Appendix C. Site Visit Protocol

Location:	Date and time:
Type of organization: Pediatric, Academic, Free-standing, Community	Interview Code: Role:

Testing materials checklist

___ Site Visit Protocol
___ Facilitator clock/watch
___ Pens and notepads
___ Informed consent forms (1 copy for participant to sign, plus 1 copy for participant to keep)

Project Background

In 2010, AHRQ began work with the American Institutes for Research (AIR) and its subcontractors, Dr. Tony Slonim, Virginia Tech College of Engineering, and Outcome Engineering, to conduct a proactive risk assessment of the policy and clinical practice factors leading to surgical site infections in ASCs or outpatient centers and subsequently to design an intervention to mitigate the occurrence of these infections. The AIR team identified four local ASCs or outpatient centers from whom to learn about the policies, procedures, and practices in place in different types of ambulatory surgical settings. The ASCs or outpatient centers participating in this study include: (1) the George Washington University Ambulatory Surgery Center, (2) Shady Grove Adventist Hospital Outpatient Surgery Center, (3) the Surgery Center of Chevy Chase, and (4) Children's National Medical Center Outpatient Surgery Center. With the goal of building upon the infection control practices already in place, AIR will conduct site visits to each of these four ASCs/outpatient centers to learn about the infection control processes in place. The objectives for these informal site visits are stated below.

Site visit goals

Gather information about ambulatory surgery centers and procedures performed there.
Learn about the process flow of patients and identify the steps in preoperative, operative, and postoperative care.
Capture information about infection control policies and the potential barriers to ensuring sterilization.
Gather perceptions about potential interventions considered critical for reducing the probability of surgical site infections.
Obtain useful information for AHRQ on how best to implement any future patient safety activities around health care associated infections.
Conduct individual interviews with relevant and knowledgeable staff members, including an administrator, an infection control specialist, a surgical nurse, and a surgeon for no longer than one hour each.

The purpose of the interviews is described in detail next.

Interviews and Purpose

Before we can identify the challenges associated with surgical site infections, we need to develop a better understanding of ASCs/outpatient centers and the general workflow for patients' visits. In addition, we need to learn about the infection control policies and procedures in place. The first phase in developing this background understanding is to conduct site visits and informal interviews with staff at each site.
The site visits and interviews are intended to help us better understand how infection control is carried out in each phase of a patient's visit to an ASC/outpatient center. At each site, we will conduct similar exploratory discussions with qualified individuals serving in a variety of roles (e.g., administrators, surgeons, surgical nurses, and infection control professionals).
It should be noted, however, that none of the information we gather from the site visits will be reported directly to AHRQ, nor will it be used for publication purposes. The AIR team is conducting these interviews for informational purposes only and will synthesize the information across all four sites to inform the proactive risk assessment model.
All data gathered is considered confidential and will not be linked to the interview participants or their organization. Participation is completely voluntary and can be discontinued at any point without consequence.

Outcomes

Ultimately, the information collected during the site visits as well as any policies and procedures provided by the ASCs/outpatient centers will be used to develop a general process map for patient flow in ASCs/outpatient centers. This general process map will, in turn, be used to identify where potential human factors risks exist in surgical and infection control procedures. Finally, we will use this information to design an intervention to mitigate the risk of infections.
Upon approval by AHRQ, the AIR team will share the results of the proactive risk assessment, as well as the intervention and any best practice information obtained, with the participating ASCs/outpatient center upon completion of the project.

Introduction 5 min

(As participants arrive, greet them and give them informed consent forms (one to sign, one to keep).

Welcome
- Thank you for agreeing to participate in our focus group today.
- My name is {Name} and I'll be talking with you today. I work for the American Institutes for Research (AIR), an independent not-for-profit research organization.
- Allow ten minutes for participant introductions and for them to gather food (if applicable).
Background—explain purpose of the interview
- Our discussion today is part of a project sponsored by the Agency for Healthcare Research and Quality (AHRQ). AHRQ contracted with the American Institutes for Research (AIR), Virginia Tech's College of Engineering, and Dr. Tony Slonim to develop an understanding of infection control practices in the ambulatory surgery setting.
- Specifically, we are conducting a proactive risk assessment to identify potential challenges to maintaining infection control with the aim of designing an intervention to overcome these challenges.
- Before we can identify the challenges, we need to develop a better understanding of ambulatory surgery centers (ASCs) and the general workflow for patients' visits. In addition, we need to learn about the infection control policies and procedures in place. Because of this, we are collaborating with four ASCs/outpatient centers in the Metro Washington area to help build our background understanding about ambulatory surgery and infection control. The first phase in developing this background understanding is to conduct site visits and focus groups with staff at each ASC.
- The site visits are intended to help us better understand how infection control is carried out in each phase of a patient's visit to an ASC. At each site, we're conducting similar discussions with qualified individuals serving in a variety of roles (e.g., administrators, surgeons, surgical nurses, and infection control professionals).
- Ultimately, we will synthesize all information to develop a general process map for patient flow in ASCs/outpatient centers. We will then use this general process map to identify where potential human factors risks exist in surgical procedures and the infection control procedures associated with them. Finally, we will use this information to design an intervention for AHRQ to test and validate.
- It should be noted, however, that none of the information we gather here today will be reported directly to AHRQ. Our team will synthesize all information and report it at an aggregate level.
- All data gathered here is also considered confidential and will not be linked to you or your organization. Your participation is completely voluntary and can be discontinued at any point without consequence.
- If you have questions about our research, you may contact the Project Director, Dr. Alexander Alonso, at 202-403-5176 or aalonso@air.org. You may also contact the Principal Investigator for this work, Dr. Tony Slonim, tslonim@adventisthealthcare.com. Should you have comments or concerns about the research, you may also contact AIR's Institutional Review Board at IRB@air.org.
Go over ground rules
- The interview will take no longer than one hour with three major activities.
- We have a lot to talk about today, so there may be times when I need to move the discussion along. Please understand that when I ask that we move to a new topic, I don't mean to be rude.
- Do you have any questions before we get started?

Administrator Questions 50 min

Current Role
1. Tell me about your current role. What are your primary responsibilities? {Collect information on all responsibilities}
  
  Probe:: Can you tell me a bit about your role in patient safety and quality improvement activities in general, not just this project?
  
  Probe:: How long have you worked at this organization? How long have you worked in the field of patient safety at this organization? Overall?
Facility Information
1. Please tell us about the ASC's capacity and the facility.
  
  Probe:: Approximately how many patients are seen a day or month?
  
  Probe:: How many staff work at the ASC? What is the breakdown of staff? How many are nurses? How many are administrative staff? How many are surgical assistants? How many are house staff?
  
  Probe:: Approximately how many surgical procedures are performed here in a given year?
  
  Probe:: What are the most common surgical procedures? Why are they the most common? Is it related to the surgeon mix?
  
  Probe:: In reviewing the list of procedures sent to AIR, which are the most difficult to prepare for? Which ones require the most effort to ensure infection control? If an infection were to occur, which surgeries carry the greatest consequence for the patient (e.g., length of hospital stay, length of recovery period)?
  
  Probe:: What major organizational or clinical outcomes related to delivery of care does the administration measure?
2. Please tell us about the quality improvement and patient safety initiatives underway at your ASC.
  
  Probe:: Please list all quality improvement initiatives you can recall.
  
  Probe:: What metrics does your ASC use for quality improvement and patient safety?
  
  Probe:: Does your ASC participate in outcomes reporting activities like the Healthcare Cost and Utilization Project's State Ambulatory Surgery Database or the Outcomes Monitoring Program sponsored by Ambulatory Surgery Center Association?
  
  Probe:: Does your ASC focus quality improvement efforts on healthcare associated infections?
  
  Probe:: Who is the accrediting body for your ASC?
  
  Probe:: Does your accrediting body have specific standards for infection control?
  
  Probe:: Does your accrediting body have specific standards for infection control in ambulatory surgery?
General Throughput
1. Please walk us through the process of patient flow.
2. What does a typical patient's flow look like?
3. Can you share with us an example of a patient from preoperative instructions to postoperative care and discharge?
  
  Probe:: Who is responsible for delivering preoperative instructions to the patient?
  
  Probe:: Where does the patient go on arrival?
  
  Probe:: What information is collected from the patient/family upon arrival at reception?
  
  Probe:: What information is sent from the surgeon's office about the specific procedure and the patient's condition?
  
  Probe:: After reception, where does the patient go next?
  
  Probe:: Who is seeing to the patient's care in the semi-restricted area?
  
  Probe:: After preparation, where does the patient go next?
  
  Probe:: Who is responsible for the patient's care in the restricted (sterile) area?
  
  Probe:: Where do staff sterilize and prep for the surgical procedure?
  
  Probe:: When the patient's procedure is finished, where do they go?
  
  Probe:: Who is responsible for their care until discharge?
Phase 1: Preoperative Stages
1. Who are the key members of the surgical team at this point?
2. What responsibilities are shared across the team?
3. Who is responsible for conveying preoperative instructions to the patient?
4. Who is responsible for confirming patient readiness for procedures 24 hours before the procedure? Does patient readiness assessment include questions about potential patient infections or exposures to infections?
5. Who gets the patient and procedure information to the ASC? How is that information transmitted typically?
6. Upon arrival who confirms patient information and conducts intake?
7. How are allergies, especially to antibiotics recorded? What procedure for the need and prescribing of preoperative antibiotics? Is a preoperative assessment for need of antibiotics sent to surgeons for all cases?
8. What is the surgical team doing prior to the procedure but after other procedures?
9. When does room sterilization take place? Who is responsible for this?
10. What is procedure for cleaning of room between cases? How is this documented?
11. How does information go from intake/reception to the semi-restricted area?
12. What are the clothing and hair restrictions for the semi-restricted area?
13. How are reusable instruments such as various endoscopes sterilized? What is staff training to comply with manufacturers recommendations?
Phase 2: Operative Stages
1. Who are the key members of the surgical team at this point?
2. What responsibilities are shared across the team?
3. When a patient is taken into the surgical sterile area, who is responsible for their care prior to the procedure?
4. Is there a “clean corridor” or “clean passage for sterile equipment” into the OR?
5. Where is surgical team sterilization taking place? When does the surgical briefing occur? Does it contain information about potential patient infections or exposures to infections?
6. What is taking place to sterilize the operating room? What products and procedures are being used?
7. Who is responsible for operating room turnaround and sterilization?
8. What obstacles exist to ensuring effective turnaround and sterilization?
9. What are the clothing and hair restrictions for this area?
10. What is the air exchange system in the OR? How often are filters changed? How often are air sampling and cultures performed?
Phase 3: Postoperative Stages
1. Who are the key members of the surgical team at this point?
2. What responsibilities are shared across the team?
3. When a patient is taken out of the surgical sterile area after the procedure, who is responsible for their care?
4. Where is surgical team sterilization taking place at this point? When does the surgical debriefing take place? Does it contain information about potential violations or threats to infection control standards?
5. What is taking place to sterilize the operating room? What procedures are being used? How long after a procedure does a sterilization team wait?
6. Who is responsible for operating room turnaround and sterilization?
7. What obstacles exist to ensuring effective turnaround and sterilization?
8. What are the clothing and hair restrictions for the postoperative area?
9. Who is responsible for patient care at this point? Where are patient and incision care instructions delivered? If and when is the patient or family instructed of potential risks for surgical site infection?
10. Who is responsible for confirming patient follows care instructions after the procedure?

Infection Control Specialist Questions 50 min

Current Role
1. Tell me about your current role. What are your primary responsibilities? {Collect information on all responsibilities}
  
  Probe:: Can you tell me a bit about your role in patient safety and quality improvement activities in general, not just this project?
  
  Probe:: How long have you worked at this organization? How long have you worked in the field of patient safety at this organization? Overall?
Infection Control Policies
1. What, if any, infection control policies are in place at your facility?
2. What infection control standards are enforced or adhered to? What is/are the source(s) of these standards?
3. What barriers to adherence of infection control policies do you encounter? Are the following potential barriers to adherence: (1) lack of imperative or precise wording, (2) lack of easily identifiable instructions specific to each profession, (3) lack of concrete performance targets, and (4) lack of timely and adequate guidance on personal protective equipment and other safety measures?
  
  Probe:: What are the potential risks or challenges involved with infection control in the preoperative stages of care? What are the potential risks or challenges involved with infection control in the operative stages of care? What are the potential risks or challenges involved with infection control in the postoperative stages of care?
  
  Probe:: Of the following, which are the biggest obstacles to successful infection control?
  - The type of practice and all surgical specialties involved
  - The patient case mix
  - The patient case load
  - HCW level of training and education
  - Level of nursing support for the practice
  - Types of invasive procedures performed and where they are usually performed
  - Specific instruments and equipment used
  - Facility design
  - At-risk patient populations
  - At-risk procedures, such as those requiring invasive devices
  - Causes, risks, and patterns of infections that arise in a particular healthcare setting
  - Control of bloodborne pathogen exposure
  - Standard precautions and hand hygiene
  - An occupational health program
  - Medical waste and specimen handling and disposal
  - Surveillance and reporting activities for patients and staff
4. How would you change or improve infection control policies and practices? Where is there room for improvement?>
5. What are the responses to sterilization failure? Who is notified and when? Who is responsible for this?
6. Let's discuss policies and practices for sterilization of equipment, instruments and devices.
  
  Probe:: Can you tell us about a time when flash sterilization was required and how it was carried out?
  
  Probe:: What are the procedures and steps for sterilizing equipment and devices during normal operations?
  
  Probe:: Can you think of a time when equipment and device sterilization was not carried out effectively? What went wrong? How would you have corrected the procedures? Was a root cause or potential pitfall in infection control procedures identified?
  
  Probe:: Are there any particular devices that cause more consistent issues with sterilization? Are scopes sterilized by gas, autoclave or soaking? Are these procedures carried out in accord with manufacturers recommendation? How is this documented?
  
  Probe:: When equipment malfunctions, how is it taken out of service? How is a replacement cycled in while ensuring proper infection control? How is this process carried out when there is a recall?
  
  Probe:: What potential challenges are there when cleaning autoclaves? Are there any ways that this could be improved?
  
  Probe:: What are the steps involved in cleaning and caring for instruments and powered tools? Are there any ways that this process could be improved? What the potential infection risks with this process? What are the most common challenges to biological monitoring of surgical instruments?
  
  Probe:: What are the challenges involved with disposal of non-sterile equipment, instruments, devices and other materials? How often is non-sterile equipment disposed of? Is the policy for disposal clearly posted or known among staff?
  
  Probe:: What forms of sterilizers are used at your facility? Who is responsible for using these sterilizers and monitoring their effectiveness? When are these used? Where are they used in the sterile surgical areas? How are they applied? What challenges exist to their effective use?
7. Let's discuss policies and practices for sterilization of operating rooms.
  
  Probe:: Can you tell us about a time when you walked into an operating that was not sterile? How could you tell? What markers were apparent?
  
  Probe:: What are the procedures and steps for sterilizing operating rooms during normal operations? What are the procedures and steps for sterilizing operating rooms between procedures? What are the procedures and steps for sterilizing operating rooms at the beginning and end of each day?
  
  Probe:: Can you think of a time when equipment and device sterilization was not carried out effectively? What went wrong? How would you have corrected the procedures? Was a root cause or potential pitfall in infection control procedures identified?
  
  Probe:: What potential challenges are there when cleaning operating rooms? Are there any ways that this process could be improved?
  
  Probe:: What are the challenges involved with disposal of non-sterile equipment, instruments, devices and other materials? How often is non-sterile equipment disposed of? Is the policy for disposal clearly posted or known among staff?
  
  Probe:: What forms of sterilizers are used at your facility? Who is responsible for using these sterilizers and monitoring their effectiveness? When are these used? Where are they used in the sterile surgical areas? How are they applied? What challenges exist to their effective use? How do steam and oxide sterilizers differ? What are the challenges to working with these?
  
  Probe:: What traffic restrictions are in place to ensure infection control? Who is allowed in this area? What must they be wearing to enter and operate in this area?
8. Let's discuss sterilization for staff and surgical teams.
  
  Probe:: Is a two-person donning and doffing method used for gowning and gloving? Is a one-person donning and doffing method used for gowning and gloving?
  
  Probe:: What chemicals are used for sterilization? What tools and procedures are being used to ensure surgical hand and arm asepsis?
  
  Probe:: What types of gloves are used? Are single-layer, two-layer, or three-layer micromesh antimicrobial gloves used?
  
  Probe:: Can you tell us about time when you feared infection control was threatened via a puncture in clothing or gloves? How was this situation dealt with? Were staff and the patient/family notified? Is this a common occurrence?
  
  Probe:: What is the procedure for follow-up on patients to assure capture of all SSIs? What is procedure for investigating those occurrences? What is reporting mechanism?

Clinical Staff (Nurse or Surgeon) Questions 50 min

Current Role
1. Tell me about your current role. What are your primary responsibilities? {Collect information on all responsibilities}
  
  Probe:: Can you tell me a bit about your role in patient safety and quality improvement activities in general, not just this project?
  
  Probe:: How long have you worked at this organization? How long have you worked in the field of patient safety at this organization? Overall?
Infection Control for Clinicians
1. Let's discuss surgical wounds and their classification.
  
  Probe:: Which procedures are more likely to result in surgical site infections? Why would these produce this result?
  
  Probe:: What are the potential risks involved with wound care postoperatively that can result in surgical site infections?
  
  Probe:: How is the classification of surgical incisions used? Who is responsible for this classification?
  
  Probe:: Can you tell us about a time when a surgical wound classification resulted in an immediate transfer to a hospital? What were the major risk factors encountered? Did a surgical site infection occur? How could this have been prevented?
Let's discuss clinical situations where the risk for surgical site infections are increased.

Probe:: How is temperature control a factor in reducing the risk of surgical site infections? How is temperature control executed at your facility?

Probe:: What role does blood glucose control play in reducing surgical site infections? What steps does the surgical team take to reduce the risk? What preoperative steps are taken to assure adequate preoperative sugar control?

Probe:: When postoperative SSIs occur, are they reported to ASC?

Conclusion and Final Insights for Each Interview 5 min

Before we end, I'd like to give you chance to share any additional thoughts or comments about the information we talked about today. Is there anything else you would like to add that you didn't have a chance to say during our discussion today and you think is important for us to know?

Thank you very much for participating in this discussion today. We appreciate your time.

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Proactive Risk Assessment of Surgical Site Infection in Ambulatory Surgery Centers