BIOLOGICAL SAFETY PROGAM

This Manual was prepared to provide you with information and basic work practices to reduce the significant risk posed by exposure to biologic substances and to provide health and safety protection in the laboratory work place. It provides reasonable procedures to follow whenever dangerous incidents occur. It is sufficiently informative to enable you to be aware of the hazards present and to know what work practice to follow to reduce the probability of injury and accidents. Nevertheless, the manual is not meant to cover every conceivable situation or to be the final, authoritative source for all laboratory safety. It is a resource fostering a positive and considerate attitude towards health and safety. With your corporation and common sense we can be assured that the goals herein expressed may be realized. The New York Medical College Biosafety Safety Manual assigns and communicates safety and health responsibilities in several distinct sections, so that supervisors, students and laboratory personnel can easily find and understand what performance is expected of them. The valuable contributions of the Office of the Vice President, the Office of the General Counsel, the Department of Environmental Health and Safety, the Security Department, the Department of Health Services, and the members of the Academic Community are hereby acknowledged in developing this manual. __________________________________________________________________ William Liedy Associate Vice President for Campus Operations ___________________________________________________________________ William Collesano, MS, CSP, RS/REHS Director of Environmental Health and Safety Date__________________________

4/30/2003

EMERGENCY PHONE NUMBERS

Security Mr. Matthew Hersh 914-594-4226 Environmental Health & Safety Mr. William Collesano 914-594-4078 Facilities Mr. Jon Darcy 914-594-4574 Health Services Joseph Dursi, M.D. 914-594-4234 Hudson Valley Poison Control Center Phelps Memorial Hospital 800-336-6997

BASIC SCIENCES BUILDING

Biochemistry Ernest Y.C. Lee, Ph.D. 914-594-4055 Cell Biology & Anatomy Joseph D. Etlinger, Ph.D. 914-594-4028 Microbiology Ira S. Schwartz, Ph.D. 914-594-4175 Pathology Myron R. Melamed, M.D. 914-594-4150 Pharmacology John C. McGiff, M.D. 914-594-4075 Physiology Gabor Kaley, Ph.D. 914-594-4085 Comparative Medicine Ellen M. Levee, D.M.V. 914-594-4215 Instrument Shop Mr. Nicholas P. Ludas 914-594-4024 Medical Sciences Library Ms. Diana Cunningham 914-594-4200 Cafeteria Mr. Neil Fern 914-594-4580

CLINICAL DEPARTMENTS

Anesthesia Kathryn E. McGoldrick, M.D. 914-493-7692 Community & Preventive Medicine Joseph Cimino, M.D. 914-594-4253 Continuing Medical Education Joseph Dursi, M.D. 914-594-4487 Dentistry Joseph F. Morales, D.D.S. 914-493-7622 Dermatology Bijan Safai, M.D. 914-594-4566 Emergency Medicine Gregory Almond, M.D. 212-423-6262 Family Medicine Joseph L. Halback, M.D., Ph.D. 914-594-4605 Medicine William Frishman, M.D. 914-594-4383 Neurology Brij Singh Aluwalia, M.D 914-594-3222 Neurosurgery William Couldwell, M.D., Ph.D. 914-594-3202 Obstetrics & Gynecology Jeffrey C. King, M.D. 212-604-2512 Ophthalmology Joseph B. Walsh, M.D. 212-979-4447 Orthopedic Surgery David E. Aspirino 914-493-8294 Otolaryngology Steven D. Schaefer, M.D. 212-979-4071 Pediatrics Leonard J. Newman, M.D. 914-594-4280 Psychiatry Joseph T. English, M.D. 914-493-1905 Radiation Medicine Basil Hilaris, M.D. 718-920-9752 Radiology Terence Matalon, M.D. 914-493-8546 Rehabilitative Medicine Catherine Hinterbuchner, M.D. 914-594-4274 Surgery John A Savino, M.D. 914-594-4352 Urology Muhammad S. Choudhury, M.D. 914-594-4300

4/30/2003

SAFETY COMMITTEE MEMBERS

Academic Administration Bonnie Gurran-Heindl 914-594-4517 Administration 914-594-4570 Administration & Finance Ed Jacobson 914-594-4632 Biochemistry 914-594-4068 Cell Biology & Anatomy Ms. Joanne Abrahams – 1199 914-594-4242 Comparative Medicine Ellen Levee, D.V.M. - Chair 914-594-4215 Comparative Medicine Ms. Louisa Cassone – 1199 914-594-4215 Employee Health Services Ms. Diane Hackert 914-594-4235 Environmental Health & Safety Mr. William Collesano 914-594-4447 Environmental Health & Safety Mr. Gary Hohenstein 914-594-3293 Environmental Health & Safety Mr. Matty Mozzor 914-594-4448 Environmental Health & Safety Ms. Colleen O'Meara 914-594-4721 Environmental Health & Safety Mr. Justin Williams 914-594-3454 Environmental Health & Safety Ms. Janet M. Powers-Secretary 914-594-4078 Environmental Health & Safety Mr. Patricio Villalon 914-594-3292 Facilities Mr. Jon Darcy 914-594-4574 Facilities Mr. Joseph Harnach 914-594-3061 General Counsels Office Mr. Waldemar Comas 914-594-4567 General Councils Office Ms. Avda Kay Bartsch 914-594-3024 Human Resources Ms. Theresa Gelchie 914-594-4563 Human Resources Mr. Thomas Darcy 914-594-4599 Operations Mr. William Liedy 914-594-3755 Pathology Alan Jeffrey, Ph.D. 914-594-3105 Pharmacology C. Andrew Powers, Ph.D. 914-594-4136 Physiology Michael Wolin, Ph.D. 914-594-4093 Physiology Mr. Manuel Ochoa – 1199 914-594-4098 Security Mr. Matthew Hersh 914-594-4226 Student Housing Ms. Candy Hack 914-594-4832

4/30/2003

RADIOISOTOPE COMMITTEE MEMBERS

Academic Administration Ms. Rosemary Martino 914-594-4517 Biochemistry Esther Sabban, Ph.D. 914-594-4068 Cell Biology & Anatomy Kenneth Lerea, Ph.D. 914-594-4097 Comparative Medicine Ellen M. Levee, D.M.V. 914-594-4215 Environmental Health & Safety Mr. Matty H. Mozzor 914-594-4448 Environmental Health & Safety Mr. William Collesano 914-594-4447 Environmental Health & Safety Ms. Janet M. Powers - Secretary 914-594-4078 Dept. of Medicine Annarosa Leri, M.D. 914-594-4168 Microbiology Jan Geliebter, Ph.D. 914-594-4873 Operations Mr. William Liedy 914-594-3755 Pathology Henry Godfrey, M.D. 914-594-4160 Pharmacology C. Andrew Powers, Ph.D. - Chair 914-594-4136 Physiology Francis L. Belloni, Ph.D. 914-594-4109 Radiology Maynard High, Ph.D. 914-493-1410 Radiology St. Vincents, NY Hussein Abdel-Dayem, M.D. 212-604-8783 Security Mr. Matthew Hersh 914-594-4226

4/30/2003

BIOLOGICAL SAFETY PROGRAM

TABLE OF CONTENTS

1.0 Introduction 1.1 Scope 1.2 Chemical Safety 1.3 Radiation Safety 1.4 Responsibilities 1.5 Periodic Review

2.0 Laboratory Design 2.0 General 2.1 Risk Assessment 2.2 Biological Inventory 2.3 Primary Barriers 2.4 Secondary Barriers 2.5 Personal Protective Equipment 2.6 Biosafety levels 2.7 Recombinant DNA 2.8 Cell Lines/Cultures 2.9 Waste Disposal 2.10 Biological Spills 2.11 Decontamination 2.12 Medical Consultation 2.13 Signage 3.0 Select Agents 4.0 Exposure Control Plan-General 4.1 OSHA Bloodborne Pathogen Standard-A Brief Overview 4.2 New York Medical College Policy 5.0 Standard Operating Procedures

5.1 Autoclave 5.2 Biological Spill 5.3 Centrifuge Use 5.4 Containment Laboratory Operations 5.5 Controlled Drugs 5.6 Personal Protective Equipment 5.7 Regulated Medical Waste 5.8 Emergency Response

A. Autoclave B. Biological Spill C. Illness and/or Injury Response D. Needlestick and Bloodborne Response

5.9 Standard Operating Procedures for Transferring or Receiving Select Agents

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6.0 Regulated Medical Waste-General 6.1 Regulations 6.2 Definitions 6.3 General Labeling, Packaging, and Disposal Procedures 6.4 Non-Regulated Medical Waste 6.5 Regulated Medical Waste Chart 7.0 Training 7.1 Laboratory Safety Training Program 7.2 Bloodborne Pathogen Training Program 7.3 Regulated Medical Waste Training Program 7.4 Autoclave Safety Training Program 8.0 Regulatory Agencies 8.1 OSHA 29 CFR 1910.1030 8.2 OSHA 29 CFR 1910.1450 8.3 New revision to 29 CFR 1910.1030 8.4 6 NYCRR Part 360, 364 8.5 DOH 70-3.2 8.6 DOH 70-1.4, and 3.3-3.4 8.7 42 CFR Part 1003 9.0 Appendix A Classification of Agents Based on Risk Assessment B. Biosafety Cabinets C. Biosafety Levels D. New York Medical Policy on Exposure Control E. Biohazard Sign F. Federal Laws and Regulations Affecting Laboratories G. Select Agents H. Shipping Requirements of Biohazardous Materials

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INTRODUCTION

It is the policy of New York Medical College to prevent and minimize, to the fullest extent practical, all risks to the health, safety and well being of all employees and students while at NYMC. Pursuant to the requirements of health, safety, and environmental regulations issued by Federal, State of New York, and local agencies the College established this Biological Safety Manual to protect employees and students from potential health hazards associated with the handling, use, storage and disposal of biological organisms in the laboratory.

1.1 Scope

The Biological Safety Manual applies to all laboratories at NYMC, except those clinical laboratories located at Affiliation Hospitals of New York Medical College. These hospitals have their own Biological Safety Plan. The safe handling, use, storage and disposal of biological organisms in the laboratory require policies for the protection of students, employees, and the environment. Biological organisms are the focus of increasing regulatory actions by the federal, state, and local governments. The purpose of this plan is to provide the user with basic safety information regarding the use of biological organisms. The Biological Safety Manual is an adjunct to the New York Medical College Chemical Hygiene Manual, and the Radiation Safety Manual, copies of which are available at the Department of Environmental Health and Safety, Room 230, Vosburgh Pavilion, phone 594-4078.

1.2 Chemical Safety

The Chemical Hygiene Manual applies to all laboratories at New York Medical College. The safe storage, handling, use and disposal of chemicals in the laboratory require policies for the protection of the students, employees and the environment. See the Chemical Hygiene Manual for proper work practices involving chemical use.

1.3 Radiation Safety

The safe storage, use, handling and disposal of radioactive materials require control measures similar to those found in chemical safety. However, there are some differences in practice. See the Radiation Safety Manual for proper work practices involving radioactive materials.

1.4 Responsibilities

A. The Department of Environmental Health and Safety (EHS) is responsible

for working with the faculty, staff, students, and others to develop and implement appropriate biological safe practices and procedures. To accomplish this:

1. The Director of EHS or his/her designee shall be the College

Biological Safety Officer.

12. EHS will establish procedures to:

• Monitor the procurement, use and disposal of biological organisms used in the laboratory.

• Assure, on a periodic basis, that appropriate safe laboratory practices are conducted and that records are maintained.

• Help Principal Investigators (PI’s) develop precautions and adequate facilities.

• Review the current legal requirements for regulated medical waste.

B. Deans and/or department chairpersons are responsible for establishing and maintaining compliance with the Biological Safety Manual (BSM). To this end, deans and department chairs may wish to designate safety officers within the schools or departments. A designated safety officer should hold the rank of associate professor or full professor. The deans and/or department chairpersons are responsible for reporting unsafe acts, conditions or inadequate facilities to EHS.

C. A Principal Investigator (PI) [Laboratory Supervisor] has the overall

responsibility for compliance with the BSM in his or her laboratory. This responsibility may not be shifted to inexperienced or untrained personnel. Responsibilities of the P.I. include:

1. Preparation of Laboratory Standard Operating Procedures 2. Laboratory workers and others entering laboratory know and follow

biologic safety rules and Laboratory Operating Procedures. 3. Protective equipment is available, in working order and is used

properly. 4. Appropriate training has been provided to all occupants of the

laboratory. 5. Reporting unsafe acts, conditions, or inadequate facilities to their

Chair/Director, Department Safety Officer or EHS.

D. Individual laboratory workers are responsible for:

1. Planning and conducting each operation in accordance with the standard operating procedures (SOP) outlined in this BSM and Laboratory specific SOP’s

2. Wear personal protective equipment 3. While working ensure that protective equipment is operating properly 4. Developing good laboratory techniques. 5. Reporting unsafe acts or conditions to their Principal Investigator,

Chair/Director, Departmental Safety Officer, or EHS.

E. Wherever biological organisms are used a written operating procedure must be developed and implemented. These operating procedures must be capable of protecting laboratory workers and others from the hazards associated with the hazardous biological organisms used in the laboratory. This manual serves as the reference document for all operating plans developed at NYMC.

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This Biological Safety Manual (BSM) shall be: 1. Available in the laboratory for laboratory workers, safety officers,

EHS. 2. Consistent with New York Medical College’s safety policies.

F. The New York Medical College Biologic Safety Committee is responsible for advising and recommending to the Department of Environmental Health and Safety the minimum requirements of the BSM that all laboratories must follow. The Safety Committee shall review the BSM in January of each year.

1.5 Periodic Review

Principal Investigators will, at minimum, review and update the inventory list of the biological organisms to keep current in work practices. It will be the management’s responsibility utilizing the Biosafety Committee to review the entire program annually. As necessary, portions of the manual will be revised to reflect changes in the College’s operations or regulatory requirements. The changes will be approved by the Safety Committee and forwarded to the laboratories after the changes have been incorporated.

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LABORATORY DESIGN AND OPERATION

2.0 General

Microbiological laboratories are special, often unique work environments that may pose identifiable infectious disease risks to persons in or near them. Infections have been contracted in the laboratory throughout history. Research suggests that laboratory personnel are at an increased risk of being infected by the agents they handle and they have higher rates of tuberculosis, shigellosis, and hepatitis B than does the general population. This manual will serve as a general reference for some laboratory activities utilizing infectious agents, and is guided by CDC/NIH Publication: Biosafety in Microbiological and Biomedical Laboratories (BMBL), 4th edition and OSHA 1910.1030 Bloodborne Pathogen Standard.

2.1 Risk Assessment

Risk implies the probability that harm, injury or disease will occur. In the assessment of risk in the microbiological laboratory, the focus is primarily on the prevention of laboratory associated infections. The risk assessment helps to assign the biosafety levels (facilities, equipment, and practices) that reduce the laboratory worker exposure to an agent to an absolute minimum. Risk assessment provides guidance and establishes a framework for selecting the appropriate biosafety level. Factors of interest in a risk assessment include:

• Pathogenicity of the infectious or suspected infectious agent, including disease incidence and severity (i.e., acute versus chronic).

• Route of transmission (e.g., parental, airborne, or by ingestion). Agents that can be transmitted by the aerosol route have caused most laboratory infections.

• Agent stability. This is the ability of the agent to survive over time in the environment (e.g., spore forming bacteria).

• Infectious dose of the agent. The laboratory worker’s immune status is directly related to his/her susceptibility to disease when working with an infectious agent.

• Concentration. The number of infectious organisms per unit volume. • Origin. This may refer to geographic location (e.g., domestic or foreign); host

(e.g., infected or non-infected human); or nature of source (e.g., potential zoonotic or associated with a disease outbreak).

• Availability of data from animal studies. • Availability of effective prophylaxis or therapeutic intervention. • Medical Surveillance.

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The characteristics of most known infectious agents have been well identified. Information useful to risk assessment can be obtained from laboratory

investigations, disease surveillance, and epidemiological studies. If the agent is unknown a conservative approach is advisable. See Appendix A (Classification of Biohazardous Agents by Risk Group) in section 8.

2.2 Laboratory Biological Inventory

Each laboratory must develop or adopt a biosafety or operations manual that identifies the hazards that will or may be encountered, and that specifies practices and procedures designed to minimize or eliminate exposures to these hazards. Personnel should be advised of special hazards and should be required to read and follow the required practices and procedures. A biological inventory must be prepared, regularly updated, posted, and copied to the Department of Enviromental Health and Safety.

2.3 Primary Barriers

When standard laboratory practices are not sufficient to control the hazards associated with a particular agent additional measure must be taken. Those measures are additional safety practices and techniques that are supplemented by appropriate facility and engineering designs. Safety equipment includes biological safety cabinets, that are enclosed containers, and other engineering controls designed to remove or minimize exposures to hazardous biological matter. The biological safety cabinet (BSC) is the principle device used to provide containment of infectious splashes or aerosols generated by many microbiological procedures. There are three types of biological safety cabinets used in the laboratory (Class I, II, and III). See Appendix B in Section 8. Open fronted Class I and class II biological cabinets are primary barriers that offer significant levels of protection to laboratory personnel and to the environment when used with good technique. The Class II biological cabinet also provides protection from external contamination of the materials. The gas tight Class III biological cabinet provides the highest attainable level of protection to personnel and the environment. A safety centrifuge cup is another example of a primary barrier designed to prevent aerosols from being released during centrifugation. Both the appropriate safety cabinets and safety centrifuges should be used when handling infectious agents that can be transmitted through the aerosol route of exposure.

2.4 Secondary Barriers

Secondary barriers refer to the facility design and construction of the building. Secondary barriers contribute to laboratory worker protection, provide a barrier to protect persons, animals, and the community from infectious agents which may be accidentally released from the laboratory. The recommended secondary barrier will depend on the risk of transmission of specific agents. An example of a secondary

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barrier is the separation of the laboratory work area from public access, with decontamination facility, and handwashing facilities.

2.5 Personal Protective Equipment

Personal Protection Equipment is any device used to protect the laboratory worker when handling infectious agents. In addition to the biological safety cabinets, personal protection equipment may include gloves, coats, shoe covers, respirators, face shields, safety glasses, or goggles. This equipment is often used in combination with biosafety cabinets and other devices that contain the agent, animal, or materials being handled. Personal protective devices and safety equipment must be provided to all employees under the appropriate circumstances. Employees have the responsibility of properly using and maintaining them, after proper training is provided.

2.6 Biosafety Levels

There are four biosafety levels. What level a laboratory should operate by is determined after a risk assessment has been done. The different levels are described in Appendix C in Section 8. The recommended biosafety level for the organism represents those conditions under which the agent ordinarily can be safely handled. The laboratory supervisor is specifically and primarily responsible for assessing the risk and appropriately applying the recommended biosafety level. When specific information is available to suggest that virulence, pathogenicity, antibiotic resistance patterns, vaccine and treatment availability, or other factors are significantly altered; more or less stringent practices may be specified.

2.7 Recombinant DNA

This category of agents includes microorganisms that have been genetically modified through recombinant DNA technologies. These technologies continue to evolve rapidly. The National Institutes of Health publication, NIH Guidelines for Research Involving Recombinant DNA Molecules, Amendment December 28, 2000 (66 FR 1146) is a key reference in establishing an appropriate biosafety level for work involving recombinant microorganisms.

Among the points to consider in work with recombinant microorganisms are:

• Does the inserted gene encode a known toxin or a relatively uncharacterized toxin?

• Does the modification have the potential to alter the host range or cell tropism of the virus?

• Does the modification have the potential to increase the replication capacity of the virus?

• Does the inserted gene encode a known oncogene? • Does the inserted gene have the potential for altering the cell cycle? • Does the viral DNA integrate into the host genome? • What is the probability of generating replication-competent viruses?

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This list of questions is not meant to be inclusive. Rather, it serves, as an example of the information needed to judge whether a higher biosafety level is needed in work with genetically modified microorganisms.

2.8 Cell Lines/Cultures

When cell cultures are known to contain an etiologic agent or an oncogenic virus, the cell line can be classified at the same level as that recommended for the agent. Unfortunately, many cell lines have not been classified, and most cell lines have not been thoroughly tested for the presence of viruses. Several vertebrate species carry complete copies of viral genomes in their DNA, even though whole virus is not released from the cell. Scientists handling mammalian cells may be handling viruses unwittingly. The possibility exists that human material with no known infection may contain HIV, HBV, tuberculosis or other pathogens.

1. Sub-primate cell lines and continuous cell cultures, which do not harbor a

primate virus, and are not contaminated with bacteria, mycoplasma, or fungi can be handled at BSL1. (See Appendix C in Section 8)

2. The following cell lines or tissues should be handled following BSL2 containment and practices, whether or not they have been shown to harbor a pathogenic agent: (See Appendix C in Section 8).

• all non-continuous cell lines derived directly from human clinical

materials; • all human clinical materials (e.g., samples of human tissues and fluids

obtained after surgical resection or autopsy); • all non-human primate tissue; • all cell lines producing infectious viral particles • all mycoplasma-containing cell lines: and • many human or non-human primate cells derived from lymphoid

tissue, tumor tissue, or cells transformed by primate oncogenic viruses. 3. According to American Type Culture Collection (ATCC), no cell line has

been shown to harbor an etiologic agent or an oncogenic virus requiring the precautions necessary for Biosafety Level 3 or 4.

2.9 Waste Disposal

All laboratory specimens or materials consisting of, containing, or contaminated with blood, plasma, serum, urine, feces, or other human or animal tissues or fluid, as well as inoculated media, cultures, and other potentially infectious materials must be disposed of properly. New York Medical College has a Regulated Medical Waste Program in place for this purpose. See Section 5 in this manual for more details on the program. All glassware, pipettes, slides, etc., used in the examination or testing of biological material must be autoclaved or chemically disinfected before being discarded or

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prepared for reuse. Single-use bottles, tubes, vials, and other biological specimen containers should not be placed in wastebaskets customarily emptied by janitorial personnel. They should be discarded in a clearly labeled biohazard container. Any material to be sent out of the laboratory for autoclaving must be clearly marked as such. Hypodermic syringes, needles, tips, scalpels, and broken glass shall be disposed of in the appropriate size sharps container.

2.10 Biological Spills

Since spills of biological material will happen, it is important to be prepared prior to dealing with the problem. Laboratories at New York Medical College have a biological spill kit ready to use at all times. They are centrally located and easy to use with instructions available. Environmental Health and Safety is equipped to handle many spills that may occur at the College. If there is the slightest doubt how to proceed, do not hesitate to call EHS for assistance x4078. (8-5pm Monday-Friday). For specific procedures on how to clean up a biological spill see Section 4.7 for details.

2.11 Decontamination

Decontamination is defined as the reduction of microorganisms to an acceptable level. Methods applied to reach this goal can vary and most often include disinfection or sterilization. Disinfection is used when the acceptable level of microorganisms is defined as being below the level necessary to cause disease. Viable organisms are still present. In contrast, sterilization is defined as the complete killing of all organisms present. Depending on what item is needed to be decontaminated it will be either sterilized or disinfected. It is important to consider the type of biohazardous agent, concentration and potential for exposure. There are four types of physical and chemical means of decontamination:

• Heat • Liquid chemicals • Vapors and Gases • Radiation

Disinfection is normally accomplished by applying liquid chemicals or wet heat during boiling or pasteurization. In sterilization vapors and gases, radiation and wet heat (steam sterilization in an autoclave) are used. There are also liquid chemicals, which if used in the right concentration and incubation time, sterilize effectively. The laboratory worker must consult with the appropriate source to use the correct method that is needed to do the job correctly.

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2.12 Medical Consultation

Employees and students must notify their immediate supervisor or instructor of any illness and injury due to exposure to hazardous agents. Contact your supervisor, instructor, EHS, or Health Services if you have any questions regarding the procedure for treating a non-emergency injury or illness. For campus emergencies requiring an ambulance call Security x4226. Tell the security officer the location and nature of the emergency. The ambulance will take the injured person to Westchester Medical Center. Non-emergency situations should be reported to Health Services x4234.

2.13 Signage

All devices, structures and areas where hazardous material are used, or where hazards or possible hazards may exist will be identified with appropriate hazard warnings. Common sense is required in the use of Hazard Warning Signs so their effectiveness is not lost by overuse. Hazard Warning Signs are not to be abused for personal reasons such as to keep people out of an area or to discourage use of laboratory material or equipment. Any temporary posting of a hazard should be replaced as soon as possible by an acceptable permanent sign or removed when the hazard no longer exists. Biological Hazard Sign shall be used to signify the actual or potential presence of a biohazard and to identify equipment, containers, rooms, materials, experimental animals, or combinations thereof, which contain, or are contaminated with viable hazardous agents. See Appendix E in Section 8.

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Select Agents 3.0 Select Agents

The Antiterrorism and Effective Death Penalty Act of 1996 establishes provisions to regulate transfer of government defined hazardous agents which are termed select agents. A list of select agents is contained in Appendix G. Commercial suppliers of select agents, as well as government agencies, universities, research institutions, individuals, and private companies that transfer or obtain these agents, must register with the CDC. Registration is done on both an individual laboratory basis as well as an institutional basis. EHS has registered NYMC. Contact EHS for registration forms necessary to obtain and transfer select agents. The law and regulation require that NYMC identify a responsible facility official (RFO). William Collesano, the Director of EHS, has been chosen the RFO for NYMC. The law also requires that the laboratory personnel must demonstrate its ability to work safely with the select agents, and keep the records of select agents transferred to and from its facilities. All registration records will be kept in the EHS Department. PI’s must ensure their laboratories are equipped with the necessary equipment and their staff demonstrates an ability to work safely with these agents. Demonstrations are accomplished by annual inspections of laboratories working with select agents to ensure facilities and procedures provide the level of containment and personnel training necessary. All records regarding personnel competency are kept both in EHS and the specific laboratory. The principal Investigators who plan on using one of the select agents must fill out the form titled Identification of Investigators Using CDC Select Agents and Toxins, see Appendix H.

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EXPOSURE CONTROL PLAN-GENERAL

4.0 EXPOSURE CONTROL PLAN-GENERAL

New York Medical College is committed to protecting its employees from risks associated with exposure to bloodborne pathogens through implementation of its Exposure Control Plan. This plan follows the requirements established by the Occupational Safety and Health Administration (OSHA) in December, 1991 (29 CFR 1910.1030). The Rule addresses definitions, work practices, procedures, equipment and policies related to staff training, information, dissemination, preventative and post incident medical interventions. The Exposure Control Plan also incorporated the revisions mandated by the Needlestick Safety and Prevention Act that was passed in November 2000. All employees at NYMC that have a reasonable anticipated risk for exposure to bloodborne pathogens must complete appropriate training. The following principles must be followed when an employee or student has the potential for exposure to bloodborne pathogens:

• Minimize all exposures to bloodborne pathogens; • Institute as many engineering and work practice controls as possible to

eliminate or minimize employee exposure to bloodborne pathogens; • Routinely employ Universal Precautions (A method of infection control that

treats all human blood and other potentially infectious materials as capable of transmitting HIV, HBV, and other bloodborne pathogens) when exposure to blood or potentially infectious materials is anticipated.

• Initiate a safe needle program whereas non-managerial staff will evaluate safe needle use in their department.

The Exposure Control Plan for New York Medical College will be at minimum reviewed annually.

4.1 OSHA Bloodborne Pathogen Standard-a Brief Overview

(Full text located in Section 8.1 of this manual) OSHA published the Occupational Exposure to Bloodborne Pathogens Standard in 1991 because of significant health risk associated with exposures to viruses and other microorganisms that cause bloodborne diseases. Of primary concern is the human immunodeficiency virus (HIV) and hepatitis B and hepatitis C viruses. The standard set forth requirements for employers with workers exposed to blood or other potentially infectious materials. In order to reduce or eliminate the hazards of occupational exposure, an employer must implement an exposure control plan for the worksite with details regarding employee protection measures. The plan must also describe how an employer will use a combination of engineering and work practice controls, ensure the use of protective clothing and equipment, training, medical surveillance, hepatitis B vaccinations, and signs and labels, among other provisions. In response to both concern over the estimated 600,000 exposures per year and the technological developments which can increase employee protection, Congress passed the Needlestick Safety and Prevention Act. This directed OSHA to revise the Bloodborne Pathogen Standard to establish in greater detail requirements that employers identify and make use of effective and safer medical devices. That revision was published on Jan, 18, 2001, and became effective April 18, 2001.

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The revision to OSHA’s Bloodborne Pathogen Standard added new requirements for employers, including additions to the exposure control plan and keeping a sharps injury log. It does not impose new requirements for employers to protect workers from sharps injuries; the original standard already required employers to adopt engineering and work practice controls that would eliminate or minimize employee exposure from hazards associated with bloodborne pathogens. The revision does, however, specify in greater detail the engineering controls, such as safer medical devices, which must be used to reduce or eliminate worker exposure. The revision also includes an annual review and update to reflect changes in technology that eliminate or reduce exposure to bloodborne pathogen.

4.2 New York Medical College Policy (See Appendix D).

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Standard Operating Procedures

Table of Contents

5.0 Standard Operating Procedures - General 5.1 Autoclave 5.2 Biological Spill 5.3 Centrifuge Safety 5.4 Containment Laboratory Operations 5.5 Controlled Drugs 5.6 Personal Protective Equipment 5.7 Regulated Medical Waste 5.8 Emergency Response

A. Autoclave B. Biological Spill C. Illness and/or Injury D. Needlestick and Bloodborne Response

5.9 Standard Operating Procedures for Transferring or Receiving Select Agents 13

5.0 Standard Operating Procedures - General

The Department of Environmental Health and Safety (EHS) has developed Standard Operating Procedures (SOP) for equipment and certain situations encountered in the laboratory. These SOP’s were written to:

• Prevent and minimize risks to the health, safety, and well being of the employees and the students while at the College.

• Promote employee awareness and understanding of possible hazards at work and ways to counteract them.

• Ensure that New York Medical College meets the requirements of health, safety and environmental regulations issued by Federal, State, and local agencies.

Adherence to the SOPs by all New York Medical College lab workers is mandatory. It is the responsibility of the Principal Investigator of each laboratory to review the SOPs and ensure that the protective equipment and procedures outlined are in place. It is also the responsibility of the Principal Investigator to submit a written request to EHS for any deviation from the Standard Operating Procedure. EHS will evaluate the request on a case-by-case basis. Written approval of the amended policy must be in the possession of the Principal Investigator prior to implementation of the revised procedures.

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5.1 Standard Operating Procedure for Autoclave Use

Purpose To provide guidance in the use of autoclaves. Precautions and Limitations This Standard Operating Procedure is not intended to substitute for operating instructions, or training needed to operate an autoclave. If training is required see your department head or laboratory administrator. Do not operate an autoclave without having the proper training. A full copy of the operating instructions for the autoclave is located in each autoclave room. Prerequisites Persons involved in steam sterilizing should be trained in handling techniques to minimize personal exposure to hazards from this waste. Some of the techniques include:

• Use of personal protective equipment (PPE) • Minimization of aerosol formation • Prevention of waste spillage during autoclaving loading and unloading • Prevention of burns from handling hot containers-proper use of PPE • Management of spills

Procedure Because there are different autoclaves on campus the following is a list of precautions the operator should be aware of when operating the autoclave. Specific operating instructions are located in the autoclave room.

• Plastic bags should be placed in a rigid container before steam treatment to prevent spillage and drain clogging. Add 250cc of water to each bag before placing in autoclave

• Inspect the autoclave prior to use. Make sure that the drain strainer is clean and in place and that the interior is clean.

• To facilitate steam penetration, bags should be opened and caps and stoppers should be loosened immediately before they are placed in the steam sterilizer.

• Care should be taken to separate infectious waste from other hazardous waste. • Waste that contains antineoplastic drugs, toxic chemicals, or chemicals that

would be volatilized by steam should not be steam sterilized. • The autoclave temperature should be checked with a recording thermometer to

ensure that the proper temperature is being maintained for a long enough period during the cycle.

• Steam sterilizers should be routinely inspected and serviced, and the process should be routinely monitored to ensure that the equipment is functioning properly.

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• Do not overfill pans. Lids should always fit flush on top of the pan to facilitate safe stacking and transportation.

• Do not use the autoclave room for storage. • Spore Testing weekly to ensure autoclave is working properly. If positive

spore test autoclave must be cleaned and rechecked before use. • Use extreme caution due to high temperatures and proper PPE

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5.2 Standard Operating Procedure for Biological Spills in the Laboratory

Purpose This Procedure establishes the process of handling biological spills in the laboratory not posing an emergency. Precautions and Limitations:

• Only trained laboratory personnel should perform cleaning of a biologic spill. • EHS (x4078) and Security (x4226) should be notified immediately if spill

cannot be contained or employee feels he/she is in an unsafe condition.

Prerequisites

• Ensure you have a biological spill kit ready for use prior to performing any work

• Inform supervisor of spill • Don the appropriate personal protective equipment prior to attempting to clean

up the spill. • If the spill is, in the opinion of the laboratory worker, too large to handle, or

the laboratory worker does not feel he/she is able to clean up the spill safely call EHS at x4078 Monday-Friday 8-5pm. After-hours call Security x4226.

Procedure

Clear spill area of all personnel. Wait 30 minutes for any aerosols to settle before entering the spill area. Remove any contaminated clothing and place in biohazard bag for further processing by laundry. Initiate cleanup with a disinfectant as follows:

• Cover spill with paper towels or other absorbent material containing

disinfectant. • Encircle the spill with disinfectant (if feasible and necessary), being careful to

minimize aerosolization. • Decontaminate and remove all items within the spill area. • Remove broken glassware with forceps or broom and dustpan and dispose in

sharps container. Do not pick up and contaminated sharp object with your hands.

• Remove paper towels and any other absorbent material and dispose in biohazard bags.

• Apply disinfectant to the spill area and allow at least 20 minute contact time to ensure sufficient germicidal action. Remove the disinfectant with paper towels or other absorbent material and dispose in a biohazard bag.

• Wipe off any residual spilled material and reapply disinfectant before final clean up.

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• Wipe equipment with equipment compatible disinfectant. Rinse with water if necessary.

• Place all disposable materials in biohazard bags for disposing (RMW), or autoclaving.

• Place reusable items in biohazard bags, or heat resistant pans or containers with lids before autoclaving.

• Reopen area to general use only after spill clean up and contamination is complete.

• Inform all personnel and laboratory supervisor about the spill and successful clean up as soon as possible.

Hazard Assessment In the event of an emergency situation involving a spill, which presents an exposure hazard, several factors must be considered:

1. Assess risk to yourself and others 2. Think before acting 3. When evaluating the risk consider the toxicity, volatility, and volume of

material involved. 4. If necessary remove yourself and others from the area. 5. Immediately remove any contaminated clothing and wash any part of the body

contaminated by chemicals or radioactive materials. 6. Attend anyone injured. 7. Close off area to personnel 8. Turn off any potential ignition source. 9. Contact EHS x4078 and Security x4226

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5.3 Standard Operating Procedures for Centrifuge Use

Purpose To ensure that all centrifuges will be used, cared for and maintained in a safe manner. Precautions and Limitations This Standard Operating Procedure is not intended to substitute for operating instructions, or training needed to operate a centrifuge. Please see specific operating instructions for the centrifuge that is being used. Prerequisites Each centrifuge operator must be instructed on proper operating procedures of the centrifuge including balancing loads, selection of proper rotor, heads, cups, and tubes, and use of accessory equipment. The operator must be trained in using personal protective equipment (PPE). Procedure- General Centrifuge Safety Procedures

• Lids shall be closed at all times during operation. • All centrifuges should be inspected prior to use. Broken, cracked, or damaged

tubes should be discarded. • The operator shall wear PPE and not leave the centrifuge until full operating

speed is attained and the machine appears to be running safely without vibration.

• If vibration occurs the centrifuge should be stopped immediately and the load balances checked. Swing-out buckets should be checked for clearance and support.

• The appropriate warning signs must identify rooms where potentially hazardous biological, radioactive materials, toxic or other hazardous chemicals are centrifuged.

• Rotors and cups should be cleaned and disinfected after each use with non-corrosive cleaning solutions.

• Plastic centrifuge tubes should be used whenever possible to minimize breakage.

Hazards associated with centrifuge include mechanical failure and the creation of aerosols. To minimize the risk of mechanical failure, centrifuges must be maintained and used according to the manufacturer’s instructions. Aerosols are created by practices such as filling centrifuge tubes, removing supernatant, and resuspending sediment pellets. The greatest aerosol hazard is created if the tube breaks during centrifugation. To minimize the generation of aerosols:

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• Inspect tubes before each use. Use sealed tubes and safety buckets that seal with O-rings.

• Fill and open centrifuge tubes, rotors, and accessories in a BSC. Avoid overfilling.

• Add disinfectant to the space between the tube and the bucket to disinfect material in the event of breakage during centrifugation.

• Always balance buckets, tubes and rotors properly before centrifugation. 20

5.4 Standard Operating Procedure for Containment Laboratory Operations

Purpose To ensure the safety of all laboratory workers and students working with hazardous biological materials. Prerequisites

• Training on personal protective equipment • Training on laboratory safety protocol • Training on Regulated Medical Waste • Trained in working with biological safety cabinets

Procedure

1. Depending on the operations to be performed, the safety protocol may indicate

the need for specific protective clothing. At a minimum, the following shall be used: • Fully fastened disposable laboratory coat (with elastic sleeves) • Gloves • Shoe covers • Eye/face protection (i.e., safety glasses, faced shield, or combination

thereof) • Head cover • Disposable approved respirator

2. Before entering the containment laboratory

• Co-workers should be advised when a person will be working alone in a containment laboratory

3. While working in the containment laboratory room:

• There will be no eating or drinking • Put on the necessary garments as needed to do the experiment safely • Inspect room for prior signs of contamination or equipment malfunction. • Prepare work area-absorbent: Plastic backed paper shall be placed on the work surfaces Plan ahead and place chemicals, spatulas, beakers, etc., as needed to

avoid extra trips outside the containment laboratory room during the work period. Disposable laboratory supplies should be used whenever possible.

The laboratory hood or biological safety cabinets must be used to contain any procedure that involves the use of volatile chemicals or processes where aerosols could be produced.

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Only minimum quantities of agents shall be present on open benches during experimental work.

• No mouth pipetting will be allowed • Only closed container weighing techniques are to be used with the

containment laboratory analytical balances • If a volatile substance is used a vacuum pump vented into the exhaust

system shall be used. • All sharps used with human materials or infectious agents must be placed

immediately after use in a puncture resistant, leakproof container for sharps disposal.

• All personnel should wash their hands immediately upon completing any procedure in which a hazardous agent is used, and when a person is leaving the containment laboratory.

• Showering is only required when there has been an overt exposure or as required based on review of the hazardous agent risk assessment.

• Any equipment that is brought into the room must be cleaned and decontaminated before it is removed.

4. At the end of the work period:

• All waste must be properly disposed of. Liquid waste must be collected in labeled plastic or glass containers. Biological waste must be autoclaved before disposal. No waste can be poured down the drain.

• Dilute solutions of any hazardous agents prepared in the room must be transported in a secondary container to contain any spill.

• After the work is complete, the room must be cleaned and decontaminated if necessary.

5. The containment laboratories are controlled access areas. Casual visits to

these rooms are discouraged. In the event visitors are allowed to enter, they must be escorted by an authorized user and dress appropriately.

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5.5 Standard Operating Procedure for Controlled Drugs

Purpose The Controlled Substances Act of 1970 (PL-513) assigned the Drug Enforcement Administration (DEA) the responsibility for establishing policies and procedures for the ordering and use of certain drugs. This issuance summarizes these policies and procedures and establishes local procedures and supplemental policies. Summary of DEA Regulations

1. Pl 91-513 identifies substances subject to controlled use by properly registered

persons. The law classifies such substances into five schedules: I, II, III, IV, and V.

2. Persons who engage in research with controlled substances must either be properly registered with the DEA or obtain their materials in an authorized manner through another individual or organization so registered.

3. Researchers must maintain records of the use of controlled substances. 4. The procurement of controlled substances must be done in an officially

approved manner. This applies regardless of whether the substance is available at a cost to the college or not.

5. All controlled substances must be stored in a securely locked room, substantially constructed cabinet or safe.

6. Inventories must be taken at least once every two years.

Prerequisite

• The scientist or researcher must have a valid DEA number or an individual with a valid DEA number who will be responsible for the ordering of the drug.

• The researcher must have a place to store the drug while not in use. See requirements above.

• Institution Controlled Substances Registration Certificate. • DEA #222 order form.

Procedure

1. Individual investigators who desire to utilize substances in schedule I will

acquire specific individual registration for those items and will be the person responsible for controlling and storing those items.

2. Individual investigators are responsible for maintaining records of the use of the controlled substances.

3. Schedule I substances are ordered by the individual investigator who registered for the specific items. Forms (#222) are available from the DEA at:

4. 2300 W. Meadowview Road, Room 218, Greensboro, NC. 27407. Tele # 910 790-3004.

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5. Schedule II, III, IV, and V substances can be ordered directly by the College. 6. Schedule I substances will be delivered unopened directly to the investigator.

Investigator will check the contents, sign for receipt of order, and log receipt in appropriate record.

7. Schedule I substances may not be issued to anyone except the investigator who is registered for the specific drug.

8. Disposal of schedule I drugs must be witnessed, verified and signed for.

Each individual authorized to receive controlled substances must establish and maintain a current and accurate log of substances received and used. The DEA has the authority to audit these records at any time. The records must contain:

• Name of the substance • The amount received and date • The amount used, the purpose, the date, and the amount on hand, in a hard

record book which makes it possible to relate usage records to research notes.

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5.6 Standard Operating Procedure for Personal Protective Equipment

Purpose To provide procedures to select the correct personal protective equipment (PPE) for use in the laboratory. Precautions and Limitations PPE must fit properly to be effective. If not sure on the correct fit, ask your supervisor for guidance. Don’t use PPE that is damaged or defective in any way; it may be ineffective. Eyeglasses and or contacts do not substitute for safety goggles. Prerequisites Ensure the PPE you have is the correct size. If you wear glasses make sure you wear safety goggles over them. Make sure you use the correct kind of PPE in the laboratory. Attend the training class on PPE. Procedure Each piece of PPE is designed to protect the worker against particular hazards.

• PPE must fit well. Even PPE that is your size can stretch or change over time. Check the fit carefully each time you put on a piece of protective clothing or equipment

• Inspect PPE carefully before each use. Don’t use PPE that is defective or damaged in any way. Report it immediately to your supervisor and get an effective replacement.

• Practice wearing your PPE. To get good at wearing PPE you must practice wearing it in a non-hazardous situation.

• Select the correct PPE for the job. If unsure of what to wear in any particular situation ask your supervisor.

• At the end of the day or when PPE is no longer needed, inspect the PPE for damage. If damaged do not use until fixed or replaced.

• Clean the PPE after each use or dispose of properly. • When removing PPE take care to avoid contamination. Don’t let your bare

skin touch contaminated PPE. Always wash hands after taking PPE off.

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5.7 Standard Operating Procedure for Regulated Medical Waste

Purpose To ensure that New York Medical College complies with federal and state guidelines for safe disposal of Regulated Medical Waste (RMW) and to protect employees and the environment from the hazards generated from such waste. Precautions and Limitations The most important element in maintaining a safe work environment is strict adherence to good microbiological and laboratory practices and techniques. Employees and students working in the laboratory must be informed of the risks and proficient in the practices and techniques required for handling the waste generated. It is the responsibility of the Principal Investigator or manager of the laboratory to observe and train employees/students or arrange for training of all employees/students that may come in contact with Regulated Medical Waste. Prerequisites Laboratory personnel should be trained in handling techniques to minimize exposure to hazards from this waste. Some of the techniques include:

• Use of personal protection equipment • Minimization of aerosol formation • Prevention of waste spillage • Management of spills • Autoclave use

The Environmental Health and Safety Department training program Regulated Medical Waste (RMW) must be attended by all laboratory and housekeeping employees working with RMW.

Procedure Regulated Medical Waste (RMW) as defined in section 5 of this manual has three components.

1. Collection and removing of RMW from the laboratory 2. Disposal of “sharp” instruments 3. Preparing RMW for removal by Health Care Waste System (HCWS)

1. Laboratory Procedure for Collection and Removing of Regulated Medical Waste from the Basic Science Building:

Each department unit is provided with 2 stations containing 32-gallon reusable containers, biohazard supplies and spill kit can. The individual laboratories will separate the waste generated in the laboratories into non-hazardous waste and red bag waste (RMW) in accordance to the training received. The regulated medical

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waste will be in red bags and when full will be tied off and left in the laboratory so the housekeeping department will dispose of properly. Housekeeping and janitorial personnel must observe the following work practice for removal of red bag waste and sharp containers.

A. Place four to six empty 32-gallon containers with lids on the EHS flatbed. Containers are located in the BSB shed

B. Spray each container with disinfectant/deodorizer available at the RMW supply station on the lower level of the Basic Science Building (BSB).

C. Line each container with a red bag liner. The liners are available at the RMW supply station.

D. When the 32-gallon containers are full secure each with plastic wire tiebacks.

E. Place full container on flatbed. F. Replace container with an empty container and lid. G. Repeat procedure for each department. H. Return the filled containers to the shed for storage. I. All sharp containers that are not in the 32-gallon containers must be place

on the flat bed and taken to shed for storage. A generator label must be attached to the sharp container.

2. Procedure for safe disposal of sharps

The single most important aspect of sharps which gives rise to fear and apprehension is their inherent ability to cause puncture wounds and/or lacerations which may create a portal of entry for infectious agents. Although syringes with attached needles are the classic examples of sharps; other items used in the delivery of health care or in research and which have come in contact with infectious agents also must be considered. They are broken glass or rigid plastic culture tubes, flasks, beakers, pipettes and pipette tips, etc. (a more complete list is found in section 5). If at any time you are unsure if an item is considered a sharp ask your supervisor or call EHS at x4078. Laboratory personnel must observe the following work practice:

A. Discard all sharps in a puncture resistant container that is the correct size

to fit the sharp item. All sharp containers are obtained by calling EHS @x4078.

B. Fill the sharp container only to the fill line. DO NOT OVERFILL any sharp container.

C. When full attach and secure the cover. Some containers require plastic ties that are provided by EHS.

D. Place small sharp containers in the 32-gallon container at the RMW Station for janitorial pick up.

E. Place large filled sharp containers next to the 32-gallon container at the RMW station for janitorial pick up.

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3. Procedure for preparing Regulated Medical Waste for Removal by Health Care Waste System (HCWS).

Regulated Medical Waste is picked up on Wednesday and Fridays between 10:00am-2:00pm each week at three sites. Each site has an assigned account number and a purchase order and must be maintained separately. The company will call the day of the pick-up 15 minutes prior to arrival.

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Basic Science Building

A. Once all the 32-gallon containers and the large sharp containers have been placed in the shed for storage a generator label must be attached and dated. The date used is the date of the pick-up from HCWS not the date the waste was generated. The generator labels can be found at all the RMW Stations. The keys to the BSB shed are located in the Department of Environmental Health and Safety, Comparative Medicine, Facilities, and with the custodial staff.

B. On the day of pick up inspect all containers making sure that they are locked and a generator label is attached to each.

C. The HCWS driver will load the containers on the truck for transport. Containers from the shed may include 32-gallon re-useable containers, 17- gallon sharp containers, and the white 8-gallon biohazard bucket.

D. The HCWS driver will replace the 32-gallon containers taken from the shed and provide red bag liners for each.

E. After removing the shrink-wrap from the containers stack the 32-gallon containers seven high in four rows inside the shed allowing room for the lids and the transfer cart. (HCWS will help with this)

F. The 17-gallon sharp containers are stored in the waste station on the lower level of the BSB. The white 8-gallon spill kit buckets are stored in the lower level of the MEC building.

Comparative Medicine

A. All animal waste is prepared by the Comparative Medicine Department

staff in 4.3 cubic foot lined paper boxes as the secondary containment. These boxes must be lined and taped closed with heavy-duty tape.

B. A generator label must be attached to each box. The generator label verbiage for Comparative Medicine includes the words “Incinerate Only”.

C. The HCWS driver will load the containers onto the truck for transport. Make sure the driver uses the contaminated side door. DO NOT USE THE CLEAN DOOR.

D. Make sure that the chemical room and the shed are locked and any supplies are not visible at the waste station before you leave.

Vosburgh Building

A. Biohazard room must be opened for the driver via the corridor door. B. Only 32-gallon containers are picked up from the Vosburgh Building. C. Housekeeping staff will have the containers ready for pick up and

transport. D. The HCWS driver will load the containers on to the truck, will replace all

containers taken from the Vosburgh site and provide red bags liners equal to the replacement.

E. Remove all shrink wrap from the outside of the replacement containers, and stack the replacement containers eight units high in two rows and place lids in the large box.

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5.8 Emergency Response A. Autoclave B. Biological Spill C. Illness and/or Injury D. Needlestick and Bloodborne Exposure

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Autoclave Accident Response Sheet (draft 1/10/02)

There are hazards inherent in the operation of all pressurized vessels including autoclaves. Because of the inherent danger a qualified technician should regularly inspect the chamber and door seals. The following is an Emergency Response Plan, which includes the appropriate procedures for dealing with the autoclave in an emergency situation. It is the responsibility of each individual using the autoclave to become familiar with this plan. There are two reasons for autoclave failure – Failure of the operator or mechanical failure. Mistakes made by the operator may include

• Improper use of containers that block access of steam to the load. • Sealing the bag close before autoclave. • Not adding water to the load before autoclaving. • Autoclaving a bag of waste that is too large for the autoclave. • Over-filling an autoclave bag.

The operator might suddenly fully open the door causing liquids to boil over or bottles to burst. In the event that this happens:

1. If in a LIQUID cycle, turn the selector to SLOW EXHAUST and keep it in

that position until pressure is atmospheric (0 psig). 2. Then turn the selector to OFF position, omitting the dry phase. 3. Crack the door open about ½ inch and wait at least 10 min. before removing

load. 4. If in a GRAVITY cycle, you may either: 5. Turn the selector to the FAST EXHAUST position until the pressure is

atmospheric and than turn off or: 6. Turn the selector to the dry position, if a drying period for wrapped goods is

desired. 7. Then turn off.

In the event that the door does not open after a cycle:

1. Turn the wheel slightly clockwise. 2. Then again turn door wheel counterclockwise and open. 3. Turn hand wheel to extreme left to bring the ends of the holding arm inward

so that they will not strike the doorframe when the door is opened or closed. 4. If the door still does not open call Environmental Health and Safety at x4078

(8-5 Monday-Friday) or Security x4226.

Broken glass in the autoclave may block the drain to the autoclave causing hot water to be released through the door. This might cause a burn. In the event that this happens please go to Health services immediately or refer to the ILLNESS/INCIDENT response sheet. Then:

1. Observe carefully where the broken glass is. 2. If the glass is in an easily located place remove the glass carefully with safety

gloves on. 3. If glass is not seen or you are unable to remove the glass safely call EHS at

x4078. 31

If the cycle has started, but the chamber door is not sufficiently tightened: 1. Press cycle reset button on the secondary control panel. DO NOT proceed

further until chamber is at atmospheric pressure. 2. When you have reached atmospheric pressure, crack door ½ inch and wait at

least 10 min. 3. Check door and door switch operation. Then Reprocess load.

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Biological Spill Response Sheet

Each department, shop, laboratory, or work area must have an Emergency Response Plan that includes the appropriate site-specific procedure and response equipment for dealing with a biological spill. It is the responsibility of each individual using biologic organisms to become familiar with this plan. This sheet is not all-inclusive but intended as a quick resource to guide persons in certain emergency situations involving biologic spills.

If you notice a spill inside the laboratory and it is not an emergency situation:

1. Clear spill area of all personnel. 2. Wait for aerosols to settle before entering spill area. 3. Remove any contaminated clothing and place in a biohazard bag for further

processing by laundry or department. 4. Don disposable gown, or labcoat, safety goggles, and appropriate gloves. 5. Have a complete biological/chemical spill kit ready to go before you start the

clean up. 6. Cover spill with paper towel or other absorbent material. 7. Encircle the spill with disinfectant (if feasible and necessary), being careful to

minimize aerosolization. 8. Remove broken glassware with forceps or broom and dustpan and dispose in

biohazard bag. Do not pick up any contaminated sharp object with your hands. 9. Remove the absorbent material and dispose of in biohazard bag. 10. Apply disinfectant to the area and let stand at least 15 min then remove with

paper towels and dispose of in biohazard bag. 11. Decontaminate area and equipment according to lab protocol. 12. Place reusable equipment in biohazard bags and autoclave.

In the event of an emergency situation:

1. Activate alarms if necessary. Be

familiar with the location of the alarm system in your area. If the incident could threaten the health of individuals in the building or immediate area, ACTIVATE THE ALARM AND EVACUATE.

2. Dial x4226 campus security to initiate NYMC Emergency Response Plan, and x4078 (8-5pm).

3. If anyone is seriously injured see ILLNESS/INCIDENT Response sheet. 4. Remain calm. 5. Evacuate all non-essential personnel and prevent access to the area. 6. Security may initiate emergency material specific clean-up procedures if

necessary. If the spill can safely be contained and cleaned up, use the biological/chemical spill kit provided. Do not unnecessarily jeopardize your own safety. If the spill is too large to contain, security will call the appropriate agency to do this.

If the spill occurs inside a Biological Safety cabinet, proceed as above, but allow the cabinet to run during the clean up.

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Always inform all personnel and laboratory supervisors about any spill and successful clean up as soon as possible.

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Illness and/or Injury Response

Any accident, illness or incident sustained by an employee arising from or in the course of employment by the college must be treated and reported to Health Services.

1. In the event of a work-related incident notify your supervisor immediately. For non emergency situations: 2. Report to Health Services for treatment and file an Incident Report. For emergency situations: 1. Go to the Emergency Department and get the treatment needed. 2. Report to Health services and file an Incident Report.

In the event of a work-related incident, the employee is to immediately notify his/her supervisor. An incident report is to be completed in full description of the details of the incident, as well as the names of any witnesses. It is the responsibility of the employee’s supervisor to investigate the circumstances of the incident and on the basis of his/her findings complete an investigation report to be recorded on the employee’s incident report. For eye splashes:

1. At the nearest eye wash flush eyes immediately, and with lots of water. 2. Go to Health Services to fill out incident report and be seen by a health care

provider.

Questions about billing and correspondence contact Human Resource Department. Health Services Telephone number: 914 594-4234 (9am-5pm)

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Needlestick and Bloodborne Response Any needlestick, splash or exposure to bloodborne pathogens by an employee arising from or in the course of employment by the college must be treated and reported to Health services.

1. Wash the exposed body part with lots of soap and water. 2. Notify immediate supervisor. 3. Report to Health Services for treatment and incident reporting as soon as

possible. 4. Remove soiled clothing, wash skin, and change to clean clothes.

When evaluating an exposure incident, immediate assessment and confidentiality are critical issues. Employees should immediately report exposure incidents to enable timely medical evaluation and follow up by a health care professional as well as a prompt request by the employer for testing of the sources individual’s blood for HIV and HBV. The “source” individual is any individual whose blood or body fluids are the source of an exposure incident to the employee.

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5.9 Standard Operating Procedure for Transferring or Receiving Select Agents

Background The Antiterrorism and Effective Death Penalty Act of 1996 established provisions to regulate the transfer of hazardous agents and required the Department of Health and Human Services (HHS) to issue rules to implement these provisions. The CDC proposed new regulations to meet the requirements of this statute. The main objective of the CDC is to ensure protection of public safety without encumbering legitimate scientific and medical research. Purpose To ensure that NYMC transfers and receives select agents in a manner that complies with regulation 42 CFR 72.6. A list of the select agents appears in Appendix G of this manual. Prerequisites

• Registration with the CDC through the NYMC Facility Responsible Officer (RFO) for the use of select agents.

• Laboratory that is equipped and capable of handling the agents at the BL 2, 3, or 4, depending upon the agent and the type of work being performed with the agents.

• Inspection of the laboratory at the discretion of the Secretary or the registering entity in consultation with the Secretary.

• A valid registration number unique to NYMC. • Training on personal protective equipment, regulated medical waste,

autoclaves and biosafety cabinets.

Procedure

A. Prior to transfer of any agent listed in Appendix G, a CDC Form EA-101 must be completed for each transfer sought. As specified in the CDC form the information provided must include: i. The name of the requestor and the requesting facility;

ii. The name of the transferor and the transferring facility; iii. The name of the responsible facility officials (RFO) for both the

transferor and requestor; iv. The requesting facility’s registration number; v. The transferring facility’s registration number;

vi. The name of the agent(s) being shipped; vii. The proposed use of the agent(s); and

viii. The quantity (number of containers and amount per container) of the agent(s) being shipped.

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B. The form must be signed by the transferor and requestor, and the responsible facility officials (RFO) representing both the transferring and requesting facilities. A copy of the completed CDC form EA-101 must be retained by both transferring and requesting facilities RFO for a period of five (5) years after the agents are consumed or properly disposed, whichever is longer. Those forms must be filed and produced upon the request to appropriate federal and authorized local officials.

C. Verification of registration Prior to transferring any agent listed in Appendix G, the transferor’s responsible facility official must verify with the requestor’s responsible facility official,

i. That the requesting facility retains a valid, current registration; ii. That the requestor is an employee of the requesting facility; and iii. That the proposed use of the agent by the requestor is correctly

indicated on the CDC Form EA-101. In the event that any party is unable to verify the information listed above or there is suspicion that the agent may not be used for the requested purpose, then the party shall immediately notify the CDC. D. Transfer

Upon completion of the CDC Form EA-101 and verification of registration; the transferring facility must comply with the packaging and shipping requirements, or other applicable regulations when transferring the agent. (See Appendix I of this manual). The requesting facility’s responsible official must acknowledge receipt of the agent telephonically or otherwise electronically within 36 hours of receipt and provide a paper copy or facsimile transmission of receipt to the transferor within 3 business days of receipt of the agent. Upon telephonic acknowledgment of receipt of the agent, the transferor shall provide a completed paper copy or facsimile transmission of CDC Form EA-101 within 24 hours to the registering entity for filing in a centralized repository. E. Exemptions

i. The agent is part of a clinical specimen intended for diagnostic,

reference, or verification purposes. ii. The agent is a toxin having a LD50 for vertebrates of more than 100

nanograms per kilogram of body weight which is used for legitimate medical purposes or biomedical research or is one of the listed toxins which has been inactivated for use as a vaccine or otherwise detoxified for use in biomedical research procedures.

iii. The agent is an exempted strain specified in Appendix A of this document.

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F. Agent disposal

Upon termination of the use of the agent, all cultures and stocks of it will be:

i. Securely stored in accordance with prudent laboratory practices; ii. Transferred to another registered facility in accordance with the

policy; iii. Destroyed on-site by autoclaving, incineration, or another recognized

sterilization or neutralization process.

G. When an agent, previously transferred to a facility in accordance with this policy is consumed or destroyed, the responsible facility official must formally notify the registering entity, CDC or APHIS. Formal notification must be noted on the CDC Form EA-101 and a copy kept on record.

Recordkeeping

i. Retain a copy of EA-101 for 5 years after shipment or 5 years after the agent is/are consumed or properly disposed, whichever is longer;

ii. The facility must retain records for 5 years concerning the destruction, and the persons responsible for the destruction;

iii. CDC must be notified of the destruction or complete consumption of the agents;

iv. For intrafacility transfers, the facility must keep the records including the name and location of the recipient; the amount of agent transferred; and the disposal or destruction of the agent.

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Regulated Medical Waste

6.0 General Every laboratory experiment generates some waste, which may include such items as; culture plates, pipettes, disposable agar plates, and hazardous chemical or biological waste. The overriding principle governing the handling of waste in the laboratory is that no activity should begin unless a plan for the disposing of nonhazardous and hazardous waste has been formulated. New York Medical College is committed to protecting its employees, students, and the environment and in doing so has formulated this program.

6.1 Regulations The Resource Conservation and Recovery Act (RCRA) was enacted by Congress in 1976 to address the problem of waste disposal and reduction. Subtitle C of that act establishes a system for controlling hazardous waste from generation to disposal. Under the RCRA, the Environmental Protection Agency is given great responsibility in promulgating detailed regulations governing the generation, transport, treatment, storage, and disposal of hazardous waste. Occupational Safety and Health Administration (OSHA), out of the concern that the existing standards designed for exposures conditions in an industrial setting were inappropriate for the exposures in laboratories, promulgated The Laboratory Standard in 1990. The Clean Air Act (CAA) was developed for the protection of air quality and regulates emissions into the air. The amendment of 1990 rigorously affected the chemicals used in laboratories.

6.2 Definitions

Regulated Medical Waste: Regulated medical waste is the waste generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining to or in the production or testing biologicals, provided that regulated medical waste shall not include hazardous waste. Biologicals: Biological waste includes preparations made from living organisms and their products, such as serums, vaccines, antigens and antitoxins. Biohazardous agents: Biological agents and materials, which are potentially hazardous to humans, animals, and or plants, are labeled biohazardous agents. Infectious or disease causing agents, potentially infectious materials, certain toxins and other hazardous biological materials are included in the definition of a biohazard. Cultures and stocks: Cultures and stocks of infectious agents such as tissue culture material including human and primate cell lines, human blood and blood products, impure animal cell lines, preparations made from living organisms and their

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products, including vaccines, cultures, etc. intended for use in diagnosing, immunizing, treatment or research. Culture media: Culture media such as agar gel, nutrient broth, discarded media from cultures and blood agar. Culture dishes, flasks, or other devices: Culture dishes, flasks, or other devices used to transfer, inoculate and mix culture dishes such as tissue culture plates, assay plates, test tubes, centrifuge tubes, cotton swabs, pipettes, pipette tips, stirring apparatus, flasks, vials, beakers, jars, spatulas, inoculation loops, wires, corks, stoppers, cell scrappers, cell lifers, paraffin sealing paper, foil, cotton, filters, mixing sticks, tubing, etc. that have been in contact with infectious materials. Human pathological waste: Human Pathological waste including tissues, organs and body parts and body fluids that are removed during trauma, surgery, autopsy, or other medical procedures and specimens of body fluids other than urine, and has not been fixed in formaldehyde. Infectious agents: Means any organism such as a virus or bacteria that causes disease or have an adverse health impact to humans. Those organisms found in Biosafety level 2-4 (see section 8 part C). Liquid waste: Liquid waste, human blood, products of human blood, items saturated and or dripping with human blood, or items saturated with human blood that are now caked with dried blood, including serum, plasma, and other blood components, and their containers, which were used or intended for use in either patient care, testing and laboratory analysis or the development of pharmaceuticals. Intravenous bags are also included in this category. Sharps: Defined as anything that is “sharp” able to puncture the skin. Examples include glassware such as pasture pipettes and tips, glass, glass culture dishes, blood vials, glass beakers, flasks, and test tubes, slides and cover slips, etc. (regardless of the presence of infectious agents). Syringes to include hypodermic needles and other materials capable of puncturing the skin or a red bag including scalpel blades, suture needles, surgical needles, lancets, staples, instruments designed for cutting or puncturing: saws, tweezers, and scissors. Animal waste: Animal waste means discarded materials carcasses, body parts, fluids, feces, blood, or bedding originating from animals. Bedding would be included as animal waste if originating from animals known to be contaminated with infectious materials. Otherwise bedding may be discarded as regular waste.

6.3 General Labeling, Packaging and Disposal Procedures

New York Medical College has contracted with an approved vendor to transport the biohazardous waste from the College to its final destination to be incinerated. (For site specific procedures see Section 4). Most biohazardous waste will be disposed of in biohazard bags e.g. contaminated solid waste, cultures, stocks and related

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material. Currently, NYMC requires the use of red biohazard bags that include the biohazard symbol. Double or triple bags may be required to avoid rupture or puncture of the bags. All sharps must be placed in a rigid, puncture resistant, closable and leakproof container, which is labeled with the word sharps and the biohazard symbol. Contaminated Pasture pipettes are considered sharps and need to be disposed of in a sharps container. To obtain the correct size sharp container call EHS at x4226. All biohazardous waste including risk groups 2 and 3 (see section 8, part A) that are handled at a biosafety level 3 (see Section 8, part C) is to be autoclaved at the point of origin (laboratory, or facility).

6.4 Non-Regulated Medical Waste

The following waste is not considered to be regulated medical waste. Examination rooms supplies listed below are not considered RMW provided the patient is not on isolation to protect others from highly communicable disease:

• Disposable towels • Gowns and paper sheeting • Unsaturated, blood stained bandages • Gauze and cotton, cotton swabs and tongue depressors • Household waste • Ash from incineration of regulated medical waste • Human corpse, remains, and anatomical parts that are intended for

internment or cremation • Animal waste generated in animal husbandry or food production

6.5 Regulated Medical Waste (Examples)

Ordinary Trash Sharps Red Bag Waste Paper products Needles Culture dishes Cardboard Syringes Discarded live and attenuated vaccines Magazines Hypodermic needles Virus and bacterial cultures Tin Cans Broken Glass beakers Human blood and blood products Unused lab ware Glass pipettes/pipettes Tissue specimens Household waste Scalpel blades Gloves and other protective equipment Plastic bottles Cover slips Animal carcasses Newspaper Lancets Infected animals bedding/cages

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Training

7.0 Training Requirements

Principal investigators must assure that all laboratory workers and students are provided with information and training to ensure that they are appraised of the hazards of biological organism in their work area. This training is mandated by OSHA. In fulfillment of part of this training requirement, the principal investigator must assure that all new and previously untrained laboratory workers attend the Laboratory Safety Training provided by Environmental Health and Safety Department. Laboratory workers must attend annual refresher training each year following attendance of initial training.

7.1 Laboratory Safety Training Program

7.2 Bloodborne Pathogen Training Program

7.3. Regulated Medical Waste Program

7.4 Autoclave Safety Program

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Table of Contents Appendix

A. Classification of Agents Based on Risk Assessment B. Biosafety Cabinets C. New York Medical College Policy Exposure Control Plan D. Biohazard Sign E. Federal Laws and Regulations Affecting Laboratories F. OSHA Citations G. Select Agents H. Shipping Requirements for Biohazardous Materials

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