Lab Matters Winter 2023 | Page 32


Piloting the ISO 35001:2019 Standard

By Stormy Chester , specialist , Biosafety and Biosecurity and Michael Marsico , manager , Biosafety and Biosecurity
In November 2019 , the International Organization for Standardization ( ISO ) published the ISO 35001:2019 Biorisk management for laboratories and other related organisations . The 35001 standard marks a significant milestone in the realm of biosafety by promoting a process to identify , assess , control and evaluate biosafety and biosecurity controls within any laboratory . APHL and the US Centers for Disease Control and Prevention ( CDC ) established a cooperative agreement to implement the ISO 35001 standard beginning with two public health laboratories : New Hampshire Public Health Laboratories ( NH PHL ) and Virgina Division of Consolidated Laboratory Services ( VA DCLS ). As the pilot program concludes , APHL is eager to highlight the invaluable experience of these two laboratories and the impact implementing the standard had on the two institutions .
Jill Power , MS Biosafety Officer / Quality Coordinator NH PHL
Implementing the standard into our laboratory improved our safety practices , provided a standardized approach to manage those safety practices , created more participation and interest in our safety culture , and improved our quality management program . This standard brought quality and safety together , and I was hopeful that staff would see the value in it by improving their daily work processes . As part of leadership in the
Jill Power and Michael Stevenson . Photo : NH PHL laboratory , it is important to make staff feel safe working with many different microbes and other potentially infectious materials . Management strives to listen to staff regarding safety concerns . Along with monitoring safe practices , performing risk assessments and measuring safety and quality objectives , implementing the ISO 35001 standard assists in standardizing the approach to assure biosafety concerns are met .
Michael Stevenson , PhD Deputy Laboratory Director NH PHL
One of the most important changes from being involved in this project was our establishing biorisk management ( BRM ) objectives for each calendar year . Through these BRM objectives , we strive to continuously improve the quality of our safety program . Through the pilot program , NH PHL and VA DCLS came together to share resources and experiences of how to implement and sustain the objectives of the ISO 35001 standard . Similar to the APHL Biosafety Peer Network Program , both NH PHL and VA DCLS staff were able to visit the other agency ’ s institution to examine that laboratory ’ s strengths and proficiencies in biosafety and biosecurity . Lessons learned from participating in this pilot project can apply to having a robust and effective chemical hygiene plan , which also is an important component for staff to work safely in the laboratory .
Ellen Basinger Quality and Safety Manager VA DCLS
Involvement in the pilot program allowed VA DCLS to identify strengths and weaknesses in our biosafety and security programs . Having the ISO 35001 standard assessment helped to identify specific elements where there could be improvements in policies and procedures . The standard evaluated five elements :
• Leadership / organization
NH PHL promotes the culture of safety by implementing a staff bulletin board to promote wellness and highlight staff , trainings , laboratory updates and quality , security and safety . Photo : NH PHL
• Personnel
• Risk assessment
• Risk mitigation
• Performance and evaluation .
After receiving the assessment findings and suggestions , VA DCLS was able to create SMART objectives to define what needed to be improved and how to reach the end goal . The program not only provides laboratory support , but also mentors and experienced individuals to help throughout the journey . The program not only helped improve the laboratory ’ s biosafety and biosecurity program but also provided the information needed to create new programs . I would strongly recommend laboratories consider participating in this program .
APHL would like to recognize NH PHL and VA DCLS for their exceptional dedication and unwavering commitment to the 2022-2023 CDC / APHL ISO 35001 Pilot Program . APHL will continue to implement this standard and promote the value of ISO 35001 with other public health laboratories in the future . g
This article was 100 % funded with federal funds from a federal program of $ 530,721 . The production of this article was supported by Cooperative Agreement # NU60OE000104 , funded by the US Centers for Disease Control and Prevention ( CDC ). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of , nor an endorsement by , CDC , HHS or the US Government .
30 LAB MATTERS Winter 2023
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