COVID-19 Operations

IDDRC Developmental Electrophysiology and Eye Tracking Labs COVID-19 reopening SOP for users

Date: 9/10/2020

Purpose:  To provide guidance for IDDRC lab users to safely access lab space and conduct their research during the COVID-19 pandemic, as is allowed and relevant to their studies.

Scope:  This SOP applies to all individuals that enter the shared IDDRC lab spaces in the CIDD or in the Medical School Wings (383) until such time that restrictions are lifted by UNC.  University general guideline will be used for using any public space including elevators, bathrooms, stairwells, hallways, conference rooms, break rooms, and waiting rooms.

This document will be posted in each lab space (ET and EEG labs in the CIDD and the EEG lab in the Medical Wings). All SOP items must be followed in order to use the space and to conduct research. Failure to comply will lead to being asked to leave the facility and potentially have activities suspended.

1. General guidelines for all personnel in the lab space
   1. PPE: As per the SOM and OVCR. The following PPE must be worn at all times
      • A PPE/CPE mask (provided by CIDD/SOM)
      • Eye protection
        • Use guidelines are here: https://ehs.unc.edu/infectious-diseases/coronavirus/
        • Current human subjects guidelines are here: https://www.med.unc.edu/crso/in-person-activities/som-guidelines-and-processes/
2. Upon entry to the EEG facility, staff and participants must leave personal belongings in a designated area.
3. Upon entry to the EEG facility, staff and participants must use hand sanitizer containing at least 60% alcohol.
4. A QR code with a link to a virtual log will be posted outside of each EEG facility. Staff must log the date and time the participant underwent EEG, identify the PI of the study, and provide the coded subject number assigned to the participant. No personally identifiable information may be written down on the log
5. Facility moving flow:
   1. Only access the labs via the main entrances.
   2. One way flow? Or as directed via building protocols
6. Scheduling

• You must use the lab calendar to schedule and may NOT enter the lab without scheduling its use.
• The lab Google calendars will continue to be used to schedule any activity. If you need access to the calendar, please contact Mae Yefimov or Alana Campbell.
• There should be at least 15 min time interval between studies to ensure there is absolutely no overlap between users, and secure safe enter and exit the facility. Users should schedule studies accordingly so to leave at 15 min break in two studies.
• Users will be required to adhere to their scheduled time. The scheduled time should always include lab cleaning time as originally stated in the training document.

4. Room occupancy

• Occupancy of the EEG and ET lab spaces shall be limited to one user at any time. All others will be required to leave.
• Staff support for technical problems will be limited as much as possible and social distancing will be maintained. Remote diagnosis will be always conducted before in-person staff assistance. Equipment and technical needs can be routed through [email]
• Doors to the labs shall remain closed.
• Doors to all occupied rooms will be closed during use.

5. Cleaning

• Cleaning will be done on all equipment surfaces, computer keyboard, computer mouse, external hard drives, any cables that were accessed, video camera, sink, chairs, and countertop before and after
• Disinfecting will be done with one of the following items listed with the EPA.
  • 70% EtOH (spray or wipes)
  • 10% Bleach (spray)
  • Spray and allow to sit on surfaces for 2+ minutes or in accordance with guidelines.
• Disposable gloves will be worn during cleaning and hands will be washed immediately after discarding.
• Users will be instructed to practice proper hand hygiene. Soap, water, and paper towels will be provided in the bathroom or in the EEG lab. Paper towels will be used to turn off water following hand washing.
• All waste will be collected and placed in a location for housekeeping to remove daily.

6. Training

No training on EEG capping or close ET contact will be offered for June and July. For labs who need to train up staff in data acquisition and analysis techniques, they are invited to didactic trainings and to contact Alana Campbell directly at Alana_Campbell@med.unc.edu.

Changes of training in the future months will be updated to users in July.

7. Good practices
8. Users are suggested to conduct daily self-check on temperature and wellness check.
9. SAI staff will comply with the UNC guidelines to conduct daily health checks and personnel health monitoring according to guidelines.
10. Each of us should follow Wear Wash and Wait to protect the community as best as possible. Wear a mask.  Wait 6 feet apart.  Wash your hands often.
11. Application of EEG Recording Electrodes
    1. During application of EEG recording electrodes, one researcher (RP research personnel) and participant will be within 6 ft of physical space
    2. The entire procedure will be performed in < 10min.
    3. EEG recording electrode application should be performed outside (open air) and/or in a conference room when available to ensure >250 ft.sq. per individual.
       1. The external picnic table outside of the CIDD exterior entrance to the EEG lab
       2. The external picnic table outside of the CIDD med school wings (concrete on patio between Wings and Health Services).

• There are additional conference spaces available.

1. The external lab space (not recording chamber) is preferable.

9. EEG electrodes/caps will be applied to the participant from behind, thus eliminating close face-to-face contact.
10. Any additional electrodes will be placed on the skin directly using double-sided adhesive electrode collars.
11. Participants over 2 years must wear a face mask with over-the-ear loops at all times, with the mask adjusted as to fit under or over the EEG cap.
12. Participants as of now (6/27/2020) the rewards must outweigh the risk for human subjects participants. If the CIDD user study meets the needs this should be completed through:
13. The PI will initially complete a web-based form to briefly describe the study activities and his/her understanding of the risk/benefit ratio in the setting of COVID-19.

• Link to basic study information form here: https://reports.tracs.unc.edu/surveys/?s=W7TF39MTFP
• After the department review, it will then also be reviewed by the newly formed SOM Clinical Research Review Committee (CRRC) for independent review by at least 3 reviewers.
• At all steps, if not approved, the PI will be contacted by the review committee to discuss concerns and work to arrive at a solution.
• Safety Plan: ALL Researchers (clinical and basic science) must develop a 2-page safety plan per research site for their lab.  This should also be submitted to Paige Nuebel (Paige_nuebel@med.unc.edu)

1. Additionally, for EEG and ET both Research Personnel and participants must adhere to the clinical guidelines from the OVCR here: https://research.unc.edu/covid-19/
   • Briefly, this includes:
   • the use of screening prior to visits
   • PPE for all parties in the research – masks, for participants
   • adhering to the guidelines for cleaning and handwashing and scheduling (see above)