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OCR for page 46
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
OCR for page 47
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
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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
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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
OCR for page 50
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
OCR for page 51
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.
OCR for page 52
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.
OCR for page 53
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
OCR for page 54
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
OCR for page 55
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
OCR for page 56
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
OCR for page 59
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
OCR for page 60
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
OCR for page 61
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
OCR for page 62
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].
OCR for page 63
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
OCR for page 64
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.
OCR for page 65
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
OCR for page 66
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
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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
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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
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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.
Representative terms from entire chapter:
infectious agents
