CoVlD-19 (Coronavirus): Risk Mitigation & Response Plans
CoVlD-19 (Coronavirus): Risk Mitigation & Response Plans
As our communities battle COVID-19, CNS Research and Hassman Research Institute, now collectively Apex Innovative Sciences, remain committed to upholding our promises to you in the conduct of your trials and all sites remain open and actively screening new subject and conducting ongoing study visits. Our primary concern is, first and foremost, the safety of study subjects. We continue to prioritize safety of both subject and staff while also maintaining the quality of work we’ve always delivered. To adapt as an organization to what will be our ‘new normal’, we’ve enhanced several over-arching policies including the following in accordance with the current CDC, WHO, FDA and other public regulatory guidance, until further updates are provided by government agencies:
• Apex is actively practicing symptom recognition and monitoring.
• The incoming and outgoing schedule is staggered to limit the number of subjects incoming and outgoing for outpatient visits and/or inpatient stays and discharges.
• Subjects are separated / assigned one subject to a room for the duration of the inpatient stay (each subject has access to a television in the assigned room). Additionally, social distancing is practiced during mealtimes.
• When scheduling and again when confirming (the day prior) subject visits, subjects are assessed for COVID-19 symptoms via telephone utilizing a short questionnaire developed by our medical team as per CDC guidance.
• Additionally, subjects are temperature monitored prior to entry into the site provided transportation vehicle. Self-transported subjects are temperature monitored upon arrival to the facility and prior to admittance to the inpatient unit.
• Any subjects labeled “at-risk” or responding “yes” to the questionnaire developed by our medical team will not be scheduled, admitted in the transportation vehicle, or any Apex facility until cleared by our medical team.
• Visitors such as subjects, hospital visitors, monitors or sponsors will be asked to complete a brief Visitor Intake Form per CDC guideline.
• We are taking temperatures at the beginning of each shift for all staff. Additionally, subjects and visitors must allow for their temperatures to be taken prior to being allowed to stay at the facility.
• Any staff or visitor with a temperature of 100.40 F or greater or responding “yes” to the questionnaire developed by our medical team will not admitted to any Apex facility until cleared by medical team and/or their primary care physician.
• Nursing staff monitors temperatures and signs or symptoms of COVID-19 for all inpatient subjects daily.
• If any subject has a fever of 100.40 F (or greater) or complains of lower respiratory symptoms, the subject will be required to immediately put on a mask and a physician will be notified. The subject will be isolated to his/her room and vital signs will be collected.
• Each suspected incident will be treated on a case to case basis per local CDC guidelines and medical team advisement. This may include a transfer to an outside facility or hospital per treating physician recommendations.
• The sponsor will be notified by the treating physician/investigator, and/or designee immediately. Standard IRB reporting criteria and guidelines will also be followed.
• All subjects entering or currently participating in trials are provided with educational materials to enhance their understanding to protect themselves from contracting the virus and prevent the spread
• Hand sanitizer is readily available throughout all facilities
• All staff should use hand sanitizer and/or wash hands before and immediately after entering a patient room and after exiting a patient room. Any soiled hands should be washed with soap and water for minimum of 20 seconds per CDC recommendations, not with hand sanitizer.
• Patient contact surfaces (i.e. exam tables, etc.) are wiped with bleach wipes or other sanitizing wipes after each patient.
• All hard surfaces commonly touched (i.e. doorknobs, countertops, etc.) should be wiped regularly (recommended every hour) with bleach wipes or another sanitizing wipe
• Apex is actively practicing social distancing
• Chairs in common areas (such as waiting rooms, etc.) are separated by the recommended 6-feet distances. Additionally, Apex facilities have access to several waiting and exam rooms throughout the facility to further mitigate the need for subject proximity to each other.
• Weekly management meetings to provide a forum to communicate any CDC guidelines and / or staff challenges or concerns.
• Sites will conduct trials, as always, per original FDA guidelines as well as newly released FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.
• COVID-19 Risk Mitigation & Response Plans implemented and effective
• Sites have the capability for remote assessments, telemedicine and/or virtual visits
• Increased number of potential subjects and referral sources contacting sites
• The incoming and outgoing schedule is staggered to limit the number of subjects incoming and outgoing for outpatient visits and/or inpatient stays and discharges.
• Subjects are separated / assigned one subject to a room for the duration of the inpatient stay (each subject has access to a television in the assigned room). Additionally, social distancing is practiced during mealtimes.
• When scheduling and again when confirming (the day prior) subject visits, subjects are assessed for COVID-19 symptoms via telephone utilizing a short questionnaire developed by our medical team as per CDC guidance.
• Additionally, subjects are temperature monitored prior to entry into the site provided transportation vehicle. Self-transported subjects are temperature monitored upon arrival to the facility and prior to admittance to the inpatient unit.
• Any subjects labeled “at-risk” or responding “yes” to the questionnaire developed by our medical team will not be scheduled, admitted in the transportation vehicle, or any Apex facility until cleared by our medical team.
• Visitors such as subjects, hospital visitors, monitors or sponsors will be asked to complete a brief Visitor Intake Form per CDC guideline.
• We are taking temperatures at the beginning of each shift for all staff. Additionally, subjects and visitors must allow for their temperatures to be taken prior to being allowed to stay at the facility.
• Any staff or visitor with a temperature of 100.40 F or greater or responding “yes” to the questionnaire developed by our medical team will not admitted to any Apex facility until cleared by medical team and/or their primary care physician.
• Nursing staff monitors temperatures and signs or symptoms of COVID-19 for all inpatient subjects daily.
• If any subject has a fever of 100.40 F (or greater) or complains of lower respiratory symptoms, the subject will be required to immediately put on a mask and a physician will be notified. The subject will be isolated to his/her room and vital signs will be collected.
• Each suspected incident will be treated on a case to case basis per local CDC guidelines and medical team advisement. This may include a transfer to an outside facility or hospital per treating physician recommendations.
• The sponsor will be notified by the treating physician/investigator, and/or designee immediately. Standard IRB reporting criteria and guidelines will also be followed.
• All subjects entering or currently participating in trials are provided with educational materials to enhance their understanding to protect themselves from contracting the virus and prevent the spread
• Hand sanitizer is readily available throughout all facilities
• All staff should use hand sanitizer and/or wash hands before and immediately after entering a patient room and after exiting a patient room. Any soiled hands should be washed with soap and water for minimum of 20 seconds per CDC recommendations, not with hand sanitizer.
• Patient contact surfaces (i.e. exam tables, etc.) are wiped with bleach wipes or other sanitizing wipes after each patient.
• All hard surfaces commonly touched (i.e. doorknobs, countertops, etc.) should be wiped regularly (recommended every hour) with bleach wipes or another sanitizing wipe
• Apex is actively practicing social distancing
• Chairs in common areas (such as waiting rooms, etc.) are separated by the recommended 6-feet distances. Additionally, Apex facilities have access to several waiting and exam rooms throughout the facility to further mitigate the need for subject proximity to each other.
• Weekly management meetings to provide a forum to communicate any CDC guidelines and / or staff challenges or concerns.
• Sites will conduct trials, as always, per original FDA guidelines as well as newly released FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.
• COVID-19 Risk Mitigation & Response Plans implemented and effective
• Sites have the capability for remote assessments, telemedicine and/or virtual visits
• Increased number of potential subjects and referral sources contacting sites
Shawna Cote, M.S.
Chief Compliance Officer
Apex Innovative Sciences, Inc
Chief Compliance Officer
Apex Innovative Sciences, Inc
