Abstract
Introduction:
Institutions implementing a biorisk management system need to establish comprehensive guidance to support the implementation of biosafety and biosecurity practices. A biorisk manual describes how a biorisk management system will be implemented in an organization and includes topics such as facility-specific policies and procedures to safely and securely handle, store, and dispose of biological agents and toxins in adherence with international guidance.
Methods:
To promote the adoption of biosafety and biosecurity in Pakistan, the Pakistan Biological Safety Association and Health Security Partners developed a biorisk manual writing project in 2019 in partnership with experts from the BioRisk Association of the Philippines 2015, Inc. This project helped 13 researchers and laboratory professionals in Pakistan develop biorisk manuals for their institutions. The project comprised two phases: an in-person group training on how to develop a laboratory biorisk manual, and 10 months of additional remote mentoring assistance for the development and finalization of the biorisk manual tailored to each institution's specific needs. By the end of the project, 12 of the 13 participants had customized biorisk manuals for their institutions in place. In January 2022, a survey was conducted among the workshop participants to learn how successful they were in implementing the developed manual in their institutions.
Results:
Participants reported varying degrees of successful implementation. They also suggested that the biosafety and biosecurity associations should engage top management at institutions to strengthen administrative support and provide a sufficient workforce to promote implementation.
Introduction
The effective management of safety and security risks posed by working with infectious organisms and toxins in laboratories is known as “biorisk management (BRM).” For consistent outcomes, improved productivity, and continuous improvement, the risks identified after a thorough risk assessment must be handled by using a management system approach. This necessitates the development of a biorisk management system in every relevant facility.
A biorisk management system, similar to any other system, needs an institution to maintain documented information to the level necessary to support the operations. These documents are specific to the facilities and are developed based on the results of risk assessments and mitigation measures identified, as well as the needs and scope of the organization. There are three basic categories for these documents
1
:
Process information, such as standard operating procedures (SOPs) for best practices in biosafety and biosecurity. Records of training, incidents/accidents, and immunization, risk assessments, Institutional Biosafety Committee (IBC) reports, etc. Operational documents such as a biorisk manual, biorisk policies, and so on that are developed to support implementation.
Records are evidence of the outcomes of numerous operations carried out in an organization, whereas SOPs are stand-alone documents that cover certain practices in detail, with only necessary references to other documents in the organization. Owing to the stand-alone nature of SOPs and records, it is essential to develop operational documents that integrate all different components of biorisk management for better management of risks, analyzing gaps, finding areas of improvement, and shaping a proper system.
A biorisk manual documents the foundational elements of a biorisk management program and communicates them to all relevant stakeholders. It also acts as facility-specific guidelines for anything from policies to safe and secure work practices. The development of a biorisk manual is included in the implementation step of the biosafety program management cycle in the World Health Organization 4th edition of the Laboratory Biosafety Manual's monograph “biosafety programme management.” 2
Depending upon the complexity of the organization, the biosafety manual can be a part of a general safety manual, can be a separate manual, or it can be a separate manual that is specific to individual laboratories. Operational working practices and SOPs can be included in the general safety manual, included in the biosafety manual, or can be standalone laboratory specific documents. 2
It is critical to maintain proper documentation and effectively communicate it to all key stakeholders to ensure a strong foundation for the implementation of biorisk management in all laboratories.
Pakistan has made significant progress in the development and strengthening of its biosafety and biosecurity capacity due to the commendable efforts on the part of national leadership to promote a culture of biosafety and biosecurity3,4; however, further endeavors are required to advance Pakistan's biorisk management capabilities. 5 One of the most urgent needs identified was the development of a standardized biorisk manual for Pakistan's research and diagnostic laboratories. In a survey conducted in 2012 in Karachi, Pakistan, only 13 out of the 250 laboratories surveyed had approved biosafety manuals. 6 In another study conducted at 20 laboratories, 60% of laboratory staff indicated that they did not have a biorisk manual. 7
To address these gaps, Pakistan Biological Safety Association (PBSA) and Health Security Partners (HSP) developed a biorisk manual writing project in 2019 with the help of experts from BioRisk Association of the Philippines 2015, Inc. (BRAP2015). The purpose of the project was to train people to develop biorisk manuals for their organizations under the supervision of international and national experts.
This project was designed to allow participants to understand the need for a biorisk manual that is customized to their institution, and examine national policy and international guidelines and standards that provide the framework for the institutional biorisk manual. Possible ways to gain institutional leadership support for the development and implementation of the biorisk manual, as well as bring together institutional stakeholders to jointly develop a laboratory biorisk manual encompassing biosafety, biosecurity, and dual-use research of concern (DURC), that is, biorisk management
Methods
The project was initiated in December 2019 with a team of experts from PBSA, HSP, and BRAP2015. The biphasic project for the development of the biorisk manual had an in-person training portion, and a remote secondary manual development phase where participants were mentored online. The participants in the study gave their informed consent to publish.
Phase I
In the first phase, a 3-day Biorisk Manual Writing Workshop (Writeshop) was conducted in Colombo, Sri Lanka in February 2020. The participants were invited to apply for this workshop through an online application form.
Eligibility for Application
To be considered for this workshop, applicants were required to be laboratory professionals working in a Biosafety Level 2 (BSL-2) or BSL-2+ clinical diagnostic, or research laboratory, and in a position to immediately implement the developed biorisk manual in their laboratories. The online application was specifically designed to include questions about past training in biosafety and biosecurity, the presence of biorisk manuals in their institutions, and their expectations of this workshop.
Participant Selection
Participants were selected based on their potential ability to get leadership buy-in and engagement in the process of the development and subsequent implementation of the biorisk manual. The institutions selected ranged from diagnostic and research laboratories wanting to improve their existing biorisk manuals, to institutions that did not have a biorisk manual in place.
Training Content
During the workshop, participants were trained on how to develop a biorisk manual for their laboratories that adhere to Pakistan's National Laboratory Biosafety and Biosecurity Policy 8 and international standards and guidelines.1,9,10 The training started with an introduction to the National Laboratory Biosafety and Biosecurity Policy, which outlines the biorisk management expectations at the institutional level in Pakistan.
In addition, participants learned about avoiding plagiarism and the importance of creating a customized and specific manual for each of their laboratories based on their risks. Because the workshop participants were from a variety of backgrounds and with varying levels of training, an overview of laboratory biosafety and biosecurity elements, biological risk assessment, mitigation, performance model, the BRM Strategy framework, DURC, and the newly released International Organization for Standardization 35001 standard 1 for biorisk management were presented to refresh participants before they began writing their manuals.
At the end of day 1, participants were given an assignment to write and assemble their institution's profile, biosafety and biosecurity principles, and the BRM process. Participants who did not have a biorisk management program in place were given the task of developing a biorisk management profile for their institution. These data were intended to be used in the following day's tasks.
On day 2, facilitators discussed the main components of a biorisk manual and assigned participants to plan the manual's basic elements and components, as well as benchmarking against references. Basic concepts of biopreparedness, incident management, decontamination and sterilization, transport of valuable biological materials, and how these aspects of biorisk management must be added to the manual were covered in the sessions. Participants were asked to compile the table of contents of the manual at the conclusion of the day and present it to the group on day 3.
On the third day, all participants made presentations to the group and facilitators about their table of contents. The next session focused on how multiple stakeholders might be brought together to form a working group in their organization, gain leadership buy-in, and how to apply the biorisk manual in their institutions after this workshop. After this discussion, referencing styles, biorisk manual documentation, record keeping, review, and retention were discussed. The facilitators also covered the most common mistakes usually made during writing a biorisk manual, as well as how to avoid them during the writing process.
At the end of day 3, participants devised a plan for Phase II of the project, during which they would develop a biorisk manual under the supervision of national experts, based on the table of contents developed during the workshop. At the conclusion of the workshop, the following aspects of the workshop were evaluated:
Did the workshop accomplish its goals?
What was the workshop's impact?
How effective was the workshop process?
How would participants apply information and experience obtained during this workshop at their institutions?
A set of questions with a Likert-type rating scale ranging from 1 (strongly disagree) to 5 (strongly agree) were used to evaluate each of these aspects.
Phase II
After the in-person training, participants were mentored for 10 months through online meetings to develop a biorisk manual for their laboratory and finalize it with their stakeholders and leadership. The table of contents, which was developed in Phase I, was broken down into three sections, and participants were given a specific amount of time (up to 8 weeks) to complete each section and submit it for review. For each section, independent national subject matter experts examined the submissions and provided feedback and suggestions for improvement. They made sure that the content is technically correct, properly organized and detailed in the manner required to fulfil the needs of end users.
These experts were chosen based on their biorisk management credentials (PBSA master trainer, International Federation of Biosafety Associations certified biosafety professional, and so on), experience developing a biorisk management system, experience drafting a biorisk manual for their institution, and availability to review the submissions. Participants were instructed to revise their work considering the reviewer's suggestions and resubmit it for a final review.
In January 2022, a survey was conducted among the workshop participants to learn how successful they were in developing and implementing the manual, and to learn about what obstacles they had encountered at different stages of the biorisk manual development and implementation.
Results
Eighty-eight laboratory and healthcare experts completed the application form for participation in this project; 68% of these applicants said that their institutions lacked a biorisk manual. Most candidates (75%) had previous biosafety and biosecurity training.
A group of 13 people were chosen from 13 different institutes [diagnostic (
During the Writeshop, participants discussed the relevance, components, and execution of a biorisk manual in the local context, and they created their own table of contents for their manual. The following commonalities were seen in all the participants' final versions of the table of contents. The technical portion of the handbook began with a list of emergency contact numbers to make information more available to people who would be using it. After that, the institutional profile, goal, scope, biorisk policy or its explanation, and roles and duties of various individuals within their organization were described.
The section on the risk assessment outlined the organization's particular risk assessment requirements and guidelines. Next followed several chapters addressing risk control measures that must be followed in that organization, such as decontamination, primary and secondary barriers, biological waste management, movement of biological materials, administrative controls, and emergency response protocols. The third component of everyone's manual addressed responsible conduct of research (for the research institutions), as well as audits and inspections for enhancing organizational performance in biorisk management. Material and pathogen safety data sheets, as well as appendices, were also included at the conclusion of the document.
The workshop evaluation showed that participants strongly agreed that the workshop enabled them to understand the need to develop a biorisk manual that is customized to their laboratories (92%), group discussions, and exercises were helpful in developing a path forward to develop biorisk manuals (85%), speakers/facilitators demonstrated subject matter expertise and contributed to the workshop's effectiveness (85%), and the workshop provided networking opportunities between institutions (100%). The rest of the responses on achieving the workshop objectives and foreseeing the application of the manual at the end of the 3-day workshop are given in Table 1.
Responses on achieving the workshop objectives and foreseeing the application of the manual at the end of the 3-day workshop
DURC, dual-use research of concern.
Twelve of the 13 workshop participants used the table of contents made during the in-person workshop to develop and finalize their biorisk manuals for their laboratories during the 10 months allotted to Phase II, with assistance from a team of experts from PBSA and HSP through webinars and online meetings.
In January of 2022, a survey was conducted to assess the implementation of the biorisk manual and to identify any obstacles to its implementation. The survey consisted of seven questions (Table 2) and written responses from participants.
Responses to the survey about the status of the biorisk manual implementation
In response to a question “what were the major challenges or obstacles, you faced during the implementation of the biorisk manual,” one of the most prevalent reasons mentioned by the participants for failing to completely develop or implement this manual was their inability to devote enough time and effort to developing and/or implementing this manual due to workload. The other prevalent reasons provided by participants for not being able to fully implement this manual were a lack of commitment from various tiers, leading to low compliance and insufficient administrative controls. Participants also advised holding seminars with upper management, as evidenced by the following comment:
By doing small one or two regional workshops with the higher-ups of the most active institutions. People from the institutional upper management need awareness in order to become supportive for the biosafety related people. Similarly, if people from provincial government are given some awareness, they can direct the institutions to take steps accordingly.
Discussion
PBSA has developed a local cadre of laboratory professionals and researchers in Pakistan with a solid understanding of biosafety and biosecurity during the past few years, through its training and capacity-building programs. PBSA has trained 1104 professionals from 258 universities since 2014. 11 In addition to training, Pakistan has developed resources that explain biorisk management in the local context.12–15 When compared with studies conducted a few years ago,16,17 current studies7,18 show that people are now more aware of biosafety.
Contributions from PBSA and several international organizations, including HSP, have greatly impacted biosafety and biosecurity awareness; however, these studies also revealed a substantial deficiency in terms of documentation and implementation.7,16 The goal of this workshop was to take the next step in translating biosafety and biosecurity awareness into skill building efforts at the institutional level in Pakistan during and after the COVID-19 pandemic. This workshop was an important step toward bolstering a safer response to the COVID-19 epidemic.
Having a customized biorisk manual would not only allow these laboratories to implement biosafety and biosecurity, but it will also serve as a reference document for all important stakeholders in these organizations. A laboratory biorisk manual, similar to an equipment manual, details the complete operation of a biorisk management system by integrating its various components, including troubleshooting, maintenance, and service 19 ; therefore, maintaining an up-to-date manual that all workers follow is crucial for guaranteeing laboratory biosafety and biosecurity.
A biorisk manual alone cannot guarantee the implementation of biorisk management. It must be effectively communicated to all laboratory personnel. Furthermore, the guidance outlined in this manual must be properly enforced by the leadership's commitment, as well as supported by biosafety officers and an IBC.
By the end of the project, 12 of the 13 institutions who took part in the Writeshop had customized biorisk manuals in place. During Phase II, reviewers assisted participants in improving the content's quality and accuracy, as well as its organization and details. The next steps include internal reviews and improvements to the manual on an ongoing basis in addition to keeping leadership engaged.
The project also accomplished the important goal of international biosafety associations (Pakistan and Asia) coming together to share training programs and experiences to bolster biosafety and biosecurity capacity. The project concept came from BRAP2015 in the Philippines and was collaboratively applied by PBSA in Pakistan. This effort can serve as a model for how a program that was developed and delivered in one resource-limited country can be shared and implemented in another country through collaborative efforts between biosafety associations. Our hope is that increased collaborations between biosafety associations will lead to improved capacities in biosafety and biosecurity.
Conclusion
This project developed biorisk manual writing capacity in individuals from 13 institutions and helped them develop biorisk manuals for their institutions by providing in-person training followed by 10 months of mentorship from a team of experts from PBSA and HSP through webinars and online meetings. These efforts enabled the institutionalization of biosafety and biosecurity best practices at participating institutions; however, there is a need to replicate this process for additional institutions in Pakistan. In addition, expanded collaborations between national biosafety associations in Asia is also recommended based on the success of this project's collaborative efforts.
Footnotes
Acknowledgments
We thank HSP for funding support for this project. We also thank colleagues at HSP for initiating the partnership between PBSA and BRAP2015 and for the review of the article. We also thank our mentors, Prof. Dr. Shamsul Arfin Qasmi, Prof. Dr. Saeed Khan, and Oliver Shane R. Dumaoal for facilitating the project.
Authors' Contributions
Conceptualization, methodology, project administration, and writing—original draft by S.S. Methodology, conceptualization, and writing—review and editing by M.M.N.M.II. Project administration by M.C. Writing—review and editing by U.B.A. Supervision, writing—review and editing by A.I.
Authors' Disclosure Statement
With regard to the research, writing, and/or publication of this article, the authors declare that they have no potential conflicts of interest.
Funding Information
This project was funded by Health Security Partners (HSP), USA.