Consumer Product Testing℠ Company, Inc. (CPT℠) has petitioned the Governor of New Jersey and our NJ legislators providing them our Biosafety and Security Policy. We re-opened our clinical and photobiology laboratories today, June 8, 2020, with the expiration of the Executive Order on June 6th.
We are excited to be restarting studies that were interrupted during this unprecedented time and initiating new clinical and photobiology trials with the additional necessary safety precautions.
CPT℠ has implemented a Biosafety and Security Policy, with the core objective of establishing sustainable safe operations for our employees, and visitors, in response to the COVID‐19 pandemic. Coronavirus Disease 2019 (COVID‐19) is a respiratory disease caused by the SARS‐CoV‐ 2 virus.
CPT℠ based the framework of this policy upon analyzing best practices and guidance from the Centers for Disease Control and Prevention (CDC)¹, Occupational Safety and Health Administration (OSHA)², National Safety Council (NSC)³ and local and state guidance in New Jersey. We have engaged corporate consultants and physicians working in conjunction with our management team in developing continuity planning to provide sufficient resources, training and communication to our employees.
The CDC has indicated that COVID‐19 can cause illness ranging from mild to severe. Symptoms may appear in as few as two days, or as long as 14 days after exposure. People are thought to be most contagious when they are most symptomatic, however, there have been reports of asymptomatic/pre‐symptomatic transmission with this virus. People with these symptoms may have COVID‐19:
- Shortness of breath or difficulty breathing
- Muscle pain
- Sore throat
- New loss of taste or smell
CPT℠ has implemented strict measures as defined in this policy to address to the best of our ability, to limit the exposure to the virus, and the transmission to our employees, visitors and subjects, and will revise our business response plan as needed.
The risks are defined under two categories; occupational and non‐occupational. Nonoccupational risk factors result from actions taken at home and in community settings. Occupational risk is determined by an assessment of an employee’s individual risk factors, presence of chronic medical conditions, or pregnancy; industry type, and the need for contact within 6 feet of people who may be, or suspected to be infected with COVID‐19. Classification of worker risk can be divided into four risk exposure levels: very high, high, medium and lower risk. CPT℠ workers will fall in the lower exposure or medium exposure risk levels.
Infection Prevention Measures
On March 2, 2020 CPT℠ implemented basic infection prevention measures. Training for all employees was performed on CDC recommendations for handwashing, use of Personal Protective Equipment (PPE), sanitizing methods and stay at home measures for the workforce should they become ill. CPT℠ has continually reviewed and assessed our policies, as the COVID‐19 crisis continued. CPT℠ has used appropriate combinations of controls from the hierarchy of controls to limit the spread of COVID‐19, including engineering controls, workplace administrative policies and personal protective equipment (PPE) to protect workers from the identified hazards:
- We have conducted a thorough hazard assessment to determine if workplace hazards are present, or are likely to be present, and determine what type of controls or PPE are needed for specific job duties.
- For those engineering and administrative controls that cannot be implemented or are not fully protective, we have:
- Determined what PPE is needed for workers’ specific job duties.
- Selected and provided appropriate PPE to our staff at no cost.
- Trained our staff on its correct use.
- Cloth face coverings are not considered PPE in a laboratory setting. For that reason, cloth face coverings are not allowed in any laboratory at CPT℠.
Using OSHA’s Occupational Risk Pyramid, we have classified worker exposure to SARS‐CoV‐2 (COVID‐19). Controlling exposure to occupational hazards is a fundamental purpose of this policy. Effective in March 2020, CPT℠ had put into place a sanitization policy that is carried out daily at various time periods throughout the facility. We have developed and employed a workplace reconfiguration plan for the physical distancing of workers and staggered shifts for the avoidance of physical congregating. Additional engineering controls include physical barriers, increasing ventilation (fresh air turnover) rates and altering traffic flow patterns for employees, service technicians and subjects to limit personal contact.
Facilities and Equipment
- We have assessed job hazards for the feasibility of engineering controls.
- We have altered workspaces to maintain physical distancing. Examples include:
- Configuring partitions as a barrier shield.
- Moving payment of subjects to a single cashier.
- Used verbal announcements, signage and visual cues to promote physical distancing.
- Removed/rearranged furniture and laboratory work areas.
We have reviewed the American Society of Heating, Refrigerating, and Air‐Conditioning Engineers (ASHRAE)4 Guidance for Building Operations During the COVID‐19 Pandemic; implementing the following recommendations:
- Ensured ventilation systems operate properly and provide acceptable indoor air quality for the current occupancy level for each space.
- Increased outdoor air ventilation, using caution in highly populated areas. With a lower occupancy level in the building, this increases the effective dilution ventilation per person.
- Disabled demand‐controlled ventilation (DCV) where possible.
- Further open minimum outdoor air dampers (as high as 100%) to reduce or eliminate recirculation. In mild weather, this will not affect thermal comfort or humidity. However, this may be difficult to do in cold or hot weather.
- Improved central air filtration to the MERV‐13 or the highest compatible with the filter rack, and seal edges of the filter to limit bypass.
- Checked filters to ensure they are within service life and appropriately installed.
- CPT℠ has always kept systems running longer hours, 24/7, to enhance air exchanges in the building space.
On March 19, 2020 CPT℠ instituted several health screening policies which remain in effect:
- All employees and visitors have their temperature taken for a Pass/Fail (>100.4) status before they are allowed to enter the building. Should someone fail, they are sent home and provided instructions on the next steps to take.
- Extended telework arrangements to staff members that can perform all essential functions of their position at home. Internal and external meetings are scheduled through our online video and audio system and meetings that cannot be held electronically are scheduled with minimum participation following CDC guidelines for physical distancing and wearing of PPE.
- All employees are provided with combinations of Personal Protective Equipment (PPE) and training on use depending on their job description.
- Employees who have traveled outside of the country, are required to self‐isolate for 14 days in their home, maintain a record of their health status and report those findings to the HR Director on a daily basis.
- Employees who have traveled outside of the state or come in contact with another person who has a suspected/active case are required to self‐isolate for 72 hours or longer, maintain a record of their health status and report those findings to the HR Director on a daily basis.
- Employees who are experiencing signs of illness are sent home to self‐isolate for at least 72 hours. Dependent upon the progression and identification of their illness they are allowed to return to work 72 hours after all symptoms have resolved without the aid of medication. Should an employee experience any signs of illness related to Influenza-Like Illness (ILI) or to COVID‐19 Illness (CLI), CDC recommendations are implemented. The employee is required to self‐isolate until the employee’s symptoms have resolved and are allowed to return to work 72 hours after all symptoms have resolved without the aid of medication.
To ensure continuity of operations of essential functions the CDC advises that critical workers may be permitted to continue work following potential exposure to COVID‐19, provided they remain asymptomatic and additional precautions are implemented to protect them and the community.
A potential exposure means having close contact within six feet of an individual with confirmed or suspected COVID‐19. The timeframe for having contact with an individual includes the period of time of 48 hours before the individual became symptomatic.
CPT℠ critical workers who have had exposure but remain asymptomatic should adhere to the following practices prior to and during their work shift:
- Pre‐Screen for employee’s temperature and assess symptoms prior to them starting work.
- Regular Monitoring of COVID‐19 symptoms.
- The employee should wear a face mask at all times while in the workplace.
- The employee will maintain physical distancing at six feet as work duties permit.
Cleaning and Disinfection
CPT℠ has performed an evaluation of all common areas, offices and laboratories to determine what kinds of surfaces and materials make up that area. Most surfaces and objects will only need normal routine cleaning. Frequently touched surfaces and objects like light switches and doorknobs will be cleaned and then disinfected to further reduce the risk of germs on surfaces and objects.
- First, clean the surface or object with soap and water.
- Then, disinfect using an EPA5 approved disinfectant.
- If an EPA‐approved disinfectant is unavailable, a solution of 1/3 cup of bleach added to one gallon of water, or 70% alcohol solutions may be used to disinfect.
Standard Operating Procedures have been generated for each department to address specific housekeeping standards concerning hard surfaces, equipment and frequently used items by laboratory staff.
We have instituted additional cleaning procedures as follows:
- Routinely clean all frequently touched surfaces in the workplace such as workstations, keyboards, telephones, handrails and doorknobs.
- Provide disposable disinfecting wipes so that employees can wipe down commonly used surfaces (e.g., doorknobs, keyboards, remote controls, desks, other work tools and equipment) before and after each use.
- Store and use disinfectants in a responsible and appropriate manner according to the label.
- Advised employees to always wear gloves and PPE appropriate for the chemicals being used when they are cleaning and disinfecting based on the setting and product.
- Discouraged workers from using each other’s phones, desks, offices or other work tools and equipment when possible.
Performing enhanced cleaning and disinfection after persons suspected/confirmed to have COVID‐19 have
been in the facility. If a sick employee is suspected or confirmed to have COVID‐19, CPT℠ will follow the CDC cleaning and disinfection recommendations:
- Using alcohol‐based (at least 60% alcohol) hand sanitizer when soap and water are not available.
- Always wear gloves and gowns appropriate for the chemicals being used when you are cleaning and disinfecting.
- Wear additional PPE depending on the setting and disinfectant product being used. For each product being used, consult and follow the manufacturer’s instructions for use.
- Clean dirty surfaces with soap and water before disinfecting them.
- To disinfect surfaces use products that meet EPA criteria for use against SARS‐Cov‐2, the virus that causes COVID‐19, and are appropriate for the surface.
- Close off areas used by the person who is sick.
- Companies do not necessarily need to close operations if they can close off affected areas.
- Open outside doors and windows to increase air circulation in the area.
- Wait 24 hours before areas are cleaned or disinfected. If 24 hours is not feasible, wait as long as possible.
- Clean and disinfect all areas used by the person who is sick such as offices, bathrooms, common areas, shared electronic equipment like tablets, touch screens, keyboards, remote controls and ATM machines.
- Vacuum the space if needed. Use vacuum equipped with high‐efficiency particular air (HEPA) filter, if available.
- Do not vacuum a room or space that has people in it. Wait until the room or space is empty to vacuum, such as at night for common spaces or during the day for private rooms.
- Consider temporarily turning off room fans and the central HVAC system that services the room or space so that particles that escape from vacuuming will not circulate throughout the facility.
- Once the area has been appropriately disinfected, it can be opened for use.
- Workers without close contact with the person who is sick can return to work immediately after disinfection.
- If more than 7 days since the person who is sick visited or used the facility, additional cleaning and disinfection is not necessary.
- Continue routine cleaning and disinfection. This includes everyday practices that businesses and communities normally use to maintain a healthy environment.
Personal Protective Equipment
All employees are provided with combinations of the following PPE and training on the use depending on their job description:
- Surgical Masks
- N95/KN95 Face Masks
- Face Shields
- Lab coats
- Safety glasses
- Hair coverings
- Foot coverings
Custodial staff is provided with additional PPE to address their specific work duties for the cleaning and sanitizing of the facility. They include but are not limited to disposable laminate coveralls, chemical resistant gloves and respirators.
- The risk of exposure to cleaning staff is inherently low. Cleaning staff should wear disposable gloves and gowns for all tasks in the cleaning process, including handling trash.
- Gloves and gowns should be compatible with the disinfectant products being used.
- Additional PPE might be required based on the cleaning/disinfectant products being used and whether there is a risk of splash.
- Gloves and gowns should be removed carefully to avoid contamination of the wearer and the surrounding area. Staff must clean their hands after removing gloves.
- If gowns are not available, coveralls, aprons or work uniforms can be worn during cleaning and disinfecting. Reusable (washable) clothing should be laundered afterward. Clean hands after handling dirty laundry.
- Cleaning staff should immediately report breaches in PPE such as a tear in gloves or any other potential exposures to their supervisor.
- Cleaning staff and others should clean their hands often including immediately after removing gloves and after contact with an ill person, by washing hands with soap and water for 20 seconds. If soap and water are not available and hands are not visibly dirty, an alcohol‐based hand sanitizer that contains at least 60% alcohol may be used. However, if hands are visibly dirty, always wash hands with soap and water.
Non‐Occupational Risks and Practices
CPT℠ encourages all staff members to follow CDC guidelines for maintaining a safe and healthy home. We urge our staff to create habits and healthy practices for hygiene and disinfecting their homes to limit their risk of contracting COVID‐19.
We ask that they follow normal preventive actions while at work and home including cleaning hands and avoiding touching eyes, nose, or mouth with unwashed hands.
- Try to avoid close contact with sick people.
- While sick, limit contact with others as much as possible to keep from infecting them.
- If you are sick with flu symptoms, the CDC recommends that you stay home for at least 72 hours after your fever is gone except to get medical care or for other necessities. (Your fever should be gone for 72 hours without the use of a fever‐reducing medicine.)
- Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
- Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based rub.
- Avoid touching your eyes, nose and mouth. Germs spread this way.
- Clean and disinfect surfaces and objects that may be contaminated with germs like the flu.
If you come to work showing symptoms of the flu, we will send you home to recuperate.
Follow Five Steps to Wash Your Hands the Right Way
Washing your hands is easy and it’s one of the most effective ways to prevent the spread of germs. Clean hands can stop germs from spreading from one person to another and throughout an entire community—from your home and workplace to childcare facilities and hospitals.
Additional key times to clean hands include:
- After blowing one’s nose, coughing, or sneezing.
- After using the restroom.
- Before eating or preparing food.
- After contact with animals or pets.
- Before and after providing routine care for another person who needs assistance such as a child.
Follow these five steps every time.
- Wet your hands with clean, running water (warm or cold), turn off the tap and apply soap.
- Lather your hands by rubbing them together with the soap. Lather the backs of your hands, between your fingers and under your nails.
- Scrub your hands for at least 20 seconds. Need a timer? Hum the “Happy Birthday” song from beginning to end twice.
- Rinse your hands well under clean, running water.
- Dry your hands using a clean towel or air dry them.
Use Hand Sanitizer When You Can’t Use Soap and Water
You can use an alcohol‐based hand sanitizer that contains at least 60% alcohol if soap and water are not available.
How to use hand sanitizer:
- Apply the gel product to the palm of one hand (read the label to learn the correct amount).
- Rub your hands together.
- Rub the gel over all the surfaces of your hands and fingers until your hands are dry. This should take around 20 seconds.
- For electronics such as tablets, touch screens, keyboards, remote controls and ATM machines, remove visible contamination if present.
- Follow the manufacturer’s instructions for all cleaning and disinfection products.
- Consider the use of wipeable covers for electronics.
- If no manufacturer guidance is available, consider the use of alcohol‐based wipes or sprays containing at least 70% alcohol to disinfect touch screens. Dry surfaces thoroughly to avoid the pooling of liquids.
Linens, Clothing and Other Items That Go in the Laundry
- In order to minimize the possibility of dispersing virus through the air, do not shake dirty laundry.
- Wash items as appropriate in accordance with the manufacturer’s instructions. If possible, launder items using the warmest appropriate water setting for the items and dry items completely. Dirty laundry that has been in contact with an ill person can be washed with other people’s items.
- Clean and disinfect hampers or other carts for transporting laundry according to guidance above for hard or soft surfaces.
Workplace Controls for Human Clinical Evaluations
Our Clinical Evaluations department is a healthy subject site. Historically, we have conducted approximately 3,500 clinical trials per year to ascertain the safety and/or efficacy of products such as pharmaceuticals, medical devices, cosmetics and specialty chemicals that are submitted to us by our clients. Our consultant doctors include Board Certified dermatologists, ophthalmologists, pediatricians, dentists and gynecologists. Our protocols, Institutional Review Board submissions trial conduct and report development are all overseen by our Principal Investigators.
- CPT℠ has assessed the physical space in which clinical testing is performed and determined the maximum capacity possible when occupants are maintaining physical distancing and has subsequently reduced our subject population allowed to be present in the facility at any one time.
- CPT℠ has installed physical barriers where appropriate to limit contact between subjects.
- CPT℠ has altered traffic flow patterns for subject ingress and egress from the laboratory.
- CPT℠ has employed licensed security officers for 4 years to maintain an orderly flow of subjects in our facility and their presence during all hours of operation for the clinical laboratory will remain in effect. They will ensure subjects remain physically distanced and follow this biosecurity policy.
- CPT℠ had previously instituted appointment times for subjects who visit our clinical laboratory and we have further limited congregation of subjects with the implementation of online and telecom recruitment of subjects.
- Sanitization protocols are in place which will be implemented between subjects.
- We have minimized the number of contact points for subjects during the course of a study visit.
Subjects who wish to participate in clinical trials at our facility must meet the following requirements:
- Prior to your visit, you will be asked a number of questions concerning your general health and you will be required to confirm those answers when you visit the facility. Any subject exhibiting signs of COVID‐19 will not be scheduled for a clinical trial and will be turned away from our facility, should they appear.
- Subjects will be required to arrive at the facility 15 minutes prior to their scheduled time. Personal items other than identification required for participation will not be allowed in the facility. You may be asked to wait in your car until you are called into the building. Please dress appropriately.
- Subjects will not be allowed to have anyone accompany them into the facility for their appointment.
- Subjects will be required to wear masks that meet minimum standards for their protection and the safety of our staff. If the security officers deem that a mask does not meet the minimum standards you will not be allowed in the building.
- Subjects who are scheduled for a trial will have their temperature taken for a Pass/Fail and any subject that fails will not be admitted to the facility.
- Subjects who are admitted into the facility will sanitize their hands prior to entering the laboratory.
- Subjects shall refrain from touching hard surfaces such as doorknobs, counters and benches.
- Subjects will follow all traffic flow patterns established in the building following the visual cues as well as all directions from staff for physical distancing.
- Subjects shall be provided trial documents that need to be read and signed in a container that will be sanitized after each use. Their daily schedule, instructions and additional study paperwork, will be provided in this sealed plastic zip‐lock bag. Each time that subjects arrive for their clinical trial they will return with their trial documents in that sealed plastic zip‐lock bag.
- Subjects shall not loiter in the building but will exit the building immediately upon completion of their trial visit.
CPT℠ is registered with the United States Food & Drug Administration as a testing facility for drug products, medical devices and other regulated items. As such, CPT℠ management and staff maintain compliance with all applicable regulations (cGMP, GLP, GCP, and ISO/IEC 17025:2005).
- Centers for Disease Control and Prevention. CDC Activities and Initiatives Supporting the COVID‐19 Response and the President’s Plan for Opening America Up Again
- Occupational Safety and Health. OSHA 3990‐03 2020 Guidance on Preparing Workplaces for COVID‐19
- National Safety Council. SAFER. Safe Actions For Employee Returns
- American Society of Heating, Refrigerating, and Air‐Conditioning Engineers (ASHRAE) Guidance for Building Operations During the COVID‐19 Pandemic.
- Environmental Protection Agency. List N: Disinfectants for Use Against SARS‐CoV‐2 (COVID‐19)