary contact for study participants. 
Randy Loftus 
III. Funding/Other Support 
III
.1 
Funding Sources 
Source Entered 
as Text 
DSP 
Link 
Type 
Source 
Grant 
Title 
Name of PI on 
Grant 
Source is entered as 
text no 
 Private 
Foundation/Associati
on 
Anesthesia Patient Safety 
Foundation 
Reducing 
Periopera
tive S. 
aureus 
Transmis
sion via 
use of an 
Evidence-
Based, 
Multimod
al 
Program 
Continual
ly 
Randy W Loftus 

Optimize
d by 
Innovativ
e 
Surveilla
nce (OR 
PathTrac) 
* Source is entered 
as text yes 
 Private 
Foundation/Associati
on 
RDB Bioinformatics 
Reducing 
Periopera
tive S. 
aureus 
Transmis
sion via 
use of an 
Evidence-
Based, 
Multimod
al 
Program 
Continual
ly 
Optimize
d by 
Innovativ
e 
Surveilla
nce (OR 
PathTrac) 
Randy Loftus 
Source is entered as 
text no 
 Departmental / PI 
Discretionary 
 
 
 
* new source name 
III.2 
What type of funding agreement would be completed? 
Corporate/Industry Funded 
III.3 
Does any member of the research team have a financial conflict of interest related to 
this project according to the Conflict of Interest in Research policy? If yes, please 
indicate which members below. 
Name 
Has Conflict of Interest 
Randy Loftus, MD 
Yes 
Lauren Allan, DO, BA 
No 
Kiran Annam, ARNP 
No 
Raven Brenneke, BA 
No 
Cheryl Byrnes, Advanced Registered Nurse Practioner 
No 
Nicholas Cardillo, MD 
No 
Brian Clark, PA-C 
No 
John Cromwell, MD 
No 
Megan Davis-de Geus, MSN 
No 
Sundar Durgempudi Tripura, MD, FRCA 
No 
Bradley Erickson, MD 
No 
Lance Evans, BA 
No 
Mark Fisher, MD 
No 
Luis Garcia, MD 
No 
Joshua Godding, BS 
No 

Michael Goodheart, MD 
No 
Thomas Granchi, MD 
No 
Brent Hadder, MD 
No 
Alexia Herber, High School 
No 
Jean Hogan, ARNP 
No 
JoAnne Hudachek, BSN 
No 
Gretchen Kass, ARNP 
No 
John Keech, MD 
No 
Prashant Khullar, MD 
No 
Susan Kloos, BSN, RN 
No 
Walter Lawrence, MD 
No 
Yasmin Lyons, DO 
No 
Megan McDonald, MD 
No 
Patrick McGonagill, MD 
No 
Nicole Miller, BA, PA-C, BS 
No 
Andreea Newtson, MD 
No 
Nicolas Noiseux, MD 
No 
Brittany Parchert, BSN 
No 
Denise Peck, ARNP/PA 
No 
Deanna Persons, BS 
No 
Andrew Pugely, MD 
No 
Roseanne Rath, PA-C, MA 
No 
Joan Ricks-McGillin, BSN 
No 
Rebecca Rosenberg, PA 
No 
Jonathan Rueter, PA-C 
No 
Jennifer Shanklin, MD 
No 
Mel Sharafuddin, MD 
No 
John Sharp, MD 
No 
Zita Sibenaller, PHD 
No 
Lori Stout, RN, BSN 
No 
Judy Swafford, RN 
No 
Chad Tracy, MD 
No 
Alicia Walter, ADN, M.A. 
No 
III.5 
What is the current status of this funding source? 
Source 
Status 
Other Status Description 
Anesthesia Patient 
Safety Foundation 
Awarded  
RDB Bioinformatics 
Other 
RDB is not providing funding. RDB is listed 
because they are providing kits that are paid 
for by the grant. 
IV. Project Type 
IV.1 
Do you want the IRB to give this project 
Regular (expedited or full board) review 
IV.2 
Enter the date you will be ready to begin screening subjects/collecting data for 
this project. (If you do not have a specified date, add "upon IRB approval") 
4/01/18 

IV.3 
Are you requesting a waiver of informed consent/authorization (subjects will 
not be given any oral or written information about the study)? 
No 
V. Other Committee Review 
V.1 
Does this project involve any substance ingested, injected, or applied to the body? 
• 
Do not answer yes, if the involvement includes a device, wire, or instrument 
• 
Yes 
V.1.a 
What is/are the substance(s): 
These are all currently used in care: 
Nasal povidone iodine (Povidone-Iodine Solution 5%, 3MTM, St. Paul, MN 
55144-1000) 
2% Chlorhexidine Gluconate (CHG) Cloths, FDA-approved antiseptic solution 
(Sage Products LLC 2018 · 3909 Three Oaks Rd, Cary, IL 60013) 
We will also be using a catheter care product (Catheter Care Station, 
HubScrubTM and DOCitTM, Mentor Ohio US 44060)that disinfects open or 
closed lumens with 62% isopropyl alcohol and includes a hand hygiene 
component with 62% alcohol. 
V.1.b 
Are any of these substances defined as a Schedule I - V Controlled Substance? 
No 
V.2 
Are any contrast agents used for any purpose in this study? 
No 
V.4 
Are all drugs or substances in this study being used within the FDA approved 
population (i.e., children, adults)? 
Yes 
V.5 
Are all drugs or substances in this study being used within the FDA approved 
indication (i.e., disease, condition)? 
Yes 
V.6 
Are all drugs or substances in this study being used within the FDA approved 
dose? 
Yes 
V.7 
Are all drugs or substances in this study being used within the FDA approved 
route of administration? 
Yes 
V.9 
Will any subject be asked to undergo a diagnostic radiation procedure (including 
radiographic, nuclear medicine, DEXA)? 
No 
V.14 
Will any subject be asked to undergo a radiation therapy procedure (including external 
beam therapy, brachytherapy, or nuclear medicine therapy)? 
No 
V.20 
Does this project involve the deliberate transfer of recombinant or synthetic nucleic 
acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid 
molecules, into one or more human research participant? 
No 
V.21 
Will any portion of this project be conducted in the CRU, or does it use any CRU 
resources? 

No 
V.22 
Will this project use: 
• 
any resource/patients of the Holden Comprehensive Cancer Center 
• 
involve treatment, detection, supportive care, or prevention of cancer 
• 
No 
V.25.a 
Will the study involve any of the following activity at UI Health Care, even if subjects 
or their insurance will not be billed for the item or service, and regardless of the study 
funding source (including studies with departmental or no funding)? 
• 
Procedures, tests, examinations, hospitalizations, use of Pathology services, 
use of clinic facilities or clinical equipment, or any patient care services, 
including services conducted in the Clinical Research Unit; or 
• 
Physician services or services provided by non-physicians who are 
credentialed to bill (ARNPs, Physician Assistants, etc.) 
• 
Yes 
V.25.b 
Will there be any procedures or services that may happen as part of a 
subject’s regular medical care and as part of the study? 
Yes, but all procedures/services will be paid for by the sponsor, even if 
the service is standard care 
V.25.c 
Will any study equipment or devices be supplied by a study sponsor? 
No 
V.25.e 
Is there or will there be an internal budget for this study? 
Yes 
V.25.f 
Is there or will there be an external budget for this study? 
Yes 
V.26 
The study involves Department of Nursing Services and Patient Care nursing, 
nursing resources or evaluates nursing practices at UI Health Care. 
Yes 
VI. Subjects 
VI.1 
How many adult subjects do you expect to consent or enroll for this project? 
2800 
VI.2 
What is the age of the youngest adult subject? 
18.0 
VI.3 
What is the age of the oldest adult subject? 
120.0 
VI.4 
What is the percentage of adult male subjects? 
50 
VI.5 
What is the percentage of adult female subjects? 
50 
VI.6 
How many minor subjects do you expect to consent or enroll for this project? 
0 
VI.13 
Describe EACH of your subject populations 

• 
Include description of any control group(s) 
• 
Specify the Inclusion/Exclusion criteria for EACH group 
• 
This study will involve treatment (bundle) and usual care groups. 
Surgical service lines will include orthopedic total joint, orthopedic spine, 
gynecology/oncology, thoracic, general, hernia, colorectal, open vascular, plastic, and 
open urological procedures. These lines will be randomized 1:1 to either the bundle of 
activities or usual care. The unit of randomization is the service line. The perioperative 
environment (the patient, the patient to follow, and all providers caring for the patient 
and the patient to follow) for the randomized service line (treatment or usual care) will be 
involved in surveillance. This means that all patients, all providers caring for those 
patients (changes day by day), and care environments (equipment and stopcock sets) will 
be involved in surveillance. Surveillance from treatment and control groups will yield S. 
aureus transmission events that will be processed to guide proactive improvements in the 
treatment bundle. 
Treatment group (bundle) inclusion/exclusion criteria: 
Inclusion criteria: Patients seen at UIHC who are scheduled to undergo surgery from 
providers in one of the service lines above, documentation of informed, written consent, 
>18 years of age, procedure requiring general/regional anesthesia. 
Exclusion criteria: Lack of documented informed, written consent, patients <18 years of 
age, procedures outside of the surgical service lines listed above, not requiring 
general/regional anesthesia, patients not seen in the UIHC clinics, and an allergy to 
iodine/shellfish or chlorhexidine. 
Usual care group (existing practice at UIHC) inclusion/exclusion criteria: 
Inclusion criteria: Patients seen at UIHC who are scheduled to undergo surgery from 
providers in one of the service lines above, documentation of informed, written consent, 
>18 years of age, procedure requiring general/regional anesthesia. 
Exclusion criteria: Lack of documented informed, written consent, patients <18 years of 
age, procedures outside of the surgical service lines listed above, not requiring 
general/regional anesthesia, patients not seen at UIHC, and an allergy to iodine/shellfish 
or chlorhexidine. 
VI.14 
Provide an estimate of the total number of subjects that would be eligible for inclusion 
in each of your study populations (include your control population if applicable) 
We anticipate that >80% of all patients undergoing surgery in the surgical service lines 
above will be eligible for the study. 
We do not know what the service line will be for the treatment and control until we 
randomize. We do not know exactly how many patients each line will see over the next 2 
years. There are 24,000 patients that undergo adult surgery at UIHC each year. Over two 
years, that is 48,000 patients. The lines selected in total represent >80%, at least 38,400. 
That is 3840 per line, or roughly 1500 patients each year per line. Thus, we expect that 
80%, or roughly 1200 patients, will be eligible for the study for each line over the 2 year 
period. In terms of providers, approximately 10 providers will be involved in the care of 
each patient in the OR and discharge area combined. Thus, over two years, there will be 
12,000 providers (not exclusive; as providers may be repeatedly sampled over the two 
year period). 

Treatment group (bundle): 80% of all patients in the randomized service lines are 
expected to be eligible, N=1200 for each service line. We expect participation from the 
majority (>80%) of providers in the OR and in the discharge area, N=12,000 providers 
for each line. 
Usual care group: 80% of all patients in the randomized service lines are expected to be 
eligible, N=1200 for each service line. We expect participation from the majority (>80%) 
of providers in the OR and in the discharge area, N=12,000 providers for each line. 
VI.15 
Describe how you will have access to each of your study populations in sufficient 
number to meet your recruitment goals. 
We will be attempting to capture all patients that meet inclusion criteria which could 
include patients seen and consented in the clinic, seen and consented on the hospital 
floor, intensive care units (inpatient surgery), or pre-anesthesia testing (PAT). Any 
patient meeting inclusion criteria that the surgeon obtains surgical consent for could be 
captured. Poster reminders will be placed in the clinics, on the ward, and PAT. The study 
consent forms will be attached to the surgical consent forms. Surgical providers 
obtaining surgical consent will obtain study consent when possible. This will otherwise 
be executed via our research team via pager. Preoperative kit orders will be completed by 
surgical providers or physician study team members when needed. The signed and held 
order will populate a list in EPIC for the PI (Loftus)that will be filtered by type of 
surgery, surgeon, and date of surgery within 10 days. It will include the patient medical 
record number, address/phone number, and an icon indicating the POC signed and held 
order. Loftus will work the list to send ordered kits to patients. Loftus will enter a new 
signed and held order for the kit and will associate the assigned kit number with the 
order, which will create a new ICON indicating ordered kit sent to patient. This will also 
update the Clarity report in EPIC with the kit number in addition to the other previously 
mentioned fields. The patient will receive the kit along with a reminder for why they 
received the kit (see attached in miscellaneous), use the kit (up to 3 reminders will be 
provided by Loftus study team), and RDB will receive and process the kits. Patients will 
use a prepaid mailer to send the kits to RDB which will have the RDB address in the 
send and return fields so that patients are not revealing their identity to RDB (process 
okay per USPS). RDB will send returned kit numbers to Loftus daily. Loftus will 
complete the signed and held orders for patients in the Clarity report that returned kits for 
processing. The completed POC will generate another ICON indicating received and 
processed and will again update the Clarity report. The research assistants will work the 
list to select 2 patients with completed POC orders, treatment and control, for OR 
PathTrac Observation each day. The assistants will confirm 1st patient consent. Once 
confirmed, an OR PathTrac Kit will be ordered in EPIC which creates an ICON 
indicating consent confirmed, a consent confirmed box checked in the RDB microEMR 
will be placed (3 ways for tracking consents, the written document and two electronic 
confirmations), and the preoperative swab and OR PathTrac kit numbers entered into the 
microEMR along with baseline patient demographic information (OR room number and 
case number, surgery duration, date and time). Informed, written consent will be 
obtained from the second patient on the day of surgery (see attached consent for patient 
2),an OR PathTrac Kit ordered, demographic information (see previous) entered into the 
microEMR, and surveillance completed. If the second patient does not provide consent 
for their samples, the pair will be excluded and recruitment continued to reach 1,000 
pairs. Our prior experience and recent experience at the University of Iowa strongly 
suggests that patient refusal to provide written consent for intraoperative cultures will be 
a rare event. The assistant will then follow the 1st patient to the recovery area for 
sampling as previously described using the Ward Environment Surveillance (WES) kits. 
The WES kit number will be associated by the micro EMR to the other kit units. This 

will allow RDB processing, tracking, and reporting of S.aureus transmission during the 
entire perioperative period. 
VI.16 
Do you plan to recruit/enroll non-English speaking people? 
No 
VI.18 
Do you propose to enroll any of the following in this study as subjects? 
• 
Employee of the PI or employee of a research team member 
• 
Individual supervised by PI or supervised by member of research team 
• 
Individual subordinate to the PI or subordinate to any member of the 
research team 
• 
Student or trainee under the direction of the PI or under the direction of a 
member of the research team 
• 
No 
VI.20 
Will subjects provide any information about their relatives? 
No 
VI.23 
Will anyone (other than the subject) provide you with information about the subject 
(e.g. proxy interviews)? 
No 
VI.26 
Is this project about pregnant women? 
No 
VI.27 
Will this project involve fetuses? 
No 
VI.28 
Does this project involve adult subjects who may be incompetent or have limited 
decision-making capacity on initial enrollment into the study? 
No 
VI.32 
Does this project involve subjects whose capacity to consent may change over the 
course of the study? 
No 
VI.37 
Does this project involve prisoners as subjects? 
No 
VII.A. Project Description (A) 
VII.A.1 
Where will project procedures take place (check all that apply)? 
• 
UIHC - Preanesthesia testing, surgical clinics, postanesthesia care unit, hospital 
floors (wards). 
• 
Other UI campus site - RDB Bioinformatics at the University of Iowa 
Bioventures Center. 
VII.A.2 
Is this project also being conducted by other researchers at their own sites (e.g. a 
multi-site collaborative project)? 
No 
VII.B. Project Description (B) 
VII.B.1 
Does this project involve any of the following (Check all that apply): 
• 
 

Registry – The collection and maintenance of data (not including biologic 
samples) in which: (1) the individuals in the registry have a common or 
related condition(s), and/or (2) the individuals in the registry are interested 
in being contacted for future studies by investigators other than those 
listed in Section II of this project.(UI Guide) 
• 
 
Repository – The collection, storage, and distribution of human biologic 
samples and/or data materials for research purposes. Repository activities 
involve three components: (i) the collection of data and/or specimens such 
as blood, tissue, saliva, etc.; (ii) the storage of data or specimens, and data 
management function; and (iii) the sharing of data/specimens with 
recipient investigators other than the original investigators. (paraphrased 
from OHRP) 
• 
 
Expanded Access – A process regulated by the Food and Drug 
Administration (FDA) that allows manufacturers to provide 
investigational new drugs to patients with serious diseases or conditions 
who cannot participate in a clinical trial. Examples of expanded access 
include non-protocol access to experimental treatments, including protocol 
exception, single-patient IND, treatment IND, compassionate use, 
emergency use, continued access to investigational drug, and parallel track 
(ClinicalTrials.gov & FDA). 
• 
 
Clinical (or Treatment) trial – A prospective biomedical or behavioral 
research study of new treatments, new drug or combinations of drugs, new 
devices, or new approaches to surgery or radiation therapy. (NIH 
and ClinicalTrials.gov & FDA) 
• 
 
Physiology intervention/study – A pharmacologic or measurement study 
aimed at understanding basic mechanisms of disease and/or of normal 
human physiology, often without any therapeutic intent (though a clinical 
trial could include such components, often labeled as “translational” or 
“basic science” aims.) Measurements in such studies could include, but are 
not limited to, a blood draw, EKG, EEG, MRI, auditory or sensory testing, 
checking vital signs, DEXA scans, eye tracking, specimen collection, 
exercise, fasting, special diets, etc. 
• 
 
Behavioral intervention/study – May be used to refer to studies of 
individual or group behavior. This option does not include drugs, 
biologics, or devices but could include psychotherapy, lifestyle 
counseling, behavior modification, etc. 
• 
 
Diagnostic trial – Protocol designed to evaluate one or more interventions 
aimed at identifying a disease or health condition 
(ClinicalTrials.gov & FDA) 
• 
 

Non-clinical – any college/department that would regularly submit 
to IRB-02 
• 
 
Other 
VII.B.1.a 
Does this project involve any of the following (Check all that apply): 
• 
 
Phase I trials – include initial studies to determine the metabolism 
and pharmacologic actions of drugs in humans, the side effects 
associated with increasing doses, and to gain early evidence of 
effectiveness; may include healthy participants and/or patients 
(ClinicalTrials.gov & FDA) 
• 
 
Phase II trials – include controlled clinical studies conducted to 
evaluate the effectiveness of the drug for a particular indication or 
indications in patients with the disease or condition under study 
and to determine the common short-term side effects and 
risks(ClinicalTrials.gov & FDA) 
• 
 
Phase III trials – include expanded controlled and uncontrolled 
trials after preliminary evidence suggesting effectiveness of the 
drug has been obtained, and are intended to gather additional 
information to evaluate the overall benefit-risk relationship of the 
drug and provide an adequate basis for physician 
labeling(ClinicalTrials.gov & FDA) 
• 
 
Phase IV trials – studies of FDA-approved drugs to delineate 
additional information including the drug’s risks, benefits, and 
optimal use(ClinicalTrials.gov & FDA) 
VII.B.1.b 
Provide the NCT (National ClinicalTrials.gov Identifier) number 
NCT03638947 
VII.B.2 
Does this project involve a drug washout (asking subject to stop taking any 
drugs s/he is currently taking)? 
No 
VII.B.6 
Will any subjects receive a placebo in this study when, if they were not 
participating, they could be receiving an FDA-approved treatment for their 
condition? 
No 
VII.B.11 
Is there a separate, written protocol that will be submitted in addition to this IRB New 
Project form? (Note: a grant application is not considered to be a protocol) 
No 
VII.B.18 
Does this project involve testing the safety and/or efficacy of a medical device? 
Yes 
VII.B.19 
Describe in detail procedures in place for maintaining device shipment 
and receipt records: 
The medical device utilized in this study is a software program (RDB 
Bioinformatics, Omaha, NE 68154) designed for bacterial differentiation. 
All devices, equipment, culture supplies and media used for the purpose 

of bacterial differentiation are considered exempt for FDA regulations 
(like the MALDI-Toff used at Iowa for culture specimens). This is a 
cloud-based device, so procedures for maintaining device shipment and 
receipt records to not apply. 
VII.B.20 
Who will be responsible for maintaining these shipment and receipt 
records? 
This is a cloud-based device, so procedures for maintaining device 
shipment and receipt records to not apply. 
VII.B.21 
Describe in detail procedures in place for tracking use and disposition 
of devices described in this study: 
This is a cloud-based device, so procedures for maintaining device 
shipment and receipt records to not apply. 
VII.B.22 
Who will be responsible for maintaining these use and disposition 
tracking records? 
This is a cloud-based device, so procedures for maintaining device 
shipment and receipt records to not apply. 
VII.B.23 
Describe in detail procedures in place to limit access to authorized study 
personnel for the storage, control, and dispensing of the investigational 
devices. (For example, investigational devices are kept in a locked area 
away from approved devices or have a keyed interlock, and only study 
personnel authorized to dispense the device have the keys) 
Two-factor authentication is required for access to the software. Only 
study personnel and the infection control perioperative team will be 
granted access. Access will be limited based on participation. For 
example, laboratory personnel will only have access to the laboratory 
component of the software, clinical research assistants will only have 
access to the data entry fields, and the infection control perioperative team 
will only have access to the reporting platform. The study personnel will 
have complete access. A signed data management plan with UIHC is in 
place. 
VII.B.24 
Is the device FDA-approved for the way it will be used in this study? 
No 
VII.B.25 
Is there an IDE (Investigational Device Exemption) for this 
device in this research project? 
No 
VII.B.29 
Indicate the appropriate FDA status you and/or the 
sponsor are requesting for the use of this device in this 
study. 
Non-Significant Risk (NSR) device/software 
VII.B.31 
Provide a detailed rationale for why this device 
meets the FDA definition of a Non-Significant 
Risk Device (NSR) 
This software program is indicated for bacterial 
differentiation and is therefore considered exempt 
from FDA regulations. It is not an implanted device 
purported to preserve or sustain human life, is not 
intended to diagnose, cure, or mitigate human 
disease, does not impair usual practice or provide 
any risk to the patient. The device serves to 
differentiate bacterial specimens collected from the 
perioperative care environment into hyper 
transmissible, resistant, and virulent pathogens. 
Once identified, the system maps those "super 
bugs" so that healthcare environments can 

understand where their gaps in basic preventive 
measures are. For example, where the gaps in hand 
hygiene are. Once identified, the institution can use 
the information to design, measure, analyze, 
improve, and control the super bug spread. We 
hypothesize that this can help to reduce infections. 
As this device does not meet the FDA definition of 
a significant risk device (SRD), it is a NSR. 
VII.B.32 
Provide a summary of prior investigations with 
this device. 
This device was tested in a beta project at UIHC 
where bacterial traffic in the operating room was 
catalogued. 
VII.B.33 
Have there been any prior IRB reviews (at UI or 
elsewhere) and/or determinations made with 
regard to this device? 
Yes 
VII.B.34 
Provide a discussion of these 
reviews/determinations. 
I have not seen Dr. Reddy's IRB 
determinations, but they are on file with the 
IRB. The device and study were determined 
to be of no significant risk to patients. 
VII.B.35 
Has the FDA made an assessment of risk with 
regard to this device? 
No 
VII.B.36 
Has this device/software been approved by the FDA for 
another indication or in another form from its use in this 
project? 
No 
VII.C. Project Description (C) 
VII.C.1 
Does this project involve any research on genes or genetic testing/research? 
No 
VII.D. Project Description (D) 
VII.D.1 
Check all materials/methods that will be used in recruiting subjects (you will need to 
attach copies of all materials at the end of the application): 
• 
Pictures/diagrams/models - 
• 
Posters - 
• 
Use of any information available to the researchers or their colleagues because 
this person is a patient OR use of any information considered to be Protected 
Health Information (PHI) OR review of patient/clinic records - We will use the 
EPIC lists as previously described to send kits, track receipt, and guide 
surveillance. Email will be used to communicate with surgeons regarding 
subjects meeting inclusion criteria. 
• 
Letter - 
VII.D.2 
List the individual data elements you will need to access/use from the patient or 
clinic records to identify potential subjects for recruitment 
Age >18 (this will be differentiated by the order in EPIC where only patients age 
>18 have the order included in preoperative order sets) 

Surgical clinic visit (involving orthopedic total joint, orthopedic spine, 
gynecology/oncology, cardiothoracic, general abdominal, colorectal, open 
vascular, general breast, and open urological procedures). Also documented 
allergies. 
VII.D.3 
Describe why you could not practicably recruit subjects without access to and 
use of the information described above 
We cannot approach every patient in the clinic without this information. 
VII.D.4 
Describe why you could not practicably obtain authorization from potential 
subjects to review their patient or clinic records for recruitment purposes. 
It is impractical for us to approach every patient in the clinic to get authorization 
to review their medical record. 
VII.D.5 
Describe plans to protect the identifiers from improper use or disclosure 
The patients are protected by the HIPAA policy at the University of Iowa 
Hospitals and Clinics. PHI will be stored in EPIC. EPIC protects this data based 
on UIHC policy. Patient demographic factors entered into the RDB 
Bioinformatics will be de-identified, only associated to kit numbers. This 
information will be protected by 2-factor authentication and encrypted. A data 
safety plan signed by RDB and UIHC affiliates is in place. 
Source documents (RDB kit inserts for reservoir collection, printed screen shots 
of the OR PathTrac microEMR,and patient demographic factor collection 
documents (see attached documents)will be kept in a binder that will be stored in 
a locked cabinet in the locked office of the PI. 
Only research team members will have access to the EPIC lists of patient 
information linked to preoperative kit orders. 
VII.D.6 
Describe plans to destroy identifiers at the earliest opportunity consistent with 
conduct of the research 
We will not be collecting patient identifiers except on consent forms that will be 
stored as records and in EPIC lists. OR numbers and dates in the microEMR will 
only be associated with kit numbers and basic demographic information, not 
patient MRN or other identifiers. Once the study is complete with all primary and 
secondary endpoints collected, the EPIC lists will be deleted if possible by HCIS. 
VII.D.7 
Does the research team agree that the requested information will not be reused 
or disclosed to any other person or entity, except as required by law, for 
authorized oversight of the study, or for other research for which the use or 
disclosure of the requested information would be permitted by the HIPAA 
Privacy Rule 
Yes 
VII.D.8 
Will a member of the research team discuss the study with the subject in person prior 
to the subject agreeing to participate? 
Yes 
VII.D.9 
Describe the physical location where the consent process will take place: 
Surgical clinic, preanesthesia testing (PAT), on the surgical floor if inpatient 
surgery. 
VII.D.10 
Will a member of the research team discuss the study with the subject by phone prior 
to the subject agreeing to participate? 
No 
VII.D.12 
Who will be involved in the consent process (including review of consent 
document, answering subjects' questions)? 

Name 
Consent Process 
Involvement 
Randy Loftus, MD 
No 
Lauren Allan, DO, BA 
Yes 
Kiran Annam, ARNP 
Yes 
Raven Brenneke, BA 
Yes 
Cheryl Byrnes, Advanced Registered Nurse Practioner 
Yes 
Nicholas Cardillo, MD 
Yes 
Brian Clark, PA-C 
Yes 
John Cromwell, MD 
Yes 
Megan Davis-de Geus, MSN 
Yes 
Sundar Durgempudi Tripura, MD, FRCA 
Yes 
Bradley Erickson, MD 
Yes 
Lance Evans, BA 
Yes 
Mark Fisher, MD 
Yes 
Luis Garcia, MD 
Yes 
Joshua Godding, BS 
Yes 
Michael Goodheart, MD 
Yes 
Thomas Granchi, MD 
Yes 
Brent Hadder, MD 
Yes 
Alexia Herber, High School 
Yes 
Jean Hogan, ARNP 
Yes 
JoAnne Hudachek, BSN 
No 
Gretchen Kass, ARNP 
Yes 
John Keech, MD 
Yes 
Prashant Khullar, MD 
Yes 
Susan Kloos, BSN, RN 
No 
Walter Lawrence, MD 
Yes 
Yasmin Lyons, DO 
Yes 
Megan McDonald, MD 
Yes 
Patrick McGonagill, MD 
Yes 
Nicole Miller, BA, PA-C, BS 
Yes 
Andreea Newtson, MD 
Yes 
Nicolas Noiseux, MD 
Yes 
Brittany Parchert, BSN 
No 
Denise Peck, ARNP/PA 
Yes 
Deanna Persons, BS 
Yes 
Andrew Pugely, MD 
Yes 
Roseanne Rath, PA-C, MA 
Yes 
Joan Ricks-McGillin, BSN 
Yes 
Rebecca Rosenberg, PA 
Yes 
Jonathan Rueter, PA-C 
Yes 
Jennifer Shanklin, MD 
Yes 
Mel Sharafuddin, MD 
Yes 

John Sharp, MD 
Yes 
Zita Sibenaller, PHD 
Yes 
Lori Stout, RN, BSN 
Yes 
Judy Swafford, RN 
No 
Chad Tracy, MD 
Yes 
Alicia Walter, ADN, M.A. 
Yes 
VII.D.15 
Check all materials that will be used to obtain/document informed consent: 
• 
Other - The attached poster which summarizes elements of the study consent 
will be made available as a visual aide/reminder for both the surgical team and 
the patients. 
• 
Consent Document 
VII.D.16 
Are you requesting a waiver of documentation of consent (either no subject signature 
or no written document)? 
Yes 
VII.D.17 
Choose one of the following to indicate why you are requesting that the IRB 
waive the requirement to obtain a subject signature as documentation of 
consent: 
A.  The research presents no more than minimal risk (minimal risk means the 
probability and magnitude of harm or discomfort anticipated in the research are 
not greater in and of themselves than those ordinarily encountered in daily life or 
during the performance of routine physical or psychological examinations or 
tests) 
    AND 
The study involves no procedures for which consent is normally required ouside 
of a research context. (This type of waiver is often permitted for a minimal risk 
mail-out survey that includes a cover letter with all elements of consent, and 
returning the survey indicates consent. You cannot request this waiver if the study 
also involves the use of any protected health information (PHI).) 
VII.D.18 
Explain why this meets the chosen criteria in A. or B. above: 
This applies only to the clinician subjects, and, this is minimal risk. We are not 
collecting provider identifiers. All bacteria collected from providers will receive a 
unique barcode that will not be linked to the specific provider, only to the type of 
provider (anesthesia attending or anesthesia assistant). 
VII.D.19 
Before the subject gives consent to participate are there any screening questions that 
you need to directly ask the potential subject to determine eligibility for the study? 
Yes 
VII.D.20 
List any screening questions you will directly ask the potential subject to 
determine eligibility. 
Are you allergic to iodine, shellfish, or chlorhexidine? If the answer is yes, they 
will not be enrolled 
VII.D.21 
Will you keep a screening log or other record that would include information 
on people who do not enroll in the study? 
Yes 
VII.D.22 
Describe the information being collected and the purpose for keeping 
this information. 
For each service line, we will collect age and sex for those patients so that 
we can assess for biases, such as selection bias. 
We will also track patients who did not send the kits in (via EPIC reports). 
These patients will not undergo surveillance because they will not have 

completed the required screening component. If three calls are made and 
they do not use the kits, they will be considered lost to f/u. This will be 
important information when results are reported. 
VII.D.23 
Will this information be shared with anyone outside the UI research 
team members? 
No 
VII.D.25 
After the subject agrees to participate (signs consent), are there any screening 
procedures, tests, or studies that need to be done to determine if the subject is eligible 
to continue participating? 
Yes 
VII.D.26 
List and describe screening 
As described in VII.D.22, the patient must use and return the preoperative swab 
kits. Three reminders will be provided. If they do not complete the initial 
screening process, they will be considered lost to f/u. Information required to 
meet inclusion criteria will be self evident (age which is in the chart, surgical 
service line which is already known...they are in the randomized line, and need 
for general/regional anesthesia (this is decided by the procedure). 
VII.D.27 
Discuss how much time a potential subject will have to agree to consider participation 
and whether or not they will be able to discuss the study with family/friends before 
deciding on participation. 
The patient will be seen in clinic, PAT, or on the floor/ICU as part of their visit. The 
initial time to decide will be limited by the study visit, as a preoperative order must be 
placed. However, they will be able to decline at any point down the road as previously 
described, including simply deciding not to use and return the ordered kit. 
VII.D.28 
How long after the subject agrees to participate do study procedures begin? 
Our goal is to focus on a 10-day window prior to surgery so that the kit can be shipped 
(two days), received (two days), processed (up to 2 days), and in the treatment group, 
treated for 2-4 days. 
VII.D.29 
Provide a description of the enrollment and consent process for adult subjects 
• 
Describe each study population separately including control population 
• 
Include when recruitment and consent materials are used 
• 
Use 3rd person active voice “The Principal Investigator will identify subjects. 
For example, the principal investigator will identify potential subjects, the 
study coordinator will discuss the study with subjects over the telephone and 
schedule the first study visit, etc...” 
• 
Describe the steps that will be taken by the research team to minimize the 
possibility of coercion or undue influence during the consent process 
• 
We will be attempting to capture all patients that meet inclusion criteria which could 
include patients seen and consented in the clinic, seen and consented on the hospital 
floor, intensive care units (inpatient surgery), or pre-anesthesia testing (PAT). Any 
patient meeting inclusion criteria that the surgeon obtains surgical consent for could be 
captured and tracked by the preoperative order. 
Preoperative signed and held orders for preoperative swab kits will populate a list in 
EPIC for the PI (Loftus). This list will be filtered by type of surgery, surgeon, and date of 
surgery within 10 days. Members of the research team will send out the kits after 
approval from the PI. Either treatment or control kits will be sent based on the service 
line, which will be linked by the kit number, and this will determine delivery of usual 
care or the treatment bundle on the day of surgery. 

Before a kit is sent to the patient, a new signed and held order will be placed and 
associated with the kit number (specific to the kit sent to the patient) which will update 
the EPIC list with the kit number. The kits sent by the patient to RDB will be 
accomplished by a prepaid mailer. Patients will use and return the kits to RDB. 
RDB will receive and process the kits. RDB will track the returned kit numbers and 
provide a list to Loftus. Loftus will complete the signed and held orders for patients in 
the Clarity report that returned kits for processing. 
The completed POC will again update the Clarity report. The research assistants will 
work the list to select 2 patients with completed POC orders, treatment and control, for 
OR PathTrac Observation each day. 
The assistants will confirm 1st patient consent. Once confirmed, an OR PathTrac Kit will 
be ordered in EPIC, a consent confirmed box checked in the RDB microEMR, and the 
preoperative swab and OR PathTrac kit numbers entered along with baseline patient 
demographic information. 
Informed, written consent will be obtained from the second patient and the process 
repeated. If the second patient does not provide consent for their samples, the pair will be 
excluded and recruitment continued to reach a total of 1,000 complete pairs. Our prior 
experience at multiple centers and recent experience at the University of Iowa strongly 
suggests that patient refusal to provide written, signed consent for intraoperative samples 
will be a rare event. The assistant will then follow the 1st patient to the recovery area for 
sampling as previously described. 
Providers: We will send out an email to all providers (anesthesia attending physicians, 
anesthesia residents, and circulating nurse anesthetists) that describes the study. A 
sample email has been attached which was based on that used for the OR PathTrac study. 
Providers will be given the opportunity to opt out. If they email a statement that they 
would not like to be involved, they will not be approached on the study day. If they do 
not provide a written response, they will be approached, but they can still opt out. This 
will be explained. If they opt out at that time, their name will be added to the list of 
providers who are not to be approached. This is to avoid coercion. When providers are 
approached in the case that they have not opted out, they will simply be reminded of the 
study, the purpose of the study, and they will be asked to dip their hand in a bag of 
sterile, balanced electrolyte solution. They will also be asked to use provided hand 
hygiene and catheter disinfection systems (treatment bundle). The hand hygiene solution 
was previously used in the OR PathTrac study, and providers are familiar with this 
solution. There were no issues previously. If they opt out, other providers will be 
sampled in the case that they do not opt out so as to maximize the efforts put forth by 
patient participation prior to the OR date and provider assignment to the patient's 
surgery. 
VII.D.37 
Does the study include any form of deception (e.g., providing participants with false 
information, misleading information, or withholding information about certain study 
procedures)? 
Examples: 
• 
Procedure includes a cover story that provides a plausible but inaccurate 
account of the purposes of the research. 
• 
Participants will be provided with false information regarding the particular 
behaviors of interest in the research. 

• 
Procedures include a confederate pretending to be another participant in the 
study. 
• 
Participants will be told that the research includes completion of a particular 
task, when in fact, that task will not be administered. 
• 
Study is designed to introduce a new procedure (or task) that participants are 
not initially told about. 
• 
If yes, a waiver of informed consent must be requested under question IV.3. 
• 
No 
VII.E. Project Description (E) 
VII.E.1 
Will subjects be randomized? 
Yes 
VII.E.1.a 
Will any subjects be blinded to which study arm they have been 
assigned? 
Yes 
VII.E.1.b 
Does the protocol permit telling subjects their treatment 
assignment at the end of the entire study? 
No 
VII.E.1.d 
Justify why subjects cannot be told what study arm they 
have been assigned. You will need to disclose to subjects 
in the consent document that they cannot receive this 
information. 
This is a quality improvement project protected by quality 
assurance. 
VII.E.2 
Describe randomization scheme/assignment including ratio such as 1:1, 2:1 
etc. 
The service lines have been previously described. These lines will be randomized 
1:1 to treatment (bundle) and usual care. This randomization will be computer 
generated by RDB software. 
VII.E.3 
Will any questionnaires, surveys, or written assessments be used to obtain data directly 
from subjects in this study? 
No 
VII.E.5 
Does this project involve creating any audiotapes, videotapes, or photographs? 
No 
VII.E.6 
Provide a detailed description in sequential order of the study procedures following the 
consent process - DO NOT cut and paste from the Consent Document. 
Describe study populations separately if they will be participating in different 
procedures - include CONTROL population if applicable. 
DESCRIBE: 
• 
What subjects will be asked to do/what happens in the study (in sequential 
order) 
• 
The time period over which procedures will occur 
• 
The time commitment for the subject for individual visits/procedures 
• 
Long-term followup and how it occurs 

• 
Preoperative swab kit orders will track informed, written consent and will populate a list 
in EPIC for the PI (Loftus) that will be sorted by type of surgery and filtered (at the top 
of the list) by patients with orders for the kit that are actually booked for surgery within 
10 days of the current date. That list will be used by Loftus to send kits to patients for 
preoperative swabbing and if in the treatment group, decolonization with Povidone 
iodine. Before sending, a new signed and held POC preoperative swab kit order will be 
placed and associated with the kit number. The kits will be sent by the research team to 
the patient along with a prepaid mailer. The kit will include 3 swabs (nasal, axillary, and 
groin), preprinted instructions for use, and an insert briefly summarizing the study for a 
reminder (see attached documents). The patient will follow the kit instructions and send 
the kit to RDB for processing. 
RDB will process the samples and enter the results into the software platform. RDB will 
send a list of kit numbers received to Loftus. Loftus will complete the signed and held 
order in EPIC for those received. This will create an ICON indicating complete. The 
complete ICON will guide OR PathTrac Surveillance, where a treatment and control 
patient are selected each day, as geographically dispersed as possible in the OR. 
Patients in treatment lines with completed orders who are selected for surveillance will 
receive the treatment bundle (see below). Patients in usual care lines with completed 
orders who are selected for surveillance will receive usual care. All second patients in the 
observational pairs described below will receive usual care. Only the first patient in a 
treatment pair will receive the bundle (The goal is to examine the impact of an evidence-
based bundle in preventing spread of bacteria from one patient to another). 
For surveillance in the OR for both treatment and control patients selected for 
observation, the observational unit will be a case pair. The first patient will have been 
previously consented. This will be confirmed by the research assistants. An OR PathTrac 
Kit will be ordered by Loftus or another physician research team member once consent is 
confirmed. The OR PathTrac and preoperative swab kit numbers will be entered into the 
RDB microEMR along with patient demographic information. Source documents will 
include a screen shot of the microEMR page with kit numbers and demographics and the 
kit insert. The OR surveillance as directed by the OR PathTrac kit will be conducted. The 
kits will be transported to RDB by the research team for processing. RDB will enter the 
results into the software platform. 
The second patient will be approached for informed, written consent by the research 
team. This document is distinct from the first patient consent, as the second patient will 
not receive Povidone iodine, will not be asked to use the preoperative swab kit, and will 
not undergo postoperative surveillance. Only the OR PathTrac kit surveillance (while 
they are in the OR) will be conducted for the second patient. Once written consent is 
obtained, an OR PathTrac Kit will be ordered by Loftus or another physician research 
team member, the kit number associated with the first patient's preoperative swab kit and 
OR PathTrac kit numbers in the microEMR, and the demographic information entered 
into the microEMR as well. Source documents will include a screen shot of the 
microEMR page with kit numbers and demographics and the kit insert. The OR 
surveillance as directed by the OR PathTrac kit will be conducted. Kits will be 
transferred to RDB by the research team. RDB will process the kits and enter the results 
into the software platform. OR PathTrac kit orders electronically confirm obtained 
written consent. 
The first patient will be followed to the recovery period. A ward environment 
surveillance (WES) kit will be used for surveillance. The kit will be associated to the 
above information in the microEMR as previously described. Ward (this is the recovery 
area, could be the intensive care unit, post anesthesia care unit, second stage recovery, a 
hospital floor, etc)surveillance will be conducted as directed by the kit. Kits will be 

transferred to RDB by the research team. RDB will process the kits and enter the results 
into the software platform. 
The treatment bundle will continue with the first patient for up to 48 hours into their 
recovery period. Usual care patients, and all second patients in a pair, will continue with 
usual care. 
Treatment and control patients will be followed for up to 90 postoperative days to 
identify the occurrence of one or more healthcare-associated infections according to 
National Healthcare Safety Network (NHSN) definitions and will be called at the 90 day 
mark (up to 3 attempts will be made) to determine if they developed an infection. A 
research assistant will review the patient's electronic medical record via EPIC for 
bacteriology results for urine, sputum, wound, sterile sites and blood. If a positive culture 
is identified, the RA will provide the UIHC Clinical Lab with an accession number so 
that the isolate can be saved. Samples will be sent to RDB for analysis in order to 
determine if the organism was clonally-related to an organism isolated from one or more 
reservoirs during the pre/peri/post-operative period. At no point will personal ID 
information be attached to isolate(s). 
All microbiological data will be entered into the RDB software platform. The platform 
will identify transmission events. This information will be graphically displayed, 
continually updated, and will bring genomic analysis to the bedside by providing a 
mechanism for the research team to continually optimize treatment bundle delivery. 
The above process is summarized in the diagrams attached in the misc. documents. 
These diagrams, along with bullet points of the study in poster format, will be placed on 
the wall of physician offices where consent will be taking place to remind providers of 
the study and to serve as a visual aide for the patient during the consent process. The 
information on the posters will simply state the purpose of the study and participation 
requirements as outlined in the consent. Please see the poster attached in miscellaneous. 
Procedures: 
Preoperative, Intraoperative, and Postoperative Patient Culture Procedures: 
This will involve use of a sterile ESwab to obtain nasal, axillary, and inguinal swabs. 
Nasal: the swab is to be inserted into each nares no more than 3/4 of an inch and rotated 
360 degrees 10 times. Axillary: the swab will be applied to the middle of the armpit, 
pressed firmly against the skin, and rotated 10 times. Inguinal: the swab will be applied 
to the inguinal crease, pressed firmly against the skin, and rotated 10 times. After 
collection, each swab will be inserted into the collection medium (Aimes transport 
medium), the applicator stick snapped off as directed, and the cap placed on the tube to 
seal the contents. 
Treatment Bundle: 
Decolonization: Each patient in the treatment group will receive Povidone iodine 
treatment for their nose and potentially their surgical site on the day of surgery in the 
Day of Surgery Admissions(DOSA) area. The surgical team will approve and guide the 
application of the povidone iodine to the likely surgical incision site(s) or it will not be 
placed. The application of the povidone iodine to the inside of the nose will be guided by 
a member of the research team. 2% Chlorhexidine body Wipes are currently used in 
UIHC Day of Surgery Admission (DOSA) to help disinfect patient skin before surgery 

and we will make sure that treatment patients are properly administered these wipes and 
educated on their use. 
Vascular care: Each patient in the treatment group will receive the Ultraport zero 
(BBraun Medical) closed, disinfectable stopcock set and the DOCit and HubScrub 
disinfection system (Saxa Medical). The DOCit is a cap that providers in the OR will 
insert syringes into to keep them free of environmental contamination, organized, and 
sterile given the 62% isopropyl alcohol in each cap. This is a FDA approved device that 
is on the market. It has been shown to reduce infections with a number needed to treat of 
16. The HubScrub is a cap with the same disinfectant that providers will use to scrub the 
injection ports, or stopcock sets. This cap contains 62% alcohol and brushes for 
mechanical disruption of biofilms. The cap disinfects the port in 10 seconds, maintains 
disinfection for >72 hours when covered, and only needs to be turned 2 times to disrupt 
any biofilm. It is also evidence based and proven to reduce infections. It is also FDA 
approved and on the market. The DOCit and HubScrub systems will be provided in the 
preoperative area, affixed to the IV pole for easy access by the anesthesia provider in the 
OR, and transported with the patient to the recovery unit. 
Hand Hygiene: The Saxa system also contains a single-handed hand hygiene device that 
allows the provider to disinfect their hands at every opportunity. It is affixed to the IV 
pole and will be used preoperatively, intraoperatively, and postoperatively. 
Environmental cleaning: Surveillance will map ORs affected by residual contamination 
with hyper transmissible, resistant, and virulent organisms. This information will be 
communicated to the environmental cleaning service in the OR electronically, 
automatically updated each day, in order to guide improved routine and terminal cleaning 
for affected ORs. Improved routine cleaning will involve use of the conventional 
quaternary ammonium compound with a microfiber cloth followed by a surface 
disinfection wipe. Improved terminal cleaning will involve robotic cleaning using UV 
robots (using UV light in the OR for under an hour) at night/morning if not being used, 
or will involve increased duration of application of the previously described cleaning 
procedure. 
Surveillance will be used to identify gaps in each of the above components in order that 
they can be addressed. For example, a particular service line may not be facile at 
achieving effective decolonization. This would be addressed with patient outreach to that 
service line. All steps will be determined by a dedicated infection control perioperative 
team that will use surveillance to guide proactive, evidence-based, plan-do- study-act 
cycles. 
OR PathTrac surveillance procedures: Research assistants will culture the baseline 
anesthesia environment (adjustable pressure-limiting valve and agent dial of the 
anesthesia machine)using environmental swabs, anesthesia attending hands on entry to 
the OR but after an opportunity to wash their hands using the wall-mounted devices 
using a modified glove juice technique that is simply dipping the dominant hand in a 
sterile bag containing a sterile, balanced salt solution, the same procedure for resident 
hands at baseline, the patient nasopharynx, axilla, and inguinal regions following 
induction of anesthesia and patient stabilization using patient Eswabs as described above, 
the same provider hand, patient, and environmental cultures at case end, and the patient 
intravenous stopcock at case end that will be cultured using an environmental swab. All 
cultures in the OR will be obtained using aseptic practice where the research assistant 
will be wearing a hat, a mask, and will wash their hands prior to dawning gloves. These 
same procedures will be applied to the patient to follow (the patient undergoing surgery 
in the same OR after the patient above. 

Postoperative Surveillance Cultures: The first patient will be followed to recovery in 
same day: postanesthesia care unit (PACU), intensive care unit (ICU), hospital floor, or 
other units. Patients, provider hands, and environmental surfaces will be sampled using 
the procedures as described above within. A sample proximal to the surgical wound, but 
outside of the dressing, will be sampled. Patient samples and samples from the patient's 
recovery room environment will be collected within 48 hours prior to discharge. 
Sample Processing: All samples will be sent to RDB Bioinformatics for processing. 
Results will be entered into the software. The software will guide testing to identify S. 
aureus transmission events. S. aureus transmission events will be processed to identify 
transmission stories, and transmission stories will be reported in the software platform to 
guide proactive improvements in the bundle. 
Infection Tracking: The patient will be followed for 90 days postoperatively to identify 
and infection. Initial screening criteria will include an elevated white blood cell count, 
fever (T>38 degrees), anti-infection order, culture, or office documentation of infection. 
If one or more criteria are present, the patient will undergo a full chart review to 
determine if they developed a healthcare-associated infection (HAI) as determined by 
National Healthcare Safety Network (NHSN) definitions. All patient cultures obtained 
for infectious workup by the usual healthcare teams will be saved by the clinical 
microbiology laboratory. Samples will be sent to RDB for analysis in order to determine 
if the organism was clonally-related to an organism isolated from one or more reservoirs 
during the perioperative period. 
Confounding Factor Analysis: Information from the patient medical record will be 
collected by the study team: date and time of surgery, diagnosis, ASA status (a system 
for assessing the fitness of patients before surgery), age, comorbidities (the presence of 
one or more additional diseases or disorders co-occurring with (that is, concomitant or 
concurrent with) a primary disease or disorder), surgery type and duration, type of 
anesthesia provided, operating room number, gender, dirty or infected surgery (yes/no), 
preoperative location, postoperative location, and duration of anesthesia. Data will 
password protected and kept in microEMR. 
All patients will be called at 90 days (Up to 3 attempts will be made) to determine if they 
developed an infection. 
VII.E.7 
Will you attempt to recontact subjects who are lost to follow-up? 
No - those lost to followup will not be recontacted 
VII.E.9 
Will subjects be provided any compensation for participating in this study? 
No 
VIII. Risks 
VIII.1 
What are the risks to subjects including 
- emotional or psychological 
- financial 
- legal or social 
- physical? 
Patients: Possible anxiety about properly following instructions on how to decolonize 
with povidone iodine. There is a rare but possible risk of topical hypersensitivity with 
topical iodine or chlorhexidine antiseptic solutions. 
Providers: None apparent. 

VIII.2 
What have you done to minimize the risks? 
• 
If applicable to this study ALSO include: 
o 
How you (members of your research team at Iowa) will monitor the 
safety of individual subjects. 
o 
Include a description of the availability of medical or psychological 
resources that subjects might require as a consequence of 
participating in this research and how referral will occur if necessary 
(e.g. availability of emergency medical care, psychological 
counseling, etc.) 
Patients will be consented. Patients will receive thorough instructions for proper use of 
swab kits, Povidone iodine, and chlorhexidine. The consent process will require 
confirmation that there are no known allergies to shellfish, Povidone iodine, or 
chlorhexidine. The rare possibility of a hypersensitivity reaction to the topical Povidone 
or chlorhexidine antiseptic agents will be communicated. It will be recommended that 
they call their primary care doctor if they do develop a rash. 
Providers will also have an opportunity to decline. Emails will be sent out to providers 
initially and the day before, and providers will have the opportunity to decline at any 
point the day of. 
VIII.3 
Does this study have a plan to have an individual or committee review combined data 
from all subjects on a periodic basis (such as summary or aggregate safety and/or 
efficacy data)? 
No 
IX. Benefits 
IX.1 
What are the direct benefits to the subject (do not include compensation or 
hypothesized results)? 
None 
IX.2 
What are the potential benefits to society in terms of knowledge to be gained as a result 
of this project? 
Successful implementation of this study will provide an organized, cost-effective 
pathway to reduce patient harm for up to 7% of patients undergoing surgery and could be 
extended hospital-wide to improve quality of care delivered to thousands of patients each 
year, save the hospital system billions of dollars, and address the issue of antibiotic 
resistance. 
X. Privacy & Confidentiality 
X.1 
What are you doing to protect the privacy interests of the subjects? 
Subjects are consented in a private location. The team member obtaining consent waits 
until medical personnel have completed their business with the subject and have left the 
room before beginning the consent procedures. 
X.2 
Are you collecting the Social Security Number of any subjects for any purpose? 
No 
X.4 
How will information/data be collected and stored for this study (check all that apply): 
• 
Paper/hard copy records (hard copy surveys, questionnaires, case report forms, 
pictures, etc.) - EPIC lists will remain in EPIC. No PHI will be transferred from 
UIHC to RDB. Each face sheet of the microEMR (the patient demographic 
entry sheet) for OR PathTrac and Postoperative observational units will be 
printed by the research assistant each day, placed into a binder, and the binder 

stored in the locked office of the PI. Consents will be maintained in a study 
binder and stored in the locked office of the PI. 
• 
Electronic records (computer files, electronic databases, etc.) - Preoperative 
orders will be protected within EPIC. For OR and postoperative surveillance, 
we will be using the RDB Bioinformatics (University of Iowa Research Park, 
2500 Crosspark Rd. E133 Coralville, IA 52241, United States) surveillance 
system. This system is comprised of an encrypted laptop that contains a micro 
electronic medical record (EMR) into which patient identification and kit 
identification numbers are entered as well as surgical clinic testing, ward 
anesthesia surveillance, and OR PathTrac system modules. The micro EMR and 
OR PathTrac systems have already undergone beta implementation at Iowa. 
They are protected by 2-factor authentication and are only accessible to research 
team members. The clinic and ward surveillance systems will be linked to these 
systems in the current study. RDB and UIHC have a signed data security plan. It 
is planned that long term storage of data will be with RDB Bioinformatics at UI 
Bioventures. This will be discussed in the BAA. 
o 
Name - Brandon Gordon 
o 
Title - Affiliate 
o 
University Job Classification - PZ01 
• 
Biologic samples (blood draws, check swabs, saliva samples, tissue samples, 
etc.) - We will use IATA methods for bacterial transport/transfer. Patient swab 
samples will be stored and identified solely by the kit identification number 
used to obtain the swab. In the event that a patient subsequently develops an 
infection, patient cultures will be managed initially by the UIHC clinical lab in 
accordance with usual care. In addition, samples will later be transferred to 
RDB Bioinformatics. It is planned that long term storage of biological materials 
will be with RDB Bioinformatics at UI Bioventures. 
o 
Name - Randy Loftus 
o 
Title - Associate Professor 
o 
University Job Classification - FS12 
X.5 
Do the confidentiality protections indicated above allow only members of the research 
team to access the data/specimens? 
No 
X.6 
Describe 
RDB Bioinformatics is at UI Bioventures. Bacterial cultures will be de-identified 
(barcode) and demographic data linked to the barcode. Only bacterial culture 
data, OR date, surgical duration, OR room and case number, and kit numbers will 
be shared with RDB. 
X.7 
Does your study meet the NIH criteria for a Certificate of Confidentiality or will you 
be applying for Certificate of Confidentiality? 
No 
XI. Data Analysis 
XI.1 
Describe the analysis methods you will use, including, if applicable, the variables you 
will analyze 
Enrollment/Randomization: Randomization is by the surgical line to treatment or control. 
The treatment bundle will include the improved RDB Bioinformatics S. aureus 
decolonization and screening processes described as above, as well as the previously 
described hand hygiene, environmental cleaning, and vascular care interventions. Active 
surveillance of bacterial transmission in the perioperative setting for both bundle and 
usual care groups will be used to drive activities that should further reduce the incidence 
of bacterial transmission. We will not disrupt processes that are already in place, and 
results will be entered into the medical record via standard laboratory resulting processes.

Patients that undergo S. aureus screening in treatment and control groups will be tracked 
via the RDB system (OR PathTrac) when the kits are employed as previously described. 
The bundle will be implemented in the treatment service lines. Usual care will occur in 
usual care lines. Transmission data will be used by an infection control perioperative 
team to continually optimize bundle interventions through plan-do-study-act cycles. The 
infection control perioperative team will consist of Drs. Cromwell, Goodheart, 
McGonagill, Noiseux, Tripura, Tracy, Garcia, Fisher, Keech, Pugely, Sharafuddin,Brent 
Hadder,Dr. Erikson, and Loftus and Michelle Mathias and another circulating nurse 
(TBD). The surveillance team will include a research assistant at 1.0 FTE and an 
assistant at 0.5 FTE whose responsibility will be to sample all reservoirs at the start of 
each case, the end of each case, and the post-operative area. All patients will be followed 
for 90 days by the research assistants. 
Surveillance Instruments: For the primary outcome of S. aureus transmission events, the 
surveillance instrument will include the perioperative environment for the randomly 
selected patient. This will include the preoperative cultures, the intraoperative cultures, 
and the postoperative cultures. These samples will be collected via use of ordered 
bacterial reservoir collection kits. 
Reservoir sampling: These include the Clinical Arena in which the patient nasopharynx 
is sampled, the OR Arena case pair where 13 sites are sampled per case for a total of 26 
sites that include anesthesia attending hands prior to surgery, anesthesia assistant 
(resident, student nurse anesthetist, Certified-Registered Nurse Anesthetist) hands prior 
to surgery, anesthesia machine adjustable pressure-limiting valve and agent dial (1 swab) 
at baseline, patient nasopharynx, axilla, and groin after patient induction and 
stabilization, the same provider groups case end, the same environmental sites at case 
end, and the stopcock case end. Finally the Postoperative Arena will entail surveillance 
any of these areas to which patients are transported such as day of surgery second stage, 
postanesthesia care unit, intensive care unit, floor (ward). Sites sampled will include 
primary nurse hands (one measurement), same patient sites (N=3), environmental sites 
(bed rail, side table, sink---same swab), surgeon attending hands (if present), and resident 
attending hands (if present). 
Kits will be transported to RDB Bioinformatics laboratory for processing following 
sample acquisition. The dynamic surveillance software platform will guide proven, 
systematic phenotypic and genomic processing of collected samples in order to identify 
clonal transmission events occurring within and between operating room reservoirs in the 
observational unit (case pair). Guidance will be based on the strength of epidemiological-
relatedness as follows: A transmission event will be defined as the presence of one or 
more isolates in a measured reservoir that was not present at case start. Transmission 
events within an observational unit will be further analyzed as directed by the RDB 
platform to identify clonally-related S. aureus transmission events. 
The RDB Bioinformatics software platform will process transmission dynamics in order 
to continually summarize the epidemiology of S. aureus transmission. This information 
will be continually displayed in order to identify the most common reservoir of origin, 
the most common transmission locations (vectors), the most common mode of 
transmission (vertical or horizontal), and involvement of key portals of entry (stopcocks). 
To address strain characteristics, reports will focus on more pathogenic strains defined 
by the top 5 most transmissible, resistant, and virulent strain characteristics. 
Automated analysis reports for overall transmission and for transmission of more 
pathogenic strains will be used by the infection control perioperative team to continually 
optimize the interventions affecting all patients in the treatment clusters as described 
further below. The platform will automatically quantify transmission events occurring in 

treatment and control clusters such that involved in data collection and data entry will be 
blinded to the primary outcome. 
All data will be analyzed by the statistician (Dr. Todd MacKenzie) at Dartmouth 
Hitchcock Medical Center who will not be involved in data collection. 
Work flow: Monday-Friday only. Limited to patients that are seen in UIHC clinics. 1,000 
case pairs: (500 treatment and 500 usual care) will be studied during the 2-year study 
period. This corresponds to one case pair in the “bundle” group and one case pair in the 
usual care group each day (5 days a week for 50 weeks each year). All patients will be 
followed for 90 days for infection development. 
Data Handling: A multidisciplinary infection control perioperative team (the team) 
comprised of surgical, nursing, anesthesia and infectious disease providers will manage 
the information provided by the S. aureus transmission surveillance instruments to 
proactively optimize the multimodal program outlined below. 
Treatment Interventions: The following applies only to 500 patients in the “bundle” 
treatment group (500 patients will be sampled in the clinic and will receive the bundle. 
The case to follow the screened patient in the OR will be included in order to determine 
whether the optimized bundle for the first patient can prevent transmission of S. aureus 
to the second patient. The second patient will not receive the bundle. They will receive 
usual care. Both patients in the 500 treatment pairs (1000 total patients) will undergo 
surveillance). The 500 patients that are screened in the clinic in the control group will 
undergo usual care as will the patient to follow. Both patients in the 500 control 
pairs(1000 total patients) will undergo surveillance. 
• Improved patient decolonization: The additional decolonization with povidone-iodine 
addresses antibiotic stewardship because S. aureus is becoming more resistant to topical 
antibiotics as a result of widespread use. 
• Improved vascular care and hand hygiene: All patients in the “bundle” treatment will 
receive closed, disinfectable stopcock sets (Ultraport Zero, BBraun Medical Inc, 
Bethlehem, PA 18018-3524), and catheter disinfection will be optimized with HubScrub 
and DOCit disinfection caps that address both the injection port and syringe tips (Saxa 
Medical Solutions, Mentor, OH 44060-4862) and leverage desiccation and mechanical 
disruption. Perioperative stopcock contamination rates will be monitored by surveillance 
reports filtered by stopcock involvement, and monthly reports of contamination will be 
used by the team to optimize catheter care via individual and group feedback. The 
vascular care system also contains a hand hygiene unit designed to link hand 
decontamination events with vascular care via proximity. 
• Improved environmental cleaning: Environments (OR and ward) affected by high-risk 
S. aureus transmission events will be mapped by surveillance and addressed by 
automated reporting to the anesthesia workroom supervisor. This will trigger 
improvements in routine (standard cleaning using quaternary ammonium compound and 
micro cloth followed by a surface disinfection wipe) and terminal [improved routine 
technique followed by employment of robotic cleaning (Ultraviolet light)] cleaning. 
Fatigue mitigation: The team will use surveillance to continually monitor the impact and 
fatigue of the proposed interventions as conveyed by failure mode analysis of 
transmission dynamics involved clonal S. aureus transmission. 
XI.2 
Provide the rationale or power analysis to support the number of subjects proposed to 
complete this study. 
Statistical Analysis: The unadjusted primary intention to treat analysis will compare the 
proportion of clonally-related S. aureus transmission events occurring in treatment vs. 
control perioperative (preoperative, intraoperative case pair, and postoperative) 
observational units across the 6 randomized service lines using the Chi squared test. We 
will assess for balance for variables known to be associated with intraoperative 

transmission (case, duration > 2 hours, and discharge location). In the case of imbalance, 
we will use multivariate techniques to further explore the treatment effect using a 
generalized linear models approach. 
Initial Power Analysis (see amendment below based on reviewer concerns): We intend to 
screen a total of 1000 patients for up to 10 surgical service lines. Service lines will be 
randomized 1:1, yielding 500 patients in each treatment arm. Each patient will provide 4 
observational units that include preoperative to intraoperative, intraoperative case 1 to 
intraoperative case 2, intraoperative case 1 to postoperative, and preoperative to 
postoperative opportunities for detection of S. aureus transmission. Thus, 500 patients in 
each arm will provide 2,000 observational units for a total of 4,000 observational units 
during the two-year study period. We originally calculated that this provided 90% power 
to detect a 30% relative reduction in the primary outcome (10.58% down to 7.41%). The 
estimated clonally related S. aureus transmission rate was based on a previously reported 
detection rate of 58 events in 548 observational units for all-comers to the operating 
room at 3 major academic medical centers in the United States. To address service line 
variation, we supposed that the logit-frequencies of the primary outcome for each service 
line were distributed as a normal distribution with a mean of -0.41 and standard deviation 
of 0.20. This amount of between-line variation corresponds to an intra-cluster correlation 
(ICC) of approximately 1%. It can also be interpreted as the amount of variation in which 
service lines in the top quartile of rates would have an average frequency (after removing 
within subjection binomial variation) of 46% while service lines in the lowest quartile 
have an average frequency of 33%. These calculations were accomplished using Monte 
Carlo simulations written in R 3.3, and using in part the following approximation for the 
ICC when rates are logit-normal, 1/(1+1/[pa(1-pa)&#963;2 (which can be readily derived 
using the delta theorem) where pa is the average frequency across centers and &#963; is 
the standard deviation on the logit scale. We calculated that this provides 85% power to 
detect a 30% relative reduction in the primary outcome (40% down to 28%) if there is 
significant variation between service lines. If indeed there is no variation between service 
lines, the power is 98%. 
We expect to lose some patients that are consented and enrolled in this study to non-
compliance with study protocol. There may also be instances where the first OR case 
consented to the study but the following OR case does not consent on the day of surgery, 
making it an ineffective pairing for the study. Patients may also consent to the study 
when in the surgical clinic but change their mind and not consent to the study on the day 
of their operation. It is the patient's right to be able to exit the study at any time. In 
anticipation of patients who are consented but are not able to be used in the study we will 
need to consent more than the minimum 2000 total patients to reach the needed power. 
We estimate that consenting 2800 patients will give us enough room after drop-
out/ineligibility due to a number of causes to generate a final amount of 2000 (as detailed 
above) successful patients that generate data for out study. 
We have completed a pilot study at UIHC to evaluate the above power analyses. The 
pilot involved bacterial surveillance in approximately 40 observational units, or 80 cases. 
A total of 81 cases were enrolled because there was an unexpected cancellation. The 
primary outcome was intraoperative S. aureus transmission events. For the pilot, 
transmission events were defined as possible epidemiologically-related events, not yet 
clonal-additional testing required. 
Below is a summary of the case-pairs observed stratified by service line. 
Case Type # of Cases 
Colorectal 10 
Cardiothoracic 2 
Gyn/onc 24 

Orthopedics 44 
Vascular 2 
Total Cases 81 
As orthopedic and gyn/onc procedures represented the majority of randomized units, we 
considered that those cases would serve as the best estimates for service line variation in 
S. aureus transmission detection. The incidence of S. aureus transmission detection 
ranged from 28% (orthopedic cases) to 58% (gyn/onc) cases. These results support our 
prior assumptions of anticipated service line variation, power calculations, and study 
design, and the variation is likely to be less with additional genomic analysis. Our hope 
is that this additional work and discussion can alleviate the reviewer concerns regarding 
study design. 
XII. Future Research 
XII.1 
Do you wish to keep any information about subjects involved with this research project 
so that members of the current research team may contact them in the future for your 
own research projects? 
No 
XII.2 
Do you wish to keep any information about subjects involved with this research project 
so that other researchers may contact them for future research? 
No 
XII.4 
Does this project involve storing any data, tissues or specimens for future research? 
Yes – contribution for future use is mandatory for participation in the study