Following our Part 1 summary of considerations critical to resuming operations of life science businesses, Part 2 of our analysis focuses on safe workplace practices, additional privacy considerations, quarantine protocols, transportation/commuting, travel considerations, engineering controls, cleaning/disinfection practices and training programs.
Quarantine Protocols and Contact Tracing Technology
The information related to how best manage quarantine requirements as well as how to do contact trace assessments is evolving daily. The CDC’s website is updated regularly with the latest protocols and best practices (CDC guidance).
Since we now know that asymptomatic persons are able to spread the virus via community transmission, contact tracing applications are actively being developed to help public health officials and government entities to determine interactions that an infected person may have had with others before becoming symptomatic. These apps aim to track an employee’s movements and interactions if a healthy person subsequently contracts the virus. This technology has serious privacy concerns but dramatically reduces the need for rigorous social distancing requirements in the absence of a vaccine.
Google and Apple have announced a joint effort to enable the use of Bluetooth technology to help governments and health agencies reduce the spread of the virus, with user privacy and security central to the design. They have published several documents that explain the privacy concerns and their approach to resolving those issues. The notice can be found here: Google Apple Contact Tracing.
A Wired Magazine article discusses the various apps in development (Wired Contact Tracing). Another contact tracing tool would be some form of a chip or bar code embedded in work badges. Again, there are privacy issues associated with this option that are still being explored. These issues relate to HIPAA medical privacy issues, and the right of employees to confidentiality of their medical information. The “minimum necessary” concept referred to in Part 1 should be incorporated into any tracking program. Because of the extraordinary circumstances of the global health emergency these options are being given serious consideration. Businesses will need to review the available information and make informed decisions that best suit their models.
Employee Policies and Procedures
The CDC has provided guidance in order to help companies to determine the need for alternative sick leave policies that are not punitive and much more flexible in consideration of the new pandemic environment. This includes the need to quarantine newly symptomatic employees.
Develop Policies and Procedures for Prompt Identification and Isolation of Sick People, if Appropriate
- Prompt identification and isolation of potentially infectious individuals is a critical step in protecting workers, customers, visitors, and others at a worksite.
- Employers should inform and encourage employees to self-monitor for signs and symptoms of COVID-19 if they suspect possible exposure.
- Employers should develop policies and procedures for employees to report when they are sick or experiencing symptoms of COVID-19.
- Where appropriate, employers should develop policies and procedures for immediately isolating people who have signs and/or symptoms of COVID-19, and train workers to implement them. Move potentially infectious people to a location away from workers, customers, and other visitors. Although most worksites do not have specific isolation rooms, designated areas with closable doors may serve as isolation rooms until potentially sick people can be removed from the worksite.
- Take steps to limit spread of the respiratory secretions of a person who may have COVID-19. Provide a face mask, if feasible and available, and ask the person to wear it, if tolerated.
- If possible, isolate people suspected of having COVID-19 separately from those with confirmed cases of the virus to prevent further transmission—particularly in worksites where medical screening, triage, or healthcare activities occur, using either permanent (e.g., wall/different room) or temporary barrier (e.g., plastic sheeting).
- Restrict the number of personnel entering isolation areas.
- Protect workers in close contact with (i.e., within 6 feet of) a sick person or who have prolonged/repeated contact with such persons by using additional engineering and administrative controls, safe work practices, and PPE.
Develop, Implement, and Communicate about Workplace Flexibilities and Protections
- Actively encourage sick employees to stay home.
- Ensure that sick leave policies are flexible and consistent with public health guidance and that employees are aware of these policies.
- Talk with companies that provide your business with contract or temporary employees about the importance of sick employees staying home and encourage them to develop non-punitive leave policies.
- Do not require a healthcare provider’s note for employees who are sick with acute respiratory illness to validate their illness or to return to work, as healthcare provider offices and medical facilities may be extremely busy and not able to provide such documentation in a timely way.
- Maintain flexible policies that permit employees to stay home to care for a sick family member. Employers should be aware that more employees may need to stay at home to care for sick children or other sick family members than is usual.
- Be aware of workers’ concerns about pay, leave, safety, health, and other issues that may arise during infectious disease outbreaks. Provide adequate, usable, and appropriate training, education, and informational material about business-essential job functions and worker health and safety, including proper hygiene practices and the use of any workplace controls (including PPE). Informed workers who feel safe at work are less likely to be unnecessarily absent.
Mass Transit and Public Transportation Considerations:
- Give strong consideration to extending telecommuting and work from home options for any roles that can be accomplished remotely.
- Give strong consideration to implementing flexible work hours, and possibly rotating work days (including non-traditional days) in order to allow employees to use public transportation during non-peak hours/days.
- Encourage employees who must use public transportation to wear a mask at all times while in public and comply with social distancing requirements as much as possible.
Social Distancing Considerations:
- Arrange offices such that a 6 foot distance is maintained between employees.
- Implement flexible work hours in order to achieve social distancing goals. Reduce employee density during a given shift.
- Limiting meeting sizes to not more than 10 individuals based on the physical space available in the conference room. Discourage “cafeteria or hallway” meetings.
- Discontinue operations of on-site fitness centers and gyms.
- Evaluate the arrangement of tables in cafeterias and break areas. Modify to comply with social distancing standards.
- Evaluate cafeteria operations related to self-service salad bars, sandwich bars, beverage coolers and other self-service stations. Determine if the cafeteria operations can be altered to a full service alternative, or if operations should be suspended. If so, how will employees be accommodated for meal times?
Employee Safe Work Place Policies:
Employers should prominently display safe workplace practices. Most effective may be infographics as bulletin board postings. Here are several recommended notifications from the CDC guidance.
As appropriate, all employers should implement good hygiene and infection control practices, including:
- Promote frequent and thorough hand washing, including by providing workers, customers, and worksite visitors with a place to wash their hands. If soap and running water are not immediately available, provide alcohol-based hand rubs containing at least 60% alcohol. Hand sanitization stations in entries and public areas.
- Encourage workers to stay home if they are sick.
- Encourage respiratory etiquette, including covering coughs and sneezes.
- Provide customers and the public with tissues and trash receptacles.
- Discourage workers from using other workers’ phones, desks, offices, computers, mouse, keyboards or other work tools and equipment, when possible.
- Infographics suitable for posting are available both at the CDC and the World Health Organization (WHO COVID 19 Infographics).
All employers should consider eliminating all non-essential travel for the foreseeable future. If essential travel is required, travelers should regularly check CDC travel warning levels at: www.cdc.gov/coronavirus/2019-ncov/travelers.
With the risk of community transmission, individual travelers should consider the current outbreak statistics for the city they are considering traveling to.
Some types of travel (bus, plane, train) may require sitting next to others for a period of time. Travel may also expose the employee to new parts of the country with differing levels of community transmission. And, if the employee is infected, his/her travel may put others at risk– along the way, at the destination, and when they return home.
If employees must travel, consider the following risks they might face, depending on what type of travel is planned:
- Air travel: Because of how air circulates and is filtered on airplanes, most viruses and other germs do not spread easily on flights. However, there may be a risk of getting COVID-19 if the employee is seated within 6 feet of someone who has the virus.
- Bus or train travel: Sitting or standing within 6 feet of others for a prolonged period of time can put the traveler at risk of getting or spreading COVID-19.
- Car travel:The stops needed along the way could put the traveler in close contact with others who could be infected.
Engineering and Facility Controls
Engineering controls involve isolating employees from work related hazards. In workplaces where they are appropriate, these types of controls reduce exposure to hazards without relying on worker behavior and can be the most cost-effective solution to implement. Engineering controls for SARS-CoV-2 include:
- Installing high-efficiency air filters.
- Increasing ventilation rates in the work environment.
- Installing physical barriers, such as clear plastic sneeze guards or lexan partitions between work stations.
- Installing a drive-through window for customer service.
- Specialized negative pressure ventilation in some settings, such as for aerosol generating procedures.
Cleaning and Disinfection – Frequency and Disinfectants
- Focus on high-touch surfaces including phones, remote controls, counters, touchscreens, tabletops, desktops, other work tools (staplers, tape dispensers), desk chairs, door knobs, bathroom fixtures, toilets, keyboards, mice, tablets, monitors, kitchenette areas, shared refrigerators, break room furniture.
- Providing resources and a work environment that promotes personal hygiene. For example, provide tissues, no-touch trash cans, hand soap, alcohol-based hand rubs containing at least 60 percent alcohol, disinfectants, and disposable towels for workers to clean their work surfaces.
- Requiring regular hand washing or using of alcohol-based hand rubs. Workers should always wash hands when they are visibly soiled and after removing any PPE.
- Post handwashing signs in restrooms.
- Maintain regular housekeeping practices, including an increased frequency of routine cleaning and disinfecting of surfaces, equipment, and other elements of the work environment. When choosing cleaning chemicals, employers should consult information on Environmental Protection Agency (EPA)-approved disinfectant labels with claims against emerging viral pathogens (EPA Disinfectant List). Products with EPA-approved emerging viral pathogens claims are expected to be effective against SARS-CoV-2 based on data for harder to kill viruses. Follow the manufacturer’s instructions for use of all cleaning and disinfection products (e.g., concentration, application method and contact time, PPE).
- Consider rotating cleaning agents on a weekly or monthly frequency.
- Routine cleaning should be conducted on a daily frequency. A checklist of items to be cleaned daily, weekly and bi-weekly should be prepared. The checklist should be used and completion recorded by the cleaning personnel.
- Routine Cleaning
- Routine cleaning and disinfection methods are appropriate in particular for those disinfectants claimed as having “limited virucidal activity” (formerly “partially virudical”)
- Positive COVID-19 Case
- Disinfection in addition to routine cleaning, e.g.:
- Alcohol solutions with at least 70% alcohol
- Bleach at minimum concentrations of 1000 ppm
- Disinfectants claimed as having “limited virucidal activity”
- Application according to supplier’s recommendations or in-house procedures
- Manufacturing areas – follow and use only recommended and approved cleaning agents so as to not effect product contact surfaces
- Disinfection in addition to routine cleaning, e.g.:
Businesses will need to disseminate the newly developed policies and procedures via a variety of training methods. Cloud or web-based training modules can be implemented and employees can begin the training process while still in their work-at-home environment. All training programs should include some form of an “Acknowledgement of Understanding” that the employee signs upon successful completion of each module.
Existing and all new employees will require training. Training should focus on the actionable elements and new behaviors that will be required.
Depending on the duration of the pandemic and the rate of infection in the business location, it may be required to conduct periodic refresher training for the workforce.
About Validant: At Validant, our vision is to ensure safe and reliable access to the world’s life-saving healthcare products. As the leading Quality, Compliance, and Regulatory consulting firm, we blend industry expertise with innovation to create custom solutions for companies on the frontier of health. We can help you to structure and implement your COVID 19 Resumption of Business Response plan. If required, we can also help you to develop and implement your infectious disease response plan. For inquiries please contact Stephanie Colotti at firstname.lastname@example.org or email@example.com. Validant is a GHO company.
About the Author: Stephanie Colotti is an industry expert in the area of Aseptic Manufacturing and serves as a Senior Partner with Validant. She has worked in the regulated pharmaceutical and consulting industries for over 30 years. Her background in validation, aseptic parenteral manufacturing, clean room and barrier isolator manufacturing, and delivery of various quality compliance remediation/rescue programs are among her unique qualifications. She can be reached at firstname.lastname@example.org.
Primary sources of information were the CDC, OSHA and WHO guidance documents and COVID 19 websites.
With Validant, I have the opportunity to work with pharmaceutical companies worldwide that are working to positively impact patient health. My skills from 37 years in industry in Quality System Implementation and Quality Remediation are directly applicable to help our clients.
John M. | Validant Managing Partner since 2016
Validant offers win-win solutions for clients and consultants, continually building and maintaining lasting relationships. Their experts in business development and recruiting ensure that subject matter expertise and skill set is matched for the client and the best consultants are placed on the project.
Janet W. | Validant Consultant since 2013
In the spring of 2015, my firm had a significant FDA audit with serious findings concerning sterility assurance and data integrity. We had utilized Validant for a previous engagement successfully. Before the audit concluded, I was already in contact with the Validant team for assistance. I was very impressed by how quickly they orchestrated data integrity audits at all of our 20+ other sites. We then turned to them for assistance with our third-party oversight of our manufacturing operation and quality control laboratories.