All non-exempt research that involves recombinant DNA [rDNA] molecules must be in compliance with the NIH Guidelines for Research Involving rDNA Molecules [NIH Guidelines]. The NIH Guidelines are published in the Federal Register and specify practices for constructing and handling (i) rDNA molecules and (ii) organisms and viruses containing rDNA molecules. The NIH Guidelines can be accessed from the NIH Office of Biotechnology Activities web page, http://www4.od.nih.gov/oba. The Institutional Biosafety Committee [IBC] is responsible for the review of all research involving rDNA and assessment of the risk and the biosafety containment level required by the NIH Guidelines for the proposed research.

Each investigator proposing to use rDNA must register such experiments with the IBC and receive approval. This must be done regardless of the source of funding and includes research supported by departmental funds. As for all research compliance practices, such as the use of human and animal subjects, awarded grants will not be authorized until the rDNA experiments are reviewed and approved.

1. Molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate inside living cells, or;
   
2. Molecules that result from the replication of those described in (1) above.

Experiments using rDNA molecules as defined above are to be registered with the IBC. Note that experiments using transgenic animals are not exempt and must be registered with the IBC. However, the purchase or transfer of transgenic rodents for experiments that require BL1 containment are exempt.

Experiments involving the following must be registered with the IBC, Office of Biotechnology Activities (OBA) at the NIH, and submitted to the FDA for approval before initiation:

• Transfer of a drug resistance trait to microorganisms that do not acquire the trait naturally.
• Human gene transfer experiments (see Appendix M of the NIH Guidelines).

The IBC is comprised of at least, but not limited to, five members with collective experience and expertise in rDNA technology and the capability to assess the safety of rDNA research and identify any potential risk to public health or the environment. Committee members are appointed by the Vice Dean for Research and serve for unlimited terms. The membership of the IBC includes:

1. at least two members who are not affiliated with the New York University School of Medicine (apart from their membership on the IBC) and who represent the interest of the surrounding community with respect to health and protection of the environment, such as officials of state or local public health or environmental protection agencies, members of other local government bodies, or persons active in medical, occupational health, or environmental concerns in the community;
2. at least one member representing the laboratory technical staff;
3. at least one member with expertise in rDNA technology, biological safety and physical containment;
4. the Biological Safety Officer;
5. at least one individual with expertise in plant, plant pathogen or plant pest containment principles when experiments involve plants and required prior IBC approval (See NIH Guidelines, Appendix P);
6. at least one scientist with expertise in animal containment principles when experiments involve animals and require prior IBC approval (See NIH Guidelines, Appendix Q);
7. or has available as consultants persons knowledgeable in New York University School of Medicine commitments and policies, applicable law, standards of professional conduct and practice, community attitudes and the environment.

When the New York University School of Medicine participates in or sponsors rDNA research involving human subjects, the IBC will have adequate expertise and training or will appoint ad hoc consultants, as necessary, to ensure that the Committee has the professional competence necessary to review such research.

The New York University School of Medicine will file an annual report with the National Institutes of Health/Office of Biotechnology Activities (NIH/OBA) which includes:

1. a roster of all IBC members; and
2. biographical sketches of all IBC members, including community members.

No member of the IBC will be involved, except to provide information requested by the IBC, in the review or approval of a project in which he/she has been or expects to be engaged or has a financial interest (See Investigator Financial Disclosure and Conflict of Interest Policy).

1. All non-exempt research involving rDNA shall be conducted in accordance with the current version of the NIH Guidelines.
2. All non-exempt research involving rDNA molecules shall be performed at the appropriate biosafety level, as described in the current editions of the NIH Guidelines and Centers for Disease Control (CDC)/NIH Guidelines: Biosafety in Microbiological and Biomedical Laboratories. .
3. Principal investigators shall assume primary responsibility for the proper use, handling and disposal of all rDNA molecules associated with their research.
4. Failure to comply with this policy may result in an administrative review and a possible suspension of approval to work with non-exempt rDNA molecules, as outlined in section XII of this policy.

The NIH has determined that the following rDNA molecules are exempt from the NIH Guidelines. Researchers do not need to register experiments involving these molecules with the IBC:

1. Those that are not in organisms or viruses.
2. Those that consist entirely of DNA segments form a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
3. Those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means.
4. Those that consist entirely of DNA from an eukaryotic host including its chloroplasts, mitochondria, or plasmids (but not excluding viruses) when propagated only in that host (or a closely related strain of the same species).
5. Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers is prepared and periodically revised by the NIH Director with advice of the Recombinant DNA Advisory Committee [RAC] after appropriate notice and opportunity for public comment (see Appendices A - I through A - VI of the NIH Guidelines for a list of natural exchangers that are exempt from the NIH Guidelines).
6. Those that do not present a significant risk to health or the environment, as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment (see Appendix C of the NIH Guidelines for other classes of experiments, which are exempt form the NIH Guidelines).

1. Experiments involving the purchase of, or the transfer of, transgenic rodents that require Biosafety Level 1[BL-1] containment are exempt from the NIH Guidelines.
2. Other experiments involving transgenic animals generally are not exempt from the NIH Guidelines.

• The Vice Dean for Research is the institutional official charged with the responsibility of ensuring that research conducted at or sponsored by NYU School of Medicine fully conforms to the provisions of the NIH Guidelines.On behalf of the NYU School of Medicine, the Vice Dean assumes the responsibilities delineated in Section IV-B-1 of the NIH Guidelines.
• The Institutional Biosafety Committee (IBC) reports to the Vice Dean for Research. The IBC is responsible for reviewing all experiments involving rDNA for compliance with the NIH Guidelines. The Committee's responsibilities include:

1. Assuming all of the responsibilities delineated in section IV-B-2 of the NIH Guidelines.
2. Meeting semi-annually and as needed to review and approve experimental protocols and discuss programmatic issues.
3. Investigating allegations of non-compliance with the NIH Guidelines and determining appropriate follow-up on a case-by-case basis.
4. Providing training to conduct experiments at the appropriate biosafety levels. Training will be done by the Biosafety Officer and the Environmental Services department, and includes on-line tutorials for working with blood borne pathogens and an introduction to biosafety.
   
• Principal Investigators [PI's] are responsible for full compliance with the NIH Guidelines in the conduct of their rDNA research. This includes
  1. Assuming all of the responsibilities delineated in Section IV-B-7 of the NIH Guidelines.
  2. Registering all non-exempt rDNA experiments with the IBC.
  3. Filing annual renewal forms with the IBC for all non-exempt rDNA experiments.
  4. Re-registering their experiments with the IBC when there are significant changes.
  5. Instructing and training laboratory and support personnel in the practices and techniques required to insure safety and proper emergency response, and notification procedures in the event of an accident or injury.
  6. Providing written instructions to laboratory and support personnel when the research involves large-scale uses of organisms containing rDNA, as required in Appendix K-II-B of the NIH Guidelines.
  7. Familiarizing laboratory and support personnel with the symptoms of exposure and other pertinent information about the materials used in the experiment before allowing them to work with the materials.
  8. Supervising the safety performance of laboratory personnel to ensure that the required safety practices and techniques are employed.
  9. Informing laboratory and support personnel of the reasons and provisions for any precautionary medical practices advised or requested, such as immunization or serum collection.
  10. Selecting personal protective equipment (e.g., lab coats, gloves and eye protection) based on the experimental procedures used in the lab, and providing it to laboratory personnel.
  11. Maintaining written documentation of training, including instruction in laboratory safety procedures, for all laboratory personnel.
  12. Having biosafety cabinets certified by the NYU School of Medicine contractor on an annual basis, and when moved.
  13. Notifying and reporting in writing to the IBC Coordinator any significant problems or incidents pertaining to the operation and implementation of containment practices and procedures, and reporting such incidents to the Biological Safety Officer, Animal Facility Director (where applicable), NIH/OBA, and other appropriate authorities (if applicable) in accordance with Section IV-B-7-e-2 of the NIH Guidelines.
  14. Correcting conditions that may result in the release of biohazardous materials.
  15. Complying with all reporting requirements for human gene transfer experiments delineated in Appendix M of the NIH Guidelines.
      
• The Senior Director of Environmental Services is the Biological Safety Officer [BSO].
  • The BSO or his designee is responsible for:
    1. Assuming all of the responsibilities defined in Section IV-B-3 of the NIH Guidelines.
    2. Inspecting lab and animal facilities, if applicable, whenever a project requires containment at or above BL-2. Assessing whether the facilities provide appropriate containment.
    3. Serving as a resource to PI's and the IBC on matters pertaining to biosafety.
• The Associate Dean for Research Administration for the Office of Sponsored Programs Administration is responsible for coordinating the activities of the IBC. This includes:
  1. Maintaining IBC registration forms and records.
  2. Communicating with IRB or IACUC when experimental protocols involve human subjects or animals.
  3. Providing an initial review of allegations of non-compliance with the NIH Guidelines, and preparing reports for the IBC.
  4. Preparing reports required by the NIH Office of Recombinant DNA Activity.

VII. PROCEDURE FOR REGISTERING AND RENEWING REGISTRATION OF EXPERIMENTS INVOLVING rDNA WITH THE IBC

The forms used to register and renew rDNA research, along with the Biosafety Level-2 Checklist, are available from SPA and on their website at:
Forms and Applications.

• Initial Registration
  1. The Registration Form for Recombinant DNA Experiments [Registration Form] is used to register such research with the IBC. A Registration Form is valid for 3 years, with an annual review during this time. A new Registration Form must be filed whenever there are significant changes in an experiment.
     
  2. The Biosafety Level-2 [BL-2] Checklist for Labs [the BL-2 Checklist] is an attachment to the Registration Form. It solicits information about the PI's facilities, containment equipment, and procedures. The BL2 Checklist must be completed and submitted with the Registration Form whenever a project requires containment at or above BL-2.
     
     • The NYU School of Medicine Biological Safety Officer, or his/her designee, will arrange for an inspection of the lab to assess whether containment facilities are appropriate for the designated experiments.
• Annual Renewal
  1. An approval is valid for a maximum of one year.
  • Approximately 35 days before the end of the approval period, the IBC Coordinator reminds the PI to submit a Renewal Form. However, PI must file a revised registration form at any time that significant changes are made in the approved protocol.
    
• Re-registration
  1. After 3 years, the PI must submit a new Registration Form.
  2. Approximately 35 days before the end of the approval period, the IBC Coordinator reminds the PI to submit a new Registration Form.

VIII. IBC REVIEW AND APPROVAL OF EXPERIMENTS

1. Registration Forms and BL-2 Checklists, when required, are submitted to the IBC Coordinator for entry into the database.
2. Chair and BSO provide an initial review of protocols. If the experiments require containment conditions at BL-2 or higher, BSO interviews the PI and inspects the proposed laboratory and/or animal facilities.
3. Chair and BSO indicate whether the protocols should be approved, revised to address additional issues, or referred to the entire committee for review.
4. If required, the IBC meets to discuss and resolve issues concerning those Registration Forms that are not approved. Otherwise, the Chair will approve re-reviews.
5. A list of protocols and actions taken, with comments from the Chair and BSO, will be forwarded to committee members every two months.
6. The IBC Coordinator informs PI's, whose experiments are under review, about the status of approval process.
7. The IBC Coordinator forwards copies of approved Registration Forms and/or approval letters to other Committees as appropriate (e.g., Institutional Animal Care and Use Committee, Human Subjects Internal Review Board).

IX. REGISTRATION OF HUMAN GENE TRANSFER PROTOCOLS

Human gene transfer research protocols must be submitted to the NIH Recombinant DNA Advisory Committee (RAC) for review prior to local IBC approval. No research participant may be enrolled in a clinical study until the RAC review process is completed and IBC and IRB approvals and applicable regulatory authorizations are obtained.

Investigators seeking IBC approval for human gene transfer protocols must submit the following:

1. Response to Appendix M of the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (7 copies).
2. Copy of RAC review and any comments (7 copies).
3. Investigator's Brochure and Protocol (2 copies).
4. IRB-approved Informed Consent Form (7 copies).
5. Standard Operating Procedures [SOP] for the planned protocol in a document separate from the Response to Appendix M (7 copies) including:

   A. Facilities: List all buildings and rooms where the genetically engineered virus will be stored, prepared, administered, and where in-patients will be housed following treatment. Infection Surveillance and Environmental Services must inspect and approve all facilities.
   B. Personnel: List all personnel (e.g. physicians, pharmacists, nurses) involved in the handling and administration of the genetically engineered virus and the care of participating subjects. Provide names, titles, and departments of personnel.
   

   i. The PI must arrange for Environmental Services or Infection Surveillance to provide Biosafety Training covering the hazards of working with genetically engineered virus and the necessary safety procedures before final IBC approval.
   

   ii. The PI also must arrange for Environmental Services to provide any required Respiratory Protection Training and Fit-Testing before final IBC approval.

   C. Standard Operating Procedures (SOPs): The SOPs must incorporate the manufacturer's recommended precautions and address the specific conditions at NYU Medical Center as described below
   

   i. SOPs must include specific procedures for the following:
   

   a) Work with virus in the Pharmacy (or preparation area)
   b) Transport within the Medical Center, and to off-site locations
   c) Administration of virus d) Post-administration subject care (in-patient and out-patient)
   e) Post-administration handling of subject samples and specimens
   f) Autopsy
   g) Spills
   h) Accidental personnel exposures

   
   ii.The SOPs should identify the type of Infection Control Precautions (e.g. Standard Precautions, Contact Precautions, Respiratory Precautions) required for the protocol. In addition, SOPs should describe clearly all equipment (e.g. biosafety cabinets), safe work practices, protective equipment (e.g. gloves, gowns, goggles, masks), and personal protective equipment (e.g. respirators) needed to protect staff, subjects, and family members.

X. IBC REVIEW AND APPROVAL OF HUMAN GENE TRANSFER PROTOCOLS

1. IBC Coordinator distributes copies of required documents to committee members for preliminary review.
2. Following preliminary review, additional information may be requested prior to the IBC meeting.
3. The IBC will approve, disapprove, or withhold approval pending revisions. No protocol will be approved until PI submits documentation that protocol has been submitted to the RAC.
4. The PI is responsible for complying with NIH OBA annual data reporting requirements. Annual data report forms are forwarded by NIH OBA directly to investigators. Investigators must file a copy of their annual report with the Coordinator of the IBC.
5. The PI is responsible for reporting any serious adverse event immediately to the IRB, IBC, Office for Human Research Protections (if applicable), and NIH OBA, followed by submission of a written report filed with each group.

XI. ACCIDENTS INVOLVING rDNA

1. Spills

• All spills involving potentially hazardous rDNA must be treated promptly with an appropriate disinfectant.
• Any spill involving a material that is assigned to Biosafety Level 2 or 3, which occurs outside a biological safety cabinet, must be reported to the BSO (x35159).

2. Exposures

• All exposures (inhalation, inoculation, ingestion or skin contact) involving material that is assigned to Biosafety Level 2 or 3 must be immediately referred to Employee Health Services of the Emergency Room.

3. NIH Reporting Requirements

• Significant problems with or violations of the NIH Guidelines, and accidents and exposures involving rDNA must be reported to the IBC Coordinator, who prepares reports as required by the NIH.

XII. NON-COMPLIANCE WITH THE NIH GUIDELINES

1. Allegations of non-compliance with the NIH Guidelines are forwarded to the IBC Coordinator.
2. The IBC Coordinator reviews the allegations and submits a report to the Chair of the IBC.
3. If the review indicates that an approved user may have willfully or negligently violated School of Medicine policy governing the use of rDNA, the IBC determines the appropriate course of action:
   • The Chair of the IBC may place an administrative hold on the rDNA experiments.
   • The Chair of the IBC may call an emergency committee meeting to discuss the allegations and any action that needs to be taken.
   • The IBC may temporarily suspend or revoke an approved user's IBC approval. A quorum of voting members is needed to take this action.

XIII. APPEALS

Disputes regarding interpretation of this policy or decisions made by the IBC are referred to the Vice Dean for Research for adjudication.

APPENDIX: STANDARD OPERATING PROCEDURES FOR HUMAN GENE TRANSFER PROTOCOLS

APPENDIX A:
Standard Operating Procedures for Preparation of Human Gene Transfer (HGT) Products (modeled after OSHA's guidelines for preparing hazardous drugs)

1. Purpose

• To establish minimum standard operating procedures for the preparation of HGT products requiring biosafety level 2 containment.
• The Institutional Biosafety Committee may require more stringent procedures, or permit less stringent procedures based on its assessment of risk for each protocol.

2. Personnel

• A Registered Pharmacist, trained in the preparation of HGT products, will provide oversight and maintain required records.
• Individuals will receive appropriate training before they are allowed to prepare gene transfer products.

3. Storage of HGT Products

• Products will be stored in locked cabinets posted with a BIOHAZARD sign.

4. Work Areas

• Access to the preparation area will be restricted when gene transfer products are being prepared. Signs restricting the access of unauthorized personnel will be displayed prominently on all entrances to the work area.
• The preparation area will have a sink for hand washing.
• Eating, drinking, smoking, chewing gum, applying cosmetics, and storing food in the preparation area will be prohibited.
• Procedures for spills and personnel exposures will be posted in the work area.

5. Biological Safety Cabinets

• HGT products will be prepared in a Class II biological safety cabinet which has been certified and maintained in accordance with National Sanitation Foundation Standard Number 49. Arrangements for certification and maintenance will be made through Environmental Services.
• Live viral vectors will not be prepared in the same biological safety cabinet as chemotherapy or other drugs.
• The biological safety cabinet will be located in an area with minimal air turbulence, in order to minimize leakage to the environment.
• When feasible, the biological safety cabinet will not be used for other purposes during the course of a HGT study. It will be dedicated exclusively to the study.
• The interior of the biological safety cabinet will be thoroughly decontaminated before preparation of a gene transfer product, and after such use.
  • The exhaust fan/blower will be left on during cleaning.
  • The interior surface will be wiped with a 10% solution of chlorine bleach. Spray bottles will not be used, due to the risk of spraying the HEPA filter.
  • Removable work trays, if present, will be lifted in the biological safety cabinet so the back and any sump below can be cleaned. In the event that cleaning the sump requires cabinet disassembly (e.g. removing screws), this need only be done at terminal disinfection.
  • During cleaning, personnel will wear gloves and a closed front gown. If there is a removable work tray, personnel also will wear splash goggles and a NIOSH-approved particulate respirator (N-95 or better).
  • Cleaning will proceed from least to most contaminated areas.
  • All materials from the decontamination process will be discarded into autoclave bags or sharps disposal containers, and autoclaved prior to disposal.

6. Personal Protective Equipment

• Gloves
  • Personnel will wear latex or nitrile gloves that are long enough to cover the gown cuff when preparing gene transfer products.
  • Personnel will wear double gloves if this does not interfere with their technique.
  • Gloves will be changed hourly or immediately if they are torn, punctured, or contaminated due to a spill.
  • Hands will be washed with a germicidal soap before gloves are put on and after they are removed.
  • Personnel will avoid touching gloved hands to their faces.

 

• Gowns
  • A protective disposable gown made of lint-free, low-permeability fabric with a closed front, long sleeves, and elastic or knit closed cuffs will be worn when gene transfer products are being prepared.
  • The cuffs will be tucked under the gloves. If double gloves are worn, the outer glove will be over the gown cuff and the inner glove will be under the gown cuff.
  • When the gown is removed, the inner glove will be removed last.
  • Gowns and gloves will not be worn outside the preparation area.

7. Work Equipment

• Gene transfer products will be prepared in a biological safety cabinet on a shallow tray covered with a disposable, plastic-backed paper liner.
  • The liner will be changed after preparation is completed for the day.
  • Liners also will be changed after any overt spill.
• Syringes or IV fittings will be of the Luer-lock type.
• A sharps container will be in, or immediately adjacent to, the biological safety cabinet for disposal of contaminated glass and sharps.
• Autoclave waste containers will be located immediately adjacent to the biological safety cabinet for disposal of all other contaminated materials (including gloves, gowns, and paper liners).

8. Work Practices

• Personnel will use aseptic technique when preparing gene transfer products.
  • Manipulations will not be performed close to the work surface of a biological safety cabinet.
  • Unsterilized items, including liners and hands, will be kept downstream from the working area.
  • Entry and exit of the cabinet will be perpendicular to the front.
  • Rapid lateral hand movements will be avoided.
• Gloves and gowns will be donned before work is started in biological safety cabinet.
• All items necessary for product preparation will be placed within the biological safety cabinet before work is begun.
• Extraneous items will be kept out of the work area.
• Vacuum lines and systems will be protected with disinfectant traps and filters.
• All syringes and needles used in the course of preparation will be discarded in sharps containers without being crushed, clipped or capped.
• If it is necessary to recap contaminated needles, personnel will use a one-handed technique.
• If it is necessary to remove contaminated needles from syringes or IV lines, personnel will use a method that minimizes the risk of needle stick, such as forceps removal.
• IV administration sets will be attached and primed within the biological safety cabinet, prior to addition of the gene transfer product.
• If priming must occur at the site of administration, the intravenous line will be primed with a fluid that does not contain gene transfer product, or a back-flow closed system will be used.
• Extremes of positive and negative pressure in vials will be avoided, e.g., attempting to withdraw 10 cc of fluid from a 10-cc vial or placing 10 cc of a fluid into an air-filled 10-cc vial.

9. Packaging Gene Transfer Products for Internal or External Transport

• The outside of bags or bottles containing the prepared product will be wiped with alcohol moistened gauze.
• Entry ports will be wiped with moist alcohol pads and capped.
• Prior to transport, bags, bottles, and syringes will be placed in sealed plastic bags or containers designed to avoid breakage.
• The outside container will be labeled with a BIOHAZARD label, the agent, the number of viral particles or plaque forming units, the owner's (responsible person's) name and telephone number, and the notation "SPECIAL HANDLING & DISPOSAL PRECAUTIONS".

10. Waste Disposal

• All needles and sharps will be placed in puncture-resistant sharps disposal containers immediately after use.
• All waste possibly contaminated with gene transfer products will be autoclaved before being placed in regular hospital waste stream for disposal as regulated medical waste.

11. Personnel Contamination

• Initial treatment
  • 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 several minutes, taking care not to vigorously disrupt the skin. They also will take care not to squeeze the inoculation site, since this may increase the risk of spread of the gene transfer product
  • Eye contact: Personnel will flush the eyes with copious amounts of running water for several minutes.
  • Personnel will not use bleach or other strong chemicals to clean an exposure or other wound site, because harsh chemicals can damage the skin and increase chances of infection through the skin.
• After initial treatment, personnel will report to Health Services or the Tisch Hospital Emergency Room (if Health Services is closed) and complete an Employee Occupational Illness and Injury Report.
• Personnel will notify the Principal Investigator about the incident, so he/she can file an Incident Report with the Institutional Biosafety Committee.

12. 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/she can file an Incident Report with the Institutional Biosafety Committee. A large spill is one which cannot be absorbed with one 4"x4" gauze pad or one paper towel.
• Spill Clean-up Supplies
  • The following spill clean-up supplies will be kept in or near preparation areas: a freshly prepared 10% solution of chlorine bleach, protective gloves, low-permeability gowns, shoe covers, splash goggles, NIOSH-approved particulate respirators (N95 or better), absorbent towels, gauze pads, a sharps container, an autoclave waste container, and a small scoop to collect glass fragments.
• Clean-up of Spills in Biological Safety Cabinets
  • The exhaust fan/blower will be left on during cleaning.
  • Personnel will wear double gloves and closed front gowns.
  • Spilled material will be covered gently with absorbent towels or gauze pads and flooded with an appropriate germicide, such as 10% chlorine bleach.
  • After the absorbent materials are picked up, the area will be wiped clean with a 10% solution of chlorine bleach, followed by water, and then 70% ethanol.
  • Any broken glass fragments will be picked up using a small scoop and placed in a sharps container.
  • If the area underneath the main work surface becomes contaminated, it will be decontaminated with a 10% solution of chlorine bleach, followed by water, and then 70% ethanol.
  • Contaminated reusable items, such as glassware and scoops, will be decontaminated with a 10% solution of chlorine bleach before being removed from the biological safety cabinet.
  • The interior surface of the biological safety cabinet will be wiped with a 10% solution of chlorine bleach. Spray bottles will not be used, due to risk of spraying the HEPA filter.
  • Used clean-up materials and any other contaminated waste will be discarded in autoclave bags.
• Clean-up of Small Spills outside Biological Safety Cabinets
  • A small spill is one that can be absorbed with one 4"x4" gauze pad or one paper towel.
  • Personnel will wear double gloves, closed front gowns, shoe covers, splash goggles, and NIOSH-approved particulate respirators (N95 or better).
  • Spilled material will be gently covered with absorbent towels or gauze pads and flooded with an appropriate germicide, such as 10% chlorine bleach.
  • After the absorbent materials are picked up, the area will be wiped clean with a 10% solution of chlorine bleach, followed by water, and then 70% ethanol.
  • Any broken glass fragments will be picked up using a small scoop (never the hands) and placed in a sharps container.
  • Used clean-up materials and other contaminated waste will be placed in autoclave bags.
  • Contaminated reusable items, such as glassware, scoops and splash goggles, will be placed in the biological safety cabinet and decontaminated with 10% bleach.
• Clean-up of Large Spills outside Biological Safety Cabinets
  • A large spill is one that cannot be absorbed with one 4"x4" gauze pad or one paper towel.
  • 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 proceed as in Clean-up of Small Spills outside of Biological Safety Cabinets.

13.Training

• Personnel will be trained in the hazards of the specific products, and to properly implement these standard operating procedures.
• Personnel will be trained to use NIOSH-approved particulate respirators, and will be fit-tested by Environmental Services.

APPENDIX B:
Standard Operating Procedures for Administration of Human Gene Transfer (HGT) Products (modeled after OSHA's guidelines for preparing hazardous drugs)

1. Purpose

• To establish minimum standard operating procedures for the administration of HGT products requiring biosafety level 2 containment.
• The Institutional Biosafety Committee may require more stringent procedures, or permit less stringent procedures based on its assessment of risk for each protocol.

2. Personnel

• Only licensed healthcare providers will administer HGT products.
• Personnel will not administer HGT products unless they have received adequate instruction from Environmental Services or Infection Surveillance about the hazards of the specific products and how to properly implement these standard operating procedures.
• Support staff (e.g. housekeepers, dietary aids) will not enter rooms used to administer HGT products unless they have received training from Environmental Services or Infection Surveillance on the potential hazards and the measures they need to take to protect themselves.
• Personnel who are required to use NIOSH-approved particulate respirators, will be trained and fit-tested by Environmental Services before using them.

3. Facilities

• HGT products will be administered in private negative pressure rooms that have at least 6 air changes per hour and either 100% exhaust or HEPA filtration prior to recirculation.The Institutional Biosafety Committee and Infection Control Committee will consider requests for exemptions from this requirement if it can be demonstrated that aerosols cannot be generated during or after the procedure.
• The administration room will have a sink for hand washing.

4. Personal Protective Equipment

• Personnel administering HGT products will wear gowns, latex or nitrile gloves, eye protection, and NIOSH-approved particulate respirators (N95 or better) unless the Institutional Biosafety Committee approves a lower level of protection.
• Support staff who enter administration areas will wear the same personal protective clothing and equipment as administration personnel.

5. Work Practices

• The doors to the room will remain closed during HGT product administration.
• Personnel will wash their hands with a germicidal soap 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 autoclave waste 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. 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 done at the administration site, the line will be primed with a solution that does not contain HGT product or a back-flow closed system will be used. IV containers with venting tubes will not be used.
• Surfaces (e.g. countertops) and equipment (e.g. IV pumps) will be wiped clean of any HGT product contamination with a 10% solution of chlorine bleach.
• Reusable goggles will be cleaned with a 10% solution of chlorine bleach and properly rinsed.

6. Waste Disposal

• Used needles and syringes and administration sets will be placed into autoclaveable puncture-resistant sharps containers, identified specifically for HGT waste, immediately after use.
• Other waste, including disposable protective clothing and equipment, will be discarded into autoclave bags.
• Unused HGT product and all other waste generated in the administration area will be returned to the preparation area. All waste will be autoclaved before it is placed in the regular waste stream for disposal as regulated medical waste.

7. Housekeeping and Linen

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

8. Personnel Contamination

• Initial treatment
  • 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 several minutes, taking care not to vigorously disrupt the skin. They will also take care not squeeze the inoculation site, since this may increase the risk of spread of the gene transfer product
  • Eye contact: Personnel will flush the eyes with copious amounts of running water for several minutes.
  • 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.
• After initial treatment, personnel will report to Health Services or the Tisch Hospital Emergency Room (if Health Services is closed) and complete an Employee Occupational Illness and Injury Report.
• Personnel will notify the Principal Investigator about the incident, so he/she can file an Incident Report with the Institutional Biosafety Committee.

9. Spills

• Spill Kits
  • The following spill clean-up supplies will be kept in or near administration areas: a freshly prepared 10% solution of chlorine bleach, protective gloves, low-permeability gowns, shoe covers, splash goggles, NIOSH-approved particulate respirators (N95 or better), absorbent towels, gauze pads, a sharps container, an autoclave waste container, and a small scoop to collect glass fragments.
• Personnel who administer HGT products 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/she can file an Incident Report with the Institutional Biosafety Committee. A large spill is one which cannot be absorbed with one 4"x4" gauze pad or one paper towel.
• Clean-up of Small Spills
  • A small spill is one that can be absorbed with one 4"x4" gauze pad or one paper towel.
  • Personnel will wear double gloves, closed front gowns, shoe covers, splash goggles, and NIOSH-approved particulate respirators (N95 or better).
  • Spilled material will be gently covered with absorbent towels or gauze pads and flooded with 10% chlorine bleach.
  • After the absorbent materials are picked up, the area will be wiped clean with a 10% solution of chlorine bleach, followed by water.
  • Any broken glass fragments will be picked up using a small scoop (never the hands) and placed in a sharps container.
  • Used clean-up materials and any other contaminated waste will be placed in autoclave bags.
  • Contaminated reusable items, for example glassware, scoops and splash goggles, will be placed in the biological safety cabinet and decontaminated with 10% bleach.

10. Clean-up of Large Spills

• A large spill is one that cannot be absorbed with one 4"x4" gauze pad or one paper towel.
• 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 proceed as in Clean-up of Small Spills.