PHASE 6: PROTECTION & PREVENTION PLAN DURING THE COVID-19 EMERGENCY

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 continue 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 September 1^st, 2021, we will begin with Phase Six of our Protection & Prevention Plan during the COVID-19 emergency.
  • The Protection & Prevention Plan will be shared with Alliance personnel in a staff meeting.
  • By now, all staff members, investigators, coordinators, and other research personnel should have provided evidence of their vaccination.

 

All people entering the Alliance Clinical Research Center facilities are required to observe Universal Prevention Measures:

Alliance staff members, investigators, coordinators, research staff, students, study monitors, contractors, and other visitors 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. Everyone entering the facilities should provide evidencevaccination card or VACU ID or a negative COVID-19 testPCR or Antigent done within 72 hrs. before the scheduled visit to the center. Research coordinators are responsible for notifying their participants that they need to bring this document with them on the day of the visit.

• • This requirement will not apply to participants of SARS-COV-2 studies; they will need to provide negative PCR test results.

2. Service schedule:

• • Alliance staff members will continue working their complete workday. Each service supervisor will schedule for the personnel to cover different shifts from 7 am to 5 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 am to 3:30 pm, depending on the expected length of stay. Exceptions must to authorized.

 

3. Access 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 use this door to exit the facility.

4. Face mask. We will continue to require the use of a surgical face mask at all times.

 

5. 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, and take your temperature before entering the facilities).
  • Participants and visitors will have screening conducted by the Alliance nursing staff before entering the facilities. The screening process includes providing evidence of vaccination or a negative COVID-19 test (PCR or Antigen) done within 72 hrs. of the visit day, temperature, and answering a few questions).

 

6. Wash hands:

• • We will continue to require all people to wash their hands at arrival. Investigators, research staff, students, visitors, 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).

 

7. 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 (if both are in agreement). Arrangements for lunch should be done considering the appropriate distance. The main conference room will continue to be available for lunch.
  • Health professional-participant interactions and interventions should consider appropriate distancing whenever possible, and the use of personal protective equipment at all times.
  • Waiting areas: 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.

 

8. 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.

 

9. Clean and disinfect:

• • The Medical Sciences Campus administration has assigned a janitor for the cleaning and garbage disposal, including biomedical waste disposal. The janitor will continue to perform his tasks early in the morning.
  • Personnel from the Medical Sciences Campus General Services Department will continue to conduct the disinfecting fogger procedure once a week. This procedure is performed on Friday mornings; consequently, staff members will enter after 8 am.
  • We will continue to require all employees and visitors to wash their hands at arrival. Staff members are required to wash their hands frequently. Investigators and participants will be asked to wash their hands using antibacterial soap and water.
  • On arrival, Alliance nurses will disinfect the triage area, the nursing counter, and the medical equipment to be used during the day. Alliance nurses also disinfect treatment rooms and equipment at the end of each use or at the end of the day. Disinfection wipes will be provided by the administration.
  • On arrival, Alliance administrative coordinators and program administrator will disinfect the waiting area (chairs, registration desk, counter, and phone). Disinfection wipes will be provided by the administration.
  • All research staff members are encouraged to disinfect the things they use daily (e. g. research binders, equipment, working station surface, computer, chair, and others) before beginning to work. Disinfection wipes will be provided by the administration.
  • Alliance staff members, investigators, participants, and others are required to dispose of all PPE as potentially contaminated

10. Avoid sharing personal items.

11. Avoid touching your eyes, nose, and mouth with unwashed hands.
12. For domestic traveling: employees, investigators, research staff, and other visitors should follow the Department of Health and CDC recommendations (according to the institutional COVID-19 Plan, August 3^rd, 2021):

• • Before you travel:
    • Inform your supervisor
    • The supervisor/administration must inform MSC Occupational Health Office and Human Resources Office.
  • After traveling, before coming to work or visiting the Clinical Research Center:
    • 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.

13. For international traveling: employees, investigators, research staff, and other visitors should follow the Department of Health and CDC recommendations (according to the institutional COVID-19 Plan, August 3^rd, 2021):

• • Before you travel:
    • Inform your supervisor
    • The supervisor/administration must inform MSC Occupational Health Office and Human Resources Office.

• • After traveling, before coming to work or visiting the Clinical Research Center:
    •  For Fully Vaccinated People:
      • Get tested with a viral test 3-5 days after travel and send the results to your supervisor and the MSC Occupational Health Office.
      • Self-monitor for COVID-19 symptoms; isolate and get tested if you develop symptoms.

 

• • For Unvaccinated People (not fully vaccinated)
    • Get tested with a viral test 3-5 days after travel AND stay home and self-quarantine for a full 7 days after travel.
    • Even if you test negative, stay home and self-quarantine for the full 7 days.
    • If your test is positive, isolate yourself to protect others from getting infected.
    • If you don’t get tested, stay home and self-quarantine for 10 days after travel.

 

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.

  

14. Continuous Monitoring: The Alliance Nursing Supervisor, Program Administrator, and Program Director will be responsible for:
15. Continuous monitoring of new/possible risks
16. Overseeing compliance with the precaution procedures
17. Making changes to the plan
18. Determining if the next phase will be implemented or if the current phase will be extended or if there is a need to return to a prior stage.
19. Overseeing the Employees’ health:

• • If an employee feels sick, she/he will be required to stay home and seek medical care.
  • Employees will be encouraged to take care of themselves; get rest, stay hydrated and eat healthily.
    • If an employee develops COVID-19 symptoms while working, he/she will be asked to leave the facilities and seek medical care (according to OSLI’s guidelines, at the Industrial Hospital. The Program Administrator will complete de PR OSHA-300 Form; and notify the Medical Sciences Campus Occupational Health Clinic- Office for Security and Surveillance (787-758-2525, extension number 1000), and the Office of Security in Research Laboratories-OSLI, Medical Sciences Campus, University of Puerto Rico (jossian.pagan@upr.edu; 787-758-2525, extension number 1687 or 1688). He/she will be asked to observe quarantine during 14 days at home and seek medical care as needed. The work area will be disinfected; and the Program Director will decide if the Center should be closed to observe quarantine.
    • Once the employee recovers, she/he will be required to bring a medical certificate notifying she/he does not represent a health risk for others
    • Staff members are encouraged to share their emotional needs with the program leaders. If needed, staff members will be referred to the PAS-MSC Office for mental health and wellness assistance.
    • Alliance leaders recommend employees make sure their personal belongings (e. g. cellular-phone, purse) are not exposed to other persons while working.
    • Employees with high-risk conditions (pregnant, older than 65 years, comorbidity) will work from home whenever possible; if he/she needs to work at the Center, high-risk protection (N95 surgical mask, face shield, surgical gown, and gloves) will be provided.

 

15. 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.

 

16. 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.

 

17. 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).

 

References:

1. Plan de Control de Exposición al COVID-19, Comité de Plan de Reintegración al RCM, Última revision: 3 de agosto de 2021
2. https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel-during-covid19.html