Assessing the Operational Readiness of Biocontainment Laboratories
John Lopez, Lovelace Respiratory Research Institute
It is not unusual for many new facility projects to be designed and constructed without any significant involvement by the users or operations and maintenance personnel. The procedures for operating and maintaining these facilities are thus subsequently developed in response to the facility as designed. This may be an acceptable approach for some new facilities. However, this approach is not ideal for high-hazard facilities such as biocontainment facilities. This approach may not be ideal for several reasons, which include:
- The need to develop procedures and conduct training that might delay full operation of facility.
- Insufficient funding for operation and maintenance.
- Delays in approval by regulatory agencies.
- A lack of trained personnel to operate and maintain the facility. An ideal approach integrates design and operations and maintenance objectives throughout the entire project life cycle.
One model for implementing this integrated approach is the application of four primary controls for biocontainment facilities. These four primary controls include engineering, operations and maintenance procedures, administration (such as training management), and personal protective equipment. The four primary controls should be applied to all the fundamental design and operating objectives for the facility including such objectives as environmental control, containment, decontamination, and sterilization.
The application of sound risk assessment principles and practices plays a major role in the integrated project development approach using the primary controls. Trade-offs may be necessary to achieve acceptable balances among the primary controls to achieve the primary performance and operating objectives for the facility. Whatever the ultimate outcome in terms of the application of the four primary controls, the facility design and operating objectives need to be verified through commissioning and validation.
Ultimately, the question is: "Is your biocontainment facility ready to operate?" The question may be asked by regulatory agencies, funding organizations, and management. Answering this question can take many forms. The method being presented in this presentation will be referred to as an Operational Readiness Review (ORR). The ORR evaluates operational readiness for each of the four primary controls. Examples of the elements to be included in assessing operational readiness are:
- Engineering controls – Commissioning and validation
- Personal protective equipment controls - Type and use of personal protective equipment
- Work practices controls - Entry and exit, sterilization and decontamination, and emergency response procedures
- Administrative controls - Training, security, and immunization
John Lopez's experience includes the management of major capital projects, facilities operations and maintenance, research engineering, procurement, property, quality, environmental restoration, and environment, health, and safety. This includes 30 years of design, construction, and operating experience with a wide variety of research animal facilities and facilities designed to work with hazardous chemical, radioactive, and biological aerosols. Since 1994, Mr. Lopez has been responsible for ten biosafety level (BSL)-2 and BSL-3 projects totaling 16,000 square feet. A significant portion of Mr. Lopez's experience and effort since 2004 has been focused on the successful design, construction, commissioning, validation, operation, and maintenance of a 10,000-square-foot ABSL-3 biocontainment facility. This facility is designed and operated for GLP-compliant research using multiple research animal species and bioagents including Centers for Disease Control select agents. Mr. Lopez also conducts training in the area of facility design and engineering controls for biocontainment facilities. Mr. Lopez has participated in national biocontainment conferences as a speaker in the areas of biocontainment facility design, commissioning, and operation.
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