Is Your Research, Clinical, or Diagnostic Biocontainment Program Compliant? The NIH Guidelines are an extensive set of requirements needing a multifaceted approach for compliance.
Lessons Learned from BSL3 Autopsy Facilities. From Hantavirus incidents in the American Southwest to the “anthrax letters” of 2001, Federal and State government health officials have seen the need for autopsy facilities designed to BSL3 guidelines.
The demands for biosafety, biosecurity, and biorisk management have dynamically changed over the past several years. Highly publicized events involving issues of biocontainment, public and global health, and biosecurity have raised public and legislative alarm.
Domestically, there has been a greater impetus on protecting funding for Federal and state initiatives, academic programs, and research within private organizations, providing a focus on engineering and operational compliance. Internationally, predominately in developing regions, current laboratories are progressively lagging compared to facilities and programs employed in developed countries. Despite compromised health and laboratory networks, the proliferation of clinical and diagnostic laboratories, biosafety programs, and conceptual based training mechanisms in the developing world is exponential. Yet, developing countries remain eager and strive for their own self-sustainable laboratory programs, in all capacities. Amongst all of this, both the developed and developing world aggressively seek new tools, facilities and programs to combat infectious disease. Unfortunately, as long as funding remains minimal, these needs will remain unmet.
There are few firms that recognize and understand firsthand the distinct challenges research, clinical and diagnostic laboratories face, both in the U.S. and across the developing world. Moreover, few know how to mitigate and quickly adapt to funding and resource limitations in a global context. Alliance Biosciences offers a diverse portfolio of services that are tailored to the specific needs of our clients, in any part of the one world, and one health we share. We provide seamless laboratory design and consulting, serving the following markets:
» Public & Global Health
I am pleased to introduce Alliance Biosciences, a comprehensive source of consulting services aimed at providing authoritative solutions for your laboratory needs.
Ryan N. Burnette, Ph.D.
Alliance Biosciences, a division of Alliance Engineering, Inc., is the leading laboratory design and biorisk management consulting firm in the Mid-Atlantic region. Alliance Biosciences has the privilege of collaborating with academic, government (Federal, State, and International), and private institutions in the U.S. and around the world. As a full-service consulting engineering and biorisk firm, Alliance leads biocontainment (BSL-2/3/4, ABSL-2/3/4, BSL-3-Ag, BSL-3-Autopsy), clinical, diagnostic and research laboratory projects. Core capabilities include:
Alliance has accumulated arguably the most respected team of lab design and biorisk management specialists in the industry, comprised of former, private and academic leaders. Each member has over 25 years of domestic and international experience in:
With a unique combination of biosafety expertise, the Alliance Biosciences team draws upon a wealth of experience in a broad set of disciplines to offer you the confidence you need from design through implementation and inspection readiness.
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RYAN N. BURNETTE, Ph.D.
CHRISTINA THOMPSON, M.S., RBP, CBSP
JONATHAN RICHMOND, Ph.D., RBP
MARIAN DOWNING, RBP, CBSP
MALCOLM BARTH, Ph.D.
JAMES (JIM) A. HERD, P.E.
ROBERT J. HAWLEY, Ph.D., RBP, CBSP
Jenna E. Hess, M.S., Deputy Director, Operations
J. Craig Reed, Ph.D., RBP, Senior Project Manager
Mary Cipriano, MBA, RBP, CBSP, SM (NRM), RBP, Biological Safety Consultant
Access end-to-end biosciences expertise, from diagnostics to solutions and from project/program management through construction. We have the turnkey resources in place to address, support and serve the specialized design, construction and manufacturing needs of the bioscience industry. You can move from molecule to market quickly with Alliance Biosciences. Our core services include:
|Expand/Collapse||BIORISK BIORISK management is a comprehensive approach to the overall biosafety and biosecurity needs for any institution handling infectious biological material. Alliance Biosciences team of biosafety and biosecurity experts, along with our in-house full-service engineering group, can help you plan and execute a highly-effective BIORISK management program. Reach out to Alliance Biosciences for expert guidance with: View Service >|
- BIORISK assessments
- Emergency response preparedness
- BIORISK program management
- Infectious agent inventory management
- Biosafety Manual & SOP development
- Containment facility evaluations
- Custom biosafety training
- Required Select Agent annual exercise
|Expand/Collapse||BIODESIGN Alliance Biosciences’ BIODESIGN services provide an integrated approach to plan and effectively execute your project. We provide biosafety and engineering expertise, deliver construction management, and certify, commission, and train your personnel offering a turnkey approach to your biocontainment lab project. It’s this cumulative expertise that makes Alliance Biosciences leaders in the industry. Reach out to Alliance Biosciences for expert guidance with: View Service >|
- Conceptual planning of biocontainment labs
- Basis of Design development & guidance
- Preconstruction architectural & engineering evaluation
- Full-service architectural and engineering capabilities:
- civil, structural, architectural (CSA)
- mechanical/HVAC, electrical/controls, piping/plumbing (MEP)
- Biosafety and biosecurity program and facility development
- Program & project management
- Construction management
- Animal research facilities & vivariums
- Commissioning & Certification
|Expand/Collapse||BIOCERTIFIED Commissioning and certification are not the “last steps” in a biocontainment lab project; they are part of the entire lifecycle. Don’t wait until your lab is built to assign a commissioning and certification team. Get Alliance Biosciences on-board early for guidance with: View Service >|
- Lab conceptual planning
- Design consultation
- Commissioning and certification/verification timeline and budget development
- Commissioning master plan development
- Facility-specific certification/verification audits
- Final execution of commissioning and certification/verification evaluations
- Facility annual re-verifications
- Facility decommissioning
|Expand/Collapse||BIOMENTOR Alliance Biosciences is one of the few biosafety and biosecurity consulting firms with the resources to fortify your biosafety program by placing one of our experts on-site at your institution. Nearly all biosafety and biosecurity programs can benefit from the Alliance Biosciences’ BIOMENTOR Program. Whether you are just getting started with a new containment lab, need operational guidance with the Select Agent program (IBC), or have a temporary vacancy, an Alliance Biosciences’ Mentor can bring industry-leading knowledge to bear at your institution. Our experts are former agency, private industry, or academic biosafety and biosecurity professionals with the ability to help manage any program at any level of complexity. We are prepared to assist your team with: View Service >|
- NIH, APHIS and CDC audit and inspection preparedness
- BSO, IBC, IACUC and IRB program managerial duties
- Custom biosafety training
- OSHA Bloodborne Pathogen regulatory program development & training
- Select Agent program guidance and readiness
- On-site laboratory and program management
- Medical and laboratory waste program management
|Expand/Collapse||2013 Alliance Biosciences Training Course Catalog Released Last year, Alliance Biosciences unveiled our training course catalog, providing on-demand webinars, live online training and in-person training options in multiple areas of biorisk management. In 2013, we have added new course content to provide for even more needs at academic, industrial and government institutions. View Service >|
- Baseline Inventory Assessment: Alliance Biosciences will visit with your lab managers to provide an initial inventory assessment. Through observation, interviews and cursory inspection, our team will provide the groundwork for a fully functional infectious agent inventory management platform. We will take this information back with us to begin the design phase of your customized inventory program.
- Infectious Agent Inventory Program Design: Our biosafey and biosecurity staff will work hand-in-hand with our IT professionals to customize an affordable, user-friendly software platform for use in your lab to maintain a rigorous inventory of all of your infectious agents. This program is designed with the intended use and needs of the specific lab, and is compatible with hardware that is delivered as part of the package.
- Delivery, Installation and Training of Infectious Agent Inventory Program: Alliance Biosciences will deliver the hardware (bar code label maker, bar code scanner) and customized software to your facility, install it, and train your staff how to maintain your new infectious agent inventory system.
- Independent, Secure Backup of Infectious Agent Inventory Data: Alliance Biosciences maintains an independent,
secure server capable of backing up and maintaining all of your inventory records. Our IT staff members are DOJ
cleared for Select Agent Program usage. Access your inventory data in real-time, and never worry about losing your
Included in this service are:
- Initial lab inventory assessment
- All hardware (bar code label maker, bar code scanner)
- All customized inventory program software
- Design of customized software
- Installation of hardware and software
- Training of staff for inventory program management
- Set-up of all infectious agent inventory records on our secure, independent server (annual maintenance fee required)
In conjunction with Alliance Engineering Inc., Alliance Biosciences also provides the following turn-key biosafety services:
|Expand/Collapse||Cleanroom and Lab Services|
- Equipment Selection (Bioprocess/Homogenization/Fermentation)
- Design Troubleshooting of Existing Cleanrooms/Labs
- Process Design (Aseptic Processing & Air Flow Focus)
- Purified Water Process Evaluation (Water For Injection, R/O, DI)
- Biological Contaminant Solutions
- Material Surface Selection
- Cleanroom Control Systems (Field Bus, DCS, PLC, PC)
|Expand/Collapse||Validation, Commissioning & Calibration|
- Process Validation
- Master Plan Development
- Lab Equipment Validation & Calibration
- Custom Software for Calibration, Validation & Preventative Maintenance Programs
- Environmental Monitoring System Calibration & Validation
|Expand/Collapse||Bioprocess Consulting & Training|
- Process Optimization
- Scale-up Consulting & Analysis
- Cleaning & Sanitation Program Development
- Aseptic Process Training
Alliance Biosciences’ experts have consulted on a number of projects for a variety of clients, ranging from SOP and biosafety program evaluations to facility inspections and design guidance.
High-containment Facility Design Projects:
Facility Inspections and SOP Reviews:
Biosafety Training and Program Assessments:
With a world-class team of biosafety experts on board, Alliance Biosciences often makes the news. As a resource, Alliance Biosciences is compelled to also keep its clients aware of newsworthy events that are making headlines, or that we are attending.
The Centers for Disease Control and Prevention (CDC) laboratories and many other federal, private and university laboratories work with biological select agents and toxins (BSAT). These laboratories, wrongly referred to as “bioterror labs” while in reality they should be referred to as research and teaching laboratories, are vigorously pursuing safe diagnostic and therapeutic procedures and products to protect humans, animals and the environment. View More >
From Dr. Robert Hawley, Biosafety and Biosecurity Project Manager at Alliance Biosciences: “I wish to comment on recent reports concerning the laboratories at CDC and the fact that they have been cited in private government audits for failing to properly secure potential agents of bioterrorism and not training employees who work with them. A report released by the Department of Health and Human Services' Inspector General in December 2010 (http://s3.documentcloud.org/documents/607441/hhs-inspector-general-cdc-select-agent-report-2010.pdf) indicated these weaknesses could have compromised the ability of the CDC to safeguard select agents from accidental or intentional loss and to ensure the safety of individuals. Some of the information in the report was redacted, thus the qualifications of the individuals conducting the audit could not be evaluated. However, from September 17-21, 2012 there was an external review of the CDC Animal Biosafety Level 3 Vivarium Facility by biosafety professionals - four individuals practice in Canada and two individuals practice within the U.S. (http://s3.documentcloud.org/documents/607522/public-health-agency-of-canada-team-final.pdf). The report summarized the compliance verification process and results, and also provided some recommendations to further enhance best practices. Salient findings included:
- There were no observed findings of regulatory non-compliance or missing elements that pose a risk to CDC employees, the surrounding laboratory/building space, the public or the environment.
- The standard security practices described in the manuals and demonstrated by the Security Operation Center meet the requirements set out in the current U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (BMBL), current U.S. Select Agent Regulations and international best practices.
- A review of the maintenance processes confirmed that existing practices meet current BMBL requirements, and some exceed international best practices, ensuring the safe and efficient operation of the building systems serving the vivarium.
The message gleaned from the above findings strongly indicates that the CDC is adhering to the demands of the many regulations imposed upon their daily internal and external operations.
The number of practicing biosafety professionals in the U.S. is very small, compared to other scientific disciplines. According to the American Biological Safety Association, there are a total of 370 credentialed biosafety professionals as of March 9, 2013. Of this total, 177 have the designation of Certified Biological Safety Professional (CBSP) that is earned through a review of transcripts, references and work history. It also includes the successful completion of an examination administered by the National Registry of Certified Microbiologists of the American Society for Microbiology. Successful applicants also have the designation of Specialist Microbiologist in Biological Safety Microbiology (SM [NRCM]. A total of 193 individuals have the designation of Registered Biosafety Professional (RBP). This designation is awarded to individuals with a documented university education plus specialized training in relevant biological safety disciplines (in part, microbiology, laboratory procedures, regulatory compliance, risk assessment and management, communication...). Of the total of 370 individuals, 75 have the designation CBSP and RBP. For the incredible volume and frequency of all these inspections or audits, I question why these biosafety professional resources are not called upon more frequently to exercise their fullest capabilities based on their daily laboratory and operational experiences.
The key principles of biological safety are risk assessment and containment. I firmly believe that the key to success in management and operation of a containment laboratory working with BSAT, or in fact any other microorganism that may pose a risk to humans, animals or the environment, is Risk Communication. That is, timely education and involvement of the public, oversight agencies and those tasked with development of policies. There is an inherent risk when working in a laboratory handling microorganisms. Speaking from experience of working in microbiology laboratories for over 50 years, and practicing biological safety for over 25 years, these disciplines are exciting - but microbiology can be dangerous and is not without risk (http://www.im.microbios.org/1003/1003217.pdf). Zero risk is only possible when a facility is not operational, with scientists and support personnel having to seek other employment. However, danger is mitigated by adopting strict biosafety principles regarding practices, equipment and facilities designed to prevent hazardous exposures to co-workers, the community and environment.
It appears that many of the inspection and audit reports that addressed issues at federal, private and university laboratories are exaggerated or present an incomplete picture. Most, if not all, of these laboratories must follow the specific letter of the regulatory law(s) and implement and practice the guidelines promulgated in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories-5th ed. I acknowledge that an occasional lapse in policy or procedure may occur resulting in an accident. I also acknowledge that it is unfortunate that such occurrences are over-emphasized giving the public the impression that this is the norm rather than an exception. Scientists and support personnel are doing admirable work in this regulatory-laden environment. We should continue to support their effort, through appropriate risk communication, and not place additional burdens upon their tasks - let them do the science that they were trained to do. I believe this is a win-win situation for scientists, biological safety professionals, the public and regulatory agencies.”
Glove boxes are ubiquitous in many biocontainment facilities. Lab Manager Magazine called on Alliance Biosciences’ Marian Downing, RBP, CBSP to contribute her expertise, assisting lab users make informed decisions about which types of glove boxes are appropriate. View More >
Over the past several months program evaluations, conducted by the Office of Biotechnology Activities (OBA; National Institutes of Health), revealed many institutions are still lagging with respect to NIH Guidelines for Research Involving Recombinant DNA (rDNA) Molecules (NIH Guidelines). The NIH Guidelines are an extensive set of requirements needing a multifaceted approach for compliance. A comprehensive biosafety program must be established, including an Institutional Biosafety Committee (IBC), which will provide regulatory and compliance oversight within the institution during laboratory inspections, and biosafety education for faculty, staff and students. View More >
In some instances, additional staff members, such as a Biosafety Officer may be necessary to meet requirements as set forth in the Guidelines. Further, research must be carefully monitored, especially as it pertains to research involving transgenic plants or animals, as well as projects which use recombinant DNA in human research. Other OBA documents offer guidance on appropriate biosafety procedures for research centered on the use of various infectious agents, to include retroviral vectors. Despite the appearance and accessibility to these guidance documents, many institutions are at an impasse interpreting the Guidelines, and subsequently find themselves non-compliant.
Non-compliance is not taken lightly by the OBA, and failure to comply with the Guidelines can result in civil or criminal penalties for an investigator or institution. Detrimentally, this can also result in termination of all funding to an institution’s NIH supported projects. In fact, historically, financial penalties have been recorded.
Alliance provides NIH Guidelines, IBC and biosafety program management services to clients across the U.S., often after an OBA inspection has revealed deficiencies. To help NIH-funded institutions avoid retroactive measures for compliance, Alliance Biosciences offers courses focusing on NIH Guidelines. Our in-person or webinar training programs are designed to give institutions and investigators the background and information they need to comply with all aspects of the Guidelines. Moreover, the course discusses compliance in terms of how to establish and administer a successful IBC, the various types of protocols an investigator might submit to the IBC, how to conduct laboratory audits, and gives special consideration to the biosafety issues involved in the use of retroviral vectors in recombinant DNA research.
From Hantavirus incidents in the American Southwest to the “anthrax letters” of 2001, Federal and State government health officials have seen the need for autopsy facilities designed to BSL3 guidelines. In recent years, BSL3 autopsy (BSL3-Aut) facilities have emerged in a few States and more are planned. BSL3-Aut facilities present unique challenges from design, to certification, to operation. What are some of the challenges and lessons learned from these novel laboratories? View More >
Published by the Centers for Disease Control and Prevention and the National Institutes of Health, Biosafety in Microbiological and Biomedical Laboratories, 5th ed., Biosafety Level 3, or BSL3, applies to a variety of labs handling indigenous or exotic agents with the potential to cause serious or lethal disease via aerosol exposure, or inhalation. In other words, the jump from the next level down (BSL2) to BSL3, is a big one due to the fact that agents posing a threat to lab or medical workers that can be inhaled. This critical distinction in routes of exposure is what dictates many of the design and operational criteria of BSL3 facilities. Further, all work with potentially infectious agents performed within a BSL3 lab must be conducted in a primary containment device, such as a biosafety cabinet (BSC) within secondary containment (the lab itself). Primary containment devices for manipulating these aerosol-transmissible agents, including sealed centrifuge tubes and rotors, closed blenders, etc. protect the worker from inhalation hazards.
Contrast the information above with an typical autopsy facility where autopsies are conducted on an open table. When primary containment would normally be required, it is not possible to place a cadaver into a BSC. The potential risk here is obvious: that extra level of inhalation hazard protection provided by the BSC is gone. Medical workers conducting the autopsy are “out in the open” as aerosol biohazards are generated from the autopsy procedure. The room becomes the primary containment barrier, and the workers must rely on improved techniques and personal protective equipment for personnel safety. Enhanced room improvements make the BSL3-Aut facility an even safer work environment.
In fact, BSL3-Aut labs are one of the few examples when a BSL3 facility is actually operating as primary containment. Add to this the fact that autopsies produce a variety of aerosols (insert mental image of a circular bone saw here). For these situations, the best prevention strategy lies in worker practices and training, and increased respiratory protection. As these facilities come on-line and autopsies are conducted it is expected that detailed SOPs will evolve.
The Alliance Biosciences team is one of the first firms in the U.S. to have executed a certification/ verification process of a BSL3-Aut facility, from which these obstacles were gleaned. Probably the biggest lesson learned from this effort is that the medical examiner staff and biosafety professionals will have to work together to mitigate the risks. As BSL3-Aut facilities are propagated in the U.S. and around the world, cooperation amongst these entities will provide valuable guidance for future high containment autopsy facilities.
The need for diagnostic and clinical labs to combat emerging and reemerging infectious diseases, such as tuberculosis (TB), continues to grow in India. As budgets and timelines are tight even in India’s growing economy, new construction isn’t always an option. Alliance Biosciences and the Foundation for Innovative New Diagnostics (FIND) executed a novel demonstration project combining the elements of facility evaluation, upgrade and BSL3/TB training at four sites across India. The result: four improved labs, with improving diagnostic capabilities under budget and in a matter of months, instead of years. View More >
The Foundation for Innovative New Diagnostics, a non-profit based in Geneva, Switzerland with branch operations in India and Africa, approached Alliance with a crazy idea: evaluate, upgrade and train lab workers in multiple TB diagnostic labs on the other side of the planet on a shoestring budget and a pace-breaking timeline. Naturally, Alliance Biosciences accepted the challenge.
After nearly 18 months of planning, the Alliance Biosciences team along with FIND, travelled to India. Alliance conducted a 3-day intensive workshop of TB biosafety and BSL3 operations. Following this, Alliance and FIND travelled to Bangalore, Chennai, Puducherry and Vishakhapatnam, India to evaluate four TB diagnostic facilities.
Novel to this effort is a Remote Project Management approach. FIND recruited engineers in Delhi to serve as general project managers of the upgrade portion of the effort, while Alliance provided guidance and project management from the U.S. This model reduced the overall cost of the effort, by nearly 50%. Currently, the four TB labs are being upgraded to comply with BSL3 WHO guidelines. The future: these labs will receive better TB diagnostics, allowing for faster, more accurate diagnosis of TB. Further, this model of Remote Project Management for the evaluation and upgrade of diagnostic labs will continue in India, and spread to other developing regions where the need is high, but the budgets are tight.
Working to protect the wellbeing of your employees and the general public is paramount - and that’s why the safety of your facility and your program is so important. You can trust the experts at Alliance Biosciences to assist you as you work to achieve the highest standards in biosafety. To get started, simply reach out to us today.
For all general, media, and business develoment inquiries in the US and abroad, please contact:
Jenna E. Hess, M.S.
Deputy Director, Operations - Alliance Biosciences
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