Training for Personnel Working In or Around Biological Research

Training must take place:

• To allow people to work knowledgeably and safely
• To meet local, state, and federal requirements
• To produce scientific research of the highest quality

5.1 Training Documentation Requirements

For liability and regulatory compliance purposes, we must:

• Document all training (i.e., initial, refresher, lab-specific topics, awareness, or remedial training).
• Document proficiency evaluations.

Why are the records important?

Training records are subject to examination during inspections or audits by oversight and regulatory agencies, and especially during investigations following an incident or exposure. Being able to prove that appropriate training took place can greatly impact the outcome of an investigation in the wake of a lab accident, e.g., fines imposed, criminal prosecution, etc.

How long must records be maintained?

Completed training records (electronic or printed) must be retained for the duration of each person’s employment or activity period in the lab, and for at least 3 years after a lab worker’s separation date.

Where/how must records be maintained?

Printed copies of training records can be kept in the Biosafety Manual, or filed in an easily accessible location in the laboratory.

Electronic copies of training records can be stored in the lab’s SMS records, or other local electronic storage site that is easily accessible to the PI, Lab Manager, and lab personnel.

Who should access and/or maintain the records?

PIs or other supervisory personnel in the lab who have been designated as administrators for the lab in the SMS system can access and track EHS training records for the entire lab group.

5.2 Who Needs To Be Trained, How, And Why

New personnel who will work with biohazards must receive:

1. General training – initial, foundational training in lab safety, biosafety, autoclave use, etc., available in online EHS modules. These trainings have a 3-year expiration, at which time they must be renewed.  Certain other trainings, such as Bloodborne Pathogens and Respiratory Protection, have an OSHA-based annual renewal requirement.
   
   The following training modules must be completed by each person who will be working with biohazardous materials PRIOR to beginning their work at the bench:

• General Laboratory Safety (EHS online module)*
• Biosafety For Research Labs (EHS online module)*
• Introduction to Biological Safety Cabinets  (EHS online module)*
• Safe Autoclave Use (EHS online module)*
• Laboratory Hazardous Waste (EHS online module)*
• Personal Protective Equipment (EHS online module)*
• Any work-dependent training **
• Any specific lab training ***

* Please note that successfully completed EHS online training is recorded electronically. Trainees can access their online training profiles at any time through the EHS Safety Management System; it will display a list of completed trainings and their expiration dates, registrations for training not yet taken, and expired training. A record of completed EHS trainings can be printed from the SMS, if needed. The SMS also allows PIs/lab managers to view/monitor the training records of their lab groups for tracking completions, expired training, etc.

** Work-dependent training includes but is not limited to:

• Persons who work with rDNA molecules or synthetic nucleic acids must complete training on NIH Guidelines for Research Involving Recombinant DNA molecules.
• Additional training may be required or recommended, according to the person’s occupational tasks/risks in the lab, such as Compressed Gas Cylinder Safety and Portable Fire Extinguisher training.  Additional determinations may be made by EHS, IBC and Occupational Health review, in collaboration with the PI.  Example: Respiratory Protection.

*** Specific training – initial orientation and training that is specific to your lab practices, equipment, procedures, and research. This is what is meant by “lab-specific” training, and is provided by PI or designee. Please use the Biosafety Training Record for New Lab Personnel as a guide for this initial, lab-specific training provided by PI or designee, and as a record sheet to document that training.

Existing personnel who work with biohazards will or could need:

1. Lab topics training on new techniques, equipment, biological agents, etc. as they are added to your research program.*
2. Refresher training as needed, or at a regular interval as a lab group (annually, for example).*
   * Use Lab Topics Training Record to document lab topics training or refresher training. The specific topic or reason for a session is entered at the top of the page, and signatures of participants in the training session are recorded on the page. REMEDIAL training when mistakes, exposures, accidents/incidents or “near misses” occur, followed by a proficiency evaluation.
3. Higher level training and proficiency evaluation, such as for those preparing for lab management roles. Please use the Biosafety Proficiency Checklist (5 pages) as a customize-able guide for training, and for documenting proficiency evaluations for remediation or for higher level skills.

The PI or designee is responsible for providing these trainings and evaluations.

Lab personnel from other groups with whom you share lab space, or share common-use equipment or facilities need:

1. Awareness training on the hazardous biological materials manipulated in your lab space or used with common equipment or in common facilities. This should include:

• the identity of the biohazards used or present, and what is done with them
• how to avoid exposure to the biohazards
• how to recognize signs/symptoms of disease caused by your agents, and how to respond if signs/ symptoms occur
• how to respond to and report an incident involving your biohazards

Please use the Bioawareness Training Record as a guide for bioawarness training topics, and to record the training for individuals or groups. The record sheet consists of a topics page, and an optional signature page if you are training a group.

The PI or designee is responsible for providing bioawareness training.

Personnel who work in or around the lab but do NOT work with biohazards need:

1. Awareness training in biohazards as described above.

Please the Bioawareness Training Record as a guide for training topics, and to record the training for individuals or groups. The record sheet consists of a topics page, and an optional signature page if you are training a group.

The PI or designee is responsible for providing this training.

5.3 Guidelines For Trainers/ Proficiency Evaluators To Use

The training record sheets/ checklists themselves (links provided in this manual) can serve as guides or templates. In addition, these documents can be customized by adding additional lab-specific topics as needed.

PIs/ designees can also design their own guidelines or templates.

5.4 Training Delivery

The actual means by which trainees receive their lab-specific training is up to the trainer’s preference.

Example 1: Create a stand-alone session (via PowerPoint, etc.) by using the training topics on the appropriate record sheet as an outline, then supply specific details for/about your lab, per topic. This method works well for initial training for new personnel, and for awareness training.

Maintain copies of any PowerPoint trainings that you develop in the file folder, electronic folder, or section in your Biosafety Manual where you keep personnel training records so that auditors/ inspectors can see the training you provided. Actual delivery of such PowerPoint training can take place in a number of ways; for example:

• trainer presents it in person in a slideshow
• trainees view it on computers on their own schedules
• trainees work through it in hard copy in a notebook

Example 2: Trainer meets with trainees to provide information per topic, using the training record sheet as a guide. PIs/designees can deliver initial lab-specific training, refresher training and awareness training to individuals or groups in this way. Also, this is the most common scenario when a technical specialist, visiting scholar or other person outside the lab group provides a “Lab Topics” training, e.g., a demonstration of a new technique, product, or piece of lab equipment.

5.5 Proficiency Evaluations

When mastery of knowledge, skills and lab techniques need to be assessed for lab personnel, proficiency evaluations are used. The PI can determine the content of the evaluation, and/or the Biosafety Proficiency Checklist can guide an evaluation. The Checklist can be customized to include your specific laboratory proficiency topics.

Prior to being evaluated, lab personnel may need mentoring, coaching, or extra training at the bench; they may also need guidance in finding or accessing educational material to read or study.

Proficiency evaluations must take place through a person-to-person interview between the individual being evaluated, and the person who is evaluating him/her; evaluators must have the necessary expertise and experience in pertinent topic areas. Besides interviewing the person to evaluate his/her knowledge and understanding, the evaluator must also observe the person at work.

5.6 Personnel Biosafety Training Summary

PEOPLE TO TRAIN

1. New lab personnel who will be working with biohazards

• Type of training needed: EHS Online Training
  
  • Training document to use: Training is documented electronically in EHS training database and can be accessed on an individual's EHS Training Profile.
  • What the document certifies: Trainee is credited with successful completion of module. Trainee name, date of completion of training, and when training expires.
  • Who provides training: EHS – online training modules
     
• Type of training needed: Biosafety Training Specific to Your Lab’s Procedures, Equipment and Agents and Safety Orientation (e.g., evacuation routes, safety equipment, reporting procedures, etc.)
  
  • Training document to use: Biosafety Training Record for New Lab Personnel (serves as lab-specific training template for topics to cover, training record sheet, and record of proficiency)
  • What the document certifies: Trainee understands topic areas covered. Trainee is generally proficient in lab procedures covered. Trainee/trainer names, signatures, and date of training
  • Who provides training: Principal Investigator or designee

2. Existing lab personnel who will be working with biohazards

• Type of training needed: Biosafety Refresher or Review and Specific training on new procedures, equipment, etc.
  
  • Training document to use: Lab Topics Training Record (trainer fills in the lab topic covered; trainees/participants sign on a signature page)
  • What the document certifies: Topics covered. Trainee/trainer names and date of training.
  • Who provides training: Principal Investigator or designee

   

• Type of Training Needed: Higher-level, Comprehensive Lab Training and Remedial Training in One or More Areas
  
  • Training document to use: Biosafety Proficiency Checklist (serves as template for topics to cover and proficiency evaluation; can be customized according to need)
  • What the the document certifies: Trainee understands all topic areas covered. Trainee has demonstrated proficiency in specific lab skills and methods covered. Trainee/trainer names, signatures, and date of training.
  • Who provides raining: Principal Investigator or designee

3. Lab Personnel from Other Groups with Whom You Share Lab Space, Facilities or Equipment or Personnel Working In/Around Lab But NOT with Biohazards

• Type of Training Needed: Lab-Specific Training to Provide Awareness of Biohazards Present in Lab, and Appropriate Response to Exposures, Signs of Disease, Lab Incidents
  
  • Training document to use: Bioawareness Training Record (serves as template for topics to cover and training record sheet; can be customized according to situation)
  • What the document certifies: Trainee understands topic areas covered.Trainee/trainer names, signatures, and date of training
  • Who Provides Training: Principal Investigator or designees