RS105 - Procedure for New Laboratories

Objective

To establish a procedure whereby Principal Investigators will be introduced to regulatory requirements and Office of Research practices related to employee health, safety, and environmental compliance.

Scope

This procedure shall apply to all Principal Investigators new to Memphis campus of University of Tennessee Health Science Center and existing Principal Investigators who are moving research operations into new laboratory space.

Roles

Principal Investigators or Laboratory Supervisors shall:
- Ensure that personnel within their lab comply with UTHSC procedures for safety and regulatory compliance. This includes complying requirements of the IACUC, IBC and RSC as well as meeting all requirements pertaining to the completion of training requirements, the use of PPE, hazardous materials handling, and waste disposal.
- Complete the Research Laboratory Move-In Checklist or delegate the completion of the checklist to the Laboratory Safety Manager.
- Delegate the responsibilities of the Laboratory Safety Manager to a researcher within their lab. If no employees are available to act as Laboratory Safety Manager, the Principal Investigator or Laboratory Supervisor shall personally assume the role to ensure completion of those responsibilities.
- Review the performance of the Laboratory Safety Manager and research personnel as part of the annual employee performance review process.
The Laboratory Safety Manager (if appointed) shall:
- Ensure that laboratory activities are conducted at the appropriate chemical safety level or biosafety level and ensure that work practices comply with the institutional requirements expressed in the Chemical Hygiene Plan, Exposure Control Plan, IBC and IACUC protocol requirements and other UTHSC procedures.
- Ensure that all laboratory personnel complete the required safety training.
- Complete the UTHSC Research Laboratory PPE Procedure Template to articulate the laboratory procedure for PPE use and the consequences for non-compliance with PPE requirements.
- Enforce PPE requirements and waste disposal practices within the laboratory on behalf of the Principal Investigator.
- Maintain an accurate hazardous chemical inventory for the hazardous chemicals in the lab using the EHS Assistant web application.
- Perform and document the weekly flush of emergency eyewash stations in the work area.
- If applicable, use EHS Assistant to maintain accurate use and disposal records for radioactive materials.
Office of Research Safety Affairs shall:
- Meet with Principal Investigators to introduce Office of Research requirements for the preparation and filing of research protocols, employee safety training, PPE requirements and other Office of Research Safety Affairs policies.
- Inspect research laboratories prior to the initiation of research, including research on IACUC, IBC or RSC protocols. This inspection is to ensure completion of the Research Laboratory Move- In Checklist, safety training requirements, the availability of PPE, that equipment has been properly set up and certified, and that standard operating procedures (SOPs) have been established for activities involving highly hazardous materials including highly reactive compounds (e.g. pyrophoric materials) or acutely toxic compounds.
- Confirm that a Laboratory Safety Manager has been delegated to monitor or perform routine safety responsibilities.
- Assist with risk assessments and provide guidance for the preparation of IACUC, IBC and RSC protocol preparation.

Definitions

Biological Safety Level (BSL) – A combination of laboratory practices, techniques, safety equipment and laboratory facility features employed to mitigate risk of work with biohazardous agents.

Chemical Safety Level (CSL) – A combination of laboratory practices, techniques and safety equipment employed to mitigate the risk of working with hazardous chemicals.

EHS Assistant – Web-based software application maintained by the Office of Research Safety Affairs and accessible to researchers. EHS Assistant is used to maintain hazardous chemical and radioactive material inventories, document training, and track other regulatory requirements.

Hazardous Chemical – Any substance that capable of causing an acute or chronic health condition in humans or adversely impacting the environment. Substances that are considered physical hazards (flammable substances, explosives, shock sensitive, etc.) are included in the definition of a hazardous substance. The OSHA Hazard Communication Standard, 29 CFR 1910.1200 and the OSHA Chemical Hygiene Plan 29 CFR 1910.1450 are the two main standards that define a hazardous substance.

Institutional Animal Care and Use Committee (IACUC) – UTHSC committee responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and the Guide for the Care and Use of Laboratory Animals (Guide).

Institutional Biosafety Committee (IBC) – The UTHSC committee is responsible for reviewing research activities utilizing recombinant or synthetic DNA (rDNA), infectious agents, biological toxins, and other biohazardous materials to ensure that UTHSC principal investigators and lab personnel utilize appropriate best practices when performing this type of work. All research by UTHSC investigators that utilizes rDNA, as defined in the NIH Guidelines, and other biohazardous materials must be registered with the UTHSC IBC according to policies established in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Laboratory Animal Care Unit (LACU) – The Laboratory Animal Care Unit (LACU) functions as a full-service core supported by the Office of Research, serving all animal related research on the UTHSC campus. The core operates several animal facilities throughout the campus, to best serve the individual research departments and to maintain health status of the colonies.

Laboratory Safety Manager – Individual with safety and compliance responsibilities assigned to them by their supervisor or Principal Investigator.

Principal Investigator (PI) – The holder of an independent grant administered by a university and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often used as a synonym for “head of the laboratory” or “research group leader.”

Radiation Safety Committee (RSC) – The UTHSC committee responsible for reviewing research activities using ionizing and non-ionizing radiation. The RSC will serve as the general procedure forming body for the activities which involve the use of radioactive materials and/or other sources of ionizing and non-ionizing radiations.

Procedure

Upon opening a research laboratory at UTHSC new Principal Investigators shall arrange an orientation meeting with the Office of Research Safety Affairs. This meeting is intended to provide the new Principal Investigator with an introduction to UTHSC policies, procedures, training requirements and filing requirements for research protocols subject to the oversight of the IACUC, IBC, IRB, and RSC.
Complete the safety training requirements assigned by the Office of Research Safety Affairs. Training requirements are determined based on the hazardous materials to be handled and procedures to be performed in the lab. The IACUC also maintains training requirements that must be completed by research personnel prior to entering LACU facilities.
New Principal Investigators and Principal Investigators moving into new laboratory space must complete the Research Laboratory Move-In Checklist included as an attachment to this procedure. Upon completion and prior to initiating research activities this checklist must be emailed to labsafety@uthsc.edu.
Job responsibilities often prevent Principal Investigators from providing a routine presence in their labs. To adequately maintain the laboratory environment and ensure compliance with regulatory requirements the Principal Investigator must delegate a Laboratory Safety Manager. The responsibilities that the Laboratory Safety Manager must meet in the effort to support the Principal Investigator are articulated in the Responsibilities section of this procedure.
Obtain PPE for personnel and visitors entering the lab. PPE requirements are identified in the UTHSC Chemical Hygiene Plan. At a minimum this includes gloves, a lab coat and eye protection for each researcher or visitor. A hazard risk assessment must be performed to determine if additional PPE is required for activities performed in the lab. The PPE must be appropriate for the work to be performed and the materials being handled. Each individual is responsible for maintaining their PPE in clean and useable condition.
Establish a laboratory procedure for the use of PPE. Minimal requirements for PPE use are detailed in the UTHSC Chemical Hygiene Plan. Principal Investigators may opt for more protective and more easily enforceable PPE requirements for their lab. Examples of such alternate policies would be to require the wearing of a gloves, a lab coat and eye protection whenever working at the bench or whenever in the lab. The laboratory procedure for PPE use must include an escalation procedure for staff members not properly wearing PPE in accordance with laboratory procedure. It must also articulate the procedure for when lab coats must be changed out and how this protective equipment is to be laundered. All laboratory personnel must be familiar with this procedure and the consequences for non- compliance.
Contact the Office of Research Safety Affairs to schedule a work area inspection prior to the initiation of research activities in new laboratory space. The intent of this inspection is to verify completion of the UTHSC Laboratory Move-In Checklist, to identify the name of the Laboratory Safety Manager and ensure that the lab is compliant and ready for research activities.

Contact Information

IBC Chairperson: Dr. Mark Miller ibc@uthsc.edu IACUC Chairperson: Jeff Steketee, PhD.

jstekete@uthsc.edu

IRB Reporting/IRB Director Cameron Barclay, cbarclay@uthsc.edu

Occupational Health: Evelyn Wright-Lewis, eohs@uthsc.edu

Office of Research Safety Affairs: (901) 448-6114

labsafety@uthsc.edu

Responsible Official & Additional Contacts

Subject Matter	Office Name	Telephone Number	Email/Web Address
Policy Clarification and Interpretation	Research Safety Affairs	901-448-6114	labsafety@uthsc.edu
Policy Training	Research Safety Affairs	901-448-6114	labsafety@uthsc.edu
Procedure for New Laboratories	Research Safety Affairs	901-448-6114	labsafety@uthsc.edu

Appendices

UT Health Science Center Laboratory Move-In Checklist

UTHSC Research Laboratory Move-In Checklist

Prior to initiating work on research protocols this checklist must be completed to ensure that new research laboratories are set up properly, safety training has been completed and research personnel have completed the orientation necessary to safety handle hazardous materi als. Upon completion this checklist must be emailed to labsafety@uthsc.edu.

Building: Room #(s)

Principal Investigator: Department:

Lab Safety Manager for Lab: Title: Date:

Item	Completed			Date Completed
Research
1. All research projects utilizing recombinant or synthetic DNA, infectious agents, biologically derived infectious materials or biologically active agents (i.e. toxins, allergens, venoms) are registered with the UTHSC Institutional Biosafety Committee (IBC).	Yes	No	N/A
2. All human materials have been registered with the UTHSC Institutional Review Board. (except cell lines from exempt vendors).	Yes	No	N/A
3. All animal protocols are registered with UTHSC Institutional Animal Care and Use Committee (IACUC). Review the Guide to Animal Research at UTHSC to get started.	Yes	No	N/A
4. All research projects involving the use of radioactive materials or ionizing radiation (e.g. x-rays, gamma irradiator, etc.) have been registered with the UTHSC Radiation Safety Committee.
5. The Responsible Official (RO) for the institution, must be notified of all quantities (including exempt quantities) of Select Agent Toxins. (i.e. Tetrodotoxins, Botulinum neurotoxins) as well as the quantify of each. Contact her by emailing jstabeno@uthsc.edu.	Yes	No	N/A
Training
1. New hires have attended HR orientation for your school/department/division/faculty.	Yes	No
2. All staff members, including PI, have completed Laboratory and Chemical Hygiene training http://www.uthsc.edu/research/safety/training.php	Yes	No
3. All staff members, including PI, working with rDNA or materials to be handled at BSL2 have completed Principles of Biosafety (BSL2) training. http://www.uthsc.edu/research/safety/training.php	Yes	No	N/A
4. All staff members, including PI, working with human materials including cell lines have completed Bloodborne Pathogen training. http://www.uthsc.edu/research/safety/training.php	Yes	No	N/A
5. All staff members, including PI, working with radioactive materials, x-rays or lasers have completed Radiation Safety Training. http://www.uthsc.edu/research/safety/training.php	Yes	No	N/A
6. All staff members responsible for shipping infectious substances or dry ice have completed IATA Dangerous Goods and Hazardous Materials Shipping. http://www.uthsc.edu/research/safety/training.php	Yes	No	N/A
7. All Principal Investigators and staff members that handle DEA controlled substances must complete Handling Controlled Substances in Research. http://www.uthsc.edu/research/safety/training.php	Yes	No	N/A
8. Research personnel accessing LACU facilities have completed the Research Personnel Training Requirements and completed the training mandated by the IACUC.	Yes	No	N/A

Manuals and Plans (Must be located and reviewed by all personnel)

Item	Completed			Date Complet ed
1. UTHSC Emergency Response Plan is available at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No
2. UTHSC Chemical Hygiene Plan is available at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No
3. UTHSC Exposure Control Plan is available (if applicable) at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No
4. UTHSC Biosafety Manual is available at: https://www.uthsc.edu/research/safety/documents/campus-safety-biosafety- manual.pdf
Occupational Health
1. Complete the Occupational Exposure to Bloodborne Pathogens or Hepatitis B vaccine (acceptance/declination) form at Occupational Health. Keep records of vaccination offer with Exposure Control Plan.	Yes	No	N/A
2. All staff members entering LACU facilities must complete Initial Health Questionnaire and submit it to Occupational Health for review.	Yes	No	N/A
3. All staff members required to wear a respirator (N95, half-face, full-face or PAPR) must complete the Medical Evaluation Questionnaire for Respirator Users and submit it to Occupational Health for review and approval prior to wearing a respirator.	Yes	No	N/A
4. Complete the Occupational Exposure to Bloodborne Pathogens or Hepatitis B vaccine (acceptance/declination) form at Occupational Health.	Yes	No	N/A
Safety Equipment
1. The lab has the correct and adequate Personal Protective Equipment (PPE) in the lab. (i.e. gloves, safety glasses and/or goggles, lab coats or disposable gowns, UV protective face shield, N95 respirator, etc.)	Yes	No
2. Personnel required to wear a tight-fitting respirator (e.g. N95) must be fit tested by the Office of Research Safety Affairs. Email labsafety@uthsc.edu to schedule fit testing.	Yes	No
3. All PPE (e.g. lab coat and gloves) must be removed before entering non-research areas (i.e. offices, bathrooms)	Yes	No
4. Laboratory policy for PPE policy use, including the escalation procedure for non- compliance, has been completed and reviewed with staff members.	Yes	No
5. Each eyewash station or drench hose in each lab must be inspected, flushed, and documented weekly. Weekly documentation form is located at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No
6. All staff members have received orientation to the location of the nearest emergency eyewash station, safety shower, fire extinguisher, fire alarm pull station and the area of refuge where personnel will congregate in the event of a fire alarm or other emergency in the building.	Yes	No
7. The safety shower been inspected and documented for its annual inspection by facilities?	Yes	No
8. Centrifuges used to handle large volumes or high concentrations of potentially infectious material are equipped with safety cups or sealed rotors with O-rings to contain accidental spills or the potential release of infectious aerosols.	Yes	No	N/A
9. The fume hood been inspected within the last 12 months?	Yes	No	N/A
10. All Biosafety Cabinets (BSC) have been certified within the last 12 months?	Yes	No	N/A
11. An appropriate disinfecting agent (e.g. bleach or hydrogen peroxide-based solution) is available to clean the work surface and grill inside the BSC? (The UTHSC IBC prohibits the use of alcohol as a surface disinfectant IBC-approved protocols.)	Yes	No	N/A
Chemicals

Item	Completed			Date Completed
1. A chemical inventory for materials in the lab has been created and emailed to labsafety@uthsc.edu or entered into EHS Assistant. (Up-to-date chemical inventory must be maintained.) http://www.uthsc.edu/research/safety/safety- information.php	Yes	No	N/A
2. Safety Data Sheets (SDS) for all hazardous chemicals handled in the lab are available on a community computer or in a binder that is accessible to staff members. The MSDS Online internet database can be used to access SDS for the materials in your lab.	Yes	No	N/A
3. All containers (including water) must be labeled to identify their contents. Containers of hazardous chemical must be labeled to identify both the contents and the hazards.	Yes	No	N/A
4. All chemical containers must be closed when not actively in use.	Yes	No	N/A
5. Chemical containers must be properly segregated to separate incompatible materials (i.e. acids from bases, oxidizers from flammables, inorganic acids from organic acids, etc.)	Yes	No	N/A
6. Flammableliquidmaterials stored outside of a flammable liquid storage cabinet must be limited to materials that are “in use.”	Yes	No	N/A
7. No more than 10 gallons of flammable liquid chemicals are permitted from being stored outside an NFPA approved cabinet.	Yes	No	N/A
8. Flammable materials can ONLY be stored in an NFPA rated refrigerator or freezer.	Yes	No	N/A
9. Organic peroxide-forming chemicals (e.g. diethyl ether, THF, 1,4-dioxane, etc.) must be labeled with a received and opened date. Peroxide test strips must be available to periodically test the peroxide concentration in containers of these compounds. Containers with >30ppm of organic peroxides must immediately be discarded as hazardous waste.	Yes	No	N/A
10. Chemical containers stored on the floor must be stored in secondary containment.	Yes	No	N/A
11. Standard operating procedures (SOPs) created for the handling of highly hazardous materials and procedures. These must be reviewed and followed by laboratory staff performing these procedures.	Yes	No	N/A
Controlled Substances
1. Must have a current DEA Registration and TN Board of Pharmacy license to purchase and handle all controlled substances.	Yes	No	N/A
2. All controlled substances must be properly secured and stored when not actively being used.	Yes	No	N/A
3. Access to controlled substances is limited to only Authorized Users.	Yes	No	N/A
4. All Authorized Users must be properly trained in handling, documentation, and how to report lost, stolen or missing controlled substances.	Yes	No	N/A
5. An inventory of all controlled substances must be kept as well as a usage form for each container. A documented audit of this inventory must be performed at least every 2 years.	Yes	No	N/A
6. All expired controlled substances must be properly disposed of by contacting labsafety@uthsc.edu. An accompanying DEA Form 41 must be completed for this disposal and the documentation retained with the DEA registrant’s records.	Yes	No	N/A
Select Agent Toxins
1. All Select Agent Toxins must be properly secured when not in active use.
	Yes	No	N/A
2. Labs that store Select Agent Toxins must keep the lab door locked when nobody is in the lab.	Yes	No	N/A

3. An inventory and usage log must be kept for each container of material.	Yes	No	N/A
4. All unwanted Select Agent Toxins must be deactivated prior to disposal.	Yes	No	N/A
Compressed Gases
1. Each cylinder must be stored upright and secured to the wall or bench counter with chain or a strap.	Yes	No	N/A
2. Cylinder caps must be placed and secured onto the cylinder when the regulator is not attached.	Yes	No	N/A
Chemical Waste
1. All chemical waste must be stored in a container that is in good condition and compatible with the contents to be stored within it.	Yes	No	N/A
2. All chemical waste containers must be closed kept closed when not actively being filled with waste.	Yes	No	N/A
3. All chemical waste containers must be labeled as “hazardous waste” and their contents listed. Labels available at http://www.uthsc.edu/research/safety/safety- information.php	Yes	No	N/A
Biohazardous Waste Handling and Disposal
1. You must decontaminate reusable glassware prior to washing.	Yes	No	N/A
2. Liquid biohazardous waste must be chemically disinfected (e.g. 10% bleach solution) for an appropriate time period, disposed of down the drain, and rinsed with a suitable quantity of water.	Yes	No	N/A
3. All biohazardous solid waste must be collected in a red or orange bag labeled with the biohazard symbol. Biohazard bags are available for purchase at General Stores in the General Education Building (GEB).	Yes	No	N/A
4. Biohazard bags containing solid waste must be placed in Stericycle boxes for shipment and disposal as Regulated Medical Waste. Contact your Business Manager or the Institutional Biosafety Officer (rray3@uthsc.edu) for the location of the Stericycle collection site nearest to you. (BSL2 solid waste does not have to be autoclaved prior to be disposed of into the Stericycle shipment box.)	Yes	No	N/A
5. All biohazardous waste containers must be closed when not actively collecting waste. A nonporous lid must be used for easy decontamination.	Yes	No	N/A
6. All sharps containers must be made of leak proof and puncture resistant material and must be covered when not actively adding material to container.	Yes	No	N/A
7. If using the autoclave for sterilization of glassware please familiarize each staff member with the proper procedures. Located at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No	N/A
General Safety
1. A Laboratory Safety Manager has been appointed to complete ongoing safety and compliance responsibilities such as eyewash station flushing, chemical inventory updates, enforcement of PPE requirements and other items on this checklist.	Yes	No
2. No food or drinks may be stored or consumed inside the lab. Lab staff should be informed where they may take breaks involving food or drink.	Yes	No
3. All staff must wear closed-toed shoes while in the lab	Yes	No
4. All staff must wear long pants or a dress that providing body coverage to at least below the knee. Hair longer than shoulder length must be tied back.	Yes	No
5. Each lab should have available a small first-aid kit for minor incidents.	Yes	No
6. The lab should be free of clutter and organized.	Yes	No
7. Aisles in the lab must be unobstructed at least 36” wide.	Yes	No
8. Minimize the storage of items above eye level, including chemicals.
	Yes	No
9. Cloth chairs not capable of being disinfected are not permitted in the lab space.	Yes	No

UTHSC Laboratory Checklist (continued)

Item	Completed			Date Completed
10. Needles and razor blades must be properly stored to prevent accidental punctures and cuts.	Yes	No
11. If using P32 or I125 radioactive isotopes in the lab you must have available a Geiger counter which Radiation Safety will calibrate every 12 months.	Yes	No
12. Work surface covers must be discarded when dirtied/contaminated.	Yes	No
13. Aspiration flasks on the floor must be stored in secondary containment.	Yes	No
14. An in-line hydrophobic filter must be used when connected to the in-house vacuum line.	Yes	No
15. Purchase a “Broken Glass” box from general stores for all non-biohazardous broken glass. No chemicals, syringes, or biological contaminated materials are permitted in broken glass boxes.	Yes	No
16. A laboratory hazard assessment placard must be completed and posted at the main entrance door to the lab(s). Email labsafety@uthsc.edu if additional placards are needed.	Yes	No
17. Equipment used to store or handle biohazardous material must have a biohazard label affixed.	Yes	No	N/A
18. Equipment and areas used to store and handle radioactive material, including waste, must have a radioactive label affixed. Lab doors must have a radioactive door placard affixed.	Yes	No	N/A
19. The Tennessee Regulation for Radiation Notice signage “Notice to Employees” and “Pregnant Workers” sheet must be posted in labs storing and handling radioactive materials. Located at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No	N/A
20. All refrigerators, freezers, microwaves located in each lab must have a “NO Food” label affixed. Located at http://www.uthsc.edu/research/safety/safety- information.php	Yes	No	N/A
21. All ice machines must be labeled “Ice Not for Human Consumption”. Located at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No	N/A
22. Electrical panels or breaker panels must not be obstructed. At least 36” of unobstructed space must be provided in front of the panel.	Yes	No	N/A
23. Missing or damaged electrical outlet face plates located in the lab must be identified and reported to Facilities by contacting your Business Manager or completing an work order request using the Archibus system.	Yes	No	N/A
Emergency Response
1. The Emergency Contact Numbers sheet posted in the lab. Located at https://www.uthsc.edu/research/safety/documents/emergency-contact-numbers.pdf.	Yes	No	N/A
2. Post biological spill procedures and review them with staff. Located at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No	N/A
3. Post chemical spill procedures and review them with staff. Located at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No	N/A
4. Post radiological spill procedures and review them with staff. Located at http://www.uthsc.edu/research/safety/safety-information.php	Yes	No	N/A