Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
5 Safety Management A. ADMINISTRATIVE ORGANIZATION AND RESPONSIBILITIES 1. Introduction Every institution, irrespective of size, should have a safety program. Such a program should be de- signed, when appropriate, to ensure compliance with (1) Occupational Safety and Health Administration (OSHA) requirements for health and safety, (2) Nu- clear Regulatory Commission (NRC) requirements for safe handling of radioactive isotopes, (3) Envi- ronmental Protection Agency (EPA) regulations de- signed to implement the Resource Conservation and Recovery Act (RCRA), (4) relevant state and local regulations, and (5) requirements of accrediting bod- ies, such as the Joint Commission on Accreditation of Healthcare Organizations. Even when a safety program is already in effect, a new laboratory activity may require that the program be modified to address the following issues: · the unique hazards introduced by the new activity; · the methods of controlling these hazards; · the new procedures needed (e.g., signs, waste disposal, and personnel monitoring); · the orientation of personnel; and · ways of ensuring that the new procedures are followed. Not only should safety programs be a part of an institution's effort, but such an activity should be a central focus of a small office or clinical laboratory as well. 46 2. The Laboratory Safety Program a. Goals of a Laboratory Safety Program The goals of a laboratory safety program should be to protect those working in the laboratory, others who may be exposed to hazards from the laboratory, and the environment. Hazardous materials should be handled and disposed of In such a way that people, other living organisms, and the environment are pro- tected from harm. b. Responsibility for Laboratory Safety The ultimate responsibility for safety within an institution lies with its chief executive officer, who, along with all immediate associates (e.g., vice presi- dents, deans, deponent heads, laboratory directors, and project directors), should have a continuing, overt commitment to the safety program. This commit- ment, as well as tangible support, should be obvious to all. A potentially effective safety program that is ignored by top management will fail because it will certainly be ignored by many others. Essential to an effective institutional safety program is a safety co- ordinator (or safety officers appropriately trained in relevant safety technology. This individual, besides supplying advice and recommendations, should see that records are kept showing whether the institu- tion's physical facilities and safety rules are inter- nally consistent and compatible with potential risks, as well as with both state and federal laws. The responsibility for safety in a deparanent or other administrative unit of the institution lies with its chairperson or supervisor. In small institutions, it
SAPETY MANAGEMENT may be feasible for one person to perform more than one set of duties. For example, a significant fraction of a faculty member's time might be allotted to the duties of the departmental safety coordinator. To be effective, safety coordinators should work closely with administrators and investigators to develop and implement written policies and practices needed for safe laboratory work. Collectively, this group should routinely monitor current operations and practices, see that appropriate audits are maintained, and con- stantly seek ways to improve the safety program. If laboratory goals dictate operations or substances not suited to the existing facilities, it is the responsibility of the safety coordinator and laboratory supervisor to advise and assist the investigator in developing ade- quate facilities and appropriate work procedures. The responsibility for authorization of a specific operation, delineation of appropriate safety proce- dures, and instruction of those who will carry out the operation lies with the project director. Taking time to identify potential hazards through a job analysis and to think through its safety aspects is necessary to avoid accidents and illnesses. This practice has proven to be of immense value to indus- try. Job analysis consists of breaking a job down into its logical steps, analyzing each for its ha ard poten- tial, and deciding the safe procedures to use. The process should be designed by a supervisor with input from employees and should be outlined in writ- ing for tasks with potential for injury or other inci- dents. Safety awareness should be a part of everyone's habits, and can only be achieved if senior and re- sponsible staff evince a sincere, visible, and continu- ing interest in the prevention of injuries and occupa- tional illnesses. Laboratory personnel, for their part, must accept responsibility for carrying out their work in a way that protects themselves and their fellow workers. c. Safety Plans Because experience has shown that voluntary safety programs are often inadequate, prudent prac- tice requires clearly defined safety rules and moni- toring for compliance. These rules should be readily available in writing to all involved in laboratory op- erations. This goal is often accomplished by prepar- ing a laboratory safety manual containing elements 47 such as outlined below in Section C of this chapter. Safety plans should be coordinated with institu- tional and local community emergency services. Discussions with the emergency groups should be held prior to any need for their services, so that they can become familiar with any potential problem ar- eas (e.g., hazardous pathogens, radioisotopes, and chemicals) that may be encountered when they are called for assistance. Telephones or other methods of rapid communication in the event of an emer- gency should be readily available. The institution has the responsibility to require that all hazardous materials (e.g., infectious agents, certain chemicals, and radioisotopes) are properly labeled. In addition, persons in the laboratory re- sponsible for handling an emergency should be des- ignated, with telephone numbers posted, so that emer- gency service personnel and others, such as security guards, know whom to contact at all times of the day or night. d. Safety Meetings and Safety Corruruttees In the most effective safety programs, everyone concerned with the laboratory becomes involved. This involvement is usually accomplished by ensuring maximum participation in planning, and by conduct- ing group safety meetings. In large industrial research laboratories, it is com- mon practice to have monthly meetings of all scien- tists and technicians reporting to a research supervi- sor. The chairperson is responsible for developing the agenda of safety topics relevant to the group's activities. Minutes of the meeting are sent to the group members, to the safety coordinator, and to higher management. In such laboratories, it is customary to have a staff safety committee consisting of the laboratory director and several research supervisors, managers, employees, and the laboratory safety coordinator. The primary purpose of this group is to lead the safety effort, set policy for the group, review acci- dents and near-accidents, and decide if changes in policies, program, or equipment are needed. In an academic setting, safety meetings may be held by research groups and by professors and assis- tants responsible for undergraduate courses. A com- mittee of several professors and the departmental safety coordinator may direct the safety program in
48 the department. Representatives of several depart- ments, including some laboratory technicians, may constitute a committee guiding laboratory safety for the entire institution. Small laboratories with no formal safety organi- zation should hold periodic safety reviews to discuss actual or potential hazards and how to deal with them, in order to maintain a safety awareness. e. Safety Communications Safety communications alert people to newly rec- ognized hazards, remind them of basic safety prin- ciples, and instill good attitudes toward safety. Large laboratories often have regular safety news- letters containing useful safety advice and accounts of laboratory accidents along with the lessons to be learned from them. Safety posters are helpful, but less so than the other kinds of safety communication. Posters should be changed at least every month to catch people's attention. Reference books on laboratory hazards, occupa- tional health, and good laboratory practices should be readily available. The Material Safety Data Sheets (MSDS) that chemical manufacturers must now sup- ply should also be readily available to all those work- ing in a biomedical laboratory. The OSHA Hazard Communication Standard (the "right-to-know" ruled [1263 requires that every em- ployee be trained to understand the hazards of the substances with which they work, and that current toxicity information be readily available. f. Monitoring Safety One of the essential elements of a good safety program is the monitoring of the safety performance of a laboratory. Observations of individual safety practices, operability of safety equipment, and com- pliance with safety rules should be part of the audit. An inspection team, with members selected from several sections of the laboratory, will provide an objective view of the state of safety. Reports of deficiencies and suggestions for correction should go to the people directly concerned. Any malfunction- ing facility or equipment should be reported and repaired. Feedback about a particular problem should be brought to the attention of the appropriate super BIOSAFETY IN THE FLORA TORY visor, and, if a problem is widespread, the entire laboratory should be notified. Essential safety equipment, such as sterilizers and eye wash fountains, should be tested periodically and a record kept of their last inspection. Malfunctioning equipment should be repaired promptly. Personal protective equipment for use in an emergency should be checked periodically, and the qualified users should receive updated training. B. FACILITIES 1. Introduction The following discussion presents an overview of the roles of facility design, construction, and mainte- nance in biosafety. A number of other publications, or references cited therein, address facility design in more detail [19,106,137,1451, and others address accreditation [41,72,921. State and local require- ments should also be considered. For pathogens of veterinary interest' U.S. Depart- ment of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), and Veterinary Services (VS) personnel should be consulted on fa- cility design. APHIS and VS personnel may elect to inspect the laboratory and animal facilities before a permit is issued to an investigator to begin work with animal pathogens. The physical facility is a secondary Darner, and it should be designed to ensure a functional laboratory environment that minimizes potential hazards to those working in the immediate area and to others through- out the institution. The design should control traffic, prevent dispersal of aerosols to other areas, and pro- vide for safe movement of hazardous materials and waste. Properly designed physical facilities can pro- vide an environment that is safe, if work procedures are adequate and personal safety devices and primary barriers are properly used. Proper design should, however, allow the laboratory work to be performed in a convenient and cost-effective manner compat- ible with control of the hazards. Well-designed fa- cilities are also adaptable to changes in equipment and technology or in the kinds of work performed. Resources allocated to the development of the facili- ties should be commensurate with the risks of the work to be performed. If the facilities are unsatisfac- tory for the kind of work that is proposed, then either
SAFETY M^AGEMENI the facilities, the work, or the method of performing the work should be modified. Before beginning the design of a laboratory in which biohazardous materials will be used, consid- eration should be given to the known or potential agents to be handled, the procedures to be used, and the quantities of the agents that will be encountered. Facilities should comply with local, state, and federal building and fire codes, as well as with the requirements of accrediting bodies such as the Joint Commission on Accreditation of Healthcare Organi- zations, where applicable. 2. Laboratory Design Biosafety is only one consideration in laboratory design; others include chemical, electrical, fire, and radiation safety. Proper design of a laboratory is a team effort that should include the scientist, engi- neer, architect, manager, and the safety officer. Too often, an administrator assumes that the architect knows how to design Biosafety facilities and that the contractor will construct them properly. In order to minimize costly modifications during and after con- struction, it is recommended that when new facilities are being built or those extant are being modified, the plans be reviewed by the safety officer and by one or more laboratory scientists to ensure that Biosafety requirements will be fulfilled. These individuals should inspect the facility during and at the comple- tion of construction to ensure that plans were fol- lowed before the facility is accepted. Final construc- tion (as-built) drawings should be kept available for future reference. A number of Biosafety features should be consid- ered, depending upon the work to be performed in the laboratory. Overall layout of laboratory facilities should consider traffic patterns of personnel and materials; this consideration becomes more impor- tant as the Biosafety level increases. Facilities should be designed to meet standards described in Appendix A for Biosafety levels 1 through 4. a. Ventilation Ventilation is a vital aspect of biosafety. Air handling systems should be such that minimal dust accumulates. Laboratories operating at Biosafety Level 3 or 4 must have directional airflow so that air 49 from these laboratories does not reach other areas. This must be accomplished regardless of the opera- tion of certain equipment, such as biological safety cabinets, that may alter airflow. There are no uniformly accepted standards of ventilation for Biosafety Level 2 laboratories. Direc- tional airflow is desirable for Biosafety Level 2 labo- ratories in hospitals. There should be an adequate number of air changes per hour (1) to provide a comfortable work environment, (2) to provide for safe operation of any chemical hoods and biological safety cabinets that are vented directly to the outside or into the exhaust system, and (3) to comply with the appropriate building codes and regulations. Air from rooms in which biohazardous work is performed should not be recirculated to areas of lesser hazard and is best exhausted to the outside. For example, air from Biosafety Level 3 and 4 areas should not be recirculated. The exhaust air from Level 4 areas should be filtered through HEPA filters and discharged to the outside. In hospitals it is desirable that air from microbiology laboratories and animal rooms not be recirculated, especially to pa- tient care areas. Building codes and regulations in different localities vary and must be followed. Ventilation exhausts should be remote and not upwind from air intakes, and should not exhaust onto loading docks or patios. If there is a need for filtra- tion or incineration of exhausted air, the integrity of the duct work and proper functioning of the filters or incinerator should be substantiated periodically. It is also important that filters in the ventilation system be changed on a regular schedule. There should be periodic monitoring of ventila- tion characteristics to ensure that rooms with special requirements, such as directional airflow or a speci- f~ed number of air changes, are operating under the proper conditions. Such inspections are particularly important after work has been performed on the ven- tilating system, including balancing of the system. b. Electrical Emergency power needs for laboratories should be defined. Generally, biological safety cabinets in Biosafety Level 2 laboratories will not be on the emergency power system and thus cannot be used if there is a power failure. Circuits providing emer- gency power should be readily identifiable. Biologi
so cat safety cabinets that require auxiliary fans on the roof of the building should have an alarm system that will notify the hood operator if the fan fails, or if appropriate negative pressure is not maintained. A plan for action in the event of power failure should be developed. c. Water The water supply system should be designed so that back siphonage cannot occur; all faucets that might allow reflux to occur should be equipped with vacuum breakers. If there are both potable and non- potable water sources in the laboratory, each should be clearly labeled. Need for special types of water should be foreseen and, for certain uses, biological contamination should be controlled [8X]. Safety showers may be needed for emergencies involving certain biohazards or combined hazards. In most situations when biohazardous material is spilled on one's person, a regular shower in the locker room may be used after clothing is removed. Appro- priate handling of the contaminated clothing will depend upon the nature of the hazard. Eye washes should be available in each laboratory handling po- tentially dangerous material. d. Sewage Disposal of waste through the sewage system is frequently an effective way of eliminating material posing a low level of biohazard (see Chapter 4), although, if it is not placed in the drain DroDerlY. there is a potential for splatter or aerosolization. It may be important to check with the local sewage plant about its ability to handle waste of certain Apes or in large quantities, because certain chemicals or biologic products may affect the microbial flora of the treatment facility. Drains should contain suffi- cient liquid to ensure that the trap is sealed to prevent escape of noxious gases. If a drain is never used, the trap must be filled on a regular schedule or the drain should be sealed e. Vacuum If there is a vacuum system serving multiple ar- eas, care should be taken that there are filters in the system, and that there is an overflow trap containing an appropriate disinfectant to prevent entry of con BIOS~ETY IN THE LABORATORY laminated material into the piping system and pumps. It is often best to use either a stand-alone pump-type vacuum system, or to use a water siphon vacuum system that is attached to a faucet (provided that measures are taken to prevent back-siphonage). f. Waste Handling The layout of the physical facilities should facili- tate handling of biohazardous waste and should mini- mize the likelihood of contamination of clean mate- rial by such waste EX91. Contaminated material must be segregated front noncontaminated material by physical facilities or appropriate containers. g. Safety Equipment Biological safety cabinets, autoclaves, and other Biosafety equipment should be properly installed and checked to ensure correct operation. Biological safety cabinets should be certified before use to ensure their operation under appropriate standards (National Sani- tation Foundation Standard No. 49 [951), and should be recertified at least annually (see Chapter 3, Sec- tion J). Careful implementation of installation and certification procedures will prevent mistakes, such as leaking filters or inadequate airflow. The labora- tory director or safety officer should ensure that em- ployees are properly instructed in the use of safety equipment. The equipment should be recertified if it is moved to another location. h. Traffic Flow Pattern The pattern of traffic flow within the facility should be such that the more hazardous areas are remote from other types of operations. Access to a Bio- safety Level 3 laboratory through two sequential doors is required. In addition, unnecessary traffic into the laboratory should be discouraged. Doors to labora- tories of Biosafety Level 2 or higher should be kept closed when work is in progress in the laboratory. i. Laud Laboratory clothing and towels originating in Biosafety Level 3 and 4 facilities should be routinely decontaminated before being sent to the laundry. Consideration should be given to decontaminating overtly contaminated clothing and towels originating
SAFETY MANAGEMENT from Biosafety Level 2 laboratories. Clothing and towels from all other laboratories can be sent to the laundry without special treatment. j. Storage Areas Storage areas for infectious materials, including stock cultures, actively used infectious materials, and biohazardous waste, should be designed to control access and minimize the likelihood of contamination of personnel or the environment. It is desirable that all hazardous chemicals be stored below eye level. Freezers, especially liquid nitrogen freezers, pre- sent a particular problem because vials or other con- tainers of infectious agents may break and contami- nate the liquid nitrogen or a portion of the storage system. Storage in the gas phase of liquid nitrogen freezers is recommended. To decontaminate the freezer, the contents should be removed, the nitrogen allowed to evaporate, and the contaminated areas disinfected and cleaned appropriately. 3. Constructing, Remodeling, and Decommissioning a Laboratory During construction or remodeling of laboratory areas, there should be careful documentation of the architectural features of the constructed area, and permanent files of the blueprints (as-built drawings) should be maintained. During remodeling, the con- struction workers should be protected from potential biohazards in work sites. For example, when the dismantling of exhaust ducts from biological safety cabinets in Biosafety Level 3 laboratories is required, the workers should be informed of the potential risk and the ducts should be decontaminated before they are dismantled. If a Biosafety Level 3 laboratory is to be dismantled, or used for other purposes, it must be thoroughly disinfected to ensure that infectious agents from the previous activities no longer consti- tute a risk to the workers, before any remodeling is carried out. Workers should wear appropriate per- sonal protective devices. 4. Maintenance The physical plant or engineering group of the organization is generally responsible for maintaining the physical facilities. There should be a defined schedule of maintenance, and if there have been in 51 stances of improper or unperformed maintenance in the past, it may be appropriate to insist that records of routine maintenance be made available to the labo- ratory. It is sometimes helpful for the laboratory also to maintain records of various maintenance activities that are requested and performed. For specific pieces of equipment, records of service calls may aid in justifying replacement. In periodic laboratory in- spections, inspectors should specifically review docu- mentation that the maintenance has been properly performed. Maintenance and physical plant personnel enter- ing a laboratory where work with biohazardous ma- terial is being done should either be knowledgeable in proper methods for safely conducting their activi- ties or have proper techniques explained by safety or laboratory supervisory personnel. It is the responsi- bility of the laboratory supervisor to ensure that the area is decontaminated as needed before any mainte- nance work or inspections are carried out. 5. Housekeeping Housekeeping personnel generally do not have a scientific background or a good understanding of various biohazards. It is best that their responsibili- ties be clearly defined and generally limited to the cleaning of floors, the handling of nonhazardous waste, and other periodic housekeeping activities such as washing walls and windows. It is desirable to develop regular schedules for infrequent housekeep- ing functions. Working areas such as countertops, reagent shelves, incubators, and refrigerators should be cleaned by laboratory personnel. Spills should be handled by trained personnel, and housekeeping per- sonnel should clean the area only after the infectious hazards have been eliminated. Facilities such as cold rooms, refrigerators, and incubators should have specified laboratory individuals responsible for their regular clearung. C. OPERATIONS 1. Introduction Operations refer to the day-to-day activities of an ongoing safety program. Managing the operational aspects of a safety program requires clear definition of the responsibility and the authority of safety per- sonnel and designation of the chain of command.
52 This section provides an overview of operations management, but the reader is referred to other sources or to the references cited in them for more detail [61,106,1 171. 2. Safety Orientation and Continuing Education for Employees The extent of the orientation and continuing edu- cation programs depends upon the size of the organi- zation and the risks to which personnel and visitors could be exposed. Since it is prudent to identify and address all hazards when preparing safety training programs, biosafety should be included along with the chemical safety training required by the new Hazard Communication Standard or the "right-to- know" rule [126] and the radiation safety training requirements of the Nuclear Regulatory Commis- sion. Safety orientation and continuing education should be similar, regardless of whether the work is to be done in research, service, or clinical laborato- ries, or in academic, private, or government institu- tions. All employers are responsible for providing appropriate health and safety training for all of their employees. Employees should be motivated to de- velop a safety awareness and be encouraged to iden- tify unsafe practices or situations in their workplace. Scientists should undertake projects involving biohazards only if all involved have had the educa- tion and training for work at the appropriate bio- safety level. The guidelines for microbiological and biomedical research laboratories developed by the Centers for Disease Control and the National Insti- tutes of Health (Appendix A) define the levels of training recommended for each biosafety level. All personnel directly or indirectly involved with the containment and safe handling of known and poten- tially biohazardous materials should receive instruc- tion and become sufficiently proficient in prudent microbiological practices to allow them to work safely. The curriculum should include instruction in the biology of the microorganisms so that employees can understand the models) of transmission, infectiv- ity, and pathogenicity. It should include also hands- on training in appropriate aseptic technique and de- contamination and disposal methods. Table 5.1 lists a series of topics appropriate for training sessions in biosafety; more extensive out- lines of appropriate subjects may be found in Appen- dix F and reference 149. Documentation by the BIOSAFETY IN THE LABORATORY employee of the completion of orientation and of continuing education is essential. Training should include information concerning the beneficial aspects of the normal flora of the body, as well as the rarity with which pathogens in the en- vironment cause harm. Such sessions should help to reduce unwarranted fears in the workplace. Informa- tion should also be provided on the lack of risk to the general public, since the public perception of the risks of biohazards is far out of proportion to any known problem. Legislative representatives should be educated in a similar fashion, to prevent overreac- tion to the materials used for research and the waste that institutions have to discard. Supplementary safety training materials can be obtained from several commercial sources or may be borrowed from government agencies; they need not be developed by the institution. Some examples of sources and programs are listed in Appendix F. Each institution should have a library of reference books and teaching aids, the extent of which will depend upon the financial support and educational expertise available. Consultants can be hired to lecture on specific topics if an expert is not available in-house. To ensure a level of continuity to the program, the project leader or principal investigator may be Hained fast to serve as an instructor of the technicians on the project. The slide sets and materials in Fundamen- tals for She Microbiological Research A Series, produced in 1983 by the Division of Safety of the National Institutes of Health (see Appendix F3, in- clude instruction manuals and advice as to the posi- tion of the person in the institution who should ad- dress specific subjects. Biosafety officers, sanitari- ans, microbiologists, infection control practitioners, industrial hygienists, and others may be called upon to give the training. Only those who are knowledge- able about the actual hazards and methods for appro- priate controls, and thus capable of answering ques- tions and addressing justifiable and unwarranted fears, should present these programs. Further information on training materials and safety training courses may be obtained from the Division of Safety, National Institutes of Health; Office of Biosafety, Centers for Disease Control; the American Society for Microbi- ology; the American Biological Safety Association; and the Biohazards Section of the American Indus- trial Hygiene Association. Physicians' laboratories may contact their state health laboratories for further information.
SAFETY MANAGEMENT TABLE 5.1 Suggested Topics for Biohazard Safety Training 1. Aseptic technique and procedures 2. Personal hygiene 3. Laboratory practices (primary containment barriers) for appropriate biosafety levels 4. Personal protective equipment 5. ~ , ~ Assessment criteria for facilities at various biosafety levels Decontamination, disinfection, and steriliza- tion 7. Signs 8. Biohaz~rdous waste handling, packaging, and disposal 9. Packaging, transporting, and shipping biohaz- ardous materials 10. Effective use of a biological safety cabinet 11. Safe use of an autoclave 12. Safe use of a centrifuge 13. Monitoring and auditing 14. Reporting incidents and accidents 15. "Right-to-know" hazard communication 16. "Universal precautions" for handling human blood and body fluids NOTE: See Appendix F for sources of audiovisual matenals. Graduate degrees in biosafety are offered through the Biohazard Science Training Program, School of Public Health, University of North Carolina. Other schools of public health offer advanced degrees in environmental health or epidemiology, which can include elective or required courses in biosafety. Short courses or workshops in biosafety or related subjects are sponsored by national associations such as the American Society for Microbiology, Association of Practitioners in Infection Control, and the American Chemical Society, or as continuing education pro- grams through academic institutions. Training pro- grams sponsored from 1980 through 1983 by the National Institutes of Health have continued to be offered annually by the host institutions, Harvard University, and The Johns Hopkins University, on a fee basis, to meet the demand for such training (see Appendix F). 53 3. Evaluation of Laboratory-Associated Hazards The dangers to personnel and the environment from biohazardous laboratory activities should be assessed in a systematic fashion. A number of fac- tors should be considered, but the two most impor- tant factors are (1) the agents and (2) the potential consequences of infection. The characteristics of the microbiological agents being used are particularly important; i.e., their virulence, pathogenicity, com- municability, and route of spread are properties af- fecting the potential danger for laboratory workers and the environment. The types of procedures used with the microorganisms and the quantities handled will also affect the degree of hazard. Agents causing infections that are mild, easily treated, or readily prevented with a vaccine pose much less danger than agents that cause severe or fatal disease and cannot be prevented or treated effectively. In addition, the skills and knowledge of the employees should be considered. The individuals working in a laboratory should be trained adequately to understand the haz- ards of their work, to become proficient in the proce- dures that should be followed to minimize personal danger, and to be aware of the possibility that they might expose others to the organisms. Assessment of hazard requires good judgment in the application of general principles to the specific laboratory situation to reach a rational decision. It includes also an evaluation of the types of facilities, laboratory practices, personal protection devices, and equipment that will be needed to perform the labora- tory work safely. 4. Policy and Procedure Manuals It is essential that biosafety policies and proce- dures be clearly spelled out in a manual, including the information the laboratory worker should lmow for day-to day activities as well as for handling emer- gencies. The laboratory biosafety manual should include the following subjects: · policy and goals; · safety organization; · medical program; · procedures for general laboratory opera- tions, including: labeling and handling of speci
54 mens; methods to minimize hazards of aerosols and droplets; proper uses of needles, syringes, and "sharps"; appropriate discard of working ma- terials; sterilization and disinfection; cleanup of spills; use and maintenance of biological safety cabinets; control of insects and other pests; work with animals; and waste disposal; · safety equipment location and proper use; and · emergencies. The safety manual should be readily available to all employees. Each new employee should be re- quired to review the manual and to document that this has been done. The safety manual should be re- viewed annually by the laboratory director and by the safety officer to ensure that it is accurate and current for the laboratory in which it is being used. In addition to a safety manual, many laboratories have a manual of general procedures (standard oper- ating procedures, or SOPs). This manual should in- clude the special safety precautions required for par- ticularly hazardous steps of the various procedures described therein. Safety aspects of each procedure should be reviewed during the periodic review of the SOPs. Work that involves animals or the use of animal facilities may require additional safety procedures, which should be clearly defined in procedure manu- als. These are described in more detail in other pub- lications [44,1051. (See Appendix G. Accreditation.) Smaller laboratories, such as physicians' office laboratories or laboratories that handle minimally biohazardous materials, may address biosafety as a portion of the general laboratory procedure manual. For many small laboratories, collection and handling of specimens of blood and body fluids represent the major hazard. 5. Accident Reports and Investigations Each organization should have a defined system for reporting laboratory injuries and accidents, as well as for investigating them. These events should be documented and reported to the appropriate su- pervisory personnel and to the employee health serv- ice. For those organizations subject to the regula- tions promulgated by the Occupational Safety and Health Administration (OSHA), there are specific re- quirements for reporting injuries in the workplace. BiOSAFETY IN THE FLORA TORY There may be requirements for similar reporting by state and local governments. Most large organizations will have special forms for recording accidents. However, in smaller organi- zations an expository description will suffice for most accidents. Reports should be filled out for all labora- tory accidents. These should include a description of the accident and any factors contributing to the acci- dent. In addition, any first aid or other health care given to the employee should be included. Respon- sibility for completing these forms should be clearly defined. It might be assigned to the laboratory super- visor, employee health personnel, or safety person- nel. Accidents should be periodically reviewed by the safety committee, by the employee health unit, or by other appropriate personnel, and the individual reports or a summary should be sent to the director of the organization. The information collected from accident reports can be used to investigate specific accidents and can be collected and analyzed to assess trends in various problems. For example, is the frequency and/or se- venty of needle sticks increasing or decreasing? Have changes in procedures for handling needles affected the incidence or severity of such accidents? 6. Recordkeeping A number of records of the biosafety program are required by OSHA, and perhaps by the local and state government. In general, records should be kept for a minimum of 5 years, although some, such as medical records, should be held for 30 years. Mod- em data processing can simplify many aspects of biosafety recordkeeping. 7. Auditing Auditing (quality assurance) is essential if the safety program is to function properly. If there is no effort to ensure that appropriate procedures and poli- cies have been carried out conscientiously, the pro- gram may exist only on paper. It is helpful to have a periodic external review by a safety officer, a person who works in another laboratory, or an inspector from an accrediting organization. Examples of the latter for health care laboratories are the Joint Com- mission for Accreditation of Healthcare Organiza- lions, the College of American Pathologists, and state health deparanents. These agencies have lists of
SAFETY MANAGEMENT safety and other laboratory requirements and will 10. Signs check to see If these are fulfilled. Facilities, equ~p ment, and employee knowledge of safety and com pliance are some of the items reviewed. Internal auditing reviews of the laboratory, using a checklist obtained from such an accrediting group, also may be helpful. It is important to conduct periodic audits of key physical aspects of the biosafety system. For ex ample, during these reviews the annual certification of biosafety cabinets and periodic testing of the ven tilation and alarm systems can be confined. This practice is particularly important after modifications in the facilities have been made as a result of periodic maintenance or renovation. It is not unusual to find that supposedly negative pressure rooms are under positive pressure or have inappropriate numbers of air changes per hour. Reports of the results of the audits should be submitted to management for re view and action. 8. Registry of Agents In any large organization, a central registry should be maintained of the identity and location of the various infectious agents being handled throughout the facility, particularly for those agents requiring Biosafety Level 3 or 4 operations. A central registry is essential for dealing with emergencies. For ex ample, a fire in a laboratory might cause excessive damage if the firemen were unwilling to enter an area marked only with a conventional biohazardous or other type of warning sign if no one was readily available who could explain the nature of the poten tial hazard within that laboratory. It may be helpful to list, on the hazard warning signs on the laboratory doors, the agents, the common names of the diseases caused by them, and the names and telephone num bers of persons to be contacted in the event of an emergency. 9. Waste Management It is the responsibility of the laboratory director to see that waste is properly handled and, when neces sary, that it has been made noninfectious before being discharged into the environment. The principles of infectious waste management are described in Chap ter 4. SS Appr~riale signs should be used to identify haz- ardous laboratory areas as outlined in Appendix A (see section on Registry of Agents above). These biohazard signs should be posted at the entrances to areas if there are special conditions for entry. When there are multiple potential hazards, multiple signs are required. There should be a uniform system of signs within an institution, and it should conform with nationally recognized symbols. D. MEDICAL PROGRAM 1. General Principles The extent of the medical program for employees with potential exposure to infectious agents should be based upon the specific risks and hazards of the laboratory activities, as well as on the overall medi- cal program of the organization of which the labora- mry is a park Except for investigations of accidental exposures or inadvertent infections, the main objec- tive of the medical program should be to prevent disease. It is beyond the scope of this book to discuss the role of the medical program in promoting the general health of employees (e.g., screening for dia- betes, high blood pressure, and heart disease). Designing the program requires clear definition of goals and an appropriate plan to reach these goals [57,58,1351. Components of a medical program might include: Replacement examination (PPE), periodic monitoring evaluation (PME), treatment and docu- mentation of accidental exposure, epidemiologic study of exposure-related illness, tracking of prolonged or unusual illness, immunization, and postemployment evaluation (PEE) [62J. The program might also be involved in making recommendations to reduce ex- posure to biohazards (e.g., use of biological safety cabinets, use of personal protective devices, or changes in work practices). 2. Conditions Increasing Employee Risk of Adverse Health Outcome The risk of adverse health outcome as a result of exposure to infectious agents may be increased in individuals whose immunological or other defense mechanisms have been impaired by such conditions
56 as medication, allergy, or pregnancy. When such conditions are identified in employees potentially at risk, it is important to review the nature of their work to ascertain whether or not some change or accom- modation can be made to lower or eliminate the chances for exposure. If such actions are not pos- sible, it may be necessary to transfer the employees to other jobs. In the case of a prospective candidate, such findings may be the basis for denying employ- ment. These decisions must be individualized with input from the employee, management, the institu- tion's occupational medicine service, and if ap- propriate the employee's private physician. a. Deficiencies of lIost Defenses The considerable literature on the infection of persons working in microbiological laboratories has been described in Chapter 2, Chapter 3 (Section B), and Appendix A. Because of this occupational risk it is reasonable to conclude that, in addition to the need for engineering controls, biosafety equipment, ap- propriate work practices, and personal protective devices, laboratory workers should have unimpaired host defenses. A detailed discussion of abnormali- ties of host defenses is beyond the scope of this document, but some major factors are briefly consid- ered below. Cutaneous defenses are altered by diseases such as chronic dermatitis, eczema, and psoriasis. Per- sons with these conditions may be more susceptible to skin infections. A disrupted skin surface may allow entry of such agents as hepatitis B virus and human immunodeficiency virus, which are believed not to be able to penetrate healthy, intact skin. Antimicrobial therapy may interfere with protec- tion afforded by the normal microbial flora of the mucosal surfaces of the body. Antibiotic-related sup- pression of the normal flora, or bowel pathology that disrupts the mucosal surface, may interfere with the protective properties of the healthy, intact gastroin- testinal tract. Abnormalities of the immune system may inter- fere with antibody-mediated defenses, T-cell-medi- ated defenses, phagocytosis, or complement-medi- ated defenses. The types of infections likely to occur will vary with the nature of the alteration of the host's defenses. For example, persons who have asplenia, complement defects, antibody defects, or decreased numbers of polymorphonuclear leucocyms sIos4FETy sin THE LABORATORY are more likely to be subject to serious infection caused by encapsulated bacteria (e.g., pneumococ- cus or haemophilus), while those with T-cell defects are at a greater risk of developing active tuberculo- sis, histoplasmosis, listeriosis, or cytomegalovirus pneumonia. Treatment with corticosteroids can inter- fere with T-cell, B-cell, and phagocyte functions. b. Reproductive Hazards The laboratory environment may contain various biological, chemical, or physical hazards that can adversely affect the outcome of pregnancy, but this discussion will be limited to the biological hazards. Although sexually acquired infections with some agents (e.g., chlamydia and gonococcus) can result in infertility in either sex, it is unlikely that acciden- tal infection with these agents in the laboratory will cause this problem. Exposure to mutagenic agents would be of concern to fertile employees of either sex, and such exposure should thus be minimized. Of special concern is the potential for infection of the fetus, in utero or during delivery, resulting from a work-related infection acquired by a pregnant em- ployee. Diagnostic microbiologists, serologists, and chemistry laboratory workers who have no direct contact with patients with infectious diseases may be exposed unknowingly to a variety of infectious agents in the specimens that they process. The infectious agents that potentially may be acquired in this man- ner and that are known to cause congenital or neona- ta] infections include rubella virus, hepatitis B virus, cytomegalovirus, human immunodef~ciency virus, enteroviruses, herpes simplex virus, varicella virus, Treponema pallidum (the agent of syphilis), and toxoplasma [1121. The concern for the pregnant employee may be increased if she is handling viruses requiring Biosafety Level 3 or 4, for which the ef- fects of maternal infection on the fetus are unknown. When considering job placement or work scope for a pregnant laboratory employee, or an employee who is attempting to become pregnant, several fac- tors are important: the agent, and what is known about the risk of infection and its consequences; the means available to prevent exposure; and the possi- bility of other assignments [1441. The employee should be completely informed of the potential risks, and should be involved in tile decision-making pro- cess along with the employer and the employee's physician. In making a decision, consideration must
Sawers M4N4cEMENT be given to both the health of the fetus and the needs of the employee. c. Allergies Workers in biomedical laboratories may develop allergies to aerosolized proteins (e.g., fermentation products and enzymes), animal dander, urine pro- teins [5,14], or arthropod materials (see Chapter 3, Section C). In addition, allergies to substances (such as egg proteins) found in vaccines may preclude immunization. Specific allergies may occasionally be grounds for denying employment or job transfer or may necessitate the institution of stringent mea- sures to prevent exposure. 3. Program Design After the medical program's goals have been de- fined and the potential hazards recognized, the con- tent of the program and its participants can be deter- mined. The program should be in compliance with federal, state, and local government regulations for the protection of the health and welfare of the em- ployee (see Section F of this chapter), and should be in accord with the general policies of management. 4. Preplacement Examination (PPE) The primary goal of a preplacement examination (PPE) for a prospective employee is to reveal any medical condition that might put the worker or co- workers at increased risk because of certain job ex- posures or activities. Recommendations for job re- strictions or denial of employment should be care- fully considered and should avoid exclusions based on inaccurate presumptions of risks or future dis- abilities. Other goals of the PPE are to obtain a baseline for future comparison and to ensure that the employee has received appropriate immunizations. At the time of hiring, it is prudent to give all prospective employees a questionnaire that elicits an occupational and medical history. Workplaces not affiliated with an occupational medical service could have this done through the employees' own physi cians. Personnel who may require a more complete evaluation (e.g., physical examination and labora- tory testing) include the following: 57 · individuals working with the more hazard- ous agents, particularly those requiring Biosafety Level 3 or 4 (see Appendix A and reference 134~; · individuals working with oncogenic and terato- genic microbial agents; · animal caretakers, maintenance personnel, cus- todial and housekeeping staffs, or others who work in areas where potential exposure to infectious mate- rials is high; · personnel working in overcrowded areas or in areas where containment systems are deficient or lacking; and · individuals whose questionnaires show medi- cal conditions that would increase their risk when handling certain agents. a. Medical History The medical history should elicit information about the state of general health and host defenses, the presence of allergic conditions, past immuniza- tions, and prior significant infectious diseases. It may be useful also to inquire about the presence of specific symptoms (e.g., persistent naval congestion, headache, cough, or gastrointestinal complaints), which may be useful in the future for evaluating medical complaints of the employee and for inter- preting the significance of nonspecific early mani- festations of illness. b. Occupational Health History The occupational health history is the cornerstone of the occupational health examination [57,581. The initial occupational history should include a profane of past employment; a listing of symptoms, illnesses, or injures related to past hazardous occupational exposures; specific questions relevant to the require- ments and potential hazards of the proposed work assignment; and any significant factors concerning community and home contacts and activities. c. Physical Exarrunation If a general physical examination is performed, particular attention should be paid to evidence sug- gesting altered host defenses (e.g., lymphadenopa- thy, hepatospenomegaly, dermatitis, or allergy).
58 d. Laboratory and Other Testing Biological monitoring and medical screening can be key elements in a medical program. Biological monitoring provides evidence of infection with spe- cif~c infectious agents, e.g., the purified protein de- rivative (PPD) skin test for tuberculosis and sero- logical tests for antibody to hepatitis B virus. Medi- cal screening detects evidence of abnormal structure or function of body organs and systems, e.g., chest radiographs, total and differential white blood cell counts, and liver function tests. The purpose of biological monitoring and medical screening is to identify the occurrence of inapparent infections and to permit recognition of the early signs and symp- toms of dismse when the effects of the infection may be reversible or more easily treated [621. Selection of the laboratory testing procedures should be based upon the potential hazards, whenever possible. Skin testing of clinical microbiologists with puri- f~ed protein derivative for tuberculosis can be useful. If the PPD skin test has recently converted from negative to positive, a chest radiograph is indicated to detect active disease. Periodic chest radiographs have not been of value in monitoring asymptomatic employees with long-standing positive PPD skin tests [103,1121. It is rarely necessary to do a chest radio- graph in an otherwise healthy person who has no pulmonary symptoms and whose physical examina- tion and PPD skin test are negative. Preplacement patch testing for allergies has not proved to be a generally effective means of predict- ing a predisposition to the development of allergies in animal handlers. Pulmonary function testing should be done only in special circumstances, such as assessing the fit- ness of an individual to wear a respirator. In work situations where the competency of host defenses is important, one might consider perform- ing other tests, such as a complete blood count with differential white cell count, which might indicate the presence of conditions compromising host de- fenses. e. Serum Bank A decision to establish a serum bank should be considered carefully. A serum bank may be helpful in fading evidence for presumptive infection with certain infectious agents and in establishing the ap BIOSAFEIY IN THE LABORATORY proximate time of its occurrence. The potential use- fulness of a serum bank will depend upon the agents to which the employees may be exposed, the likeli- hood that apparent or inapparent infection will cause a change in the level of immoral antibodies, and the availability of diagnostic tests for the agents being handled. All serum specimens should be stored frozen. Comparison of the levels of antibody or antigen in the initial specimen with those in subsequent speci- mens allows detection of changes. Testing is usually not performed until there are two or more specimens that can be assayed simultaneously to ensure compa- rability of results. The serum bank can be invaluable when there are questions of job-acquired infection. 5. Immunizations The recommended childhood immunizations for diseases such as tetanus, diphtheria, pertussis, polio- myelitis, measles, mumps, and rubella are of particu- lar benefit to clinical laboratory workers and to those working with the etiologic agents causing these dis- eases or with specimens that may contain them (see Chapter 3, Section B). Maintaining tetanus immuni- zation simplifies care of penetrating injuries. Per- sons with patient contact should have immunity to rubella to protect themselves, as well as to prevent transmission of this infection to others who may be pregnant. Specific immunizations may be desirable for employees at high risk of exposure to certain agents. All laboratory workers who are exposed to human blood or body fluids should be immunized against hepatitis B virus. Rabies immunization is appropri- ate for persons working with rabies-infected speci- mens and animals (see Table 5.2~. For more specific and detailed recommendations, the reader should consult the latest edition of the American College of Physicians' Guide for Adult Immunizations [21. 6. Periodic Monitoring Examination (PME) The goals of the periodic monitoring examination (PME) include the following: · detection of the effects of possible exposure to biohazards (e.g., symptoms of clinical infection; al- lergic symptoms; or complaints related to the phar- macological effects of end-products, by-products,
SAFETY MANAGEMENT medium components, or inactivated biological agents); · detection of changes in the health status of the employee since the last evaluation that may indicate the need for a change in work procedures or job placement; and · detection of patterns of disease in the work force that may indicate work-related problems and suggest the need to evaluate the effectiveness of con- trol measures. The frequency of the PME varies depending on the employment situation, but usually is performed annually. The PME might include an update of the occupational and medical histories, biological moni- toring tests to detect subclinical infection, medical screening tests, and targeted physical examination. 7. Postemployment Evaluation (PEE) A postemployment evaluation (PEE) may be de- sirable immediately before an employee leaves the laboratory of the employer. This evaluation should resemble the PPE and include, at the least, an inter- val occupational medical history. The extent of the evaluation can be modified if the person has under- gone either a PPE or PME within the previous six months. If a serum bank has been established, it may be appropriate to obtain a final serum sample. B. Agent-Speci~c Surveillance The implementation of a surveillance system may be useful for the early detection of symptoms related to a specific etiologic agent or to the effects of expo- sure to noninfectious products in the workplace. For example, an ongoing surveillance program for all workers who may become exposed to rickettsiae in the laboratory, including maintenance and other sup- port service personnel, could result in early treatment of the disease and amelioration of its severity (see Appendix C in reference 105~. Such a surveillance system should include the availability of an experi- enced medical officer, education of at-risk personnel about the potential hazards of the infectious agents and the advantages of early treatment, a reporting system for recording all recognized exposures and accidents, and the requirement for prompt reporting of all febrile illness. 59 9. Accident Reporting Accidents, such as needle sticks or spills, should be reported immediately to the laboratory supervisor. The supervisor should refer the employee to the medical staff or consulting physician to determine whether testing, treatment, or follow-up is nee - . Accidents should also be reported to the biosafety staff, so that appropriate measures can be instituted to avoid a similar accident in the future. Protocols for preventing anticipated accidents, such as needle sticks and spills, should be prepared, and employees should be Rained to deal with these situations ac- cordingly. Laboratory personnel can be trained as "first responders" for dealing with various medical emergencies [501. Accident reporting and recording should be in compliance with legal requirements (e.g., OSHA regulations). 10. Recordkeeping and Result Notification Workers should be informed of the results of their occupational medical evaluations. Confidentiality of medical records and test results should be maintained, and information released to others only with the au- thorization of the involved employee. Authorization for the release of medical information that is perti- nent to their fitness to perform their job duties may be obtained from the workers at the time of their PPE. The personnel officer, or the biosafety officer, need only receive information about those medical conditions, restrictions or accommodations that re- late specifically to the individual's fitness for work. (See the Americal Occupational Medical Association Code of the Ethical Conduct for Physicians Provid- ing Occupational Medical Services r.71.) It is advisable to review periodically the data collected in the medical surveillance program. In larger laboratories, for example, the prevalence rates of symptoms or abnormalities in different job or exposure groupings can be examined, and the results of medical monitoring data can be related to the laboratory environmental sampling data 11. Resources The medical program should be designed and supervised by a qualified individual, such as a physi- cian or nurse practitioner. Depending upon the size
60 TABLE 5.2 Recommendations for Immunoprophylaxis of Personnel at Risk BIOS~E" IN THE BOOTERY Description Recommended Source of Disease of Product For Use In Product Anthrax Inactivated vaccine Personnel working USAMRUDa regularly with cultures, diagnostic materials, or infected animals Botulism Pentavalent toxoid Personnel working CDCC (A,B,C,D,E) rNDb regularly with cultures or toxin Cholera Inactivated vaccine Personnelworking Commercially regularly with large available volumes or high concentrations of infectious materials Diphtheria-Tetanus Combined toxoid All laboratory and animal Commercially (adult) care personnel available irrespective of agents handled Eastern Equine Inactivated vaccine Personnel who work USAMRIID~ Encephalomyelitis directly and regularly (EKE) with EKE in the laboratory Hepatitis A Immune serum Animal care personnel Commercially globulin working directly with available (ISG [Human]) chimpanzees naturally or experimentally infected with hepatitis A virus Hepatitis B Serum-derived or Personnel working Commercially recombinant vaccine regularly with blood and available blood components Influenza Inactivated vaccine (Vaccines prepared from Commercially strains isolated earlier available may be of little value in personnel working with recent isolates from humans or animals) Japanese Inactivated vaccine Personnel who work CDCC Encephalitis directly and regularly with JE virus in the laboratory
SAFETY MANA CEMENT 61 Description Recommended Source of Disease of Product For Use In Product Measles Live attenuated Measles-susceptible Commercially virus vaccine personnel working with available the agent or potentially infectious clinical materials Meningococcal Purified tetravalent Personnel working Commercially Meningitis polysaccharide regularly with large available vaccine volumes or high concentrations of infectious materials (does not protect against infection with group B meningococcus) Plague Inactivated vaccine Personnel working Commercially regularly with cultures available of Yersinia pestis or infected rodents or fleas Poliomyelitis Inactivated(IPV) Polio-susceptible Commercially and live attenuated personnel working with available (OPV) vaccines the virus or entering laboratories or animal rooms where the virus is In use Pox viruses Live (lyophilized) Personnel working with CDCC (Vaccinia, vaccinia virus orthopox viruses Cowpox, or transmissible to humans Monkey Pox or with animals infected viruses) with these agents, and personnel entering areas where these viruses are in use Q Fever Inactivated Personnel who have no USA~IDa (Phase II) demonstrable sensitivity vaccine to Q fever antigen and who are at high risk of exposure to infectious materials or animals Rabies Human diploid cell Personnel working with Commercially line inactivated all strains of rabies available vaccine virus or with infected animals, and personnel entering areas where these activities are conducted Continued
62 TABLE 5.2 Continued BIOSAFETY IN THE LAI9ORA TORY Description Recommen~d Source of Disease of Product For Use In Product Rubella Live attenuated Rubella-susceptible Commercially virus vaccine personnel, especially available women, working with "wild" swains or in areas where these viruses are in use Tuberculosis Live attenuated (BCG vaccine ordinarily Commercially (BCG) bacterial is not used in laboratory available vaccine personnel in the U.S.) Tularemia Live attenuated Personnel working CDCC bacterial vaccine regularly with cultures (IND)6 or infected animals, and personnel entering areas where the agent or infected animals are in use Typhoid Inactivated vaccine Personnel who have no Commercially demonstrated sensitivity available to Be vaccine and who work regularly win cultures Venezuelan Live attenuated Personnel working win USAMRIIDa Equine and (TCS3) viral vaccine VEE and the Equine Related Cabassou, Everglades, Encephalitides Mucambo, and Tonate viruses, (VEE) or who enter areas where these viruses are in use Western Inactivated vaccine Personnel who work USAMRIIDa Equine directly and regularly Encephalo- with WEE virus in He myelitis (WEE) laboratory Yellow Fever Live attenuated Personnel working win Commercially (LID) virus vaccine virulent and avirulent available strains of yellow fever virus a U.S. Anny Medical Research Institute for Infectious Diseases, Fort Detridc, MD 21701, telephone: (301) 663-2405. b Investigational new drug. c Clinical Medicine Branch, Division of Host Factors, Center for Infectious Disease, Centers for Disease Control, Atlanta, GA 30333, telephone: (4{)4) 639-3356. SOURCE: Adapted from recommendations of the PHS ~nunization Practices Advisory Committee and Biosafety in Microbiological and Biomedical Laboratories [105].
S~ETr MANAcEMENT of the laboratory (or company), the director of the medical program may be full-time and on site, such as at a facility-based employee health service, or part-time and off site, where employees are evalu- ated at a different location. Whatever the arrange- ment, there should be an open line of communication between the medical program director and the personas) responsible for biosafety. The medical program director must be familiar with the nature of the employees' work and its potential hazards in order to design an effective medical program. E. EMERGENCIES 1. Preparation and General Procedures a. Preparation It is the responsibility of every laboratory organi- zation to establish a specific emergency plan for its facilities. This plan should cover both the laboratory building and the individual laboratories. For the building, the plan should describe evacuation routes and shelter areas, facilities for medical treatment, and procedures for reporting accidents and emergen- cies. It should be reinforced by drills and simulated emergencies. Plans should include liaison with local emergency groups as well as with community offi- cials. To be prepared, these groups should be in- formed of plans in advance of any call for assistance. "Community right-to-know" regulations [127] require the development and coordination of emer- gency plans with local community response groups, as well as the listing of hazardous chemicals and their location. Many types of facilities are included in these requirements; however, there are exemp- tions for qualifying laboratories. Legal guidance should be obtained. For small-scale accidents in the laboratory, a good "rule of thumb" to remember is to leave the area, call for help, and then secure the area. Preplanning of work is the best way to avoid accidents and should include thinking through "what if" an accident should occur unexpectedly. In handling mixed hazards (e.g., a substance that may be infectious and radioactive, or infectious and chemically toxic, or present all three hazards) it is usually best to respond with pro- cedures for the greater hazard fast, and then follow through with those for the lesser hazards, to ensure . 63 that all appropriate steps have been taken. General emergency E~ures are discussed below, followed by guidelines for dealing with specific Apes of acci- dents. b. General Emergency Procedures The following emergency procedures are recom- mended in the event of fires, spills, explosions, or over laboratory accidents. These procedures are intended to limit injuries and minimize damage if an accident should occur. · Render assistance to persons involved and remove them from exposure to further injury if necessary; do not move an injured person not in danger of further harm. · Warn personnel in adjacent areas of any po- tential hazards to their safety. · Render immediate first aid (e.g., beginning resuscitation if breathing has stopped or washing under a safety shower). Appendix 4 of reference 83 contains an Emergency First Aid Guide. · In case of fire, call the fire department. Fol- low local rules for dealing with a small fire, e.g., if there are portable extinguishers available and the institution encourages their use, extinguish the fire. On the other hand, some institutions require all fires to be reported immediately, thereby sum- moning trained assistance. · In a medical emergency, summon medical help immediately. Laboratories without a medi- cal staff should have personnel trained in first aid available during working hours. 2. Evacuation Procedures The following evacuation procedures should be established and communicated to all personnel. a. Emergency Alarm System There should be a system to alert personnel of an emergency that may require evacuation. Laboratory personnel should be familiar with the location and operation of alarm equipment. Isolated areas (e.g., cold, warm, or sterile rooms) should be equipped with alarm or telephone systems that can be used to alert outsiders to the presence of a worker trapped inside, or to warn workers inside of
64 the existence of an emergency that requires evacu- ation. b. Evacuatzon Routes Evacuation routes should be established. An out- side assembly area for evacuated personnel should be designated, with plans for taking roll call to en- sure that all personnel are accounted for. c. Shutdown Procedures Brief guidelines for shutting down operations during an emergency or evacuation should be avail- able In writing. Biohazardous agents should be se- cured in cabinets to minimize the danger of spillage. d. Start-Up Procedures Written procedures to ensure that personnel do not return to the laboratory until the emergency is ended, and start-up procedures that may be required for some operations, should be displayed and re- viewed regularly. e. Drills All aspects of the emergency procedure should be tested regularly (e.g., every 6 to 12 months). f. Powerfailure Loss of power can result in failure of a contain- ment system, or loss of lighting, ventilation, refrig- eration, or other essentials for safety. Procedures to handle this type of emergency should, therefore, be included in planning. 3. Fires Fires within a laboratory using biohazardous ma- terials will require an immediate response to mini- mize personal exposure and to limit the potential spread of biological contamination. Fires may create toxic smoke as well as aerosols that may contain infectious materials. Small fires that may occur in a laboratory usually are extinguished by the immediate use of a portable fire extinguisher. A Halon extinguisher is preferred for use because it extinguishes the fire quickly with- out leaving any chemical residue to contaminate the BiOS~ETY iN THE ~OMTORY work area. Water from the sprinklers of the building fire protection system should extinguish the fire. In case of doubt about containing a fire, no time should be wasted in deciding to call the institutional or com- munity brigade. Fire fighters responding to the fire scene should wear self-contained breading appara- tus to protect themselves from toxic combustion by- products and aerosols generated by the burning of infectious materials. 4. Spills and Releases Experience has shown that the accidental spill and release of hazardous substances is a common enough occurrence to require procedures that will minimize exposure of personnel and contamination of property. Such procedures may range from hav- ing available a sponge mop and bucket to having an emergency spill-response team, complete with pro- tective apparel, safety equipment, and materials to contain and clean up the spill. In any event, there should be supplies on hand to deal with the spill consistent with the hazard and quantities of the spilled substance. a. Infectious Agents Some biological Beseech materials, when dropped, spilled, or set on fire, can release hazardous agents that can contaminate the area and lead to infection of laboratory workers. Prevention of exposure is the basic rule for an emergency response. When an accident occurs that may generate an aerosol or drop- lets of infectious materials, Ocularly if the mate- rial is an agent requmng Biosafety Level 2 (or higher) precautions, the room should be evacuated immedi- ately, the doors closed, and all clothing decontami- nated. Enough time should be allowed for the drop- lets to settle and the aerosols to be reduced by the air changes of the ventilation system before attempting to decontaminate the area The time required will depend upon the ventilation within the area, but a general rule is to wait approximately 30 minutes before reentry for decontamination. Protective cloth- ing and approved respiratory protection should be worn during the decontamination to prevent personal exposure to the infectious agents Cat were released. The biosafety officer should be consulted before cleanup is started, to ensure that proper techniques will be employed.
SAFETY MANACEME~ ,. ... 65 ._ - FIGURE 5.1 The cleanup of an accidental spill of biohazardous material is illustrated. A laboratory worker using protective clothing, gloves, and respiratory protection is cleaning up the spill with paper towels that have been soaked with a disinfectant. The proper emergency response for a particular spillage will depend on the volume of the spill and the infectious hazard of die matenal. Courtesy, National Institutes of Health. A spill of biohazardous material within a biologi- cal safety cabinet requires a special response and cleanup procedure. Cleanup should be initiated at once, while the cabinet continues to operate, using an effective chemical decontaminating agent (see Table 4.1~. Aerosol generation during decontamination, and the escape of contaminants from the cabinet, should be prevented. Caution must be exercised in the choice of decontaminant, keeping in mind that fumes from flammable organic solvents, such as al- cohol, can reach dangerous concentrations within a biological safety cabinet. The proper emergency response for an accidental spillage of biohazardous material in the laboratory, outside a biological safety cabinet, will depend upon the hazard of the material and the volume. A mini- mally hazardous material that is spilled without gen- erating significant aerosol may be cleaned up with a paper towel soaked with an effective decontaminat- ing agent. A spill of a large volume of infectious material with the generation of aerosols will require cleanup personnel wearing protective clothing and respiratory protection (Figure 5.1~. With M. tuber- c~osis, for example, the risk of exposure from the spill of a small quantity might be many times that of a much larger spill of E. coli. Therefore, if the agent is known, the recommended procedure and protec- tive equipment should be used. Waiting approxi- mately 30 minutes for the aerosols to settle before the cleanup of a large spill is essential. A spill kit or the best utensils available should be used to clean up, and material to be discarded should be placed in containers for decontamination and safe handling by others. Following cleanup, personnel should wash or shower. Other types of spills that may generate hazardous aerosols include spills within centrifuges and the re- lease of biohazardous materials within refrigerators, incubators, or shaker baths. The same principles discussed above apply: the area should be left imme
66 diately, protective equipment should be worn, the spill should be cleaned up, and the area should be disinfected. The personnel should then wash or shower. As with biological spills, the proper emergency response to a chemical or mixed chemicaVbiological release will depend upon the hazard of the chemical and biological agents, the volume of material, and the location of the incident. The spill should be confined to a small area while avoiding the airborne release to the extent possible. The spill should be neutralized or flushed with water and followed with a cleanup or mopping up, with careful disposal of the residue. If the spilled material is highly volatile and noninfectious, it should be allowed to evaporate and be exhausted by the hood or ventilation system. b. Handling ofSpilled Solids Generally, spilled solids of low toxicity should be swept into a dust pan and placed in an appropriate container for disposal. Additional precautions, such as the use of a vacuum cleaner equipped with a PAPA filter, may be necessary when cleaning up spills of more highly biohazardous materials. c. Biological Radioactive Emergencies The best way to avoid having a spill or other accident when working with radioactive materials is to preplan the work. Unfamiliar procedures should fast be carried out without radioactive materials, so that problems will be discovered before the radioac- tive materials are utilized. Adequate time should be allotted for the experiment to prevent rushing at the end, as this can lead to clumsy or careless actions. Should a spill occur, it is important to remember that spills of radioactive material are handled in a way similar to spills of infectious agents, except that there is additional concern for the radiation hazard. Determination of the primary hazard is of the utmost importance. In a spill involving both an infectious agent and a radioisotope, the radioactivity may be of secondary concern until the infectious agent has been inactivated. The disinfecting agent should be se- lected carefully: for example, hypochlorite will vola- tilize radioactive iodine. The first concern in any spill, radioactive or oth- erw~se, is to determine if anyone has been contami- nated. Contaminated clothing should be removed BIOSAFETY IN THE LABORATORY immediately, and if there is a spill on the skin, the person should wash the contaminated area gently with mild soap and water. The laboratory should be evacuated unless the spill is contained within a hood. The radiation safety officer (RSO) and supervisor should be notified immediately whenever there is a radioactive spill, regardless of its size. Laboratory personnel may be expected to clean up the spill, but the RSO is an essential resource and can provide important advice. In all circumstances, the radioisotope and the approximate quantity spilled should be determined first. If the radioisotope is an energetic beta and/or gamma emitter, an external as well as internal hazard may exist. The external dose rates to individuals cleaning up the spill may be sufficient to require localized shielding and careful planning prior to cleanup. A significant external dose rate to the skin may result if the skin becomes contaminated during the cleanup. If the skin is damaged, an internal exposure may also occur. Depending on the chemi- cal form, some radioisotopes may penetrate intact skin. Examples of radioisotopes that would pose both external and internal hazards include, but are not limited to, 22Na, i3iI, 32p, and 36C1. An internal hazard may also exist if the radioactive material is volatile or is easily made airborne. Monitoring devices should be worn if they are normally required when handling the radioisotope in question, or if the RSO deter- mines that they are necessary. Low-energy beta emitters such as 14C, 3H, 3ss, and 4SCa are usually not external hazards, provided that they are not deposited on the skin. Alpha particle emitters (34tAm, 239Pu) are generally not considered external hazards but are very damaging if deposited inside of the body. For internal radiation hazards, the primary concern is to prevent the isotope from entering the body by the penetration of the skin. Appropriate protective equipment, such as gloves, should be worn during cleanup. Prevention of skin contamination and of the gen- eration of airborne contamination should be consid- ered in all cases. Except for 3H, the radioisotopes listed above can be detected with an appropriate Gieger counter or other monitoring equipment. The spill should be cleaned up in a way that will minimize the generation of aerosols or the reentrain- ment of dusty materials. The area should be sur- rounded with absorbent material and cleaned from
SAFETY MANAGEMENT the outer edge inward to prevent increasing the size of the contaminated area. All items used in cleaning up the spill should be disposed of as radioactive waste, to be decontami nated (if infectious). It is important not to sacrifice thoroughness in an effort to reduce the volume of the waste resulting from the cleanup. Following cleanup, the area should be wipe-tested to verify that loose contamination has been removed. In addition, a Geiger counter survey will help find residual contamination. If residual contamination is found, the RSO should determine the requirements for additional cleanup. It may be easier to replace a floor tile than to spend hours scrubbing it to remove contamination. It is important that the RSO be consulted, as it may be necessary to follow specific procedures de scribed in the Nuclear Regulatory Commission li cense for the facility in question. 5. Other Emergencies Laboratories should be prepared for problems resulting from severe weather or loss of a utility service. In the event of the latter, most ventilation systems not supplied with emergency power will become inoperative. All hazardous laboratory work should then cease until service has been restored and appropriate action has been taken to prevent expo sure of personnel to hazardous or toxic agents. F. REGULATION AND ACCREDITATION The management, as well as those individuals directly responsible for the health and safety of em ployees, should be familiar with the statutory re quirements of federal, state, and local governments that apply to the operations of their facility. In addi tion they should be aware of the accreditation pro cesses and guidelines that may be available to assist the organization in complying with legal require- An academic biosafety training program is based meets. Numerous governmental agencies are in- on the size of the institution and the relative biohaz volved in the regulatory process, and the regulations arcs found there. In cases where institutional safety promulgated by them may be changed frequently, or personnel are not available or are not themselves new regulations may be issued. Different laborato- trained in biosafety, a faculty member with expertise ries are affected by these requirements to different in microbiology may provide training in biosafety as degrees depending on the number of employees, the an additional academic responsibility. If the pro types of hazardous materials handled, and the nature gram is large enough, a biosafety officer may be of its operation (e.g., manufacture, research, hospital employed to provide the training as well as advice on support, or teaching). In addition to the need to containment levels and practices. 67 comply, there frequently are requirements for recordkeeping to document adherence to the regula- tion. Some of the regulations provide for inspections to ascertain compliance. These inspections may be unannounced, or they can be initiated at the request of the employer or employees. Large organizations, professional societies, and publishers of specialty newsletters monitor the Fed- eral Register, a publication of the federal govern- ment that is used by the different agencies to publish proposed and final regulations. Professional socie- ties usually keep their constituencies notified of per- tinent matters through their newsletters. It is impor- tant for interested or affected parties to know when new regulations, or changes in existing ones, are being proposed, so that they can take advantage of the opportunity to participate in the regulatory pro- cess. Three other useful sources of information are (1) t h e C o n g r e s s i o n a I R e g u I a t o r y I F e d e r a 1 R e g u 1 a t o r y D i - rectory, published by Congressional Quarterly, Inc., Washington, DC 20037; (2) the United States Gov- ernment Manual, published by the U.S. Government Printing Office for the Office of the Federal Register, National Archives and Record Administration, Wash- ington, DC 20402; and (3) He Occupational Safetry and Health Reporter, Bureau of National Affairs, Inc., Washington, DC 20037. The first two publica- tions identify specific offices and provide telephone numbers for obtaining additional information about regulations. A glossary of regulatory definitions, as well as lists of regulatory agencies and accrediting bodies, is provided in Appendix G. G. TEACHING BIOSAFETY IN ACADEMIC SETTINGS 1. Introduction
68 2. Safety in Laboratory Courses It is essential that safe practices be taught in aca- demic courses at all levels, to prepare students for future responsibilities as principal investigators, teach- ers, medical,/project directors, or supervisors of labo- ratories. The management of teaching laboratories in academic institutions may be delegated to a tech- nician or to an academician, but the responsibility for safety management still resides with the department chairperson. 3. Orientation and Training of Students Safety training should begin with an orientation session in which general safety policies and a posi- tive attitude toward safety are introduced. Written institutional safety policies should be discussed and the seriousness of biosafety impressed upon the stu- dents. Safety should also be incorporated into lec- tures, seminars, audiovisual presentations, poster sessions, laboratory exercises, and other aspects of the academic experience. There should be training in the use of safety aids for controlling specific haz- ards. Biosafety training should be a required part of the core curriculum: students should not graduate without being able to handle safely the hazardous agents in their chosen field. Safe procedures and practices should be understood and mastered by all who are to work with bioha~ardous agents in unsu- pervised advanced laboratory exercises, in special research projects, and even in unsupervised hospital laboratories (so-called because of their use by interns and residents in medical or nursing programs). Medical students, nursing students, and other per- sonnel need to be taught to work safely in such laboratories. They should not handle blood or body fluid specimens or cultures of microorganisms with- out training in standard operating procedures. These individuals also need training in the use of infection control "isolation" practices when dealing with pa- tients who have certain contagious diseases or in- creased susceptibility to infection. Infectious materi- als from patients on `'isolation precautions" should not be processed in the hospital laboratories unless appropriate containment equipment is available and specific training has been received. Students should team to adhere to the personal practices required for the work, especially the restrictions on eating, drink- ing, and smoking in all laboratories. Hospital labora- tories should be operated under the Biosafety Level 2 BIOSAFETY IN THE LABORATORY conditions recommended by the CDC/NIH guide- lines (Appendix A). Graduate students or advanced undergraduate students working with biohazardous materials should be as knowledgeable about safety practices as any certified medical technician. Training in the proce- dures, equipment, and facilities necessary for each biosafety level should be a part of the knowledge base required for a graduate degree in microbiology and in other fields that involve the handling of infec- tious agents. The principal investigator or laboratory instructor should ensure that the student knows the hazards of the work, as well as the appropriate con- tainment, personal practices, and equipment to be used. For example, such students should learn how to use an autoclave or chemical disinfectant to effec- tively decontaminate biohazardous laboratory waste, and should learn how to monitor the process. Stu- dents also should be given information about the specific agents to be handled, including modes of transmission, symptoms of disease, and risk factors. The student should sign a document to acknowledge that Gaining and information have been provided. If immunizations are recommended for work with the agent, vaccines should be provided along with ap- propriate medical surveillance and access to medical care. Academic institutions should provide biosafety training for their assistants who teach in such labora- tory courses as microbiology, immunology, biochem- istry, and molecular biology. A written list of safety procedures and precautions should be tailored for each laboratory exercise, according to the materials being used and the level of hazard. 4. Design of Safe Laboratory Exercises and Experiments The safety guidelines and regulations of local, state, and federal agencies (e.g., the CDC/NIH Guide- lines, Appendix A) are also applicable to teaching laboratories that work with biohazardous materials. A biosafety officer or a knowledgeable faculty mem- ber should review the procedures to be carried out as laboratory exercises and determine if the contain- ment practices need to be improved to reduce the risk. For example, some laboratory exercises might be miniaturized, reducing the level of risk by reduc- ing the volume or potential dose of the infectious agent. In other exercises, attenuated microbial strains might be used, or a nonpathogenic organism such as
SAFETY MANAGEMENT Bacillus subtilis might be substituted for a pathogen in demonstrating a routine technique such as the streaking of a plate. Pathogens such as Salmonella typhi or Brucella suds, which have caused laboratory infections in the past or which are known to be highly infectious, should be used in sealed demonstration plates and tubes rather than in "handsaw" proce- dures. All directors of teaching and training labora- tories that use biohazardous agents are urged to re- view their procedures in order to minimize the risk to their students and trainees. S. Monitoring and Recordkeeping The institutional legal office should be consulted about recordkeeping requirements, such as the OSHA 69 log of occupational injuries and illnesses, which may be required by law. In order to correct problems, investigations of accidents and "near misses" should be documented. It is important that accidents be investigated in a timely manner, and that accident reports be completed by the teaching assistant or laboratory supervisor and forwarded promptly to the appropriate individuals for investigation. The re- ports may need to be confirmed by a responsible departmental representative. The person submitting a report should include an assessment of how the accident could have been prevented. The university legal office should provide advice as to the record- keeping requirements for injuries and accidents in- volving students.
