The Puerto Rico Clinical and Translational Research Consortium (PRCTRC) 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 a large number of people including UPR MSC employees, participants, and other visitors, and thus may pose a risk of infection for all of us.
The COVID-19 being a disease:
- Caused by the coronavirus that emerged in China in December 2019.
- With symptoms including cough, fever, shortness of breath, muscle aches, sore throat, unexplained loss of taste or smell, diarrhea, and headache.
- That can be spread from person to person through “respiratory droplets”, and by contact with contaminated surfaces.
- That can be severe, and in some cases, has caused death.
At this difficult time of the COVID-19 pandemic, the PRCTRC Clinical Research Center leadership has planned to slow down services to make sure we evaluate risks versus benefits for our users, staff, and the participants. After institutional instructions to reduce or stop work to minimize the exposure and infection of employees, we have planned to continue providing limited services while we take preventive measures to mitigate the risk of infection and learn how to work under these conditions.
The plan for the availability of PRCTRC services has been prepared considering four important factors:
- The protection of employees and participants is our priority
- Available infrastructure and personnel capacity (limited space, personal protection equipment, and limited staff members)
- It is very possible we will live under these circumstances for the next 18 or 24 months
- The PRCTRC resources will be assigned according to PRCTRC’s priorities
The availability of the PRCTRC services has also been divided into phases; the PRCTRC leadership will decide to move on to the next phase or back to one more restrictive based on compliance and COVID-19 epidemiologic data.
Employees’ Protection Plan during Phase Three:
Employees are required to observe Universal Prevention Measures: PRCTRC staff members 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 Clinical Research Center PRCTRC staff members 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 Clinical Research Center are the following:
- Wash hands often with soap and water for at least 30 seconds. Especially after blowing the nose, coughing, or sneezing; going to the bathroom; before and after eating or preparing food; before and after participant interventions. PRCTRC’s administration has prepared two hand-wash stations; one near the entrance and one near the lunchroom.
- While away from the center, if soap and water are not available, use hand sanitizer. Use an alcohol-based hand sanitizer with at least 60-70% alcohol, covering all surfaces of your hands and rubbing them together until they feel dry.
- Avoid touching your eyes, nose, and mouth with unwashed hands.
- Practice social distancing; the CDC recommends at least 6 feet.
- Wear a face mask at all times
- Avoid sharing personal items
- Clean and disinfect all surfaces
- While at the center, employees are required to use their own desk-phone, avoiding the use of another employee’s phone
- Avoid visiting other MSC buildings or areas, if not totally necessary
- Avoid traveling
PRCTRC staff members will provide services as follows:
- On-site support during scheduled clinics
- Program Director (as needed)
- Program Administrator
- One Administrative Coordinator (rotation based)
- One or two Research Nurses, as needed (rotation based)
- Medical Technologist (when needed; rotation based)
- Telework (from home)
- Research Design and Biostatistics support
- Professional Development Core activities
- Regulatory Knowledge and Support assistance
- Evaluation Core activities
- Pilot Project support
- Biomedical Informatics Core support
Staff members, risk and protection:
The PRCTRC Clinical Research Center has clinical and administrative professionals. Each staff member will have specific instructions and precaution measures according to their responsibilities and risk exposure.
Position: Research Nurses
Exposure: High-risk, direct contact with participants, including corporal fluids
Space: entrance triage, vital signs room, nursing counter, phlebotomy rooms, and treatment rooms
Protection: use of PPE, N95 surgical mask, face shield, surgical gown, and gloves is required.
Position: Medical Technologist
Exposure: High-risk, contact with potential infectious samples (e. g. corporal fluids, blood, urine, cerebral-spinal fluid, etc.)
Space: clinical laboratory
Protection: use of PPE, N95 surgical mask, face shield, surgical gown, and gloves is required.
Position: Administrative Coordinators
Exposure: low-risk, maximal distance from participants, co-workers, investigators, coordinators, and visitors
Space: reception counter and personal desk
Protection: use of mask is required
Position: Other Administrative Staff
Exposure: low-risk, maximal distance from participants, co-workers, investigators, coordinators, and visitors, when on-site.
Space: during visit to personal desk/office to pick-up documents and/or supplies for remote work.
Protection: use of mask is required.
The PRCTRC administration will provide Personal Protective Equipment (PPE) for all staff members. According to the Office of Security in Research Laboratories, Medical Sciences Campus, University of Puerto Rico (OSLI) guidelines, each professional is responsible for the use PPE for their own safety.
- Mandatory screening: All individuals, staff members, investigators, coordinators, and participants are required to have screening at the entrance (temperature and questions). See flowchart.
- Social Distance: All individuals are required to maximize physical distance from others.
- Congregation and interaction is discouraged at the PRCTRC facilities; especially in common areas (e.g., counters, waiting room, nurse, hallways). If the interaction is needed, a 6ft distance is required. It is not allowed to stand in from of the counters; communication must be at least 6ft apart or by phone.
- Waiting areas: during this event, the goal is to have these empty. If each research team receives their participates and escorts them to the assigned treatment room, no one should wait. If needed, the main waiting room should hold at most three persons (or 3 pars) at one time, sitting with pertinent distance; and the second waiting area should hold at most two persons, one at each corner. Administrative Coordinators will assist with participants’ accommodation in the waiting room if needed. See maps.
- Small areas/rooms, where social distance is difficult (record room, computer cluster, lunchroom), will be used by one person at the time. These areas will be locked, and opened only upon anticipated reservations made between the Study Investigator/Coordinator and the Program Administrator.
- Health professional-participant interactions and interventions should consider appropriate distancing whenever possible, and the use of personal protective equipment at all times.
- Employees will need to take turns accessing the lunchroom for the use of the microwave and refrigerator.
Cleaning and Disinfection:
- The Medical Sciences Campus administration has assigned a janitor for the cleaning and garbage disposal during this period, including biomedical waste disposal. The janitor will perform his tasks early in the morning before the clinic begins.
- The PRCTRC Administration has requested the Medical Sciences Campus administration specialized services for disinfection (including floors, air, and surfaces).
- The PRCTRC administration has prepared a hand-wash station near the entrance for all employees and visitors to wash their hands at arrival and before leaving the Center. Staff members are required to wash their hands frequently. Investigators and participants will be asked to wash their hands using antibacterial soap and water; however, hand-sanitizer is available.
- On arrival, PRCTRC nurses will disinfect entrance doors, the triage area, the nursing counter, and the medical equipment to be used during the day. Disinfection wipes will be provided by PRCTRC administration.
- On arrival, PRCTRC administrative coordinators and program administrator will disinfect the waiting area (chairs, registration desk, counter, and phone). Disinfection wipes will be provided by PRCTRC 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). Disinfection wipes will be provided by PRCTRC administration.
- PRCTRC staff members, investigators, participants and others are required to dispose of all PPE as potentially contaminated
Weekly Service Plan:
The Program administrator and nursing supervisor will prepare a weekly working program. Services are provided with anticipated coordination between the Study Investigator/Coordinator and the PRCTRC leadership:
- Nursing services: reservation directly with the Nursing supervisor
- Laboratory services: reservation directly with the Lab supervisor
- Access to Medication Storage: reservation with the Nursing supervisor
- Access to Research Files Room: reservations with the Program Administrator
- Access to the Computer Cluster: reservations with the Program Administrator
Significant changes have been implemented in order to assure social distancing while working at the PRCTRC facilities.
- All persons are required to use mask.
- Clinics will be held three to four days per week
- Studies will be classified according to PRCTRC’s priorities
- Investigators are encouraged to identify other mechanisms to continue their research activities
- Four to five participants will be scheduled per clinic; this will depend on the time required for each participant
- At any one time, only one to two research staff members (investigator and one coordinator/research assistant) will be allowed per clinic.
- VULNERABLE INDIVIDUALS (elderly patients, immunosuppressed patients) should NOT visit the Research Center.
- Coordinators and investigators are required to arrive early and be ready (inside the treatment room) before the participant arrives.
- Participants are required to come alone (no companions are allowed unless strictly necessary; e.g. underage or disabled participants)
- Coordinators are required to maintain phone contact with the participant in order to have him/her arrive at the Center when the research staff is ready to receive him/her and escort him/her straight to the treatment room, without waiting. If waiting between participants is needed, it should be done at the participants’ private vehicles.
- When someone arrives (staff, participant, investigator, others), the administrative coordinator at the reception will open the door and ask the person to wait at the triage area. She will announce the arrival to the nurse.
- The nurse will go out to the triage area and complete the screening procedure. Persons with fever or other COVID-symptom, will not be allowed to enter the PRCTRC facilities.
- After the screening, the nurse will escort the person to the hand-wash station and into the treatment room, if applies.
- The administrative coordinator will ask for the participant’s information (name and study) and will fill-in the daily registration list.
Access to the PRCTRC facilities:
The entrance to the Center will be very strict during the COVID-19 emergency.
- Access to the PRCTRC facilities will be allowed ONLY under the supervision of the PRCTRC staff; unsupervised use of the facilities will not be allowed.
- You may NOT access PRCTRC facilities without authorization.
- There is only one entrance, the main entrance, where all persons (without exception) will be screened (temperature and questions) before accessing the PRCTRC facilities.
- You may NOT use the back door (UDH entrance).
- Any person that refuses to follow the screening process, may be denied access to the Center.
The PRCTRC Nursing Supervisor, Program Administrator and Program Director will be responsible for:
- Continuous monitoring of new/possible risks
- Overseeing compliance with the precaution procedures
- Making changes to the plan
- 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.
- 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 healthy.
- 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 (email@example.com; 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.
- PRCTRC leaders recommend employees to 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.
Staff’s feedback and participation:
The PRCTRC leadership will continue to collect feedback from the staff members in order to ensure their recommendations are included in this plan.
All employees will be trained to understand the Plan for Service during the COVID-19 Emergency and all precaution procedures. Employees will sign a written certification acknowledging they received and understood this plan.
The PRCTRC Leaders will share this Plan for Services during the COIVD-19 for employees with all interested sectors (investigators, Medical Sciences Campus authorities, HEEND, and others.