Table 1.

How can the ISO 35001 standard be applied to laboratories handling coronavirus disease 2019-related materials?

ISO 35001 components	Considerations for COVID-19 laboratories	Examples of mitigation measures
Organization	Coordinate procurement of appropriate PPE and disinfection supplies Provision of sufficient personnel and financial resources for biorisk management for normal operations as well as for emergency situations Support for the biorisk manager (i.e., biosafety officer or biosafety responsible person) Clearly defined responsibilities and competencies Development and communication of a comprehensive COVID-19 workplace plan, in compliance with latest local/state/national guidance Personnel policies support COVID-19 isolation and quarantine policies and remote work guidance	Explore methods to reuse/recycle masks, PAPR hoods and respirators, if necessary Recruit in house (campus, pharmacy) to produce appropriate disinfectant solutions, hand sanitizers if not commercially available Encourage remote work, when possible, identify additional surge laboratory space and staggered shifts to reduce laboratory density Hire additional personnel, recruit senior year medical/nursing/medical technology, graduate students to staff surge capacity, if available Hire additional clerical help to track and report sample results, inventory, etc. If necessary, provide funding for additional biorisk management staff to provide training, review policies, and SOPs, oversee disinfection of facilities, generate policies such as those for personnel reliability and a whistleblower policy, if not already in place Review leadership communication plan Capitalize on existing trained personnel for BSL-3 containment
Leadership	Guidance and support of the biorisk management committee (i.e., Institutional Biosafety Committee, Biosafety Committee, Research Health and Safety Committee) Demonstrate management commitment to a robust biosafety and biosecurity program Laboratory staff is represented on the biorisk management committee Facilitate availability of financial resources when infrastructure changes or engineering controls need to be made or acquired Identify and communicate emergency policies with all stakeholders (laboratorians, supervisors, environmental services, emergency response, and other interested parties) Facilitate determination and implementation of emergency policies Management commitment to regular safety/biosafety meetings to include laboratory and support staff Ensure that qualified personnel (i.e., biorisk management advisor) are available to review the risk assessment Leadership displays best practices for the workplace (wearing face covers, travel avoidance, and social distancing)	Encourage/fund additional biorisk management committee meetings to address increased activities (risk assessments, protocol reviews, SOP review, etc.). Appoint a senior laboratory staff member to the biorisk management committee Involve HVAC personnel in discussions of engineering control improvements (increasing air changes/hour, adding additional fresh air to ventilation system, changing filters in HVAC to higher MERV ratings, if possible) Increase communication and training for emergency response, firefighters, police, and security personnel Schedule monthly meetings to include laboratory and support staff, encourage participation Recruit other experts (primary investigators, infection control, quality personnel, and industrial hygienists) to help review risk assessments and SOPs Encourage all staff, including directors, managers, supervisors, and laboratory workers to comply with the stated COVID-19 protocols
Planning	Identify, assess, and control the risks of handling various types (swabs, blood, fluids, and sewage) and sources (human, animal, and autopsy) of COVID-19 samples Individual risk assessments must be completed for using novel diagnostic devices and methodologies Structured process for risk assessment to define mitigation measures Provide institutional guidance to users Determine national/international containment guidance (e.g., United States and Canada: BSL-2/ABSL-2, BSL-3/ABSL-3; WHO: core, heightened containment) based upon risk assessment Determine additional training and practices necessary to mitigate identified risks	Provide training on how to perform a risk assessment. Tools include the Association of Public Health Laboratories Risk Assessment Templates,19 and the Canadian Pathogen Risk Assessment Template20 Develop training and additional SOPs for any new engineering controls, equipment, and procedures Confirm completion of bloodborne pathogen training and hepatitis B vaccination for personnel handling human source materials (good practice)
Support	Knowledgeable and competent trainers Pathogen-specific reference document (i.e., Canadian Pathogen Safety Data Sheet) Training for emergency personnel, vendors Verification of technical competency Support for biorisk management consultants if expertise is not available in house Implement policies controlling personnel reliability	If not already in place, designate a senior laboratory staff member to serve as an official trainer, provide train-the-trainer training for this individual, document all SOP and on-the-job training in writing Determine (in writing) what constitutes “competency” before allowing trainees to handle pathogenic material Assemble fact sheet for the pathogen tailored to your institution. Resources include the Canadian Pathogen Safety Data Sheets, the CDC agent-specific summaries included in the Biosafety in Microbiological and Biomedical Laboratories, or other resources Develop and provide relevant training for visitors, vendors, emergency personnel, and custodial/environmental services Recruit experienced biorisk management consultant(s) if additional expertise is needed and cannot be recruited/trained in house
Operations	Standard operating procedures for specimen processing, inactivating, transferring, shipping, and donning and doffing of PPE Facility engineering controls (i.e., airflow check, biosafety cabinet certification, and eyewash station) Centrifuge with aerosol containment Inventory management systems to control access and movement of VBMs and other laboratory reagents based on the biosecurity assessment (i.e., log of samples transferred from high containment) Inventory of inactivated samples Validation of inactivation methods Emergency alert card Quality of reagents used	Purchase additional engineering control equipment, such as centrifuge safety cups and workspace dividers Coordinate for the certification of biosafety cabinets Provide portable handwash stations and eyewash bottles in surge or mobile laboratories Purchase commercially available or develop an in-house inventory system to track VBMs, inactivated samples, and other valuable laboratory reagents Recruit BSL-3 principle investigators to assist in inactivation studies, if necessary Generate a handbook of acceptable inactivation methods, based on in-house studies Work with engineers to evaluate the ventilation system and, if possible, increase the air exchange per hour
Performance evaluation	Document name and location of individuals trained Training evaluation feedback Safety performance included as part of employee evaluation Solicit feedback from laboratory and support staff for improvement (nonpunitive) Biorisk management committee update and feedback Internal and external audits, inspections, or certifications (i.e., self-inspections, laboratory inspections, American Biological Safety Association International Laboratory Accreditation Program, regulatory inspections) Whistleblower policy	Develop a robust training and evaluation program, if not already in place The training program should include feedback opportunities, written documentation of all training, and regular retraining or competency testing Increase communication with the biorisk management committee to include regular updates on laboratory operations, assessments, and review of SOPs and policies Encourage internal and external review of facilities and operations, including policies and SOPs. Encourage laboratory safety officers to perform reciprocal inspections.
Improvement	Reporting/follow-up/root cause analysis for incidents, near misses, accidents Management meetings include discussion of incidents/near misses/accidents Periodic SOP and training review/revision Periodic occupational health follow-up Mental health support	Implement a robust incident follow-up process that requires root cause analysis of all types of incidents and near misses Schedule time during management meetings to discuss safety incidents and near misses as well as inspection findings Schedule annual review of SOPs and policies or more often if procedures change Work with occupational health to develop a program to assess and respond to specific laboratory health concerns (immune suppression, pregnancy, infectious agents handled, vaccination, exposure incidents, stress, etc.). Include the occupational health professional to the biorisk management committee.

ABSL, Animal Biosafety Level; BSL, biosafety level; coronavirus disease 2019, COVID-19; HVAC, heating, ventilation, and air conditioning; PAPR, Powered Air Purifying Respirator; PPE, personal protective equipment; SOPs, standing operating procedures; CDC, U.S. Centers for Disease Control and Prevention; VBMs, valuable biological materials; WHO, World Health Organization.