I. Experience and Proficiency Requirements
Personnel requesting access to perform work in the BSL-3 Core Facility unescorted must have extensive experience working in a BSL-2 containment laboratory and be proficient in all standard and specialized microbiological practices. Prior to working in this BSL-3 facility, documented experience performing similar work must be completed. A minimum of 2 years full-time experience in working with BSL-2 containment is required. Documented BSL-3 training and experience at another institution may be accepted. The authorized PI or designee is responsible for this training and ensuring proficiency of participating personnel. This experience is summarized on a form that is signed by the associated PI and submitted to the Safety and Security Officer for review and approval by the BSL-3 Core Facility Laboratory Director.
II. Biosecurity Requirements
Only authorized UNMC employees will be allowed access to the BSL-3 Core Facility.
The PI must have more than a 50% faculty appointment at UNMC, including research appointments, but excluding persons with only an adjunct appointment. The PI must also have an approved IBC protocol and must have successfully completed all biosafety and facility training.
Contract scientists performing work on a contract or subcontract owned by UNMC will be permitted to use the BSL-3 facility only under the following conditions:
- Each individual is on an approved IBC protocol.
- Each individual has successfully completed all required biosafety and facility training.
- Each individual has been approved by the Safety and Security Officer, Associate or Senior Biosafety Officer, and the BSL-3 Core Facility Laboratory Director.
- Each individual is always accompanied by a UNMC staff member authorized to use the BSL-3 Core Facility.
- Access will be restricted to 6 am to 6 pm Monday through Friday, unless approval is obtained by the Safety and Security Officer, Associate or Senior Biosafety Officer, and the BSL-3 Core Facility Laboratory Director.
Post-doctoral researchers and advanced graduate students may be permitted to work in the BSL-3 Core Facility only under the following conditions:
- The individual is on the approved IBC protocol for the associated UNMC PI, which is authorized to use the BSL-3 Core Facility.
- The individual has successfully completed all required biosafety and facility training.
- The individual has been approved by the Safety and Security Officer, Associate or Senior Biosafety Officer, and the BSL-3 Core Facility Laboratory Director.
- The individual is accompanied by an authorized person, until competency is confirmed in performing each given procedure that will be used with the relevant BSL-3 organism.
- The associated and authorized PI or supervisor who the post-doctoral or student researcher reports to is qualified to do so and is overseeing their work.
- Access will be restricted to 6 am to 6 pm throughout the week, unless approval is obtained by the Safety and Security Officer, Associate or Senior Biosafety Officer, and the BSL-3 Core Facility Laboratory Director.
III. Biosafety Requirements
Review and successful training and testing is based on the following manuals:
- DRC I 8021 BSL-3 Facility Standard Operating Procedure (SOP) Manual
- UNMC Institutional Biosafety Manual
- UNMC Employee Safety Training to include, as required:
- BSL-3 Biosafety Module (annual, online)
- General Biosafety (every 3 years, online)
- Bloodborne Pathogens (annual, online)
- Safety and Emergency Preparedness Competency (annual, online)
- Biohazardous Materials Shipping Training (in person, if required)*
- Radiation Safety (annual, if required)*
*Contact Environmental Health and Safety (EHS) for guidance and questions.
IV. Medical Evaluation and Clearance
An initial and annual medical evaluation must be completed at Employee Health. A medical evaluation should include a risk assessment of an individual’s health status and history (i.e., previous and current medical issues, allergies to medications, immune status, previous immunizations, laboratory tasks that they will perform, agents that they work with or may be exposed to in the laboratory, and fitness to perform duties in the laboratory). An exposure plan, specific to individuals at increased risk must be developed, prior to starting work in the laboratory. Personnel are also encouraged to discuss their health status and job risks with their primary care provider or other specialist, especially in cases where immune status, pregnancy, allergies to medications, or other factors indicate a higher risk from exposure to pathogens/infectious agents.
Medical surveillance will include the following:
- Annual TB screening that is documented
- Medical clearance to wear a fit-tested N95 respirator, and/or a PAPR (Powered Air Purifying Respirator) unit, along with documented annual training and annual fit testing with the appropriate type of N95 respirator
- Vaccinations must be current (For more information, please refer to approved IBC protocols and Medical Surveillance Form.)
V. Training Process and Requirements
Documents that must be completed include the following:
- The individual seeking authorization to work in the BSL-3 Core Facility must be listed on an approved IBC protocol for the associated PI.
- A Medical Clearance Form must be completed and returned to the BSL-3 Core Facility Safety and Security Officer. (Note that review and approval may take up two to three weeks, so starting this process early is recommended.)
- The associated PI or her/his designee must complete a form verifying that the person seeking approval to work in the facility must have already been doing similar work in a BSL-2 laboratory. If not, then a “Project Training List” must be completed by the associated PI, so that the trainee obtains these skills in a BSL-2 Laboratory.
- A current CV is required for individual seeking to work in the BSL-3 Core Facility that includes current and past research projects, along with the respective dates of these projects.
- A Personnel Assurance Form must be completed and signed by the person seeking to work in the BSL-3 Core Facility.
- A Suitability Assessment Form must be completed and signed by the person seeking to work in the BSL-3 Core Facility. (A Suitability Assessment evaluation must be performed each year for every individual authorized to use the BSL-3 Core Facility.)
VI. Facility Training
BSL-3 Core Facility orientation and BSL-3 SOP training
After the above documentation and requirements are completed, the Safety and Security Officer will submit a request to the BSL-3 Core Facility Laboratory Director for approval to begin training the individual seeking authorization to work in the BSL-3 Core Facility. After training approval is obtained, the Facility Coordinator or approved designee will proceed with the training of the respective PI, support staff, and/or advanced student(s).
The BSL-3 Core Facility orientation and SOP training will include the following:
- General BSL-3 biosafety and biosecurity aspects, as well as entering and exiting the facility
- Proper use of a PAPR unit and/or N95 respirator
- Proper donning and doffing of required PPE that includes PAPR or annually fit-tested N95 with goggles or face shield, water-impermeable back-tying gown, double pair of gloves, and shoe coverings
- Biosafety cabinet training
- Emergency associated training
- Proper use of the pass-through autoclaves that must contain a biological indicator in each run to verify decontamination/sterilization
Individual seeking to work in the BSL-3 Core Facility will be required to enter this laboratory multiple times with an authorized co-worker, so that the authorized staff member can ensure that PPE is properly donned and doffed, and so that the work is done safely and proficiently in this facility.
Research-specific training
The approved PI or designee is responsible for generating research-specific SOPs for work performed in the BSL-3 Core Facility, including inactivation of BSL-3 organisms and chemicals or reagents, both of which need to be approved by the IBC. The authorized PI or designee is responsible for training staff members seeking to work in the BSL-3 Core Facility, to ensure safe practices and proficiency in performing research-specific protocols. It is highly recommended that personnel first practice procedures omitting viable BSL-3/risk group 3 (RG-3) agents in the BSL-3 Core Facility to demonstrate proficiency. The Scientific Advisor, Safety and Security Officer, Associate or Senior Biosafety Officer, and/or BSL-3 Core Facility Laboratory Director can provide technical advice and observational feedback, including recommendations on whether the relevant personnel have mastered the required skills to begin working with BSL-3/RG-3 agents.
After the aforementioned steps have been successfully completed, the individual seeking authorization to work in the BSL-3 Core Facility must pass an exam that covers laboratory-specific SOPs, which is given by the Safety and Security Officer or appropriate designee.
VII. Final Approval
Upon successful completion of BSL-3 associated, facility-specific, and research-specific training, the Safety and Security Officer will submit the final records of the individual seeking authorization to work in the BSL-3 Core Facility to the Laboratory Director for review. After approval is obtained from the BSL-3 Core Facility Laboratory Director, the eligible individual will provide the Safety and Security Office with a four-digit personal identification number (PIN) that will ultimately allow this individual entry into the biosecure corridor of the BSL-3 Core Facility, as well as monitor and record the entry. The Safety and Security Officer will grant this eligible individual access to this facility seven days a week from 6 am to 6 pm via their UNMC proximity ID card and PIN.
VIII. Personnel Changes
Personnel changes must be approved by the IBC and the relevant individual(s) must successfully obtain medical clearance and all the aforementioned training, as well as be approved by the Safety and Security Officer, Associate or Senior Biosafety Officer, and BSL-3 Core Facility Laboratory Director.
IX. Annual Requirements
All users of the DRC I 8021 BSL-3 core facility are required to renew and update all items listed above as per institutional requirements. The approved PI and associated staff must perform annual laboratory-specific biosafety training. BSL-3 biosafety training, Occupational Health Medical Surveillance, blood borne pathogens and tuberculosis training, and Safety and Emergency Preparedness Competency are required annually. Documentation of this training will be submitted to the Safety and Security Officer.