In any research lab, meeting the requirements for safety is an ever-present concern. The consequences of not meeting safety requirements are particularly dangerous when research involves pathogens or biological toxins that have the “potential to pose a severe threat to public health and safety,” according to the U.S. Department of Health and Human Services.
For such research programs to be successful and safe they must be supported by specially trained staff, specialized equipment, and well-developed standard operating procedures.
Meeting the requirements for ABSL3 is time consuming and exacting. Whether you are interested in achieving ABSL3 or just want to make your research facilities safer, the five steps below provide a blueprint for designing and operating research facilities to effectively safeguard those facilities and personnel.
An ABSL3 facility requires extensive oversight and leaves little room for error. It’s important not to cut corners on your staffing plan. Keep in mind the detailed procedures that will need to be followed, the working conditions, and the need for an error-free work environment. Build these considerations into your job descriptions and selection process.
When you determine the number of personnel and time required to handle the husbandry and technical workload, use less than the industry average performance standard quantifiers for a standard research facility. This will ensure there is time allotted for the additional personal protective equipment (PPE) requirements and ABSL3 daily environmental duties.
It is essential to staff your team with some individuals that are experienced with the ABSL3 environment. Having a seasoned team will help your program get up and running quickly and will be extremely beneficial for training those staff with less experience.
Make sure you do all you can to retain and provide a path for career advancement for skilled care staff. You can accomplish this by structuring levels of animal caretakers, such as Animal Caretaker II (ACII) and Animal Caretaker III (ACIII). This type of structure provides a mechanism to promote an individual who has the quality caretaking skills necessary to meet the performance standards of an ABSL3 suite.
Training is paramount in the implementation, operation, and management of any animal program. That is especially true in an ABSL environment.
Effective ABSL3 training should consist of didactic classroom instruction; mock training of procedures; and one-on-one, hands-on training that include working with the actual species and agents encountered in the facility.
Training typically involves the following.
Identify Qualified and Experienced Trainers
Potential trainers should not only have vast experience and knowledge of ABSL3 operations and procedures, but also be well versed in the safety and the handling of a multitude of species and agents.
Determine Training Implementation Requirements
Training implementation in an ABSL3 facility is driven by the program’s Standard Operating Procedures (SOPs) as well as policies and procedures from other government agencies, such as the United States Department of Agriculture (USDA). Specific surveillance requirements on ‘Select Agents’ (agents regulated by the USDA) is provided by the Institutional Occupational Health and Safety program in conjunction with program management.
Effective Classroom Training
Classroom training consists of interactive presentations followed by evaluation, usually in the form of a short quiz. In addition, some hands-on training can be conducted in the classroom.
Upon completion of the classroom training, students move on to mock scenarios. Scenario training should include all aspects of working in the suite, such as sign-in procedures, aseptic cage change, technical manipulations, and exiting procedures.
This practice of training in a suite that is not posted as “biohazardous” is commonly referred to as working in a “cold suite.” This allows personnel to experience the effects of working with additional PPE requirements, such as wearing Powered Air Purifying Respirators for extended periods; and become familiar with the added procedures and precautions prior to entry into a “hot suite” (a suite that contains risk of biohazardous agents).
Provide investigators with a facility/suite orientation, starting with an all-inclusive ABSL3 overview and a walkthrough of the suite. The majority of trainings for specific agents are conducted by the Principal Investigators or their designees.
Documentation of Training
Training records are frequently reviewed during Animal Care and Use Committee (ACUC) and American Association for Accreditation of Laboratory Animal Care (AAALAC) inspections.
Simple check sheets help make sure training regimes are followed. Check sheets should list the necessary areas of training, such as dressing prior to entering the suite, animal husbandry, waste processing and disposal, and emergency egress procedures, just to name a few.
3. Standard Operating Procedures
No two ABLS3 programs are alike. Expert understanding is needed for the tasks and procedures involved, personnel, species and risks. Typical SOPs include:
- Entry Procedures
- Powered Air Purifying Respirators (PAPR)
- Daily Airflow
- Twice Daily Census Counts
- Handling of Agents, including Select Agents
- Species Specific Procedures
- Signage and Movement
- Exiting Procedures
- Emergency Egress Procedures
Entry procedures should include the proper steps to be taken when donning PPE, documenting entry, using PAPR, and entering the suite.
Procedures for using, documenting, and troubleshooting PAPRs are of great importance when training new personnel to work in the suite.
Daily airflow within animal rooms and ventilated caging needs to be documented daily and deficiencies must be reported to management immediately.
Twice daily census counts are another area of great importance. Each individual animal must be counted twice daily and recorded on a census form and faxed to management. Deviations in the census counts must be addressed immediately.
The handling of agents is another area where procedures must be clearly defined, as well as their storage, usage, tracking, and disposal.
Signage and traffic patterns need to be accurate and easy to follow. Signs in an ABSL3 suite not only aid in entering and moving through the suite safely, but are also valuable when performing procedures such as donning a PAPR or loading and running an autoclave.
Equipment is another area for standard operating procedures, particularly for bio-containment caging systems, autoclaves, and specialized equipment such as inhalation chambers and anesthesia machines.
Exiting and emergency egress procedures must be outlined to ensure the safety of those outside of the suite. The safety department and program management staff need to agree on the procedures for exiting during an emergency. Does staff decontaminate and exit in full PPE or are other methods and safeguards in place? These are just a few examples of questions to address.
4. Specialized Equipment
The operation of an ABSL3 suite requires the use of specialized equipment.
- Proper housing for laboratory animals is paramount in bio-containment environment. Bio-containment caging is a must, including negative air ventilated rodent racks, primate, and ferret/rabbit racks.
- Autoclaves are a mainstay in ABSL3 suites. Bioseal autoclaves with interlocking doors are preferred. A sterilization time of at least one hour is recommended. Autoclave monitoring is essential. Several types of monitoring devices should be employed, such as integrator strips and biological monitors.
- Biosafety cabinets are another staple piece of equipment. The preferred hood is a Class IIB hard-ducted unit. These hoods exhaust 100% of the air to the outside, which allows work with chemicals and biohazardous agents to be performed.
- Isolation rooms or cubicles are beneficial for suites that must maintain several agents in the same room. The lighting, temperature, and humidity can be set individually. When utilized correctly, various species may be housed in the same room where normally there would be physiological issues. For example, a rack of ferrets in cubicle one (the hunters) and a rack of mice (the prey) can successfully be housed in the same room.
- Transportation of tissues and samples obtained from “hot” animals to an outside facility for processing is a major concern. For this, it is recommended that a rubber gasketed biological carrier be used.
- Communication with the outside is also essential. Processes for communicating accidents, injuries, and emergencies and regular day-to-day communication procedures must be available. Computers utilizing email and instant messaging are effective, as are two-way radios used by the suite supervisor and facility manager to communicate frequently.
- Reporting equipment such as computerized monitoring is useful in tracking and monitoring airflow and temperature. Security equipment, such as electronic card readers, is also vital when working with select agents.
5. Security Requirements
Security requirements are driven by the category of biological agents to be used. The biological agent requirements are determined by its agent category, such as USDA Agricultural Agent vs. Select Agent—keep in mind that some agents fall under both categories. You can research an agent’s category at the CDC website. Once you have this information you can move forward in planning the necessary security measures.
There are several things to keep in mind, such as personnel clearance. Poor planning can cause staff shortages and a decline in operational outputs. You will want to create a good way to track where employees are in the clearance process. This includes staff with secret clearance, staff not yet given a clearance, and intermittent services such as consultants, maintenance, and repair workers. You must ensure that an unsecured employee is escorted by a cleared employee.
For room and cage security, you will want to track personnel entering and exiting. You will also want to have sealed cages that are sturdy enough to withstand accidental drops, and install proper locking mechanisms for cages when they are docked on a rack. Also, include padlocks for cage door latches, as needed.
As ABSL3 labs come online to meet the ongoing need for comprehensive research into the effects of harmful substances, the need for robust strategies to ensure the security of facilities and personnel also grows.
Program managers can create an integrated framework for ABSL3 lab management based on careful consideration of the three most critical pieces of any operation: knowledgeable and well-trained staff, state-of-the-art equipment, and clearly defined and constantly evaluated procedures.
As ABSL3 labs come on line to meet the ongoing need for comprehensive research into the effects of harmful substances, the need for robust strategies to ensure the security of facilities and the safety of personnel also grows.
With knowledgeable and well-trained staff, state-of-the-art equipment, and clearly defined and constantly evaluated procedures, lab management can successfully ramp up and maintain best-in-class environments for life-saving research.
Melissa Marrah, CMAR, RLATG, provides business development for SoBran BioScience. Previously she managed SoBran’s NIH/NIAID contract, providing daily program and personnel management in support of ABSL1-3 animal facilities and program services. firstname.lastname@example.org, 571-326-3411
Bradley A. Fisher, CMAR, LATG, provides operational oversight, business development, and strategic planning for a multitude of DHHS and DoD biomedical research contracts. He has served as NCAB AALAS Awards Chair and on the NCAB AALAS Seminar Committee. email@example.com, 301-496-9608
James Magrath, LATG, has over 20 years of experience in Laboratory Animal Science, the majority of which has included work in ABSL3 suites. firstname.lastname@example.org, 301-758-3556
Image credit: Safety measures include proper staffing and training, establishing Standard Operating Procedures (SOPs), using specialized equipment, and adhering to security requirements. Photo courtesy of SoBran.