PHASE 7: PROTECTION & PREVENTION PLAN DURING THE COVID-19 EMERGENCY

 

 

Due to the recent rise in the COVID-19 cases and in accordance with the institutional instructions, the Alliance has decided to provide support with a new phase in our Prevention and Protection Plan. The protection of staff members, investigators and participants continues to be the priority for the Alliance leadership; therefore, we will begin working and providing services on January 10^th, 2022, while we maintain preventive measures to reduce the risk of infection.

 

 

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. Due to the recent rise in the COVID-19 cases, we are moving to a new phase. The protection of staff members, investigators and participants continues to be the priority for the Alliance leadership; therefore, we will continue providing services while we maintain preventive measures to reduce the risk of infection. For this phase:

 

• On January 10^th, 2022, we will begin with Phase 7^th of our Protection & Prevention Plan during the COVID-19 emergency.
• The Protection & Prevention Plan will be shared with Alliance personnel in a staff meeting.

 

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. Evidence of Vaccination/testing:

According to the Executive Order number 2021-082, all staff members, investigators, coordinators, and other research personnel should provide evidence of full vaccination, including the booster dose (3^rd dose for Pfizer or Moderna, 2^nd dose for Janssen vaccine) (card or VACU ID) or a negative COVID-19 test (PCR or Antigen) done within 48 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 the day of the visit.
• If there is a medical contraindication for vaccination, a letter from a licensed medical provider should be presented to the nurse supervisor (Ms. Bárbara Guzmán).
• Children 2 – 11 years who cannot receive the vaccine or have not completed their vaccination schedule, should present a negative COVID-19 test (PCR or Antigen) done within 48 hrs. before the scheduled visit to the center.
• Anyone who had COVID-19 or a positive test within the last 10 days, will not access to the Center. After this period, he/she should present evidence of a positive COVID test and a medical certificate documenting that he/she has recovered.
• This requirement will not apply for participants of SARS-COV-2 studies; they will need to provide a negative PCR test result.
• This requirement will not apply for participants < 2 y/o.

 

2. Service schedule:

• Alliance services will continue during regular hours. Each service supervisor will schedule for the personnel to cover different shifts from 7:00am to 5:00pm, according to the core’s needs.
• During this period, research team members will be limited to two persons, the investigator and his/her coordinator. Access for additional persons must be authorized by the Alliance administration.
• Clinical services will be available Monday to Friday. Coordinators and investigators will have access to the examinations room by prior appointments on an hourly basis; appointments should be made reaching the head nurse or designated staff. For laboratory services, coordinators will need to reach the Lab supervisor.
• Coordinators and investigators can access the Center from 7:30am and participants should be scheduled from 8:00am to 3:30pm, depending on the expected length of stay.
• We are reducing by 50% the visits scheduled for the week of January 10 – 15, 2022. To be able to comply with our protocols and accommodate all the investigators needs, coordinators need to reschedule all the visits that could be postponed without affecting the research protocols.
• For access to the Alliance dental facilities, each investigator will need to provide special prevention plan.

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 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.

 

4. 

   Screening process, face mask and hand wash are required to enter the Clinical Research Center

   Face mask.

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

 

5. Screening at the entrance:

• During this period, all Alliance personnel, investigators, coordinators, and other research staff members will need to have screening by an Alliance nurse.
• Participants and visitors will also 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 48 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 waterbefore 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 work spaces (computer cluster, Coordinators’ room, medication storage) may be used by no more than two persons at the same time, observing physical distance. Prior reservations for the use of these facilities will be required.
• Arrangements for lunch should be done considering 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 time.
• Waiting areas: during this phase, we expect the research team to have communication with their participants at the time of her/his arrival and escort her/him to the assigned treatment room. The main waiting area will be used only by prior authorization by the head nurse or authorized person.

8. Participants’ companions:

• We recognize that some participants require companionship and that the success of our studies rely on optimal recruitment and participation. Therefore, we ask coordinators to identify participants who need to arrive with a companion and notify Alliance staff in advance.
• Since children < 5 y/o are not vaccinated, no children < 5 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.
• 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 clean and disinfect the surfaces and things they use daily (e. g. research binders, equipment, working station surface, computer, chair and others) before beginning to work, after providing service to each participant, and at the end of the day. 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:

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:

• Anyone older than 2 years must provide a negative result of a molecular or antigen test for COVID-19 performed within the period of 48 hours before arriving on the Island, regardless of being inoculated with any of the vaccines authorized by FDA or WHO.
• If the person has been fully vaccinated, there will be no need for quarantine
• For 10 days, this person will be required to used a face mask all the time while at the Clinical Research Center and avoid sharing lunch areas with other persons.
• Those who are not fully vaccinated,

Even if you test negative, stay home and self-quarantine for the full 7 days. After observing the self-quarantine, the employee will contact his/her supervisor to plan his/her return to work.

• We encourage investigators and coordinator to reschedule any visit from monitors or regulatory agencies. If the visit cannot be postponed, the investigators or research coordinators must provide a list of the visitors with all required documentation to Mrs. Bárbara Guzmán at least 48 hrs prior to the visit. Visitors must follow the travel guidelines, wear their N95 face mask all the time, and will not have access to the lunch areas. Investigators/coordinators will need to make arrangements for lunch outside the Clinical Research Center.

13. For international traveling: employees, investigators, research staff, and other visitors should follow the Department of Health and CDC:

 

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:

 

• Regardless of your vaccination status, you must provide a negative result of a molecular or antigen test for COVID-19 performed in a period no longer than one (1) day before boarding a flight to Puerto Rico. Results must be sent to your supervisor and the MSC Occupational Health Office.
• For Fully Vaccinated People:
  • No need for quarantine. Self-monitor for COVID-19 symptoms; isolate and get tested if you develop symptoms.
  • For 10 days, this person will be required to used a face mask all the time while at the Clinical Research Center and avoid sharing lunch areas with other persons.
• For Unvaccinated People (not fully vaccinated) 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.

 

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).

 

 

References:

1. Guias de Cumplimiento durante el mes de enero ante la situacion actual de la pandemia en Puerto Rico, comunicado Rectora 1/3/2022
2. Comunicado Comité Reintegración RCM, Presidenta, 12/28/2021
3. https://travelsafe.pr.gov/?fbclid=IwAR2MWWO88ihia0B4aQeZmfaRlSGfTkj_3lvaPP3lB1iQe9_mQIm4kwVgh1g#travel-requirements
4. https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel-during-covid19.html