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Elements of a Biosafety Program

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Elements of a Biosafety Program

Biosafety Officer, Biosafety Division

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Table of Contents Page

Introduction 6

Institutional Responsibility 7

Biosafety Administrative Reporting 7

Academia 8

Government 10

Industry 11

Biosafety Line Management Functions 12

Biological Safety Cabinet Certification 13

Emergency Response 14

IBC Registrations 15

Incident Reviews 17

Workplace Complaints 18

Record Keeping and Information Management 19

HEPA equipment databases 20

Research databases 21

Training databases 22

Sharing data with functional units 23

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Quarterly and Annual Reports 25

Biosafety Program Review and Revision 26

Biosafety Advisory Functions 26

Construction and Renovation 27

Communications 27

Brochures and pamphlets 27

Email broadcasts 28

Online intranet web site 28

Policy manuals 29

Signage 29

Weekly publications 31

Training 31

Biological safety cabinets 32

Bloodborne pathogens 32

Other pathogens 32

DOT and ICAO dangerous goods 33

Respiratory protection 33

Signage 34

Waste decontamination and disposal 34

Policies 35

Good laboratory practices 35

Standard operating procedures 36

Good manufacturing procedures 36

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Laboratory Surveys 37

Committee Attendance 38

Environmental monitoring committee 38

Institutional biosafety committee 38

Institutional animal care and use committee 39

Institutional review board 39

Infection control committee 40

Quality control committee 40

Risk management committee 41

Marketing and technical support committee 41

Operations, facilities, and engineering groups 41

Summary 42

Acknowledgements 43

References 43

Appendices

A BSC & CAB daily field service printout 46

B Safety section of university information checklist 48

C IBC research registrations forms 50

D Research update letters 65

E Research confirmation letters 69

F Employee training database 73

G BSC & CAB certification and service database 78

H BSC & CAB certification renewal letter 80

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I Portable HEPA unit service database 82

J PAPR service database 84

K Bag-in bag-out service database 85

L IBC research registration database 88

M IBC select agent registration database 90

N Shipping certification training database 92

O Johns Hopkins Institutions BSL-3 specifications 93

P BSL-3 standard operating procedures outline 97

Q Laboratory survey checklist 99

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Introduction

Biosafety as a professional discipline has expanded dramatically during the 1990’s as a

result of increased numbers of regulations and guidelines directed toward reducing the potential

for occupational illness and adverse environmental impacts from microorganisms and biological

materials from many sources.

Biosafety deals with safe methods for managing infectious materials in the laboratory. This

is accomplished by protection of personnel and the immediate laboratory environment from

exposure to infectious agents (primary containment) and protection of the environment external

to the laboratory from exposure to infectious materials (secondary containment). Primary

containment includes good microbiological practices and techniques as well as safety equipment

such as biological safety cabinets. Secondary containment includes good operational practices

and facility design practices. Biosafety to some individuals also deals with the preparation of

safe, US Food and Drug Administration (FDA)-regulated biologicals that are free from microbial

contamination (biological safety).

The tools of the microbiologist are now used by more researchers with diverse areas of

expertise use the tools of the microbiologist to conduct research in molecular biology and

genetics. Therefore, the need for microbiological procedure and containment practice training

and education for a wide audience has increased at a time when fewer individuals specialize in

microbiology. Biosafety officers need a good foundation in microbiological practices in order to

assist staff members who may be encountering microorganisms for the first time.

This chapter describes the major elements of the biosafety program at Johns Hopkins

University and Johns Hopkins Hospital with comparisons to programs in other settings. For

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information about chemical safety, life safety, occupational safety, and radiation safety

programs, the reader should consult publications specifically directed to those disciplines. The

information in this chapter is presented in a structured format to assist individuals who are

organizing a biosafety program.

Institutional Responsibility

The employer is ultimately responsible for promulgating and enforcing safety policies and

programs. Therefore, the senior administration must designate one or more persons who will

carry out the institution’s safety programs. The individual who heads up the overall safety

program should be at the director level of the organization and have a staff who will carry out the

daily activities required by the safety program. The principal investigator, chief, laboratory

supervisor, or section head has the day-to-day responsibility for ensuring that employees receive

proper safety training and follow the institution's safety policies.

Biosafety Administrative Reporting

The administrative reporting structure for biosafety programs varies with the size of an

organization and the service or product it produces. Generally, a biosafety program is one of

several employee safety and health programs, which may include chemical safety (industrial

hygiene), radiation safety, life safety, and occupational safety (workers compensation).

Depending on the size and diversity of an organization, there may be several other employee-

related safety and health programs such as employee health, medical surveillance, and employee

staff and family assistance programs.

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 The biosafety profession has recently become a prominent specialty because of the breadth

and depth of biosafety-related guidelines and regulations that have been enacted by the

government to protect the health and welfare of the public. Biosafety officers need to pass on

this information to employees and students.

There are now biosafety registration and certification programs for microbiologists who

choose to make this field their profession. The American Biological Safety Association (ABSA)

has two programs that recognize biosafety professionals. The ABSA Registered Biological

Safety Professional (RBP) program recognizes individuals with appropriate microbiological

training and biosafety experience. The ABSA Certified Biological Safety Professional (CBSP)

program recognizes individuals with microbiological training and biosafety experience who have

passed the American Academy of Microbiology Specialist Microbiologist examination in

Biological Safety Microbiology.

Academia

Academia includes many types of organizations, from small colleges, undergraduate

universities, large undergraduate and graduate universities, and universities that include a

medical school and a teaching hospital.

Small colleges and some undergraduate universities may have one individual who carries

out the functions of a biosafety officer, industrial hygienist, radiation safety officer, and

occupational safety officer. This individual may report to a department chair, director of human

resources, director of security, director of risk management, administrative dean, or academic

dean.

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 Universities often have a diversified safety program with at least one safety officer and a

radiation safety officer. The biosafety program may be a component of the safety officer’s duties

or biosafety responsibilities may be assigned to a faculty member with an appropriate

background in microbiology. There may be a safety manager or safety director to whom the

safety officers report. This individual often reports to a director of risk management, director of

human resources, or an administrative or academic dean.

Universities with a medical school and a teaching hospital are structured in two ways. Often

the medical school campus is physically separated from the rest of the university. When this

occurs, there may be distinct biosafety programs with different reporting structures at the two

campuses. The medical campus may have a safety program that reports to an executive medical

director or an executive administrative or academic director. The other university campus may

have a safety program that reports to a director of risk management, human resources, or an

administrative or academic dean. These safety programs often employ individuals with expertise

in each of the major safety areas, biosafety, chemical safety, radiation safety, occupational safety

and life safety.

Some universities, such as Johns Hopkins University, have a medical school, a teaching

hospital, a school of public health, and a school of nursing on one campus and traditional

undergraduate and graduate schools of arts and sciences, continuing studies, and engineering at

another campus. These universities may have a combined safety program that includes the

university and the hospital. The combined safety program offers the advantage of a uniform

application of safety policies and procedures at all schools and the hospital. Employees and

students need to become familiar with only one set of safety policies and procedures, which

makes it easier for them to move between schools and departments on the different campuses.

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Employee safety training and health records of a combined safety program can follow employees

when they move between different administrative units of the university and hospital.

The reporting structure for a combined university and hospital safety program consists of

managers of each safety section; Biosafety, Chemical safety, Life safety, Occupational safety,

and Radiation safety, reporting to an executive director of safety and health. This director may

chair a joint committee on health, safety and environment composed of directors of major

functional units at the hospital and university. This executive director may report to an academic

executive of the university and an executive head of medical affairs at the hospital.

The combined safety and health organization at Johns Hopkins has both hospital and

university employees. The safety program includes; Biosafety, Chemical safety, Life safety,

Occupational safety, and Radiation safety. The employee health program includes; Occupational

health services (employee health clinic), Occupational injury (workers compensation clinic and

office), Staff and family assistance programs, and a Center for Occupational and Environmental

Health. The Center provides safety services and occupational medicine services to companies

and organizations nationwide.

This combined safety and health organization is named Johns Hopkins Institutions to reflect the

fact that it combines both the for-profit hospital and the non-profit university safety and health

programs.

Government

Government safety programs often resemble a university structure with a chief or director of

safety and health with direct reports who manage biosafety, chemical safety, life safety, and

radiation safety. A safety representative in charge of biosafety may report to a supervising

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division chief in charge of safety personnel who reports to a division chief responsible for the

overall safety training and procedures of the facility.

Supervisors ensure that employees receive appropriate biosafety training. The safety office

responds to emergencies and publishes biosafety regulations and procedures for personnel and

facility operations. In military laboratories, a chief or director of safety and health may report to

the chief of the medical division, who reports to the commander of the facility.

The management structure of government safety and health programs has a more defined

chain of command than is the case at most universities. The safety staff may report to a

supervisor who passes the information up the chain of command to the individual who is

authorized to make decisions.

Industry

Industry safety reporting structures depend on the size of the organization. Small companies

may have a safety consultant that covers all aspects of safety programs and reports to the

president of the company. Larger companies may have a safety officer on staff who covers all

aspects of safety. This safety officer may report to the company president, operations director,

risk management director, human resources director, or other director. Biosafety issues are

incorporated into the duties of this position.

Large companies often have a larger safety staff with section managers of each safety

discipline (biosafety, chemical safety, life safety, occupational safety, and radiation safety). The

reporting structure varies depending on the company's product or service.

Most companies have a life safety and chemical safety officer who reports to a director of

medical affairs, quality assurance, operations, human resources, risk management, or executive

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administration. Companies with several facilities worldwide may have a safety staff

headquartered at the home office with general safety staff members located at strategic plants.

These individuals often report to a safety director at the home office and to a director level

executive at the local facility.

Pharmaceutical and biotechnology companies have, in addition, a biosafety officer to

oversee recombinant DNA, bloodborne pathogens, select agents, and other biosafety-related

programs. A general safety officer, an industrial hygienist, or a research scientist may take on

the duties of a biosafety officer, although many companies now employ biosafety officers who

have training and experience with microbiological practices and procedures.

Biosafety Line Management Functions

The biosafety program at Johns Hopkins Institutions has both line management and advisory

functions. Line management operations include those for which the biosafety program has direct

responsibility. Line management can be defined as vested with a certain amount of discretion

and independent judgement, or that an employee so designated is invested with the general

conduct and control of his employer’s business (Black, 1979).

Advisory functions are of a consulting nature to various functional units of the hospital and

university. Four biosafety staff members report to the biosafety officer who reports to an

executive director of employee health and safety divisions described in the academia

administrative reporting section above. Specific biosafety line management activities are

described in this section.

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Biological Safety Cabinet Certification

The biosafety staff certify and service all high efficiency particulate air (HEPA) filter-

containing equipment at Johns Hopkins Institutions. As of October 1999, this equipment

consisted of:

• 788 biological safety cabinets (BSCs)

• 112 clean air benches (CABs)

• 80 positive air pressure HEPA respirators (PAPRs)

• 28 portable HEPA filter units

• 26 HEPA filter bag-in bag-out roof top units.

The supervisor in charge of field activities is certified as a National Sanitation Foundation

Biological Safety Cabinet Field Certifier (NSF 1999). The certifier and assistant certifier receive

a printout of requests for service each day from a Microsoft Access 97 database (Appendix A)

that lists the service needed, the serial number and model of the equipment, the location of the

equipment, and the name and telephone number of the equipment's contact person. Contact

individuals are called and an appointment is made to service the equipment. Routine service,

such as routine annual certifications and filter replacements, are accomplished within two weeks.

PAPRs are permanently located at appropriate clinical nursing units and biosafety level

3 (BSL-3) laboratories where they are kept plugged into battery chargers. They are checked

monthly for damage and proper airflow. New PAPRs and those that require service are checked

for HEPA filter leaks using a small quantity of polydisperse dioctylphthalate (DOP) particles at

10+ µg per liter at 20 psi and a photometer. Some newly purchased PAPRs may have leaks

around the HEPA filter gasket, so they are leak tested before they are put into service. PAPR

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filters and rechargeable batteries are routinely replaced every two to three years. PAPR service

procedures are performed in a BSC.

Portable HEPA units are permanently located at intensive care nursing units, tuberculosis

airborne isolation nursing units, some outpatient clinics, the emergency department, and some

clinical nursing units that care for patients with low white blood cell counts. The prefilters in

these units are changed every three months to extend the life of the HEPA filters. Airflow is

checked with a hot wire anemometer when the prefilters are changed. The HEPA filters are

changed every three years after the units are decontaminated with formaldehyde gas.

Biosafety division staff deliver portable HEPA units and PAPRs to hospital locations

that do not have permanently stationed equipment. This ensures that the hospital staff receive

training on the proper use of the equipment and makes it easier for the biosafety staff to track

equipment locations.

Emergency Response

The biosafety division provides on call emergency pager service coordinated from a central

telephone switchboard that covers the hospital and university medical campus and from the

security switchboard at the undergraduate/graduate university campus. Emergency service

consists of moving portable HEPA filter units or PAPRs to hospital inpatient areas that require

supplemental air exchange or staff member respiratory protection, such as tuberculosis airborne

isolation rooms. Emergency BSC and CAB requests including service of inoperable equipment

and replacement of fluorescent lamps and ultraviolet lamps are handled within one day. Other

emergency responses often involve biological spills that may be handled by telephone or by an

on-site visit.

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 Environmental services (housekeeping) departments are trained to handle biological spills

including blood spills and fluids leaking from bags. Facilities departments are trained to wet

vacuum large spills from defrosting freezers and sanitary sewer overflows into a fifty-five-gallon

tank containing diluted bleach.

IBC Registrations

The chair of the Institutional Biosafety Committee (IBC) is a professor level faculty

member. The IBC membership consists of employees and two non-employee members as

described by the National Institutes of Health (NIH) Recombinant DNA Guidelines (R-DNA

Guidelines 1999). The IBC reports through the biosafety officer to the Joint Committee on

Health, Safety and Environment. The biosafety division is responsible for maintaining an

Access 97 database of research registrations for the IBC. The NIH IBC began to register

research with pathogens in 1988. In 1989 the biosafety division at Johns Hopkins expanded the

recombinant DNA registration program, started in 1975, to include research with pathogens,

sheep and goats (potential transmission of Q fever), and non-human primates (potential

transmission of Cercopithecine herpesvirus 1 or B virus). Research with human tissue (blood,

internal body fluids, unfixed tissue, and human tissue culture) was added in 1991 to comply with

the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard

(OSHA 1991). Research with select agents (CDC 1996) was added to the IBC database

program in 1998. As of October 1999, there were 986 registered, active research projects

including over 53 genera of pathogens.

The IBC database is indexed by the name of each principal investigator and registration

paperwork is kept in principal investigator files. The registrations are project specific, not

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laboratory specific. A university information checklist (Appendix B) accompanies each grant

application submitted to the research administration for approval. The checklist contains a

biosafety section that is completed by the principal investigator. This section is divided into

specific categories that the principal investigator checks off and fills in his or her project-specific

registration number. The registration number is obtained from the biosafety division for research

with:

• Pathogens

• Recombinant DNA

• Sheep and goats

• Non-human primates

• Select agents

• Human tissue.

In addition to an IBC registration number, each principal investigator must fill in the IBC

approval date for non-exempt recombinant DNA projects, select agent projects, and projects

conducted at laboratory BSL-3 and animal BSL-3.

Most of the select agent-related research projects at Johns Hopkins involve toxins used in

tissue culture by neurologists and cell biologists. The quantities involved in this research are

small and most of the toxins, except botulinum toxin, have an LD50 greater than 100 ng per

kilogram animal weight and are therefore exempt from the regulation.

All investigator submissions that have checked off biosafety related sections on the

university information checklist are sent to the biosafety officer for review. This ensures that the

research has received appropriate approval by the IBC and registration by the biosafety division.

The biosafety officer also reviews animal research. The Institutional Animal Care and Use

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Committee sends copies of the animal research protocols to ensure that the research has received

appropriate review for biosafety related practices and procedures. The Institutional Review

Boards (human subjects committees) also send copies of research protocols that involve human

subjects research with pathogens, recombinant DNA, or human tissue.

The IBC research registration programs have received acceptance by principal investigators

and departmental administrators because the turnaround time for registration of most

applications is within 24 hours and the forms are easy to fill out (Appendix C1-C5). The forms

are available at the Johns Hopkins intranet web site or by fax from the biosafety division

secretary. Department administrators are familiar with this process and help principal

investigators register their research before the proposals are sent to the research administration

for signature.

The biosafety division updates each research registration on its annual anniversary date of

initial registration by sending a letter, including details of the previous registration, to each

principal investigator (Appendix D1-D2). The investigator makes changes on the update letter,

usually changes in personnel, and returns it to the biosafety division so that the database can be

updated. A confirming letter with a revised registration number is then returned to each principal

investigator (Appendix E1-E2). If there are significant changes in a research project, a new

research registration form is sent to the principal investigator.

Incident Reviews

The biosafety division collaborates with the occupational injury clinic, occupational health

clinic, and infection control staff to investigate occupational exposure incidents involving

biological materials. The investigations are conducted to determine whether changes in

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administrative, engineering, or personal protective equipment policies and procedures can be

implemented to reduce the probability of subsequent occupational exposure incidents. The

incidents usually involve:

• Spills of biological materials

• Exposures involving potential bloodborne pathogens

• Improper use of personal protective equipment

• Primary or secondary biological containment issues such as defective autoclaves,

centrifuges, biosafety cabinets, and laboratory ventilation.

Workplace Complaints

Workplace employee complaints include objections to musty smells and perceived allergic

reactions to fungi in the work environment. The industrial hygiene division is the first responder

to indoor air quality (IAQ) issues. When appropriate, the biosafety division conducts airborne

microbial surveys with a portable, centrifugal air sampler using rose bengal agar for fungi and

trypticase soy agar for bacteria. Results from over four hundred microbial surveys show that

indoor microbial counts are considerably lower, usually ten-fold, than the accompanying outdoor

control samples that are always taken at approximately the same time and building location as

the indoor samples.

Only two IAQ microbial surveys had significant numbers, greater than 500 colony-forming

units per cubic meter (ACGIH 1989), of fungi or bacteria, during the past eleven years. One

IAQ area involved overcrowding of a small office area where significant numbers of normal

bacterial skin flora were isolated. The other IAQ area involved a chronically wet basement area

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that was colonized with environmental fungi that were dispersed in significant numbers

throughout the building.

Record Keeping and Information Management

The health and safety information management system was expanded in 1991 to enable

routine backups and to connect employee safety training records to the hospital and university

payroll mainframe computers (Appendix F). As of September 1999, there were 102,759

recorded training records. Employee social security numbers are used to index the records. This

system was further expanded in 1993 to include employee occupational health records (not

shown in Appendix F). The connection to payroll computers is an important aspect of the safety

information system because payroll systems are the most reliable source of employee

information such as job title, office location, department, and office telephone number.

Employee position changes between functional units and between the hospital and university

payroll systems are captured by the safety information database. Employee information on the

payroll systems not needed by health and safety programs, such as employee pay and human

resources confidential personnel records, is hidden before it is uploaded from the mainframes to

the health and safety database.

The health and safety server uses an Access 97 database available as a read only file to

health and safety functional units. The employee medical records are only available to the

occupational health and occupational injury divisions of the health and safety department.

Employee records are maintained on the database for thirty years after individuals terminate their

employment.

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 HEPA Equipment Databases

The biosafety division database for BSCs, CABs, and bag-in bag-out filter systems was

started in January 1989, as was the research database. The biosafety division database software

migrated from DB-2, DB-3, DB-4, and Access 95 to Access 97 software (Appendix G). The

data fields for each piece of equipment contain specific information about the equipment owner,

the contact person for payment, and the person in the laboratory to contact to arrange for service.

The equipment is indexed by serial number and contains certification and service details with

dates, and other information such as the presence of a thimble connection to the building exhaust

and the blower speed percent of maximum (an indicator of remaining filter life).

An assistant biosafety officer manages the database and sends out letters to contact

individuals one month before their BSCs and CABs need to be certified (Appendix H). All

equipment is certified annually, except pharmacy and biosafety level three (BSL-3) laboratory

HEPA equipment. This equipment is certified every six months. The letters request payment to

the biosafety division before the equipment is certified.

The annual certification charge is approximately half the cost of an outside certifying

company and includes free parts and labor, except for replacement filters and ultraviolet lamps.

The in-house program saves approximately one hundred thousand dollars per year in certification

and service costs.

The portable HEPA unit database (Appendix I) and the PAPR database (Appendix J)

were started in 1994 to track each unit by serial number. Certification information, filter

changes, other service procedures, location of the equipment, and contact person at the

equipment location, are maintained on the databases by the biosafety division staff. Emergency

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deliveries are recorded so that arrangements can be made to permanently place equipment at

hospital areas that request many emergency deliveries.

The bag-in bag-out database (Appendix K) includes magnehelic gauge readings

obtained by the biosafety staff every three months. There are often three gauges on each bag-in

bag-out housing. One gauge measures the pressure drop across the pre-filter(s), another reads

pressure drop across the HEPA filter(s) and a third gauge measures the drop across the pre- and

HEPA filters. These gauge readings are used to predict when pre-filters and HEPA filters will

need changing. This information is sent to each facilities department so they can budget for the

anticipated filter changes.

Research Databases

Biosafety-related research registered with the IBC, as described above, is maintained on

an Access 97 database that is indexed by a unique research registration number for each project

and ordered by principal investigator name (Appendix L). The letter prefix for each research

IBC registration number is either ‘A’, ‘B’, or ‘D’, followed by the initial date of registration

(YYMMDD), the sequence number for project registration for that day (starting at 01 to 99), and

the registration year (for example, 01 for first year, 10 for tenth year). The letter prefix indicates

whether the project is; ‘A’ - Moderate to high risk biohazard project (often BSL-3), ‘B’ - Low to

moderate risk biohazard project (BSL-2), or ‘D’ - Recombinant DNA project.

The registration number does not imply that the Johns Hopkins Institutional Biosafety

Committee (IBC) has reviewed and approved the research project. Most potential pathogenic

agent or material projects with letter ‘B’ prefixes and many recombinant DNA projects do not

require IBC review (they are given a registration number only). Examples of projects that may

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require IBC approval are: Gene therapy of human subjects; Recombinant DNA with pathogenic

host/vector gene delivery systems; Recombinant DNA research with intact animals; and

Biosafety Level 3 research projects.

If there is a date in the ‘IBCAPROV’ column, the IBC has reviewed and approved the

project on the designated date. Recombinant DNA projects that do not require IBC review are

marked ‘NA’ (not applicable).

There is a separate select agent research database (Appendix M). This database is

separate from the main IBC research database because there are many data fields that are specific

to the select agent registration program. The details of the type of select agent, method of

destruction, storage location, etc. are recorded for each research project using select agents.

Training Databases

Biosafety training records on Access 97, indexed by social security number for each

employee, are coded by a three-digit number that is specific to each training program (Appendix

F). Biosafety training programs include:

• BSL-3 laboratory training

• Bloodborne pathogens training

• Infection control training

• Risk management training for physicians

• Certification for packaging and shipping of infectious substances and diagnostic

specimens (Appendix N)

• Biological safety cabinet operating procedures

• Tuberculosis control training

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 • Positive air pressure HEPA respirator training.

The training database also includes training programs such as:

• General orientation

• Graduate student training

• Hazard communication training

• Respirator training and fit testing

• Noise control training

• Asbestos awareness

• Molecular Resonance Imaging safety

• Tow motor training

• Radiation safety

• Chemical laboratory safety

• Mercury spill training

• Hazardous chemical spill training

• Formaldehyde protection

• Ethylene oxide exposure procedures

• Ergonomics

• Fire safety.

Sharing Data with Functional Units

Employee safety training compliance information is sent to functional unit directors and

supervisors at the hospital and university. Each employee record in the health and safety

information system was recently expanded to include the name and address or their supervisor.

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Institutional policies require employees to attend mandatory training sessions and their

supervisors must record employee safety compliance on the employee's annual performance

evaluation form.

A letter is also sent to each employee, with a copy to their supervisor, when it is time

for them to participate in update training sessions. Employee bloodborne pathogens training and

positive pressure HEPA respirator training are repeated each year. Risk management training

and certification for packaging and shipping are repeated every two years.

Risk management training information is shared with the hospital medical board that

credentials physicians to practice medicine at the hospital. Physicians must complete a one hour

risk management session, that includes safety training, every two years in order to maintain

hospital privileges.

Active research project IBC registration printouts are sorted by principal investigator

and sent to academic research administration offices at the schools of arts and sciences,

medicine, and public health every few months. This information is also sent to the Institutional

Animal Care and Use Committees and the Institutional Review Boards, so they can determine

whether projects that come before their committees have been registered with the biosafety

division.

BSC and CAB certification information, sorted by administrative department, is sent to

department managers so they can arrange to have equipment in their department certified at the

same time. This saves paperwork time expended by the biosafety supervisor and laboratory staff

because there is one invoice to certify all of the department’s equipment instead of a separate

invoice for each piece of equipment. This departmental billing system is currently in place for

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the departments (oncology, pharmacy, and pathology) with the largest number of BSCs and

CABs. The program is being expanded to other departments.

The occupational health services division uses the health and safety database to send

reminder letters to employees and their supervisors when employees must complete their

immunizations, annual tuberculin tests, or other health related activities.

Quarterly and Annual Reports

All divisions of the health and safety department at Johns Hopkins Institutions submit

quarterly reports to the Joint Committee on Health, Safety, and Environment. These reports,

along with annual summary reports, document the activities of each health and safety division.

The biosafety division reports include information about:

• Outside agency inspections

• Incident investigations

• Construction plan reviews

• Laboratory surveys

• Training sessions

• Communication activities

• Details of new research registrations

• Purchases of new HEPA filter equipment

• Movement of existing HEPA filter equipment

• Service activities for BSCs, CABs, bag-in bag-out HEPA systems, portable HEPA filter

units, and PAPRs.

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 Tables and graphs are used extensively in these reports so that activities during the previous

four quarters and prior year information can be compared to activities documented in the current

report.

Other health and safety divisions report on other biosafety-related activities. For example,

the occupational injury clinic reports all occupational exposures to bloodborne pathogens. These

reports include the functional unit, type of exposure, what the employee was doing when the

exposure occurred, the source patient’s serological status if known, and whether the employee

started and completed a twenty-eight-day course of post exposure prophylaxis.

Biosafety Program Review and Revision

The quarterly and annual reports are used to analyze the daily activities of the biosafety

division so that areas of responsibility that need more resources can be identified. This may

involve the purchase of more equipment such as portable HEPA filter units and PAPRs, or

adding more biosafety division personnel to manage databases, training records, and service

functions.

Biosafety Advisory Functions

The biosafety division provides technical advice to several functional units at the hospital

and university. These advisory functions are presented in the form of documented

recommendations or telephone conversations. All incoming telephone calls are logged in by

time, subject of the call, and ending time. The telephone logs are filed by month and stored for

several years.

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Construction and Renovation

Construction and renovation plans are forwarded to the health and safety department and

logged in by date of receipt. The plans are circulated to the biosafety, chemical safety, life

safety, and radiation safety divisions for review and comment.

Recommendations are combined into a letter and sent to the appropriate design and

construction department. Biosafety division reviews concentrate on BSC placement within

laboratories, BSC thimble connections, directional negative airflow volumes of 50 to 100 cubic

feet per minute (cfm) into laboratories, locations of laboratory supply and exhaust outlets, and

BSL-3 laboratory design and construction methods (Appendix O).

Communications

Several methods of communication are used to transmit information to hospital and

university faculty and staff because no single method will reach everyone.

Brochures and pamphlets

Biosafety brochures and pamphlets are handed out at new employee orientation sessions

and at training sessions for current employees. There are multiple page brochures for the

bloodborne pathogens control program and the tuberculosis control programs. A brochure is

handed out at bloodborne pathogen training sessions. It contains a graphic illustration of the

twenty-four hour bloodborne pathogen exposure hotline, suitable for posting, and describes the

details of the hepatitis B virus vaccine program, the post exposure prophylaxis program, and the

confidential medical evaluation program for employees and students who have occupational

exposures to bloodborne pathogens.

- 27 -
 A trifold brochure containing fire, security, medical and exposure hotline numbers, and

details of the responsibilities of each health and safety division is handed out at most training and

orientation sessions. This brochure is also used to document risk management training for

hospital physicians and new house staff. A tear-off panel of the brochure is filled out and handed

in at the end of the training session. This information is entered in the training database.

Email broadcasts

Email broadcasts are used to send biosafety training schedules and important biosafety

information to all employees and students on the combined hospital and university email

network. Recent broadcasts detailed changes in dates for packaging and shipping certification

training and communicated the enhanced enforcement of shipping regulations by the Federal

Aviation Administration Division of the Department of Transportation.

Online intranet web site

The biosafety division established an intranet safety and health department web site

accessible to individuals on the internal network. The safety web site contains:

• The university safety policy and procedure manual

• The biosafety manual

• The current NIH Recombinant DNA Guidelines (R-DNA Guidelines 1999)

• The current CDC/NIH Biosafety Guidelines for Biomedical and Laboratories (CDC

1999)

• The CDC Select Agents Registration program (CDC 1996)

- 28 -
 • All research registration forms that can be downloaded, filled out, and sent to the

biosafety division.

Policy Manuals

New editions of the Johns Hopkins Institutions Safety Policy and Procedure Manual and

the Biosafety Manual were published in 1994. They were published as soft cover bound manuals

with three-hole punched spines. The manuals have pages with serrations in the left margin so

that the manuals will lay flat for photocopying. There is no plan to revise and reprint these

manuals because they are now available with hyperlinked indexes on the intranet web site.

Signage

Laboratory signage has been uniform throughout the hospital and university since the

late 1970’s. The signage was revised in 1994 to permit up to eight stickers per nine by nine-inch

yellow placard. The placards are mounted with double-sided tape to the wall next to laboratory

doors where people entering the room will notice them. The placards contain emergency contact

information for the safety department and the office and home telephone numbers of the

laboratory director and supervisor.

Clear, two- and one-half inch high by two inch wide stickers with black, red, yellow, or

orange graphics, are placed on the yellow placards so that the yellow shows through the stickers.

The selection of stickers includes:

• Biohazard symbol

• BSL-2

• BSL-3

- 29 -
• BSL-3 work practices

• Infectious agents

• Potentially infectious agents

• Infected animals

• No food or drink

• Eye protection required

• Radioactive materials

• Radiation area

• High radiation area

• Microwave radiation

• Ultraviolet light

• Laser radiation

• Cancer suspect agent

• Cancer hazard

• Chemical storage area

• Corrosive materials

• Toxic chemicals

• Toxic gas

• High voltage

• Electrical hazard

• Flammable materials

• Hearing protection required

• Protective clothing required.

- 30 -
 The yellow placards for BSL-2 laboratories have bold letters at the top stating “Caution -

Admittance to Authorized Personnel Only”. Placards for BSL-3 laboratories state “Caution -

Restricted Area – Admittance to Authorized Personnel Only”. The entrances to BSL-3

laboratory anterooms are locked. They can be opened with either a special key or an authorized

employee's ID card. Housekeeping, facilities, and other staff have been trained to understand the

difference between these two placards. They may enter BSL-2 areas, but they must have

authorization from the laboratory staff before they enter a BSL-3 area.

Weekly Publications

The health and safety department places training announcements and policies in two

weekly publications. The ten-page university newspaper permits the full text of policies and

procedures to be published. The one-page, legal size, double sided, hospital newsletter is used to

publish short announcements. The heath and safety department pays for a special edition of the

hospital newsletter when new policy announcements, such as the bloodborne pathogens control

program and the tuberculosis control program are started. These publications reach the greatest

number of employees and students.

Training

Biosafety-related training is presented by biosafety division staff and occupational

health staff to hospital and university employees and students. The details of the presentations

are documented and kept on file for inspection by outside agencies, such as the state

occupational health and safety administration. Attendance at all training sessions is recorded on

- 31 -
sign in sheets that include the trainee name, social security number, and department. All training

information is entered into the training database.

New employee safety orientation is presented by a general safety officer using a computer

presentation program that includes fire, hazard communication, bloodborne pathogens, and

emergency contact information.

Biological Safety Cabinets

When invited by laboratory groups, biosafety division staff present a training program

on the proper use of BSCs which includes a twenty-minute video from the Eagleson Institute

(Eagleson 1991). Topics covered include the design, operation, and certification of BSCs, using

gowns with knitted cuffs and gloves, disinfection of work surfaces with an iodophore

disinfectant, placement of materials on the work surface, and the effects of drafts and foot traffic

on the air curtain at the front of the BSC. Use of CABs is discouraged.

Bloodborne Pathogens

Bloodborne pathogens training is presented by the biosafety staff, occupational health

services, and the nursing department (self-study). OSHA required information is presented along

an expanded discussion of the exposure hotline, the HBV vaccination program, glove materials,

waste disposal, and retractable syringes.

Other Pathogens

The biosafety division staff present expanded training to staff and students who will

work in BSL-3 laboratories. The BSL-3 laboratory's standard operating procedure manual is

- 32 -
reviewed. The proper use and removal of personal protective equipment, autoclave

decontamination of laboratory waste, and general housekeeping procedures are discussed. The

training also includes specific information about the pathogens being researched and the

availability of medical surveillance by occupational health services.

DOT and ICAO Dangerous Goods

The biosafety division staff present a two to three hour, hands on training session that

covers all aspects of packaging and shipping infectious substances, diagnostic specimens,

biological products, dry ice, liquid nitrogen, and dangerous goods chemicals often shipped by

biomedical research laboratories.

The training is based on the current edition of the trade association manual published by

the International Air Transport Association (IATA 1999) that incorporates the International Civil

Air Transportation Organization (ICAO 1998) regulations. The revision of the U.S. Department

of Transportation (DOT) regulations for shipment of infectious substances and diagnostic

specimens (RSPA 1998) is also reviewed.

The training sessions incorporate pre- and post-tests to document the training and to

enhance the learning experience. Examples of approved and non-approved shipping containers

are circulated to the audience. The training sessions are presented every two months.

Individuals who took the course two years ago are sent letters to remind them to attend

a new training session. This complies with the ICAO requirement that shippers receive training

every two years.

Respiratory Protection

- 33 -
 The biosafety division staff present respiratory protection training for the use of PAPRs,

that are loose fitting, positive air pressure HEPA respirators and are therefore exempt from the

full OSHA respiratory protection fit testing program (OSHA 1998) administered by the

industrial hygiene division.

Employees are asked to fill out a short version of the OSHA medical surveillance

questionnaire. The questionnaire is forwarded to occupational health services for review.

Employees are given a copy of the policy on the care and operation of the equipment. The

functional units purchase the hoods (head covers) from hospital central supply and employees

keep their personal hood in a plastic bag near their work area. The hoods are only discarded

when they are damaged or become grossly contaminated.

Signage

Interpretation of signage is incorporated into orientation, bloodborne pathogen control,

tuberculosis control, and BSL-3 laboratory training. A full description is also published in the

biosafety manual.

Waste Decontamination and Disposal

The biosafety division staff present waste disposal training to functional units and

laboratories that have difficulty following the laboratory waste decontamination and disposal

policy. This training emphasizes that good microbiological practice involves autoclave

decontamination of microbial cultures for at least one hour.

The training also includes a discussion of the state of Maryland statute that prevents

landfilling waste materials that may be perceived as contaminated hospital or laboratory waste.

- 34 -
The policy requires that autoclaved microbial cultures, laboratory waste, and hospital waste from

clinical areas be incinerated in a regional medical waste incinerator. Trainees are reminded that

the statute is based on the public’s perception of hazard associated with this waste, not

necessarily on the actual risk of disease transmission.

Policies

Johns Hopkins Hospital and University implemented biosafety policies in the 1970’s. The

earliest policies followed the National Cancer Institute laboratory practice guidelines (NCI 1974)

and the NIH recombinant DNA guidelines (R-DNA Guidelines 1999). Many other policies

have been developed over the past twenty years.

Draft policies are submitted to the Joint Committee on Health, Safety and Environment for

approval before they are published. Approved policies are sent to all administrative units and

placed in weekly newsletters.

Good Laboratory Practices (BMBL)

Current biosafety laboratory policies generally follow the CDC/NIH guidelines for

research in biological and biomedical research laboratories (CDC 1999), but in some cases the

university policies are more restrictive (Appendix H). The recommendation for BSL-3

laboratories is a bag-in bag-out HEPA filtration system for BSL-3 laboratory exhaust. Cultures

of microorganisms must be decontaminated by autoclave. Autoclaved liquid waste is discarded

into the sanitary sewer system. Autoclaved solid waste is discarded into a red bag-lined

biohazard box. BSL-3 laboratory design policy recommends a double-sided autoclave with a

bioseal between the BSL-3 laboratory and the adjacent area on the other side of the wall.

- 35 -
 Policy recommends that all laboratories have Class II, Type B3 BSCs thimble

connected to the building exhaust system. BSL-3 laboratories must have one hundred percent

shutoff dampers between BSC thimble connection and the laboratory exhaust system. BSL-3

laboratories also have an alarm system in the laboratory to warn of laboratory exhaust flow

failure and an automatic supply air shut off when this occurs. The biosafety division

recommends that seamless integral cove flooring be installed before BSCs and other permanent

equipment are placed in the room. There are no vertical pipe floor penetrations and card access

to the anteroom is installed for security.

Standard Operating Procedures

All BSL-3 laboratories have a standard operating procedure (SOP) manual. An

electronic template manual is given to each principal investigator to complete with specific

procedures for that laboratory. The draft SOP is reviewed by the biosafety staff, the IBC, and

approved by the Joint Committee on Health, Safety and Environment. A typical SOP index is

included (Appendix P). The original copy is signed by the biosafety officer, the chair of the joint

safety and health committee, the chair of the IBC, and the director of the animal services

division, if appropriate. The biosafety division keeps the original, signed copy in the principal

investigator's personnel file and a copy is sent to the principal investigator.

Good Manufacturing Practices (cGMP)

The Food and Drug Administration (FDA) current Good Manufacturing Procedures

(FDA 1996) guidelines are followed for research laboratories that produce gene therapy products

intended for Phase 1 and Phase 2 clinical trials. The biosafety division consults on the design

- 36 -
and construction of the facility with the research staff and facilities design and construction.

Issues covered include BSC construction and performance specifications that include a thimble

connection to the building exhaust system. The Class 10,000 clean room supply air HEPA filters

are mounted in a metal ceiling and can be leak tested and serviced within the clean room. The

heating, ventilation and air conditioning (HVAC) system is designed to be constant air volume

with at least eight to ten air changes per hour, a recommendation followed for all biomedical

research laboratories.

Laboratory Surveys

The biosafety division staff surveys twelve BSL-3 laboratories every six months and sends a

report to the principal investigator and the department administration. The staff also assists with

the training of general safety officers who survey hospital clinical laboratories and soiled utility

rooms, as well as all university research laboratories. Each department is surveyed separately.

Biosafety staff participate in quarterly surveys conducted by the Institutional Animal Care

and Use Committees. The most common deficiencies include improper laboratory signage and

no hand soap or paper towels.

Biosafety-related elements of laboratory surveys include:

• Autoclave repair and operation records

• Proper use of personal protective equipment

• Appropriate laboratory clothing

• No food or drink in the laboratory

• Proper use of sharps and sharps disposal containers

• Proper use of red bag-lined biohazard boxes for disposal of laboratory waste

- 37 -
 • Proper laboratory signage

• Current certification of BSCs and CABs

• Hydrophobic HEPA filters on laboratory vacuum outlets

• Decontamination of microbial cultures before disposal into red bag-lined biohazard

boxes.

The instrument used to record the survey for each laboratory is a two-page, carbon-free

checklist of key elements (Appendix Q). The safety surveyor retains the original and the copies

are combined and sent to the department administration. Representatives from a department’s

administration and facilities accompany the safety officer on these surveys.

The most common biosafety-related deficiencies include improper laboratory waste

disposal, no HEPA filters on laboratory vacuum systems, and improper handling of sharps.

Committee Attendance

Biosafety staff participation in committee meetings is a central element of the biosafety

program because they are a good forum in which to communicate good biosafety practices and

procedures.

Environmental Monitoring Committee

This committee focuses on chemical and industrial hygiene issues involving employee

exposure to chemicals. Therefore, biosafety participation is minimal.

Institutional Biosafety Committee

- 38 -
 The IBC is the major forum for discussion of biosafety-related issues. Committee

findings are submitted to the Joint Committee on Health, Safety and Environment for approval.

The committee meets when needed to approve recombinant DNA protocols, select agent

registrations, BSL-3 SOP's, and to formulate policies and procedures. Telephone and fax votes

are sometimes used instead of formal meetings.

Institutional Animal Care and Use Committee

Biosafety staff participate in committee surveys of animal facilities and review all

animal protocols submitted to the committee. This ensures that proposed research protocols that

include recombinant DNA, pathogens, sheep and goats, non-human primates, radionuclides, and

toxic chemicals have has been registered with the health and safety department. Protocols that

involve medical surveillance, such as annual tuberculin skin testing for employees working with

non-human primates and immunization of employees working with vaccinia virus are forwarded

to the occupational health services division.

Institutional Review Board (Human Subjects)

These committee deal with the human subject’s consent process and compliance with

ethical standards. Although biosafety staff do not regularly attend these committee meetings, the

biosafety officer reviews all IRB submissions to ensure that proposed research protocols that

include pathogens, recombinant DNA, human blood, internal body fluids, and unfixed tissue are

registered with the IBC. Protocol reviews often identify research that is covered by the

bloodborne pathogens standard. This research is registered with the IBC as human tissue

research. Personnel associated with the research involving human blood, internal body fluids,

- 39 -
and unfixed tissue are added to the training database so that they are notified of the bloodborne

pathogen training and vaccination requirements.

Infection Control Committee

Attendance by the biosafety officer at these monthly, patient-related hospital

epidemiology and infection control committee meetings is important to the biosafety program.

Issues recently discussed at this committee have included:

• Placement of PAPRs and portable HEPA filter units at appropriate nursing units.

• Removal of carpeting in patient areas to reduce the number of airborne particles,

including fungal spores.

• Minimization of flower beds near areas where bone marrow transplant patients enter the

hospital.

• Development of a bioterrorism response plan.

• Revision of the hospital disinfection program to include dilute bleach for blood spills

and a water-based quaternary ammonium disinfectant for general disinfection.

• Use of an asbestos-style containment barrier system during construction in hospital areas

such as operating rooms, recovery rooms, bone marrow transplant units, orthopedic

surgery units, and intensive care units.

Quality Control Committee

The hospital quality control committee includes development of policies and procedures

involving administrative and engineering controls to enhance employee and patient exposures to

potential pathogens. A health and safety department representative attends these committee

- 40 -
meetings to provide input on employee safety-related issues. Recent biosafety-related issues

discussed at this committee include: Change of to a mail box style sharps container,

implementation of a needleless intravenous system, change from latex to vinyl examination

gloves on the nursing units, and design of decontamination procedure for a vacuum shuttle

delivery system.

Risk Management Committee

Biosafety participation is on an as needed basis when committee legal issues involve

containment and medical surveillance issues related to work with pathogens or bloodborne

pathogens.

Marketing and Technical Support Groups

Biosafety issues in industry marketing and technical support groups involve protection

of personnel from exposure to pathogens when they use equipment manufactured by the

company. For example, biosafety staff may develop protocols to evaluate the capacity of

products, such as flow cytometers and blood analyzers, to produce aerosols. Biosafety staff may

assist in the development of procedures for the proper use of in vitro microbiological diagnostic

equipment. This information is given to a research and development department to develop safe

operating procedures that can be forwarded to marketing and technical support departments.

Operations, Facilities, and Engineering Groups

Biosafety division staff review design and construction plans dealing with laboratories,

hospital clinics, and impatient rooms. A close working relationship with the staff of these groups

- 41 -
can save time and money that may be spent to correct deficiencies after construction is

completed.

Recommendations from the biosafety division often involve:

• Proper location of BSCs within laboratories.

• Thimble connection design.

• Location of bag-in bag-out HEPA filter housings with magnehelic gauges

connected across both pre-filters and HEPA filters.

• Constant volume laboratory air ventilation instead variable air volume systems.

• Placement of autoclaves.

• Placement of emergency eyewash and shower stations.

• BSL-3 laboratory construction details.

• Room access to HEPA filter supply systems.

Other biosafety-related issues have involved:

• Input on the design of pyrogen-free process water systems.

• HEPA filtration of carbon dioxide manifold systems.

• Heat recovery systems to transfer latent heat or cooling to incoming supply air.

• Monitoring systems for negative pressure isolation rooms.

Summary

This chapter is organized in a format that will hopefully make a biosafety manager’s

organizational and regulatory functions easier. The elements of the Johns Hopkins Institutions

biosafety program presented here is an example of a rather large program, although selected

portions of the program may be useful to individuals who are beginning a biosafety program.

- 42 -
 Biosafety management at large institutions has become a full time job – at Johns Hopkins

Institutions it is a five-person full time job. Major increases in government regulation and

adherence to biomedical/pharmaceutical industry consensus standards has required more

documentation. Regulations promulgated by the Environmental Protection Agency, the

Occupational Safety and Health Administration, the Joint Commission on Accreditation of

Hospitals, and several state and local regulatory agencies (departments of health and

environment) have produced an increase in the number of on-site inspections and fines.

Much of this regulatory activity represents an expansion from the traditional chemical and

radiation safety issues to biological safety in industry, government, and university clinical and

basic research laboratories. There is currently a deficit of microbiologically trained biosafety

professionals to handle these new regulatory activities.

Acknowledgements

John T. Balog and Timothy H. Travers assisted with BSC database information.

References

ACGIH. 1989. Guidelines for the assessment of bioaerosols in the indoor environment.

American Conference of Governmental Industrial Hygienists, Cincinnati, OH.

Black, Henry C. 1979. “Braniff v. McPherren, 177 Okl. 292, 58 P.2d 871, 872” and “U.S. Auto

Ass'n v. Alexander Film Co., D.C. Mun.App., 93 A.2d 770, 771.” page 865. Black's Law

Dictionary, 5th ed. West Publishing Co., St. Paul, MN.

- 43 -
CDC. 1996. Additional requirements for facilities transferring or receiving select agents; final

rule 42 CFR Part 72. U.S. Department of Health and Human Services, Centers for Disease

Control and Prevention. Fed. Register, Vol. 61, No. 207, October 24, 1996, p. 55190−55200.

CDC. 1999. Biosafety in microbiological and biomedical laboratories, 4th ed., May 1999. U.S.

Department Health and Human Services, Centers for Disease Control and Prevention and

National Institutes of Health, HHS Publication No. (CDC) 99-8395.

Eagleson. 1991. Safe use of biological safety cabinets or the case of the contaminated cultures.

Eagleson Institute, Sanford Maine.

FDA. 1996. Medical devices; current good manufacturing practice (CGMP); final rule 21 CFR

Parts 808, 812, and 820. U.S. Department of Health and Human Services, Food and Drug

Administration. Fed. Register. Vol. 61, No. 195, October 7, 1996, p. 52601-52662/

IATA. 1999. Dangerous goods regulations, 40th ed. International Air Transport Association,

Montreal, Canada.

ICAO. 1998. Annex 18 the safe transport of dangerous goods by air, 2nd ed., (No. AN 18),

August 1997; and Technical instructions for the safe transport of dangerous goods by air: 1997-

1998 ed., Doc 9284-AN/905 Supplement. International Civil Aviation Organisation, Montreal,

Canada.

- 44 -
NCI. 1974. National cancer institute safety standards for research involving oncogenic viruses.

U.S. Department of Health, Education, and Welfare, Publication No. (NIH) 75-790, October

1974.

NSF. 1999. NSF listings; biohazard cabinetry; class II cabinet certification field certifier

accreditation, NSF International, Ann Arbor, MI.

OSHA. 1991. Occupational exposure to bloodborne pathogens; final rule 29 CFR Part

1910.1030. U.S. Department of Labor, Occupational Safety and Health Administration. Fed.

Register, Vol. 56, No. 235, December 6, 1991, p. 64175-64182.

OSHA. 1998. Respiratory protection; final rule 29 CFR Parts 1910 and 1926. U.S. Department

of Labor, Occupational Safety and Health Administration. Fed. Register, Vol. 63, No. 5, January

8, 1998, p. 1151-1300.

R-DNA Guidelines. 1999. Guidelines for research involving recombinant DNA molecules

(NIH Guidelines), May 1999 ed. (http://www.nih.gov/od/orda/). U.S. Department of Health and

Human Services, National Institutes of Health, Bethesda, MD.

RSPA. 1998. Hazardous materials: revision to standards for infectious substances and

genetically modified micro-organisms; proposed rule 49 CFR Part 171, et al.. U.S. Department

- 45 -
of Transportation, Research and Special Programs Administration. Fed. Register, Vol. 63, No.

170, September 2, 1998, p. 46843-46859.

- 46 -
Appendix A - BSC & CAB Daily Field Service Printout

CallDate Building RoomNo SerialNo ModelNo Service Priority LabContact Comments

1/8/99 Meyer 0101011 Ultra Z cert routine John prefer Wed.

1/8/99 John ABYZ2 AB1000 HEPA routine Mary lab locked

1/10/99 Wills BU094 UB100 decon priority Joe moving

1/10/99 Meyer 2112 CA-005 cert routine Mike

1/10/99 Baer 808909 TEC9 cert routine Jane

1/17/99 Baer 0101011 Ultra Z cert routine Jeff 2nd call

1/22/99 Wilson 09890 XXX-6 fluor light priority Sue

1/22/99 Meyer 004512 AMZP2 uv light priority Joe

- 47 -
Appendix B - Safety Section of University Information Checklist

Will project involve or require any of the following?

The Principal Investigator must personally answer questions.

Yes No

  1. Use of human subjects via contact and/or survey. Use of medical records and/or

personal data (primary or secondary) for data analysis?  Yes  No

Has cognizant IRB (human subjects committee) approval been obtained?  Yes 

No

Has protocol been submitted for review?  Yes  No

IRB # ______________ Date of last approval ___________________

Senior P.I. on protocol: __________ If exempt specify category number ________

  2. Use of live, vertebrate animals? If yes, attach a copy of the vertebrate animal section

for new, competing renewal and revised applications.

Senior P.I. on protocol:___________ Protocol No. _____________________________

IACUC Approval Date:____________ If not approved, date protocol submitted: _____

  3. Use of organisms pathogenic to animals or humans? Has Biosafety Division

approved?

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  Yes IBC Number or date of approval __________  No (Call Biosafety

Division)

  4. Use of hazardous and highly toxic chemicals (e.g., carcinogens, mutagens, chemicals

with a NIOSH IDLH level of 5 ppm or less)? Has Environmental Health Division approved?

 Yes Number or date of approval ______  No (call Environmental Health

Division)

  5. Use of radioactive materials? Has Radiation Safety Office approved?

 Yes Authorization number _______  No (Call Radiation Safety Office)

  6. Use of recombinant DNA? Has Biosafety Division, HS&E approved?

 Yes IBC Number or date of approval _________  No (Call Biosafety Division)

  7. Use of human blood, blood products, internal body fluids, unfixed tissue?

Has Biosafety Division approved?

 Yes IBC Number or date of approval _________  No (Call Biosafety Division)

  8. Use of Select Agents (viruses, bacteria, rickettsia, fungi, biological toxins listed in

42 CFR 72.6)? Has Biosafety Division approved?

 Yes IBC Number or date of approval _________  No (Call Biosafety Division)

Questions about non-safety issues are not included.

- 49 -
Appendix C1 - IBC Research Registration Form

REGISTRATION OF RESEARCH WITH PATHOGENS,

HUMAN TISSUE, ONCOGENES, AND TOXINS

JHU IBC # __________________________

DATE _____________________________

BIOSAFETY LEVEL __________________

ACTION ___________________________

DO NOT WRITE IN ABOVE SPACE

APPLICATION MUST BE TYPEWRITTEN

1. Principal Investigator _________________________________________________

Academic Title ____________________ Social Security No. _____________

2. Department ___________________________ Division ______________________

3. Addresses: Office; _____________ Lab; _____________ Telephone # __________

4. Project Title _________________________________________________________

5. Name of biological agent or toxin or description of infectious material, oncogenic material,

or human material: __________________________________________________

Strain, Genotype, Catalog No. or CAS No: _________________________________

6. Is agent or material a potential human or animal pathogen or toxin? Human ( ) Animal ( )

Both ( )

- 50 -
 If a toxin, is LD50 more than 100 nanograms per kilogram body weight? Yes ( ) No ( ) Don't

know ( )

7. Do you work with quantities greater than 1 liter? Yes ( ) Largest volume No ( )

8. Do you inactivate the agent prior to other laboratory manipulations? Yes ( ) No ( )

Inactivation Method(s) Used: Heat ( ) Chemical ( ) Radiation ( ) Other ( )

9. Do you concentrate the agent or material? Yes ( ) No ( )

Method(s): Centrifuge ( ) Filtration ( ) Precipitation ( ) Other ( )

10. Do you insert this agent or material into intact animals? Yes ( ) No ( )

If Yes, species & location of animal housing. ________________________________

11. Biological containment level required: Biosafety Level BSL-1 ( ) BSL-2 ( ) BSL-3 ( )

12. Do you request biological monitoring or medical surveillance? Yes ( ) No ( )

13. Please list all professional personnel, employees and students involved in the project who

will come into contact with these materials:

NAME Mailing Address Social Security No.

_____________________________ ________________________ _______________________

_____________________________ ________________________ _______________________

_____________________________ ________________________ _______________________

14. Please attach a brief overview of the proposed research containing sufficient information to

ensure adequate review of the protocol to determine compliance with the JHI Biosafety Program,

local, state and federal regulations (Methods of Procedure or Experimental Protocol from a grant

application will suffice). Please include information such as:

a) The purpose of the research;

b) An assessment of risks to personnel working with the agent or material;

- 51 -
c) An outline of the procedure and techniques to be employed;

d) Specifically describe the safe practices, equipment, and facilities that will be used to protect

personnel from exposure to the agent or material;

e) Specifically describe methods of inactivation or disposal of the agent or contaminated

materials.

15. I accept responsibility for the safe conduct of work with this material.

I will ensure that all personnel receive training in regard to proper safety practices and personal

protective equipment needed for this work.

Principal Investigator: ______________________________ Date: __________________

Signature

MAIL OR FAX TO: Biosafety Division

Appendix C2 - IBC Research Registration Form

REGISTRATION OF RESEARCH WITH SELECT AGENTS

IBC #

DATE

BIOSAFETY LEVEL

ACTION

DO NOT WRITE IN ABOVE SPACE

APPLICATION MUST BE TYPEWRITTEN

- 52 -
1. Principal Investigator .

Academic Title Social Security No. .

2. Department Division .

3. Addresses: Office: Lab: Telephone # .

4. Project Title .

5. Name and source of select agent (list attached) .

6. Will you be doing only Clinical/Diagnostic work with this select agent? ( ) Yes ( ) No.

7. Will you be working with isolates/concentrates of this select agent? ( ) Yes ( ) No.

8. Will you use laboratory animals for any of your work with this select agent? ( ) Yes ( ) No.

9. Will you use large animals for any of your work with this select agent? ( ) Yes ( ) No.

10. Will you be doing any large scale “production level” work with this select agent? ( ) Yes ( )

No.

11. Are intact animals exposed to the select agent? ( ) Yes ( ) No.

Animal room where exposed animals are housed. _______________________________.

12. Biologic containment level required: Biosafety Level # .

13. Attach a sketch/floor plan for laboratory where work will be performed – show entry,

location of BSC, incubators, freezers, autoclaves, and other equipment specified for work with

the agent.

14. Please list all professional personnel, employees and students involved in the project who

will come into contact with the select agent:

NAME Mailing Address Social Security No.

_______________________ ____________________________ __________________

- 53 -
_______________________ ____________________________ __________________

_______________________ ____________________________ __________________

15. Describe briefly the type of work being done with this select agent.

16. Describe; 1) how you control access to laboratory where the select agent is used, 2) how you

ensure adequate training for personnel working with the agent, 3) where you store the select

agent, and 4) proposed method of disposal of select agent when work is complete.

17. Describe the air-handling system for the laboratory where the work will be performed (e.g.,

single pass or re-circulation, type of filters, method for handling safety cabinet exhaust.

18. I accept responsibility for the safe conduct of work with this material. I will inform all

personnel of all hazards associated with this work and the level of biological containment

required to perform this research safely.

Principal Investigator: Date: .

Signature

- 54 -
 SELECT AGENT LIST Exemptions: Vaccine strains may be

Viruses exempt.

1.Crimean-Congo haemorrhagic fever Bacteria

virus 1.Bacillus anthracis

2.Eastern Equine Encephalitis virus 2.Brucella abortus, B. melitensis, B.

3.Ebola viruses suis

4.Equine Morbillivirus 3.Burkholderia (Pseudomonas) mallei

5.Lassa fever virus 4.Burkholderia (Pseudomonas)

6.Marburg virus pseudomallei

7.Rift Valley fever virus 5.Clostridium botulinum

8.South American Haemorrhagic fever 6.Francisella tularensis

viruses (Junin, Machupo, Sabia, Flexal, 7.Yersinia pestis

Guanarito) Exemptions: vaccine strains may be

9.Tick-borne encephalitis complex exempt.

viruses Rickettsiae

10.Variola major virus (Smallpox 1.Coxiella burnetii

virus) 2.Rickettsia prowazekii

11.Venezuelan Equine Encephalitis 3.Rickettsia rickettsii

virus Fungi

12.Viruses causing hantavirus 1.Coccidioides immitis

pulmonary syndrome Toxins

13.Yellow fever virus 1.Abrin

2.Aflatoxins

- 55 -
 3.Botulinum toxins at an LD50 for vertebrates of more than

4.Clostridium perfringens epsilon 100 nanograms per kilogram body

toxin weight are exempt.

5.Conotoxins Recombinant organisms/molecules

6.Diacetoxyscirpenol 1.Genetically modified

7.Ricin microorganisms or genetic elements

8.Saxitoxin from organisms on this list, shown to

9.Shigatoxin produce or encode for a factor associated

10.Staphylococcal enterotoxins with a disease.

11.Tetrodotoxin 2.Genetically modified

12.T-2 toxin microorganisms or genetic elements that

Exemptions: Toxins for medical use, contain nucleic acid sequences coding

inactivated for use as vaccines, or toxin for any of the toxins on this list, or their

preparations for biomedical research use toxic subunits.

MAIL OR FAX TO: Biosafety Division

- 56 -
Appendix C3 - IBC Research Registration Form

REGISTRATION OF RESEARCH WITH RECOMBINANT DNA

IBC #

DATE

BIOSAFETY LEVEL

ACTION

DO NOT WRITE IN ABOVE SPACE

APPLICATION MUST BE TYPEWRITTEN

1. Principal Investigator .

Academic Title Social Security No. .

2. Department Division .

3. Addresses: Office: Lab: Telephone #

4. Project Title .

5. Source of DNA to be cloned (human/animal/microbial) .

6. If virus source, is it more than 2/3 of the viral genome? Yes ( ) No ( ).

7. Specify the gene sequence to be inserted into the recombinant (attach construct map).

8. Host or Environment (Cloning Vehicle) .

9. Is a Helper Virus used? No ( ) Yes ( ) If yes, a Retrovirus? Yes ( ) No ( ).

10. Vector(s)/Specific phage or plasmid .

- 57 -
11. Are intact animals exposed to the Recombinant? Yes ( ) No ( ).

Animal room where exposed animals are housed. ___________________________.

12. Are mammalian cells exposed to the Recombinant? Yes ( ) No ( ).

Cell line source. _______________________________________.

13. Please circle relevant situation(s) that apply to your project:

Host / Environment Biosafety Level

E. coli. K12 Yes/No BSL1 / BSL2

Other Bacteria: Yes/No

Non-Pathogen Yes/No BSL1 / BSL2 / BSL3

Pathogen Risk 2 Yes/No BSL2 / BSL3

Pathogen Risk 3 Yes/No BSL2 / BSL3

Toxin Gene Yes/No BSL2 / BSL3

Drug Resistance Gene Yes/No BSL2 / BSL3

Yeast/YAC Yes/No BSL1 / BSL2

Tissue Culture Cells Yes/No

R-DNA/Plasmids Yes/No BSL1 / BSL2

Segment of Virus Yes/No BSL1 / BSL2 /BSL3

Virus Vector Yes/No BSL2 / BSL3

If Virus Vector: Adeno/AAV/Retro/Vaccinia/Other

Characterized/FDA or NIH Approved/Novel

Intact Lab Animal Recipient Yes/No

R-DNA/Plasmids Yes/No BSL1-N / BSL2-N

Transgenic Yes/No BSL1-N / BSL2-N

- 58 -
 Virus Vector Yes/No BSL1-N / BSL2-N / BSL3-N

SCID/Nude Yes/No BSL1-N / BSL2-N / BSL3-N

If Whole Animal Recipients: Species

Has Institutional Animal Use & Care Committee been Notified? ( ) Yes ( ) No.

Human Subject Recipient Yes/No

R-DNA/Plasmid Yes/No BSL2 / BSL3

Pathogen Yes/No BSL2 / BSL3

Virus Vector Yes/No BSL2 / BSL3

If Human Subject Recipients: Has IRB been Notified? ( ) Yes ( ) No.

IRB Approval Number _______________.

Plants/Insects Yes/No

Field Release Yes/No BSL2-P / BSL3-P

14. Is a deliberate attempt made to obtain expression of foreign gene(s) in the cloning

vehicle?

Yes ( ) No ( ). If yes, what proteins, materials, or antigens? .

15. Give specific reference for your experiment from the NIH Recombinant DNA

Guidelines

(Refer to the University Biosafety Manual (Leave blank if not sure): .

16. Biologic containment level required: Biosafety Level # .

17. Please list all professional personnel, employees and students involved in the project

who will come into contact with these materials:

NAME Mailing Address Social Security No.

_______________________ _________________________ _________________

- 59 -
_______________________ _________________________ ___________

_______________________ ________________________ ____________

18. Project Summary

19. I accept responsibility for the safe conduct of work with this material. I will inform

all personnel of all hazards associated with this work and the level of biological

containment required to perform this research safely.

Principal Investigator: Date: .

Signature

MAIL OR FAX TO: Biosafety Division

- 60 -
Appendix C4 - IBC Research Registration Form

REGISTRATION OF RESEARCH WITH NON-HUMAN PRIMATES

(B-VIRUS & TB PRECAUTIONS)

IBC #

DATE

BIOSAFETY LEVEL

ACTION

DO NOT WRITE IN ABOVE SPACE

APPLICATION MUST BE TYPEWRITTEN

1. Principal Investigator

Academic Title Social Security No.

2. Department Division

3. Mailing Address Telephone Number

4. Project Title

5. Please indicate housing location(s) for non-human primates.

Building(s) Room(s)

6. Location where non-human primates and/or related materials will be utilized.

Building(s) Room(s)

7. Please list all professional personnel, employees and students involved in the project

who will come into contact with non-human primates or their products:

NAME Mailing Address Social Security No.

- 61 -
_______________________ ______________________ ________________

_______________________ _______________________ _____________

______________________ ______________________ _____________

_______________________ ______________________ _____________

8. Please attach a description of the procedures for use of non-human primates, including

precautions to be taken and methods used in handling blood, body fluids, tissue and

excrement and how you plan to dispose of waste material.

9. I accept responsibility for the safe conduct of work with this material.

I will inform all personnel of the hazards associated with this work and the level of

containment required to perform this research safely.

Principal Investigator: Date:

Signature

MAIL OR FAX TO: Biosafety Division

- 62 -
Appendix C5 - IBC Research Registration Form

REGISTRATION OF RESEARCH WITH SHEEP AND GOATS

(Q FEVER PRECAUTIONS)

IBC #

DATE

BIOSAFETY LEVEL

ACTION

DO NOT WRITE IN ABOVE SPACE

APPLICATION MUST BE TYPEWRITTEN

1. Principal Investigator

Academic Title Social Security No.

2. Department Division

3. Mailing Address Telephone Number

4. Project Title

5. Please indicate housing location(s) for sheep (including lambs) or goats.

Building(s) Room(s)

6. Location where sheep (including lambs) or goats and/or related materials will be

utilized.

Building(s) Room(s)

7. Please list all professional personnel, employees and students involved in the project

who will come into contact with sheep (including lambs), goats or their products:

- 63 -
 NAME Mailing Address Social Security No.

_______________________ _________________________ ________________

_______________________ _________________________ ________________

_______________________ _________________________ ________________

8. Please attach a description of the procedures for use of sheep or goats, including

precautions to be taken and methods used in handling products of conception and

excrement and how you plan to dispose of waste material.

9. I accept responsibility for the safe conduct of work with this material.

I will inform all personnel of the hazards associated with this work and the level of

containment required to perform this research safely.

Principal Investigator: Date:

Signature

MAIL OR FAX TO BIOSAFETY DIVISION

- 64 -
Appendix D1 – Potential Pathogenic Material Research Update Letter

DATE

MEMORANDUM

TO: Dr. «FSTNAMEPI» «LSTNAMEPI»

«DEPARTMENT»

«ADDRESS» «INSTITUT»

FROM: Biosafety Officer

SUBJECT: Annual Update of Potentially Pathogenic Material Research Project:

«TITLE»

• According to our records, your research project, listed above, needs an annual update

for the Institutional Biosafety Committee.

• Please change any inaccurate information, fill in any blanks, sign, and return this

memorandum.

• If your project is complete or not funded, please indicate this when you return the

memorandum.

• When major changes have occurred with this project, we will fax over a new

registration form for you to fill out and return.

- 65 -
 PLEASE CHECK THE ACCURACY OF THE FOLLOWING INFORMATION

Principal Investigator: Dr. «FSTNAMEPI» «LSTNAMEPI»

Social Security Number: «SOCSECNO» Laboratory Address: «LABS»

Telephone No.: «TELEPHONE»

IBC Registration #: «REGISTRNO»

Last Date Registered or Updated Project: «LSTREG»

Project Title: «TITLE»

Potential Pathogen or Material: «AGENT»

Biosafety Levels > Facilities: BSL «FACBL» Practices: BSL «PRABL»

Personnel Working on the Project:

«PERSONNEL»

Are Animals Used? Species Animal Housing Bldg. & Room No.

THE INFORMATION ON THIS FORM IS CORRECT OR HAS BEEN

CORRECTED:

Signature: Date:

Please FAX OR MAIL this memo to: Biosafety Officer

- 66 -
Appendix D2 – Recombinant DNA Research Update Letter

DATE

MEMORANDUM

TO: Dr. «FSTNAMEPI» «LSTNAMEPI»

«DEPARTMENT»

«ADDRESS» «INSTITUT»

FROM: Biosafety Officer

SUBJECT: Annual Update of Recombinant DNA Project:

«TITLE»

• According to our records, your research project, listed above, needs an annual update

for the Institutional Biosafety Committee.

• Please change any inaccurate information, fill in any blanks, sign, and return this

memorandum.

• If your project is complete or not funded, please indicate this when you return the

memorandum.

• When major changes have occurred with this project, we will fax over a new

registration form for you to fill out and return.

- 67 -
 PLEASE CHECK THE ACCURACY OF THE FOLLOWING INFORMATION

Principal Investigator: Dr. «FSTNAMEPI» «LSTNAMEPI»

Social Security Number: «SOCSECNO» Laboratory Address: «LABS»

IBC Registration #: «REGISTRNO»

Last Date Registered or Updated Project: «LSTREG»

Project Title: «TITLE»

NIH Guideline: «NIHREF»

Biosafety Levels > Facilities: BSL «FACBL»; Practices: BSL «PRABL»

Personnel Working on the Project:

«PERSONNEL»

THE INFORMATION ON THIS FORM IS CORRECT OR HAS BEEN

CORRECTED:

Signature: Date:

Please FAX OR MAIL to: Biosafety Officer

- 68 -
Appendix E1 – Potential Pathogenic Material Research Registration Letter

DATE

MEMORANDUM

TO:Dr. «FSTNAMEPI» «LSTNAMEPI»

«DEPARTMENT»

«ADDRESS» «INSTITUT»

FROM: Biosafety Officer

SUBJECT: Registration of Recombinant DNA; IBC # «REGISTRNO»

PROJECT TITLE: «TITLE»

NIH GUIDELINE REFERENCE: «NIHREF» IBC APPROVAL DATE:

«IBC_APROV»

BIOSAFETY LEVEL: Facilities «FACBSL»; Practices «PRABSL»

The Biosafety Division has registered your project. Please note; if you have

“Pending” next to the above IBC APPROVAL DATE, you are not approved to begin this

- 69 -
research project. You must have an IBC Approval Date before research can begin. This

memorandum acknowledges your registration in case you need it for your grant

application.

Please note that your project has a unique Institutional Biosafety Committee (IBC)

Registration Number. This number will change each year when we update your project.

Please use this number in your correspondence with us. You may register additional

recombinant DNA projects by filling out a new registration form intranet web site.

We will update your project annually. Around the anniversary month of your project

registration, we will send you an update letter. Please make any changes to your project,

laboratory or office location, changes among personnel, etc., and return the form to me.

Health, Safety and Environment will carry out periodic inspections. This will assure

compliance with work practices and laboratory facility design appropriate for the level of

biosafety assigned to your project.

Please call or email the Biosafety Officer if you have any questions or need

additional forms. You may also fill out and print an online form located at the intranet

web site. We look forward to working with you.

- 70 -
Appendix E2 – Recombinant DNA Research Registration Letter

DATE

MEMORANDUM

TO:Dr. «FSTNAMEPI» «LSTNAMEPI»

«DEPARTMENT»

«ADDRESS» «INSTITUT»

FROM: Biosafety Officer

SUBJECT: Registration of Recombinant DNA; IBC # «REGISTRNO»

PROJECT TITLE: «TITLE»

NIH GUIDELINE REFERENCE: «NIHREF» IBC APPROVAL DATE:

«IBC_APROV»

BIOSAFETY LEVEL: Facilities «FACBSL»; Practices «PRABSL»

The Biosafety Division has registered your project. Please note; if you have

“Pending” next to the above IBC APPROVAL DATE, you are not approved to begin this

- 71 -
research project. You must have an IBC Approval Date before research can begin. This

memorandum acknowledges your registration in case you need it for your grant

application.

Please note that your project has a unique Institutional Biosafety Committee (IBC)

Registration Number. This number will change each year when we update your project.

Please use this number in your correspondence with us. You may register additional

recombinant DNA projects by filling out a new registration form available at the intranet

web site.

We will update your project annually. Around the anniversary month of your project

registration, we will send you an update letter. Please make any changes to your project,

laboratory or office location, changes among personnel, etc., and return the form to me.

Health, Safety and Environment will carry out periodic inspections. This will assure

compliance with work practices and laboratory facility design appropriate for the level of

biosafety assigned to your project.

Please call or email the Biosafety Officer if you have any questions or need

additional forms. You may also fill out and print an online form located at the intranet

web site. We look forward to working with you.

- 72 -
Appendix F - Employee Training Database

Microsoft Access 97 File (column) names

Filenames are truncated in the database and the formatting has been left off to save space.

Table Cost Centers

Column COSTCENTERCODE

Column COSTCENTERNAME

Table Course Name

Column COURSECODE (###)

Column COURSENAME

Table Courses Attended

Column SOCIALSECURITYNUMBER

Column COURSECODENUMBER

Column TRAININGDATE

Column INSTRUCTOR

Column DATEENTERED

Table Demographic Update Record

Column INPUTDATE

Column DEMOGRAPHICGROUP

Column RECORDCOUNT

Column ERRORCOUNT

- 73 -
Table Department Name

Column DEPARTMENTCODE

Column DEPARTMENTNAME

Column DIVISIONNAME

Column CLINICALDEPARTMENT (Y/N)

Table Division Name

Column DIVISIONCODE

Column DIVISIONNAME

Column CAMPUSLOCATION

Table Employee Address

Column SOCIALSECURITYNUMBER

Column ORGANIZATION

Column ADDRESS1

Column ADDRESS2

Column CITY

Column STATE

Column ZIP

Column PHONE

Table Employee Department

Column SOCIALSECURITYNUMBER

Column ORGANIZATION

Column HIREDATE

Column TERMINATIONDATE

- 74 -
 Column DEPARTMENT

Column COSTCODE

Column POSITIONCLASSIFICATIONNUMBER

Column TITLE

Column ARCHIND

Column FULLPARTTIMEINDICATOR

Column SHIFT

Table Identification Only

Column NAME

Column SEX

Column BLOODBORNEPATHOGENINDICATOR

Column DEPARTMENTADMINISTRATOR (Y/N)

Table Instructors

Column INITIALS

Column INSTRUCTOR

Table JHH Bloodborne Pathogen Group

Column POSITIONCLASSIFICATIONNUMBER

Column TITLE

Column CATEGORY (ATTENDEDSESSION/NURSINGSTAFF)

Table MD Physician Information

Column SOCIALSECURITYNUMBER

Column STATEREGISTRATIONNUMBER

Column CATEGORY

- 75 -
 Column COMMITTEEACTIONINDICATOR

Column STATESTATUS (ACTIVE/INACTIVE)

Column PROVISIONALINDICATOR

Table Object Definition

Column IDENTIFICATIONNUMBER

Column PARENTINDENTIFICATIONNUMBER

Column NAME

Column OBJECTTYPE

Column EXTRA1

Column EXTRA2

Table Organization Name

Column ORGANIZATIONCODE

(UNIVERSITY/HOSPITAL/HEALTHSYSTEM/ETC.)

Column ORGANIZATIONNAME

Table Physician Categories

Column CATEGORY (FULLTIME/PARTTIME/HOUSESTAFF/ETC.)

Column TITLE

Column CATEGORYGROUP (ACTIVE/HOUSESTAFF/CLINICAL/ETC.)

Table Unrecordable Training

Column KEYNUMBER

Column SOCIALSECURITYNUMBER

Column NAME

Column COURSECODENUMBER

- 76 -
Column TRAININGDATE

Column DEPARTMENT

Column ADDRESS

Column INSTITUTION

Column DATEENTERED

- 77 -
Appendix G - BSC & CAB Certification and Service Database

Microsoft Access 97 File (column) names

Filenames are truncated in the database

Serial Number (indexed)

Construction Contract Number

Equipment Room Number

Equipment Building

Barcode Number

Contact Last Name

Contact First Name

Contact Room Number

Contact Building

Principal Investigator Name

Principal Investigator Department

Principal Investigator Room Number and Building

Institution

Telephone

BSC or CAB

Manufacturer

Model

Service Performed

- 78 -
Blower Motor % Speed

Priority (emergency, routine)

Service Call Date

Service Date

Certification Payment Method

Certification Payment Date

Certification Date

Invoice Number

Disputes

HEPA Filter Payment

HEPA Filter Change Date

Pre-filter Status

Ultraviolet Lamp & Non-contract Payment Date

Ultraviolet Lamp & Non-contract Repair Date

Other Payments

Other Dates

Part Replacement

Notes

Comments

Laboratory Contact Name

Thimble Connection (Y/N)

- 79 -
Appendix H - BSC & CAB Certification Renewal Letter

MEMORANDUM

Date

To: «FSTNAME» «LSTNAME»

«DEPARTMENT»

«OWNRADDRS»

«MAILROOM»

From: Biosafety Office

Subject: Annual certification of Biological Safety Cabinet BSC or Clean Air Bench

CAB

Your BSC or CAB listed below is due for required annual or semi-annual

certification.

University Departments: Please send me a Materials and Services Request

Form for this work. Please include the Serial Number, Room Number, and

Contact Person for the BSC or CAB to be certified.

- 80 -
 Hospital departments: Please send a check for the full amount, payable to

Biosafety Division . Please include the Serial Number, Room Number, and

Contact Person for the BSC or CAB to be certified.

Payment must be received before certification of your unit can be scheduled. You

will be contacted to schedule the required service.

Certification costs are: BSC = $xxxxx or CAB = $xxxxx

Payment entitles you to annual performance testing, free labor and replacement

parts (fluorescent lights, switches, motors, etc. by contacting the Biosafety

Division). Filters and UV lights must be paid for at the time of replacement.

Please check the accuracy of the information below and make any changes on

this memorandum. Or email to contact@yourorganization.com

Last Certification Date: «CERTDATE»

Equipment Type: «CABINET»

Manufacturer: «MANUFACTUR»

Model Number: «MODELNO»

Serial Number: «SERIALNO»

Location of BSC/CAB: «ROOMNUMBER» «BUILDING»

Laboratory Phone Number: «PHONENO»

Please attach payment and send to the Biosafety Division for scheduling

- 81 -
Appendix I - Portable HEPA Unit Service Database

Microsoft Access 97 File (column) names

Filenames are truncated in the database

Identification Number

Serial Number (indexed)

Barcode Number

Manufacturer

Model

Pre-filter Size

Pre-filter Change Date

Call for Service Date

Service Date

HEPA Filter Size

HEPA Filter Change Date

Parts

Magnehelic Gauge Reading

Comments

Location Date

Room Number

Building

- 82 -
Mailstop

Contact Name

Contact Telephone

- 83 -
Appendix J - PAPR Service Database

Microsoft Access 97 File (column) names

Filenames are truncated in the database

Identification Number

Serial Number (indexed)

Barcode Number

Manufacturer

Model

Service Call Date

Service Date

HEPA Filter Size

HEPA Filter Change Date

Airflow OK Date

Battery Charged Date

Parts

Comments

Location Date

Room Number

Building

Contact Name

Telephone

- 84 -
Appendix K - Bag-In Bag-Out Service Database

Microsoft Access 97 File (column) names

Filenames are truncated in the database

Identification Number

Barcode

Building

Location

Contact Name

Contact Address

Additional Contact Names

Institution

Telephone

Manufacturer

Housing Model

In Use (Y/N)

Exhaust Fan Number

Pre-filter Number

Pre-filter Size

Pre-filter Bag Number

Pre-filter Change Date

- 85 -
HEPA Filter Number

HEPA Filter Size

HEPA Filter Bag Number

HEPA Filter Change Date

Charcoal Filter Number

Charcoal Filter Size

Charcoal Filter Bag Number

Charcoal Filter Change Date

Magnehelic Gauge 1 Reading

Magnehelic Gauge 1 Reading Date

Magnehelic Gauge 1 Configuration

Magnehelic Gauge 1 Range

Magnehelic Gauge 2 Reading

Magnehelic Gauge 2 Reading Date

Magnehelic Gauge 2 Configuration

Magnehelic Gauge 2 Range

Magnehelic Gauge 3 Reading

Magnehelic Gauge 3 Reading Date

Magnehelic Gauge 3 Configuration

Magnehelic Gauge 3 Range

Service Call Date

Service Date

Invoice Date

- 86 -
Invoice Amount

Parts

Comments

Source

- 87 -
Appendix L - IBC Research Registration Database

Microsoft Access 97 File (column) names

Filenames are truncated in the database

Registration Number (A, B, OR DYYMMDD####)

Principal Investigator Last Name (indexed)

Principal Investigator First Name (indexed)

Academic Title

Department

Institution (School)

Room Number

Building

Telephone

Social Security Number

Lab Address

NIH Recombinant Guideline Reference

Facility Biosafety Level

Practices Biosafety Level

BSL-3 Lab Inspection Date

Non-Exempt (Y/N)

Personnel Names

Project Title

- 88 -
Potential Pathogen

Animals

Animal Committee Registration Number

First Registration Date

Last Registration Date

Comments

IBC Approval Date

Select Agents Involved

Print Record (p)

- 89 -
Appendix M - IBC Select Agent Registration Database

Microsoft Access 97 File (column) names

Filenames are truncated in the database

Registration Number

Select Agent Certification Number

Principal Investigator Last Name (indexed)

Principal Investigator First Name (indexed)

Academic Title

Department

Institution (School)

Room Number

Building

Telephone

Fax

Email

Social Security Number

Lab Room Number

Lab Building

Lab Diagram

Facility Biosafety Level

Practices Biosafety Level

Application Sent Date

- 90 -
Application Complete Date

Exempt

Biosafety Officer Inspection Date

Select Agent Class

Select Agent Name

Quantity

Agent Storage Method

Agent Disposal Method

Clinical or Diagnostic Use (Y/N)

CLIA (Y/N)

If Toxin Class, Recombinant DNA (Y/N)

Animals

Large Animals (Y/N)

Animal Location

Large Scale (Y/N)

Personnel Names

Project Title

First Registration Date

Last Registration Date

Comments

IBC Approval Date

CDC Inspection Date

Print Record

- 91 -
Appendix N - Shipping Certification Training Database

Microsoft Access 97 File (column) names

Filenames are truncated in the database

Social Security Number (indexed)

Last Name

First Name

Department

Room Number

Building

Institution

Training Date

Training Location

Instructor

Pre- & Post-Test Scores

- 92 -
Appendix O - Johns Hopkins Institutions BSL-3 Specifications

BIOSAFETY LEVEL 3 DESIGN SPECIFICATIONS:

Design Component Description

Sealed room Laboratory must be effectively air and liquid tight. Air

must pass easily under and around the door of the containment laboratory.

Air Monitoring Recommend a one inch circular cut out in the

containment laboratory door with a vertically mounted ribbon to indicate directional air

flow into the containment laboratory. Pressure monitors are not recommended.

Location Laboratory is restricted from general traffic by access

through two sets of doors. First, an anteroom (change area) and then into the laboratory

through a card access lock.

Flooring Seamless or welded vinyl coving with an integral cove,

sealed to flooring material with silicone.

Walls Material should be washable and resistant to cleaning

agents and disinfectants. Tile, Formica or epoxy paint are acceptable.

- 93 -
Ceiling Monolithic construction, recommend gypsum board with

a finish material similar to above. Removable tiles and drop ceiling tiles unacceptable.

Access to utilities via air tight ceiling panel.

Doors Self-closing and open inward.

Windows (if any) Permanently sealed shut.

Plumbing Horizontal and sealed with fire-retardant caulk. Wall and

ceiling penetrations are minimal. No floor penetrations.

Vacuum Utility Separate and independent from house vacuum system.

Electrical Utility All outlets, fixtures, junction boxes and conduit must be

surface mounted. Wall and ceiling penetrations are minimized.

Laboratory Work Surfaces Made of materials resistant to cleaning and disinfecting

agents. Sturdy furnishings spaced to permit cleaning and maintenance. Impervious to

water. Resistant to acids, alkalis, organic solvents and moderate heat.

Hand Washing Sink Located near exit. Operated infrared , wrist, elbow or

foot control.

- 94 -
Emergency Eye, Face and Located near exit proximate to sink. Recommend

Speakman Model SE921 or equivalent connected to cold, potable water supply. An

ANSI approved eyewash should also be installed.

Autoclave Double door model installed between glassware prep area

or anteroom. Drain must be inside the containment laboratory with a bioseal between the

containment laboratory and the non-containment area. High air velocity exhaust canopies

should be installed above each autoclave door. Floor penetration for drain must be sealed

or covered with a HEPA filtered cabinet.

Ventilation Ten to 12 ACPH, no recirculation, constant volume 24

hours per day. Supply and exhaust ducts in the containment laboratory must contain

100% shut off dampers to isolate laboratory air from other areas of the building. Exhaust

is not to be recirculated to any other part of the building. Ducted exhaust must be

discharged through redundant bag in bag out roof top housings with dedicated primary

and secondary back-up fans. Each bag in bag out housing should contain pre-filters and

HEPA filters with magnehelic gauges (with air vent valves) between the pre-filer housing

and the HEPA filter housing.

Biological Safety Cabinets Class II, Type B3 BSC spaced three to six inches out from

the rear wall. HEPA filtered exhaust shall be connected to the laboratory exhaust system

with a flexible eight- or ten-inch plastic duct and an air volume control damper for each

BSC. The flexible duct shall be connected to a thimble exhaust connection (JHU

- 95 -
specifications available). The thimble exhaust shall be adjusted to capture 1.5 times the

manufacturer's rated exhaust airflow from the BSC. Space near the ceiling will be

required to permit opening of TEC panels. All utility connections supplied to the BSC

shall be installed under the BSC. A gas shut off valve (with handle) shall be provided on

the right or left side the BSC that can be reached by a seated operator. The gas supply

line shall have a pipe union between the shut off valve and the connection to the BSC.

Specific JHU performance specifications (available) are required for BSC's.

Flammable Storage Cabinet Shall be vented through a chemical fume hood with a pipe

extending from a fire arrestor screen at the rear of the flammable storage cabinet and

extending behind and four inches above the bottom of the rear baffle.

Air Pressure Differentials The anteroom shall be at 100 cfm negative with respect to

an adjoining space. The containment laboratory shall be at least 100 cfm negative with

respect to the anteroom.

Directional Airflow Supply and exhaust shall be located to ensure airflow

from areas of least potential hazard toward areas of greatest potential hazard.

Supply Vents The vents shall be four-way, three-way, two-way or one-

way, depending on the location of areas of greatest hazard. Low velocity spiral vents are

preferred to standard directional vents. Vents shall be directed away from the face of

BSC's, fume hoods, and incubators.

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Appendix P - BSL-3 Standard Operating Procedures Outline

TABLE OF CONTENTS

Authorization to use this manual

Emergency contact numbers

Table of contents

Introduction

Materials and chemicals kept in the BSL3 facility

Restricted use of the facility

Training requirements

Research Facility Training Certification

Authorized facility entrance requirements

Routine operating procedures

BSL-3 work practices and guidelines

Entry control

Medical surveillance

Personal protective equipment

Facility Inspections & Public Information Office Guidelines

Containment Facility Diagram

Containment barriers

Biological safety cabinets

Protection of laboratory vacuum systems

Transport of infectious materials

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Waste disposal procedures

Biohazardous spill control

Large spill outside of BSC

Small spill outside of BSC

Radioactive spill outside of BSC

Spill outside the research facility

Autoclave quality assurance program

Resources for pathogen exposures

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Appendix Q - Laboratory Survey Checklist

UNIVERSITY LABORATORY SURVEY FIELD REPORT

Department ___________________ Bldg__________ Room________________

P.I. __________________________ Phone_________ Date_________________

Surveyor ______________________ Departmental Representative______________

Door Signage Corrected

_____ Warning labels missing (list)______________________________ _______

_____ Emergency contact information missing _____________________ _______

_____ Refrigerator signage missing (list)__________________________ _______

Improper Handling / Storage

_____ Improperly labeled or unlabeled chemicals or materials (list)_____ _______

_____ Incompatible chemicals stored together _____Flammables / Corrosives, ______

_____ Organics / Oxidizers _______

_____ Acids / Bases not segregated _______

__Flammable material in non-approved __Cabinet__ Refrigerator_ Cold-room. _______

_____ Undated or outdated chemicals (list)____________________________ _______

_____ Flammable solvents _____ > 10 gal outside flam. cab. _______

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 _____ containers > 1 gal outside flam. cab. _______

_____ Unsecured Gas Cylinders _______

Improper Waste Handling

_____ Unapproved or inappropriate container:

__ Sharps __ Lab Waste __ Autoclave Waste __Chemicals _______

_____ Over filled Container:

__ Sharps __ Lab Waste __ Autoclave Waste __Chemicals _______

Safety/ Emergency Equipment

_____ BSC / CAB Serial #-_________ Certification not current _______

_____ BSC / CAB work area cluttered _____________________________ _______

_____ Chemical Fume Hood __ Certification not current __ baffle/ slot blocked _______

_____ Personal Protective equipment not being used (specify ______________) _______

_____ Fire alarms blocked _______

_____ Fire extinguisher ___blocked, ___missing, ___not maintained, _____ _______

_____ Safety shower ___blocked, ___inaccessible ___due for inspection _______

_____ Eyewash ___blocked, ___water pressure not proper, _needed _______

Other / Comments

____ Improper attire: Specify

____ Evidence of food or drink in the laboratory: Specify

____ Improper electrical devices: Specify

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 ____ Vacuum line filter absent

____ Paper Towels missing

____ Hand Soap missing or not appropriate

____ Cosmetics on the open bench

____ Other comments

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