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University of Nebraska Medical Center

Instruments and Services

The UNMC Biosafety Level 3 Core Facility is 1392 square feet and located and located on the main campus for UNMC. There are pass-through lockers and autoclaves, well-equipped corridors and working suites, a donning/dressing anteroom, a doffing/exit room, personal storage lockers, and an additional secure room to ensure that autoclaved items are sterile. Every room has a preprogrammed phone to automatically dial the UNMC Security Dispatch. The biosecure corridor has an emergency exit, eye wash station, and overhead shower, and the doffing/exit room has a hands-free sink and a shower. There is an air pressure monitor/alarm system, along with emergency backup lighting and electrical outlets. Many features contribute to the biosafety and biosecurity of this facility and the researchers needs. 

Working Suites

Each of the five working suites in the UNMC Biosafety Level 3 Core Facility are well-equipped with the instrumentation listed below for standard molecular microbiology and tissue culture procedures. In addition, each working suite has storage cabinets with benchtops, shelving, two carts, autoclavable tubs/containers, a clock, two or three non-cloth laboratory chairs, a stepping stool, and a spill kit with extra personal protective equipment. 

Instruments in each working suite: 

Biosecure Corridor

The biosecure corridor that is adjacent to the working suites has shared equipment that includes the two-pass through autoclaves, storage cabinets for extra supplies (i.e., personal protective equipment, paper towels, and biological/chemical indicators), a large foot-operated/hands free sink, a fire extinguisher, a spill kit, and materials for sharp item cleanup, along with the following instrumentation. 

Primary instruments in biosecure corridor: 

  • Thermo Scientific -150°C Cryogenic Storage Freezer with racks and storage boxes 
  • Two Thermo Scientific TSX Series Ultra-Low -80°C Freezers with racks and storage boxes 
  • Justrite Flammable Storage Cabinet 
  • Justrite Acid/Corrosive Storage Cabinet 
  • RCA Microwave (1.1 cubic feet, 1,000-watt power output with 10 power levels) 

Services and Requirements 

The UNMC Biosafety Level 3 Core Facility staff provides guidance and facility-specific training to principal investigators and their associated researchers that are interested in utilizing this facility. The process for principal investigators and/or their staff to acquire authorization is described below. 

Biosecurity Requirements

Only authorized UNMC employees will be allowed access to the UNMC Biosafety Level 3 Core Facility. The principal investigator must have more than a 50% faculty appointment at UNMC, including research appointments, but excluding persons with only an adjunct appointment. The principal investigator must also have an approved Institutional Biosafety Committee protocol and must have successfully completed all biosafety associated training. 

Contract scientists performing work on a contract or subcontract owned by UNMC will be permitted to use the Biosafety Level 3 facility only under the following conditions: 

  • Each individual is on an approved Institutional Biosafety Committee protocol. 
  • Each individual has successfully completed all required biosafety and facility training. 
  • Each individual has been approved by the Safety and Security Officer, Biosafety Officer, and the Biosafety Level 3 Core Facility Laboratory Director. 
  • Each individual is always accompanied by a UNMC staff member authorized to use the UNMC Biosafety Level 3 Core Facility. 
  • Access will be restricted to 6 a.m. to 6 p.m. Monday through Friday, unless approval is obtained by the Safety and Security Officer, Biosafety Officer, and the Biosafety Level 3 Core Facility Laboratory Director. 

 

Post-doctoral researchers and advanced graduate students may be permitted to work in the Biosafety Level 3 Core Facility only under the following conditions: 

  • The individual is on the approved Institutional Biosafety Committee protocol for the associated UNMC principal investigator, which is authorized to use the Biosafety Level 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, Biosafety Officer, and the Biosafety Level 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 Biosafety Level 3 organism. 
  • The associated and authorized principal investigator 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 a.m. to 6 p.m. throughout the week, unless approval is obtained by the Safety and Security Officer, Biosafety Officer, and the Biosafety Level 3 Core Facility Laboratory Director. 

Experience and Proficiency Requirements

Personnel requesting access to perform work in the Biosafety Level 3 Core Facility unescorted must have a minimum of two years full-time experience working in a Biosafety Level 2 containment laboratory or documented Biosafety Level 3 training and experience at another institution, as well as be proficient in all standard and specialized microbiological practices. Prior to working in this Biosafety Level 3 facility, documented experience performing similar work must be completed. The authorized principal investigator 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 principal investigator and submitted to the Safety and Security Officer for review and approval by the Biosafety Level 3 Core Facility Laboratory Director.

Biosafety Requirements 

Review and successful training and testing is based on the following information: 

  • Biosafety Level 3 Core Facility Standard Operating Procedure (SOP) Manual 
  • UNMC Institutional Biosafety Manual 
  • UNMC Employee Safety Training to include, as required: 
  • Biosafety Level 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. 

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., medical issues, allergies to medications, immune status, previous immunizations, Biosafety Level 3 agents that they work with or may be exposed to in the laboratory, and fitness to perform the laboratory tasks). An exposure plan specific to individuals at increased risk must be developed, prior to starting work in the Biosafety Level 3 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, and/or other factors indicate a higher risk from exposure to pathogens/infectious agents. 

Medical surveillance will include the following: 

  • Annual tuberculosis screening that is documented 
  • Medical clearance to wear a fit-tested N95 respirator and/or a Powered Air Purifying Respirator (PAPR) unit, along with documented annual training 
  • Note that if a N95 respirator is used, annual fit testing with the appropriate type of N95 respirator is required 
  • Vaccinations must be current 
  • For more information, please refer to the appropriate approved Institutional Biosafety Committee protocol(s) and medical surveillance form(s). 

All laboratory personnel need to report suspect or known exposures by immediately calling the “OUCH” pager 402-888-OUCH (6824) and then entering a 10-digit callback number after the tone. The principal investigator, Biosafety Level 3 Core Facility Laboratory Director, Biosafety Officer, and Institutional Biosafety Committee must be notified within 24 hours. Additional incident reporting information can be found at the Environmental Health and Safety website.  

Training process and requirements

Documents that must be completed include the following: 

  • The individual seeking authorization to work in the UNMC Biosafety Level 3 Core Facility must be listed on an approved Institutional Biosafety Committee protocol for the associated principal investigator. 
  • Appropriate medical clearance forms (e.g., Respirator Users Health Questionnaire via Employee Health) must be completed and returned to the Biosafety Level 3 Core Facility Safety and Security Officer. 
  • Note that review and approval may take two to three weeks, so starting this process early is recommended. 
  • The associated principal investigator or her/his designee must complete a form verifying that the person seeking approval to work in the Biosafety Level 3 facility must have already been doing similar work in a Biosafety Level 2 laboratory. If not, then a “Project Training List” must be completed by the associated principal investigator, so that the trainee obtains these skills in a Biosafety Level 2 laboratory. 
  • A current curriculum vitae (CV) is required for the individual seeking to work in the UNMC Biosafety Level 3 Core Facility that includes current and past research experience, along with the respective dates of the associated projects. 
  • A Personnel Assurance Form must be completed and signed by the person seeking to work in the UNMC Biosafety Level 3 Core Facility. 
  • A Suitability Assessment Form must be completed and signed by the person seeking to work in the UNMC Biosafety Level 3 Core Facility. 
  • A Suitability Assessment evaluation must be performed each year for every individual authorized to use the UNMC Biosafety Level 3 Core Facility. 

Biosafety Level 3 Training

After the above documentation and requirements are completed, the Safety and Security Officer will submit a request to the Biosafety Level 3 Core Facility Laboratory Director for approval to begin training the individual seeking authorization to work in the UNMC Biosafety Level 3 Core Facility. After training approval is obtained, the Biosafety Level 3 core facility staff will proceed with the training of the respective principal investigator, support staff, and/or advanced student(s).

Facility-specific orientation and training 

The UNMC Biosafety Level 3 Core Facility orientation and facility-specific SOP training will include the following:  

  • General Biosafety Level 3 biosafety and biosecurity aspects, as well as entering and exiting the facility 
  • Proper use of a Powered Air Purifying Respirator unit and/or N95 respirator 
  • Proper donning and doffing of required personal protective equipment that includes a Powered Air Purifying Respirator or alternatively an annually fit-tested N95 with goggles or face shield, water-impermeable back-tying gown, double pair of gloves, and shoe coverings 
  • Biological safety cabinet training 
  • Emergency associated training 
  • Proper use of the pass-through autoclaves that must contain a biological and chemical indicator in each run to verify decontamination/sterilization 

Individuals seeking to work in the UNMC Biosafety Level 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 personal protective equipment is properly donned and doffed, and so that the laboratory work is done safely. 


Research-specific training 

The approved principal investigator or designee is responsible for generating research-specific standard operating procedures for work performed in the UNMC Biosafety Level 3 Core Facility, including inactivation of Biosafety Level 3 organisms and chemicals or reagents, all of which need to be approved by the Institutional Biosafety Committee. The authorized principal investigator or designee is responsible for training staff members seeking to work in this Biosafety Level 3 facility, to ensure safe practices and proficiency in performing research-specific protocols. It is highly recommended that personnel first practice procedures omitting viable Biosafety Level 3/risk group 3 (RG-3) agents in the Biosafety Level 3 facility to demonstrate proficiency. The Safety and Security Officer, Biosafety Officer, and/or Biosafety Level 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 Biosafety Level 3/RG-3 agents. 

 After the aforementioned steps have been successfully completed, the individual seeking authorization to work in the UNMC Biosafety Level 3 Core Facility must pass an exam that covers Biosafety Level 3 organisms and facility-specific standard operating procedures, which is given by the Safety and Security Officer or appropriate designee. 


Final Approval 

Upon successful completion of Biosafety Level 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 UNMC Biosafety Level 3 Core Facility to the Laboratory Director for review. After approval is obtained from the Biosafety Level 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 allow and record the entry of this individual into the biosecure corridor of the UNMC Biosafety Level 3 Core Facility. The Safety and Security Officer will then grant this eligible individual access to this facility seven days a week from 6 a.m. to 6 p.m. via their UNMC proximity ID card and PIN. 


Personnel Changes 

All personnel seeking authorization to utilize the UNMC Biosafety Level 3 Core Facility must be approved by the Institutional Biosafety Committee, obtain medical clearance, and successfully complete all the aforementioned training, as well as obtain approval of the Safety and Security Officer, Biosafety Officer, and Biosafety Level 3 Core Facility Laboratory Director. 


Annual Requirements

All users of the UNMC Biosafety Level 3 Core Facility are required to renew and update all items listed above, as per institutional requirements. The approved principal investigator and associated staff must successfully complete annual online training pertaining to Biosafety Level 3 biosafety and biosecurity, as well as emergency preparedness and competency. Authorized researchers using the Biosafety Level 3 facility must also obtain annual personal protective equipment and facility-specific biosafety training, occupational health medical clearance, and if wearing a N95 respirator, an annual fit test must be successfully completed. Completion of these annual requirements needs to be documented and submitted to the Safety and Security Officer.

Useful Links

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For more guidance on antibody validation, see A Proposal for the Validation of Antibodies by M. Uhlen et al. in Nature Methods (2016) 13:823–827. Also, see the following websites.