Biomedical laboratory processes should be safe, with safety reporting assured in every space and place.
Global coordination of biomedical laboratory safety should include representative voices, tied to accountability, so that individual places and spaces are at the table.
Approve the risk assessments through third party review. Most governments, administrations, organizations and healthcare guidance (including WHO) assign the responsibility of Risk Assessments to the Biomedical Laboratories. If there are standards to risk assessments, and standards to operations in laboratory science, a third party should be weighing in on risk. Risk based on animals, vectors and biotissue studied, risk based on diseases studied, risk based on prior and current laboratory professional behaviors, risk based on facility design and risk based on clinical staff are all capable of third party analysis in conjunction with self analysis. Ask facilities and government liaisons what they would like included, edited or considered with risk assessments. Ask them to consider and account for their bias as well.
Standardize the assignment of Biosafety Levels across the world. There is no reason biosafety should be a national or geographic assignment. The diseases do not care about borders, epidemiological response crosses borders, and Biosafety Levels should not be constricted by borders. Ask these countries and laboratory scientists to detail known Biosafety levels in other countries. What are the advantages, disadvantages and concerns? What do these professionals appreciate about others’ level ratings and what can we gain consensus on?
Classify animal science in biomedical laboratories. Type of animal tissue, or type of animal studied on site, should fall into categories for global organization. Importantly, animals in biomedical science are a confusing and wordy contribution to biomedical laboratory safety manuals. Biosafety in the laboratory requires better organization and clarification of animal science in the labs. This improvement may also one day assist in the overall use of animals in medicine, too. Given that animal science is unregulated and, when applied to humans, often contributes to shady scientific data, this improvement is like water in a desert: any amount is desperately needed. Gain insight on biomedical laboratory scientist perspective with animal science definitions, and seek common ground to start moving forward. Incorporate animal science regulation in conversations, and advance the standardization with assertive approach.
Improve biomedical laboratory manuals, worldwide. Inconsistent organization, inconsistent approach and unstandardized priorities communicate that biomedical laboratory safety isn’t as important as it is. Haphazard inconsistencies also communicate that laboratory scientists are either on their own or can do whatever they want to, and the world will just take it. Neither of the previous sentiments are true, so why should miscommunication continue? Details the differences, such as the U.S.’s details on Biosafety Levels [1] and the WHO’s details on containment, control and transport [2]. Be firm with requiring consistency and standardization to Biomedical Laboratory manuals.
Standardize the occupational health regulations and ongoing surveillance. Do not leave surveillance and regulation up to thrifty laboratories. Require occupational health metrics, not plans and risk assessments, to be a reported measure of laboratory science oversight. Follow up with countries and provide global occupational health liaison specialists.
Be specific on country regulation. When specifying that a multi-tiered regulatory approach is used by “many countries”, who are the “many countries”[3]? Why haven’t we detailed regulatory oversight by country? Fund initial and ongoing regulatory reports.
Tier and grade the evidence for the recommendations. Review research lab recommendations in journals and in laboratory reviews [4]. Assign specific groups to get this done, and check in on regular intervals.
Evaluate and improve how biomedical laboratory safety communication, education and improvement is conducted [5]. Assign global health for initial work and national health for ongoing reports. Ask countries about culturally competent data, request their insight and considerations.
Coordinate the accountability of biomedical safety, and use the obvious consequence: financial. How do healthcare reimbursement, medical providers, hospitals and ambulatory care centers account for their participation and ties to laboratories? How do clinical laboratories account for assistance in biomedical research? How do building owners, inspectors, construction and municipalities all take accountability for their ownership of biosafety in laboratories? How do grantors and philanthropists account for contributing to continued poor biomedical safety funding? Request national support for these details. Facilitate global support for alignment. Facilitate support for consistent approach to financial consequence enforcement.
Be specific on credentials, worldwide. There is no longer any excuse for inconsistent expectations of professionals in biomedical research. Facilitate standardization of laboratory and safety specialist education and credentialing.
Be specific on biomedical laboratory credentialing. Why are some biosecurity recommendations in the WHO manual and CDC manual “suggestions” and not requirements? Pivot from suggestions to requirements, in every way possible.
Be clear on inspection and auditors requirements. Report on the audits, and on the risk of auditor bias. Fund auditing, inspections and integrity to the auditing process.
Detail how failure management should occur. Transparent failure management or near miss management not only prevents major issues, it is an added component to geopolitical distrust. When laboratory failures are suspected, and geopolitical discourse results, it would be nice to have the documentation on prior failures and transparency. Fund international coordination on response and reports on responses. Ask countries what they need to ensure proper reporting and requesting.
Detail emergencies and laboratory safety events. Run emergency preparedness drills with global surveillance [6,7,8]. Respond to actual emergencies and events with international collaborations. Detail these responses in reports. Incentivize, do not penalize, self reporters.
It would be nice to have the documentation that no safety events were reported, noted or suspected, or that concerns were reviewed and addressed. Fund international coordination on response and reports on responses. Ask countries what they need to ensure proper reporting and requesting.
Be specific and follow through with consequences. Ask and dialogue with countries to understand this reality.
Fund and reward ongoing process improvement for laboratories and the professional agencies associated with biomedical laboratory safety. Ask facilities or countries what incentives should look like.
Be specific in lists: How many biomedical laboratories and research facilities are in a geographic area? How many professions and professional credentials are leading these facilities? Request the data from national oversight. Request multi-country partnerships to report the facility in their own lists, delineated if duplicated, so that ownership is clear.
Be specific in metrics: How many passes, failures, events, emergency response and reviews are associated with the facility? How many preemptive requests for biosafety reviews were made by the facility itself? How many facilities have zero issues or reports, and how many onsite auditors have visited these facilities to ensure proper process improvement is in place? Ask countries to help take the lead.
Be specific in consequences: what are the financial consequences to noncompliance for the facility? What are the financial consequences to noncompliance for a country? Ask global oversight to take the lead.
1] https://www.cdc.gov/labs/BMBL.html
[2] https://www.who.int/publications/i/item/9789240011311
[3] https://www.who.int/publications/i/item/9789240011311
[4] https://www.nature.com/articles/s41557-019-0375-x
[6] https://www.who.int/initiatives/eios
[7] https://isid.org/surveillance/
[8] https://www.worldbank.org/en/topic/pandemics#1
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