Administering Human Gene Transfer Products | NYU Langone Health

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Institutional Biosafety Guidelines for Research Involving Human Gene Transfer Products Administering Human Gene Transfer Products

Administering Human Gene Transfer Products

NYU’s Institutional Biosafety Committee oversees experiments involving the administration of human gene transfer products to ensure that standard operating procedures are followed. Modeled after the U.S. Occupational Safety and Health Administration’s guidelines on preparing hazardous drugs, the guidelines establish minimum standards for the administration of human gene transfer products requiring biosafety level 2 containment.

The committee may require more stringent procedures or permit less stringent procedures, depending on the risk assessment that was made of the research protocol.

Personnel

Only licensed healthcare providers will administer human gene transfer products. Personnel will not administer human gene transfer products unless they have received adequate instruction about the hazards of the specific products and how to properly implement these standard operating procedures. Support staff such as housekeepers and dietary aids will not enter rooms where human gene transfer products are being administered unless they have received training on the potential hazards and the measure they need to take to protect themselves. Personnel who are required to use National Institute for Occupational Safety and Health–approved particulate respirators will be trained in their use and fit-tested by Occupational Health Services.

Facilities

Human gene transfer products will be administered in private rooms. Surfaces within the room will be smooth and cleanable to facilitate decontamination. In addition, the room will have a sink and soap dispenser for hand washing.

Personal Protective Equipment

Personnel administering human gene transfer products will wear gowns, latex or nitrile gloves and eye protection. Support staff who enter administration areas will wear the same personal protective clothing and equipment.

Work Practices

The doors to the room in which human gene transfer products are administered will remain closed during human gene transfer product administration. Personnel will wash their hands before donning and after removing gloves. Gowns or gloves that become contaminated will be changed immediately. Personnel will not wear personal protective equipment outside the administration area. Such equipment will be discarded in red bags before leaving the administration room. Infusion sets and pumps will have Luer lock fittings and will be observed for leakage during use. A plastic-backed absorbent pad will be placed under the tubing during administration to catch any leakage. Sterile gauze will be placed around any push sites.

Intravenous (IV) tubing connection sites will be taped. Whenever feasible, priming IV sets and expelling air from syringes will be carried out in a biological safety cabinet. If these tasks are done at the administration site, either the line will be primed with a solution that does not contain human gene transfer product or a back-flow closed system will be used. IV containers with venting tubes will not be used. Surfaces such as countertops and equipment such as IV pumps will be wiped clean of any human gene transfer product contamination with a 10 percent solution of chlorine bleach. Reusable goggles will be cleaned with a 10 percent solution of chlorine bleach and properly rinsed.

Waste Disposal

Used needles and syringes and administration sets will be placed into puncture-resistant sharps containers immediately after use. Other waste, including disposable protective clothing and equipment, will be discarded into red bags. Unused human gene transfer product will be returned to the preparation area in a sealed, rigid leak-proof container.

Housekeeping and Linen

Personnel who administer human gene transfer products are responsible for decontaminating all contaminated surfaces and equipment, including spills onto linen and bedding, with a 10 percent solution of chlorine bleach. Support staff will follow routine patient isolation room procedures when cleaning rooms used to administer human gene transfer products and handling linen from such rooms.

Personnel Contamination

Personnel will immediately remove any contaminated clothing and equipment.

Accidental Inoculation or Skin Contact

Personnel will wash the area with soap and running water for at least five minutes, taking care not to vigorously disrupt the skin. They will also take care not to squeeze the inoculation site, since this may increase the risk of spread of the human gene transfer product. Personnel will not use bleach or other strong chemicals to clean an exposure site, because harsh chemicals can damage the skin and increase chances of infection through the skin.

Eye Contact

Personnel will flush the eyes with running water for 15 minutes. After initial treatment, personnel will report to Occupational Health Services, located at One Park Avenue, third floor, in Manhattan, or in off hours to the Ronald O. Perelman Center for Emergency Services, and complete an employee occupational illness and injury report.

Personnel will then notify the principal investigator about the incident, so he or she can file an incident report with the Institutional Biosafety Committee.

Spills

Personnel will be trained to clean spills, and will immediately clean up all spills. Personnel will notify the principal investigator of any large spills, so he or she can file an Incident Report with the Institutional Biosafety Committee. A large spill is one that cannot be absorbed with one 4"× 4" gauze pad or one paper towel.

Spill Clean-up Supplies

The following spill clean-up supplies will be kept in or near the administration area:

  • a freshly prepared solution containing a 1:10 dilution of chlorine bleach with a final concentration of 0.6 percent sodium hypochlorite
  • protective gloves
  • low-permeability gowns
  • shoe covers
  • eye and face protection
  • absorbent towels
  • gauze pads
  • a sharps container
  • a red bag waste container
  • a small scoop with which to collect glass fragments

Clean-up of Small Spills

Personnel will wear double gloves and closed front gowns. Any broken glass fragments will be picked up using forceps or a small scoop and placed in a sharps container. Spilled material will be covered gently with absorbent towels or gauze pads and flooded with an appropriate disinfectant, such as a solution containing a 1:10 dilution of household chlorine bleach with a final concentration of 0.6 percent sodium hypochlorite. After the absorbent materials are picked up, the area will be wiped clean with a 10 percent solution of chlorine bleach soaked absorbent followed by water. Contaminated reusable items, such as glassware and scoops, will be decontaminated with a solution containing a 1:10 dilution of household chlorine bleach. Used clean-up materials and any other contaminated waste will be discarded in red bags.

Clean-up of Large Spills

A large spill is one that cannot be absorbed with one 4"× 4" gauze pad or one paper towel. After a large spill, personnel will stop work immediately, avoid inhaling airborne materials, place absorbent material over the spill and notify others to leave the room immediately. The room will be placed off limits for 30 minutes, to allow aerosols to settle and the ventilation system to purge the air.

Personnel will then proceed as they would in the cleanup of small spills.