California Issues COVID-19 Guidance To Life Sciences Employers

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Thanks to new directives from state health officials, life sciences employers in California will need to immediately create and implement a worksite specific plan to address transmission of COVID-19 in the workplace. The California Division of Occupational Safety and Health (Cal/OSHA) and the California Department of Public Health (CDPH) recently issued industry-specific guidance and a general checklist for life science employers as they continue to operate in the midst of a pandemic requiring such a plan and providing additional directives.

Facilities that handle infectious pathogens are tasked with the additional requirement of implementing a Biosafety Plan conforming with explicit criteria set out under the Cal/OSHA-CDPH guidance. Lastly, the guidance recommends instituting additional measures to ensure a safe work environment.

On top of all that, San Diego life science companies will need to comply with additional requirements applicable to all San Diego employers, such as performing daily employee temperature screenings.

Mandatory Worksite Specific Plan

To prevent the spread of COVID-19 in life sciences facilities, Cal/OSHA-CDPH’s guidance requires all life sciences employers prepare, develop and implement a written, worksite-specific plan.

General Plan Requirements

Prior to doing so, however, you must conduct a comprehensive risk assessment at each facility to identify COVID-19 risks and prevention strategies. Examples might include everything from interactions with study participants during clinical trials, to interactions with the public, to safe handling of biological supplies. Among other requirements, the plan must designate a person responsible for implementing the plan, provide adequate training to employees, and be continuously evaluated for compliance. During this time, it is important to remain adaptable and update the worksite plan as circumstances evolve in the coming months.

Plan For Investigations

The guidance requires that the plan provide for prompt investigation of COVID-19 related illnesses and the assessment of work-related factors that may have contributed to the illness. When an employee is diagnosed with COVID-19, you are required to engage in “tracing” by identifying the close contacts of the infected employee and taking affirmative steps to isolate those individuals. You should require infected employees to remain at home for a minimum of 14 days or until cleared by a medical provider.

Biosafety Plan

Research facilities, laboratories, and other locations that handle infectious pathogens and whose operations may disperse pathogens in the air must also implement a written Biosafety Plan. The plan must be administered by your biological safety officer and include the following elements:

  • List of job classifications with exposure to infectious pathogens.
  • List of infectious pathogens known or reasonably expected to be present in laboratory materials and applicable biosafety measures.
  • Procedures to ensure all incoming materials containing pathogens are treated as virulent, until verified as deactivated or attenuated.
  • A risk assessment, performed by the biological safety officer, in accordance with CDC’s Biosafety in Microbiological and Biomedical Laboratories guidelines.
  • Feasible engineering controls including containment equipment and procedures.
  • Required safe work practice controls and prohibited unsafe work practices in accordance with the risk assessment and CDC guidelines.
  • Necessary personal protective equipment (PPE), including respiratory protective equipment.
  • Effective decontamination and disinfection procedures for laboratory surfaces, equipment, and tools.
  • Procedures for communicating hazards to employees and providing required employee training.
  • Emergency procedures for uncontrolled releases in the facility and untreated releases outside the facility.
  • Provision of applicable vaccines to employees.
  • Procedures to investigate and provide medical follow up to employees exposed to laboratory pathogens.
  • Procedures to annually inspect facilities and annually audit the facility’s biosafety procedures.
  • Procedures to record and correct deficiencies found during inspections and audits.

Recommended Actions

Cal/OSHA and CDPH encourage employers to train employees on prevention protocols, proper use of PPE, and, where required, on the facility’s Biosafety Plan. To the extent possible, you should reconfigure spaces including laboratory bench tops to ensure workspaces provide for social distancing. Finally, you should organize and schedule thorough cleanings of the facility and disinfect frequently used surfaces and equipment. When choosing cleaning chemicals, the guidance indicates that you should use disinfects that are effective against viral pathogens and provide training in accordance with Cal/OSHA requirements.

While not unique to the life sciences industry, the Cal/OSHA-CDPH guidance recommends that you provide temperature and/or symptom screenings upon employees return to work. For select California cities and counties, this may actually be required under a public health order. San Diego County is among the first to issue an order, effective May 10, 2020, requiring that essential businesses and reopened businesses conduct a temperature screening of all employees and prohibit employees with a temperature of 100 degrees or more from entering the workplace. You may use symptom screenings but only when a thermometer is not available.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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