Validation of Trust with Laboratory Science
Biomedical laboratory processes should be safe, with quality and quantity to safety reporting.
Global coordination can provide a balanced response, particularly after emergencies that induce confusion and suspicion, and particularly after emergencies tied to reports of suboptimal laboratory management.
Quality
Quality to biomedical laboratory safety can be drastically improved, worldwide. Quality should emphasize third party oversight, improved details in biomedical laboratory safety manuals and consistency across health organization manuals.
* 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 weigh in. Risk, based on animals, vectors and biotissue studies, based on diseases studied, based on prior and current laboratory professional behaviors, based on facility design and based on clinical staff are all capable of third party analysis in conjunction with self analysis.
* 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.
* 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.
* Improve biomedical laboratory manuals, worldwide. Inconsistent organization, inconsistent approach and scattered 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].
* 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.
* 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?
* Tier and grade the evidence for the recommendations. Review research lab recommendations in journals and in laboratory reviews [4].
* Evaluate and improve how biomedical laboratory safety communication, education and improvement is conducted [5].
* 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?
* Be specific on credentials, worldwide. There is no longer any excuse for inconsistent expectations of professionals in biomedical research.
* Be specific on biomedical laboratory credentialing. Why are some biosecurity recommendations in the WHO manual and CDC manual “suggestions” and not requirements?
* Be clear on inspection and auditor requirements. Report on the audits, as well as the risk of auditor bias.
* 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.
* 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.
* Be specific and follow through with consequences.
* Fund and reward ongoing process improvement for laboratories and the professional agencies associated with biomedical laboratory safety.
Quantity
* 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?
* 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?
* Be specific in consequences: what are the financial consequences to noncompliance for the facility? What are the financial consequences to noncompliance for a country?
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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