COVID19Covid 19 Update

The PRCTRC first and foremost priority is the protection of our participants and our staff, and all directives are centered around this priority.

This plan has been prepared to address some of the issues associated with the COVID-19 emergency in relation to the research activities conducted at the Puerto Rico Clinical and Translational Research Consortium (PRCTRC) Clinical Research facilities. Our objective is to provide specific instructions intended to safeguard the safety of participants and staff while supporting clinical research that is deemed essential to the health of the participants.

Specific directives to protect individuals during the COVID-19 emergency have been issued by the federal government (CDC, NIH), the government of Puerto Rico, and the University of Puerto Rico. Following the government and institutional directives to reduce or stop in-person activities 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.  To ensure the safe performance of clinical research, the PRCTRC leadership has adopted multiple measures that will require collaboration from the users and visitors of the Clinical facilities at ALL TIMES. Although this plan proposes changes for specific periods of time, it is very possible that we will live under these circumstances for the next 18 or 24 months.

The specifics of this plan have been developed taking into account unique aspects of the PRCTRC Clinical Research facilities:

  1. As previously mentioned, the PRCTRC’s first and foremost priority is the protection of our participants and our staff. We must adopt changes that limit the number of participants and individuals at any one time in our facility and provide measures to minimize the risk of contagion at all times.
  2. The PRCTRC is an NIH-supported program with the ultimate mission to advance clinical and translational research across the Island of Puerto Rico. Our main objective is to increase the number of independent investigators in clinical and translational research in areas relevant to our population.  This is accomplished by providing support to investigator-initiated research studies, including NIH-funded, other independently-funded investigator-initiated studies, and pilot (early development) studies.  As a secondary objective, it also provides support to other types of clinical and translational research studies.   To continue accomplishing our aims, we must give priority to studies that are aligned with our principal goals and objectives.
  3. The support of clinical research studies in the PRCTRC facilities usually involves the presence of multiple individuals at the same time, and activities that take place in areas with limited space. This limits the ability to maintain social distancing requirements and appropriate contact preventing measures, posing a risk for participants, staff members, and investigators.  This will require limiting times and number of people at any one time and implementing measures for distributing time and space among investigators and studies that will comply with the COVID-19 protection guidelines.
  4. Because of the COVID-19 emergency, the support personnel from the UPR Medical Sciences Campus has been reduced significantly. This has resulted in that our facilities are not receiving adequate support for proper disinfection and cleaning from the institutional services.  This implies that the PRCTRC support staff has to dispose of all the trash, clean and disinfect all the areas used during the participants’ interactions, prior to and after the clinic is completed.  This implies that access to the PRCTRC facilities has to be ALWAYS under the supervision of the PRCTRC staff.  Access to the PRCTRC facilities will be allowed ONLY IF there is PRCTRC personnel present; unsupervised use of the facilities will not be allowed.
  5. During the COVID emergency, clinical care facilities have priority on the availability of Personal Protective Equipment (PPE) over research facilities or research programs. The PRCTRC has limited supplies of PPE and available supplies have been acquired to protect our personnel. We can only offer a limited amount of PPE to our investigators; therefore, it is recommended that investigators bring their own supply of PPE to be used by them and their staff. If supplies become critically low, we may not be able to provide support to studies that do not bring their own PPE supplies.

tiered approach to classify the types of studies that will receive support

 

The availability of the PRCTRC services during the COVID emergency will be implemented in different phases, following the development of the COVID epidemic, the changes in established directives, and the compliance exhibited by users.  The PRCTRC leadership will determine 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.

 

Phase 1 March 16 -27

  • One day per week clinic
  • Only urgent interventions
  • Participants who need medications
  • Participants who need evaluation for investigational drug side effects.
  • Only one to two participants scheduled per clinic (no companions allowed unless strictly necessary; e.g. underage or disabled participants)
  • One to two research staff members (investigator and one coordinator/research assistant) per clinic
  • VULNERABLE INDIVIDUALS should NOT visit the Research Center (elderly individuals, individuals with serious underlying health conditions, including high blood pressure, chronic lung disease, diabetes, obesity, asthma, and those whose immune system is compromised such as by chemotherapy for cancer and other conditions requiring such therapy).
  • Only essential staff members will work to provide clinical services.
    • Program Director
    • Program Administrator
    • One Research Nurse (rotation based)
    • One Medical Technologist (when needed; rotation based)
  • The rest of the staff members will follow stay at home directives.
  • All individuals (staff members, investigators, coordinators, and participants) are required to submit to screening prior to accessing the facilities (temperature and screening questions).
  • Personal protective equipment: at a minimum the use of a mask is recommended to enter the PRCTRC facilities.
  • Social distancing is required.
  • Only clinical services are provided at the Center; access to the Computer Cluster is not allowed.
  • The dental room is closed. No access to the dental area is allowed.
  • The PRCTRC staff will disinfect nursing counters, waiting area chairs, entrance doors, and other areas prior to, and after the clinic is completed.
  • All research staff members are encouraged to disinfect the things they use during their research activities (e.g. research binders, equipment, working station surface, and others)
  • PRCTRC leaders will evaluate performance and risk, and make changes for the next phase.

 

Phase 2 March 31- April 30

  • We will hold two to three clinics per week
  • Priority will be given to treatment and intervention studies
  • Vaccination studies, medication and follow-up evaluations
  • Three to four participants scheduled per clinic (no companions are allowed unless strictly necessary; e.g. underage or disabled participants)
  • One to two research staff members (investigator and one coordinator/research assistance) per clinic
  • VULNERABLE INDIVIDUALS (elderly individuals, individuals with serious underlying health conditions, including high blood pressure, chronic lung disease, diabetes, obesity, asthma, and those whose immune system is compromised such as by chemotherapy for cancer and other conditions requiring such therapy)  should NOT visit the Research Center.
  • Only essential staff members will provide on-site, in-person clinical services.
    • Program Director
    • Program Administrator
    • One or two Research Nurses, as needed (rotation based)
    • Medical Technologist (when needed; rotation based)
  • The rest of the staff members will perform remote activities (work from home)
  • All individuals (staff members, investigators, coordinators, and participants) are required to submit to screening prior to accessing the facilities (temperature and screening questions).
  • Personal protective equipment: the use of a mask is required; gloves are recommended to enter the PRCTRC facilities.
  • Social distancing is required.
  • Only clinical services are provided at the Center; access to the Computer Cluster is not allowed.
  • The dental room is closed. No access to the dental area is allowed.
  • The PRCTRC staff will disinfect nursing counters, waiting area chairs, entrance doors and other areas prior to and after the clinic is completed.
  • All research staff members are encouraged to disinfect the things they use during their research activities (e.g. research binders, equipment, working station surface, and others)
  • PRCTRC leaders will evaluate performance and risk and make changes as needed for the next phase.

 

Phase 3

If you plan to request PRCTRC support please be aware that starting May 4th we will begin PHASE THREE of our PLAN FOR PROTECTION & PREVENTION DURING THE COVID-19 EMERGENCY. Make sure you understand and follow all guidelines and rules.

  • Clinics will be held three to four days per week
  • Treatment and intervention studies will be a priority
  • Investigators who have other types of studies that do not require face-to-face/ in-person visits 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 (no companions are allowed unless strictly necessary; e.g. underage or disabled participants)
  • At any one time, only one to two research staff members (investigator and one coordinator/research assistance) will be allowed per clinic.
  • VULNERABLE INDIVIDUALS (elderly patients, immunosuppressed patients) should NOT visit the Research Center.

PRCTRC staff members will provide services as follows:

Onsite and remote work personnel

  • All individuals (staff members, investigators, coordinators, and participants) are required to submit to screening prior to accessing the facilities (temperature and screening questions).
  • Personal protective equipment: the use of a mask is required; gloves are recommended to enter the PRCTRC facilities. It is recommended that investigators bring their own masks, gowns and face shields, for them and their staff members (Clinical care facilities have priority and the PRCTRC inventory is limited).
  • All individuals are required to maximize physical distancing from others, specially in common areas (e.g., waiting room, nurse counter, halls).  Small areas/rooms, where social distance is difficult, will be used by one person at a time. Congregations and close interactions are discouraged in the PRCTRC facilities. A distance of 6 feet between individuals should be maintained at all times.
  • Health professional-participant interactions and interventions should consider appropriate distancing whenever possible, and the use of personal protective equipment at all time.
  • Service requests should be coordinated with anticipation between the Study Investigator/Coordinator and the PRCTRC leadership (Nursing Supervisor and Program Administrator).
  • Nursing services: reservation based on number of participants, time for each visit, and the needs of other studies
  • Laboratory services: reservation based on tasks needed during each visit
  • Access to Medication Storage: reservation for one person at the time
  • Access to Research Files Room: reservations for one person at the time
  • Access to the Computer Cluster: reservations for one person at the time.
  • Nursing counter: only two persons at the time, one at each corner.
  • The dental area remains closed. Access and use of the dental facilities is contingent to the requirements of the ADA and the UPR School of Dental Medicine guidelines and recommendations.
  • The PRCTRC staff will disinfect nursing counters, waiting area chairs, entrance doors and other areas prior to and after the clinic is completed.
  • All research staff members are encouraged to disinfect the things they use during their research activities (e.g. research binders, equipment, working station surface, and others)
  • PRCTRC leaders will evaluate performance and risk and make changes as needed.

To consider when you are scheduling a visit to the PRCTRC:

Clinical services will be scheduled by periods of time according to the intervention of each study. Each Study Coordinator is required to:

  1. Call the Nursing Supervisor each Thursday to explore availability for the following week and schedule the visit.
  2. Schedule participants’ appointments with enough time between participants visits. Participants should arrive at the PRCTRC facilities one at a time.
  3. Call their participants the day before their appointment for a pre-visit screening. Suggested questions: Do you have or had a fever in the last three weeks? Do you have or had a cough in the past three weeks? Do you have or had breathing problems in the last three weeks? The Coordinator will need to reschedule appointments if necessary, and advice participants to seek medical care.
  4. Instruct each participant to come alone (no companions are allowed unless strictly necessary; e.g. underage or disabled participants)
  5. 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. Waiting should be done at the participants’ private vehicles.
  6. VULNERABLE INDIVIDUALS (elderly individuals, individuals with serious underlying health conditions, including high blood pressure, chronic lung disease, diabetes, obesity, asthma, and those whose immune system is compromised such as by chemotherapy for cancer and other conditions requiring such therapy) should NOT visit the Research Center.

Additional Guidelines:

  • Students will not be allowed in the Center during this period.
  • It is not allowed to stand in front of the counters or hallways to chat or hang around. Communication must be at least 6’ apart or by phone.
  • Waiting areas: during this event, the goal is to have these empty. If each research team receives their participant and escorts them to the assigned treatment room, no one should wait. If needed, the main waiting room will hold a maximum of three persons (or 3 pairs if a companion) at a time, keeping the required distancing. The second waiting area (in front of the rear nursing station) will hold a maximum of two persons, one sitting at each corner.
  • During this period:
  • 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.
  • Access is NOT ALLOWED through the back door (UDH entrance).
  • Any person that refuses to follow the screening process or does not follow directives may be denied access to the Center.

 

Wash HandsHand Wash:

During the COVID-19 pandemic, you should wash your hands frequently; while working at the PRCTRC facilities, you are required to wash your hands:

  • After you have been in a public place and touched an item or surface that may be frequently touched by other people (door handles, tables, gas pumps, shopping carts, or electronic cashier registers/screens, etc.)
  • Before touching your eyes, nose, or mouth because that’s how germs enter our bodies.
  • Before and after caring for a participant
  • After blowing your nose, coughing, or sneezing

Follow five steps to wash your hands the right way:

    1. Wet your hands with clean, running water (warm or cold), turn off the tap, and apply soap.
    2. Lather your hands by rubbing them together with the soap. Lather the backs of your hands, between your fingers, and under your nails.
    3. Scrub your hands for at least 20 seconds. Need a timer? Hum the “Happy Birthday” song from beginning to end twice.
    4. Rinse your hands well under clean, running water.
    5. Dry your hands using a clean towel or air dry them.

When you can’t use soap and water, use hand sanitizer.

(https://www.cdc.gov/healthywater/hygiene/hand/handwashing.html)

 

PHASE FOUR: date and conditions to be determined