All BSL-3 users are required to read and understand the BSL-3 User Guidelines and SOP Manual before beginning any laboratory work. This document outlines critical safety practices, workflow rules, PPE use, and emergency procedures.

You must always ensure that you are referencing the most current version of the Manual.
If you are ever unsure whether your copy is current, stop and notify the BSL-3 RA before proceeding.

It is extremely important that you take adequate time to review this information, as these guidelines are in place for your personal safety, the safety of others in the facility, and for maintaining compliance with institutional and biosafety regulations.  

Please read the Manual thoroughly before completing the remaining training requirements listed below.

Documentation Required:
Acknowledgement of review on the Access Request Form (for new users) /  BL-3 User Annual Recertification Form (for returning users).

TB screening must be completed annually through University Health Services.

Accepted tests include:

• PPD (Tuberculin Skin Test)

• Quantiferon-TB Gold

• Other institutionally approved TB screening tests
  
  

How to Complete TB Screening

1. Schedule your screening:  Email Timothy Eppich to arrange your PPD or blood test.

2. Provide billing information: Include your lab speedtype in your initial email and when you arrive for your appointment.

3. PPD Only:  If you receive a PPD, you must return 48–72 hours later for the test to be read.

4. Record your clearance:  After screening is completed, document the date of TB clearance on the appropriate form.
   
   

If You Have a History of Positive PPD or BCG Vaccination

• A baseline chest X-ray is required (one-time only).

• For annual re-certification, you will complete a TB Symptom Screening Questionnaire instead of repeat testing.

• To request the questionnaire, email Timothy Eppich.

Documentation Required:
Record the Date of TB Clearance on the Access Request Form (new users) and BSL-3 Re-Certification Form (returning users).

All BSL-3 users must complete Respirator Medical Evaluation, Respirator Training, PAPR Training, and Fit Testing before working in the BSL-3.
 

Annual renewal is required.

All instructions can be found on the Case Environmental Health and Safety Website: Respiratory Protection Training

Medical Evaluation (Required Before Training)

1. Log into the health portal: myhealthconnect.case.edu using your CWRU Network ID + passphrase. Authenticate with your date of birth

2. Navigate to: Messages → New Message → “I want to fill out a respirator form” → Continue

3. Complete and submit the form.
   
   

A University Health Services RN will review your form and send a secure message indicating whether you are cleared for fit testing. Do not send any medical information to EHS (Environmental Health & Safety).

Questions about clearance?
Visit University Health Services website or call 216.368.2450.

Respirator Training (OSHA Training & Exam)

Once medically cleared, EHS will assign the training in Canvas: OSHA Respirator Protection Standard Training + Exam. A minimum score of 70% is required for credit. If you do not receive the Canvas invitation within one week, please manually check your Canvas courses.
If the exam appears pre-filled: Select “Take the Quiz Again” to submit a new completion.

PAPR Training (Annual Requirement)

Once Respirator Training is completed: Open Canvas and search for “Powered Air-Purifying Respirator (PAPR) Training”.  Complete the training and quiz. If you cannot access the module, contact the BSL-3 RA.

Fit Testing

After Respirator and PAPR training are complete: Sign up for a fit testing appointment using the google doc link . Fit testing is conducted in person at EHS.

Important:
Fit testing requires the user to be clean-shaven in the respirator seal area. If not clean shaven, you will be required to reschedule.

Current respirator models in use:

• Moldex 2200

• Moldex 2201

• Moldex 2207

• 3M 8210

• 3M 9210

• Others may be added on request 

If You Are Not a CWRU Employee or Student

You must complete respirator medical clearance, training, and fit testing through your home institution and provide documentation to the BSL-3 RA.

Documentation Required:

Requirement                               What to Record                            New Access Form                    Re-Certification Form    

Respirator Training (OSHA) Date Completed     ✅ ✅

PAPR Training + Exam Date Completed     ✅ ✅

Fit Test Date Completed & Respirator Model     ✅ ✅

All BSL-3 users must complete the BSL-3 Safety Competency Exam prior to receiving access, and annually for re-certification.

• The exam is administered online at:  testmoz.com/1645294

• To begin the exam, email the BSL-3 RA to request the exam password.

• A passing score of 80% is required for initial access and continued access to the BSL-3.

- Users are allowed up to three attempts to achieve a passing score.

-  If a passing score is not achieved within three attempts, a review meeting and remediation plan may be required before retaking the exam.

Documentation Required:
Record the Exam Completion Date on the Access Request Form for new users, and on the BSL-3 Re-Certification Form for returning users.

This step is completed only after all previous training requirements (Items 1–4) have been met.

All new users must complete an in-person facility orientation and walk-through with the BSL-3 RA before participating in hands-on training inside the BSL-3.

During this session, the BSL-3 RA will:

• Review basic laboratory rules and expectations

• Introduce the facility layout, including:

-Anteroom, main BSL-3 rooms, equipment locations, emergency supplies

• Demonstrate entry and exit workflows, including:

-Sign-in / sign-out procedures

-PPE donning and doffing sequence

-Hand hygiene and glove changes

• Review safety and emergency procedures, including:

-Spill response

-Exposure and incident reporting

-Alarm and evacuation protocols

This orientation session typically lasts approximately 1.5 hours.
PPE practice and live workflow will occur during the Hands-On In-Lab Training session that follows.

Documentation Required:
Record Orientation Date and Trainer Initials on the Access Request Form (new users).
This step is not required for annual re-certification.

This training occurs for new users after completion of:

1. Guidelines & Manual Review

2. TB Screening

3. Respirator Medical Clearance, Training, PAPR Training & Fit Test

4. BSL-3 Safety Exam

5. Orientation & Lab Tour
   
   

Hands-on training takes place inside the BSL-3 and provides supervised, practical experience with facility workflows, PPE, equipment, and safety practices.
This training is conducted by a designated, certified BSL-3 user from the same research lab who is familiar with the specific protocols and procedures the new user will be performing.

The trainer must:

• Be an approved, active BSL-3 user

• Have prior BSL-3 experience

• Be listed as a designated trainer for their lab or project
  
  

Training Content Includes:

• BSL-3 Entry & Exit Procedures

• PPE donning and doffing, including PAPR setup and glove layering

• Correct workflow practices to reduce contamination and exposure

• BSC operation, including:

-Verifying airflow

-Proper workspace setup

-Safe pipetting and manipulation of infectious materials

• Surface and equipment decontamination

• Biohazard waste disposal and liquid waste disinfection

• Sharps handling and disposal

• Incident response procedures (spills, splash exposures, glove tears, alarms)
  
  

Training is performed at the bench and will require a minumum of 3 sessions; more depending on user proficiency and task complexity.

Training Documentation & Competency Sign-Off

A Hands-On Training Form will be completed during this process.
The form documents:

• Activities covered during training

• The user’s demonstrated proficiency

• A confidence / competency rating for each task
  
  

Both the Designated Trainer and the BSL-3 RA must sign off to verify that the user has demonstrated safe, consistent, and independent work practices.

Only after sign-off is complete may the user proceed to the next step: Requesting ID card access to work independently in the BSL-3.

Documentation Required:

Completion of Hands -One Training checklist  - signed by the trainer and BSL-3 RA
Record training dates and trainer initials on the Access Request Form.

When all the requirements above have been completed:

Complete the  BSL-3 New User Access Request Form  (for NEW users only)

For users who need to continue their access, complete the BSL-3 Annual Re-Certification Form

This step is completed only after all previous training requirements have been successfully completed and signed off.

To Receive or Restore BSL-3 ID Access:

For New Users or Users Who Have Lost Access

Complete the BSL-3 New User Access Request Form  to request initial ID card activation.
This form verifies that all required training elements have been completed and documented.

Once the form is submitted and reviewed, the BSL-3 RA will request that ID access be activated for the BSL-3 facility.

For Users Maintaining Active Access (Annual Re-Certification)

Users must complete Re-Certification Steps 1–4 within 30 days of their current access expiration date to keep access active.

If the user completes steps within this timeframe:

• Access remains active

• No additional forms are required beyond the BSL-3 Annual Re-Certification Form
  
  

If ID Access Has Already Expired

If the user does not complete re-certification within the 30-day grace period:

• ID access will automatically deactivate

• To regain access, the user must:

  1. Repeat all training requirements (1–6), not just re-certification steps

  2. Submit the BSL-3 Annual Re-Certification Form to request reinstatement

Access will only be reactivated after full training completion and RA sign-off.

Documentation Required:

• New Users: Submit BSL-3 New User Access Request Form

• Returning Users: Submit BSL-3 Annual Re-Certification Form  

Each Principal Investigator who wishes to have members of their research group work in the BSL-3 must determine whether they will be a Qualified PI or Unqualified PI.

Qualified PI

• Meets all training and certification requirements required of BSL-3 users.

• May enter and independently work in the BSL-3 facility.

• May also train members of their research group (if certified as a designated trainer).
  
  

Unqualified PI

• Does not meet user training requirements.

• May NOT enter or work in the BSL-3 facility.

• Still maintains oversight responsibility for their research personnel working in the facility.
  
  

PI Responsibilities (Both Qualified and Unqualified)

All PIs — regardless of qualification status — must:

• Ensure all personnel working under their protocols complete and maintain BSL-3 certification.

• Submit and maintain approved BSL-3 research protocols through the BSL-3 Advisory Committee.

• Ensure that all experiments conducted in the BSL-3 match the approved protocol (no unapproved methods, strains, or materials).

• Support ongoing training, safety compliance, and operational accountability for their team.

• Communicate any proposed protocol changes, personnel changes, or experimental modifications to the BSL-3 RA.

PI Agreement Form

All PIs must complete and sign a PI Agreement Form confirming that they:

• Understand the rules, operational expectations, and compliance requirements of the BSL-3 facility.

• Acknowledge their responsibility for oversight of their research personnel.

• Indicate whether they elect to be Qualified or Unqualified.
  
  

Documentation Required:
Signed PI Agreement Form (required before any lab members may begin training).