PROTECTION & PREVENTION PLAN DURING THE COVID-19 EMERGENCY PHASE 5

The Hispanic Alliance for Clinical and Translational Research has the mission to provide the faculty members with training, guidance, and support to become successful and independent investigators. Due to the nature of our services, our facility receives many people including UPR MSC employees, participants, and other visitors, and thus may pose a risk of infection for all of us.

During the COVID-19 Pandemic emergency, the availability of services has been divided in phases. According to institutional instructions, we have reestablished our services in a gradual and organized manner. After more than a year of learning how to minimize exposure and infection in the workplace, we have planned to move forward to the next phase. The protection of staff members, investigators, and participants continues to be the priority for the Alliance leadership; therefore, we will increase our services while we maintain preventive measures to reduce the risk of infection. For this phase:

• On June 21^st, we will begin with Phase Five of our Protection & Prevention Plan during the COVID-19 emergency.
• The Protection & Prevention Plan will be shared with Alliance personnel in a staff meeting.

• To be able to make the proposed changes, we will ask all staff members, investigators, coordinators, and other research personnel to provide evidence of their vaccination. Please send by email:

• • Staff members to ivette.molina@upr.edu
  • Investigators, coordinator, research staff members, study monitors, and other visitors to barbara.guzman@upr.edu
  • Students to barbara.carlo@upr.edu

All Medical Sciences Campus employees and students are required to observe Universal Prevention Measures:

Alliance staff members, investigators, coordinators, other research staff, and students are required to follow the guidelines prepared by the Office of Security in Research Laboratories, Medical Sciences Campus, University of Puerto Rico (OSLI) for the COVID-19 Pandemic. Specific rules for the Alliance Clinical Research Center are the following:

1. Service schedule:

   • Alliance staff members will begin to work their complete workday. Each service supervisor will schedule for the personnel to cover different shifts from 7:00 am to 5:00 pm, according to the core’s needs.
   • Clinical services will be available Monday to Friday. Coordinators and investigators can access the Center from 7:30 am and participants should be scheduled from 8:00 am to 3:30 pm, depending on the expected length of stay.
   • Staff members whose tasks can be performed in a remote manner and have special needs can continue with distant work and hybrid arrangements for now.

2. The entrance to the Center will continue with strict conditions:

   • Access to the Center will be allowed ONLY under the supervision of the Alliance staff; unsupervised use of the facilities will not be allowed.
   • You may NOT access the Center without authorization.
   • There is only one entrance, the main entrance, where all persons (without exception) will undergo screening or self-screening and hand wash before accessing the Alliance facilities. You may NOT use the back door to enter (UDH entrance); you may only to use this door to exit the facility

3. Face mask.

   • We will continue to require the use of a surgical face mask at all time.

4. Screening at the entrance:

   • Alliance personnel, investigators, coordinators, and other research staff members who are fully vaccinated will perform self-screening (take the decision to stay home if you feel sick, take your temperature before entering the facilities).
   • Participants and visitors will have screening conducted by the Alliance nursing staff before entering the facilities (temperature and questions).

5. Wash hands:

   • We will continue to require all people to wash their hands at arrival. Investigators and participants will be asked to wash their hands using antibacterial soap and water before accessing offices and treatment rooms.
   • Staff members are required to wash their hands frequently.
   • We will continue to use the two hand-wash stations (one near the entrance and one near the lunchroom).

6. Practice physical distancing: The CDC recommends at least 6 feet.

   • In closed offices/spaces, where there is no public, fully vaccinated personnel may work together observing at least 6 feet distance. Small workspaces (computer cluster, Coordinators’ room, medication storage) may be used by two persons at the same time, observing physical distance.
   • Health professional-participant interactions and interventions should consider appropriate distancing whenever possible, and the use of personal protective equipment at all times.
   • Waiting areas: During the COVID-19 pandemic, we learned to adjust our schedule to receive the participants at the time of her/his arrival without having them wait. As we try to get back to normal, during this phase, our waiting areas will be available with limited occupation. However, we encourage our investigators and coordinators to continue planning their clinics without waiting periods as consideration to our participants.  The main waiting area should hold at most 5 solo-sitting persons or 3 solo-sitting persons and 2 couples at one time, sitting at an appropriate distance; and the second waiting area (in front of the nursing station) should hold at most three persons.
   • The main conference room will continue to be available for lunch.

7. Participants’ companions:

   • We ask coordinators to identify participants who need to arrive with a companion.
   • We will continue to encourage fewer companions to decrease the risk of exposure in our facilities; however, each case should be considered under their own special needs understanding that some participants require companionship and that the success of our studies relies on optimal recruitment and participation.
   • Since children < 12 y/o are not vaccinated, no children < 12 y/o should be brought to the facilities, unless he/she is a participant.

8. Clean and disinfect all surfaces.

9. Avoid sharing personal items.

10. Avoid touching your eyes, nose, and mouth with unwashed hands.

11. After domestic traveling,

    

    • employees, investigators, research staff, visitors, and others should follow the Department of Health recommendations to enter the facilities:
    • If the person has been fully vaccinated, there will be no need for quarantine nor COVID-19 testing.
    • Those who are not fully vaccinated
    • will need to have a COVID-19 molecular (PCR) or antigen testing 5 days after arrival and observe quarantine until negative results are available.
    • if the person does not get tested, he/she must stay home and self-quarantine for 10 days after travel. After observing the self-quarantine, the employee will contact his/her supervisor to plan his/her return to work.
    • For the study monitor’s visit, the coordinator must request evidence of vaccination while planning the visit and send it to Mrs. Bárbara Guzmán. If the monitor is not fully vaccinated, evidence of a negative result of COVID testing must be sent to Mrs. Guzmán 1-2 days before the visit.

     

    Any person that refuses to follow the screening process, may be denied access to the Center. The preventive measures that have not been modified in this revision, will continue as they are up to date.

Staff’s feedback and participation: The Alliance leadership will continue to collect feedback from the staff members in order to ensure their recommendations are included in this plan.

Training: All employees have been trained to understand the Plan for Service during the COVID-19 Emergency and all precaution procedures. Employees have signed a written certification acknowledging they received and understood the prevention plan.

Dissemination: The Alliance Leaders will share this Plan for Services during the COVID-19 for employees with all interested sectors (investigators, Medical Sciences Campus authorities, HEEND, and others).