GENERAL BIOLOGICAL RISK ASSESSMENT FORM

Transcription

1 GENERAL BIOLOGICAL RISK ASSESSMENT FORM Please complete the form to provide information on the biological risk of your laboratory. The information provided through this document will be used to track changes related to biological risk, safety and security through anticipated awards administered through CRDF Global's Biological Risk Management Enhancement Grant Competitions. Information provided will not be disclosed outside of CRDF Global and our funders. Please note that there are multiple sheets or tabs included in this assessment. Questions are categorized in tabs and your attention to all tabs is appreciated. Note: some questions will be more applicable to your laboratory and award than others. Please complete all to the best of your ability. Name of PI (as appeared on application): Institution: Laboratory Name (if different than Institution): Address of Institution: Country: Are you completing this self-assessment before or after the project has been completed? REFERENCE INFORMATION Biosafety: Safety with respect to the effects of biological research on humans and the environment or safe handling and containment of infectious microorganisms and hazardous biological materials Biosecurity: Security from exposure to harmful biological agents; ALSO measures taken to ensure this security. Security of microbiological agents and toxins and the threats posed to human and animal health, the environment, and the economy by deliberate misuse or release. Biorisk: The process of controlling the risk associated with biological materials in regards to safety and security practices Biosafety Level (BSL) I: Limited access, protective clothing and gloves; the microbes present are not known to consistently cause disease in healthy adults and present minimal potential hazard to laboratorians and the environment; an example of a microbe that is typically worked with at a BSL-1 is a nonpathogenic strain of E. coli BSL II: BSL-1 practices plus: hazard warning signs. Class I or II biosafety cabinets (BSC) for activities that produce aerosols; decontamination of waste and cages before washing; the microbes present pose moderate hazards to laboratorians and the environment; the microbes are typically indigenous and associated with diseases of varying severity; diagnostic and health-care laboratories (public health, clinical or hospital-based) must all be designed for Biosafety Level 2 or above; an example of a microbe that is typically worked with at a BSL-2 laboratory is Staphylococcus aureus. BSL III: BSL-2 practices plus: controlled access; BSCs and special protective clothing are required for all activities; Biosafety Level 3 containment requires the strengthening of the operational and safety programmes over and above those for basic laboratories. Biosafety Levels 1 and 2; the microbes present can be either indigenous or exotic, and they can cause serious or potentially lethal disease through respiratory transmission; respiratory transmission is the inhalation route of exposure; an example of a microbe that is typically worked with in a BSL-3 laboratory is Mycobacterium tuberculosis, the bacteria that causes tuberculosis. BSL IV: BSL-3 practices plus: strictly limited access; clothing change before entering; class III BSCs or positive pressure suits; shower on exit; decontamination of all wastes before removal from facility; the microbes in a BSL-4 lab are dangerous and exotic, posing a high risk of aerosol-transmitted infections; infections caused by these microbes are frequently fatal and without treatment or vaccines; two examples of microbes worked with in a BSL-4 laboratory include Ebola and Marburg viruses.

2 Risk Group 1: (no or low individual and community risk) A microorganism that is unlikely to cause human or animal disease Risk Group 2: (moderate individual risk, low community risk) A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment; laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. Risk Group 3: (high individual risk, low community risk) A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. Risk Group 4: (high individual and community risk) A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.

3 GENERAL INSTITUTION and LABORATORY INFORMATION (Check all that apply and fill in the blank when applicable) Which of the following best describes your organization? Please select all that apply. Academic Clinical Laboratory (Medical or Veterinary) Government Contract Research Pharmaceutical/Biotechnology Hospital or University Medical Center Diagnostic Laboratory (Medical or Veterinary) Veterinary Hospital University Veterinary Center Other Which of the following best characterizes the stage of your laboratory s work with infectious diseases or toxins? Please select all that apply. Basic Research Disease Surveillance Clinical/Diagnostic Drug Discovery &/or Development Translational Other Where does your facility receive funding to conduct your bioscience work? Please select all that apply. Local, Regional or National Government Non-medical Corporation Royalties or Sales International Donors Pharmaceutical, Biotechnological or Diagnostic Company Other Private Foundation or Charity Which Biosafety levels (as described in the WHO Laboratory Biosafety Manual) best categorize your laboratory? Please refer to the definitions on the Instructions and Reference tab Biosafety Level 1 (BSL1, ABSL-1 or P1) Biosafety Level 2 (BSL2, ABSL-2 or P2) Biosafety Level 3 (BSL3, ABSL-3 or P3) Biosafety Level 4 (BSL4, ABSL-4 or P4) Not Applicable Total number of staff members in your laboratory: Total number of above individuals who have access to the laboratory: Do contractors work inside your laboratory: Yes No List below all the pathogens and toxins used or stored at the laboratory. BACTERIA: VIRUSES: TOXINS: OTHERS:

4 Biological Safety (General) Enter the value of the best answer to each question in the corresponding grey cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. Are disposable gloves available for handling potentially infectious materials? 4= Disposable gloves are not available 2= Disposable gloves are available for all personnel in limited sizes 0= Disposable gloves are available for all personnel in varying sizes Does the institute clearly display signs indicating that eating, drinking, smoking, handling contact lenses and applying cosmetics are prohibited in the laboratory? 4= No such signs or markers exist 2= No signs exist, but workers are informed of prohibited activities 0= Signs indicating prohibited activities are clearly posted in working areas and workers are informed of prohibited activities Are food and drinks stored outside of the work area? 4= Food and drinks are not stored in designated areas outside of the work area 0= Food and drinks are stored in desginated areas and refrigerators outside of the work area Are food and drinks consumed only in clean areas? 4= There are no designated "clean areas" for eating and drinking 0= Food and drinks are only consumed in designated "clean areas" Is mouth pipetting prohibited? 4= Mouth pipetting is allowed and/or common 3= Mechanical pipetting devices are available, but mouth pipetting takes place occasionally 0= Mouth pipetting is strictly prohibited and does not take place How does the institute handle laboratory acquired infections? 4= There is no protocol in place for handling laboratory acquired infections 0= The institute has protocol for reporting and documenting laboratory acquired infections Is there defined procedure for the safe handling of sharps (such as needles, scalpels, pipettes, and broken glassware)? 4= No protocol in place for handling and disposing of sharps 0= The institution has protocol for handling and disposing of sharps

5 What type of protective clothing (PPE) is used in the laboratory? 4= Personnel wear street clothes in the laboratory and typically do not use gowns or lab coats 3= Gowns or lab coats are always worn over street clothes 0= Personnel wear dedicated laboratory clothing (like scrubs) which is not worn outside the laboratory, anteroom or change room Which of the following personal protective equipment (PPE) does your laboratory provide? (Check all that apply and list specific equipment available) Gloves Coats Shoes Shoe Covers Eye Protection Respirator(s) Masks Other For agents applicable to your proposed project, please list all types of disinfectants used for decontamination: For BSL-3 and 4 laboratories, check all of the following that apply to your lab relating to aerosol exposure Enclosures for aerosol-generating equipment Room penetrations are sealed Water resistant floors, walls and ceilings Vacuums are lined with disinfectant traps, or HEPA filters Class II or III Biosafety cabinet Are eyewash stations available in the laboratory? 4=No 0= Yes What is the level of biosafety training provided? 4= No biosafety training provided 2= Biosafety training provided to employees but not unescorted (nonemployees who do not need to be accompanied by an employee) access 1= Biosafety training provided to all employees 0= Biosafety training provided to all employees, on-site contractors, guards, maintenance personnel, etc.

6 Biological Security Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. Does the laboratory have procedures for reporting missing biological samples? 4= Laboratory does not have procedures for reporting missing biological samples 2= Laboratory has procedures for reporting missing biological samples but they are not always followed 0= Laboratory has procedures for reporting missing biological samples and they are always followed What is the level of biosecurity training provided? 4= No biosecurity training provided 2= Biosecurity training provided to employees but not anyone with unescorted access (nonemployees who do not need to be accompanied by an employee) 1= Biosecurity training provided to all employees 0= Biosecurity training provided to all employees, on-site contractors, guards, maintenance personnel, etc.

7 Personnel Reliability Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. How is personnel screened and approved (vetted) prior to allowing them unescorted access to agents? 4= No vetting of personnel prior to authorize access 3= Vetting includes verification of credentials (education, prior employment) and references 2= Vetting includes verification of credentials, references, and criminal history 1= Vetting includes verification of credentials, references, criminal history and additional checks for unfavorable information (including financial checks, drug screening, interviews of contacts, personality tests) 0= Vetting includes all of the above and regular re-evaluation How is personnel vetted (approved) who will not have direct access to agents? 4= No vetting of personnel prior to authorize access 3= Vetting includes verification of credentials (education, prior employment) and references 2= Vetting includes verification of credentials, references, and criminal history 1= Vetting includes verification of credentials, references, criminal history, and additional checks for unfavorable information (including financial checks, drug screening, interviews of contacts, personality tests) 0= Vetting includes all of the above and regular re-evaluation How are people escorted? 4= Allowed unescorted access to room with restricted access 3= Administrative escorting to room with restricted access allowed 2= Escorting requirements in place but no defined escort ratios (personnel to non-personnel) 1= Escorting requirements in place and escort ratios defined 0= Escort ratios defined, dates/times of escorted visitors recorded Are badges worn? 4= Not required or routinely worn 0= Badges required Do badges indicate level of access allowed by the individual in possession of the badge (wearer)? 4= Badges not required or routinely worn 4= No indicator of the level of access by the wearer 0= Badges indicate level of access Do badges include a photo of the wearer and a time interval for when it is valid? 4= Badges not required or routinely worn 4= No way to identify if badge belongs to person wearing it 0= Badges have a photo and expiration date Are there procedures for returning badges or reporting lost badges? 4= Badges not required or routinely worn 4= No badge procedures 0= Procedures are in place for lost badges and turning in badges when access is no longer needed

8 Do employee assistance programs exist for employees going through personal hardships? 4= No support systems in place 3= Informal support network among personnel 2= Formal employee assistance program in place 1= Employees not penalized if their laboratory access voluntarily suspended due to a temporary situation 0= Anonymous whistleblower (informer) mechanism in place

9 Program Management Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. Does the laboratory have defined roles and responsibilities for biosecurity? 4= There is no identification of, or education on, biosecurity roles and responsibilities 3= Facility personnel are educated on their biosecurity roles and responsibilities 2= A biosafety officer is identified at this facility 0= Management at this facility ensures roles, responsibilities, and authorities are defined, documented, and communicated Has the laboratory made a commitment to security? 4= Management at this facility is not aware and/or interested in biosecurity concerns 3= Management at this facility is aware of biosecurity concerns but has not implemented a biosecurity policy or devoted resources to address the issue 2= Management at this facility have made some efforts to improve biosecurity at the facility but they are not comprehensive and/or are not fully implemented 1= This facility has a comprehensive biosecurity policy in place, which was developed, authorized, and signed by top management. The policy is appropriate to the nature and scale of this risk. 0= Management of the facility identifies and prioritizes program needs and allocates funds to biosecurity as necessary Does this laboratory have comprehensive biosecurity documentation? 4= This facility has no biosecurity policies, manuals, or SOPs 3= This facility has no specific biosecurity documentation 2= This facility has some biosecurity documentation but it is not comprehensive and/or not fully implemented 1= This facility has biosecurity policies, manuals, and SOPs 0= This facility s biosecurity documentation also includes risk assessment and incident response information Does the laboratory conduct biosecurity trainings or exercises? 4= This facility does not conduct any biosecurity exercises 2= This facility conducts exercises on an ad hoc (as needed) basis 1= This facility conducts annual exercises 0= The facility includes external responders (police, fire, community actors) in their exercises Does the laboratory periodically review the biosecurity program? 4= There is no review of the biosecurity program or there is no biosecurity program 3= The biosecurity program is reviewed and revised as necessary after any incidents or nearincidents 1= The biosecurity program is subject to internal self-assessments 0= Management at the facility ensures continual improvement, conducts routine selfassessments, and ensures corrective and preventive actions. Reviews include assessing opportunities for improvement and any needs for changes to the system, procedures, policies, and objectives.

10 Animal Procedures - Only complete if facility uses/houses animals Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. Are animals housed isolated or sealed to prevent aerosol escape (e.g. isolator cages or cages inside a biobubble)? Please leave blank if there are no animals in use for this procedure/laboratory. 4= Animals are housed in cases which are located in an open area and have no internal sealing/air filtering mechanism 2= Animals are housed in some form of isolator, but there are no formal procedures in place for its use 1= Animals are housed in some form of isolator, but the isolator is not regularly validated/certified 0= Animals are housed in isolated or self-contained air-isolating devices which are validated/certified and well-maintained Are animals handled (worked with) in isolation to prevent aerosol escape (e.g. in a BSC or handled inside a biobubble)? Please leave blank if there are no animals in use for this procedure/laboratory. 4= Animals are handled in an open area 1= Animals are handled in some form of isolator, but there are no formal procedures in place for its use 1= Animals are handled in some form of isolator, but the isolator is not regularly validated/certified 0= Animals are always handled in an air-isolating device (e.g. BSC) which is validated/certified and well-maintained Are animals transported in a manner that prevents aerosol escape (e.g. isolator cages)? Please leave blank if there are no animals in use for this procedure/laboratory. 4= Animals are transported in open cages 1= Animals are transported in an isolator, but there are no formal procedures in place for its use 1= Animals are transported in an isolator, but the isolator is not regularly validated/certified 0= Animals are transported in isolated or self-contained air-isolating devices which are validated/certified and well-maintained

11 Does this laboratory have animal handling procedures in place to reduce/eliminate exposures, which meet defined best practices? Please leave blank if there are no animals in use for this procedure or laboratory 4= Personnel are not specifically trained/taught to minimize animal handling exposures 1= Proper practices for animal handling exist, but they are not taught, enforced, verified, or documented 0= Proper practices for animal handling are identified in the laboratory procedures, are taught, and verified on a regular basis

12 Equipment Maintenance Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. Are biosafety cabinets certified yearly with clear labeling on units? 4= Biosafety cabinets are not certified yearly, nor clearly labeled with date of certification and date of next inspection 2= Biosafety cabinets are certified, but not yearly 1= Biosafety cabinets are certified yearly, but not clearly labeled with date of certification and date of next inspection 0= Biosafety cabinets are certified yearly and clearly labeled with date of certification and date of next inspection Are operational and maintenance personnel knowledgeable about the risk level of the laboratory? 4= Operational and maintenance personnel are not knowledgeable about risk and biosafety in areas with agents 2= Operational and maintenance personnel are sometimes knowledgeable about risk and biosafety in areas with agents 0= All operational and maintenance personnel are knowledgeable about risk and trained in biosafety applicable to areas with agents Are operational and maintenance personnel knowledgeable about equipment? 4= Operational and maintenance personnel are not knowledgeable about equipment 2= Operational and maintenance personnel are knowledgeable and trained on maintenance of specific equipment 0= All operational and maintenance personnel are knowledgeable and trained on equipment What is the process for the decontamination of equipment prior to maintenance? 4= There is no decontamination of equipment prior to or maintenance or repair 3= Decontamination of equipment prior to maintenance or repair is performed, but not validated 0= No equipment is maintained or repaired without decontamination, and the process is documented and validated

13 Facility Attributes: Physical Security Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. What type of a perimeter (i.e. security and/or boundary) exists? 4= Facility has no perimeter 3= Facility has a partial perimeter 0= Facility has a clearly defined perimeter (natural or man-made) For biological agents applicable to your project, does the building(s) housing agents have a control system to limit access? 4= Building has no access controls 3= Building has procedural access controls 2= Building has manual access controls 1= Building has electronic access controls based swipe cards or other equipment 0= Building has electronic access controls tied to the entering person; for example, a personal identification number to be entered or biometric like a signature or finger print Does the room(s) where the biological agent(s) are stored have a control system to limit access? 4= Room(s) has no access controls 3= Room(s) has procedural access controls 2= Room(s) has manual access controls 1= Room(s) has electronic access controls based swipe cards or other equipment 0= Room(s) has electronic access controls tied to the entering person; for example, a personal identification number to be entered or biometric like a signature or finger print Do the equipment (freezers, culture collection, etc.) storing the biological agents provide limited access through a control system? 4= Equipment has no access controls 3= Equipment has procedural access controls 2= Equipment has manual access controls 1= Equipment has electronic access controls based swipe cards or other equipment 0= Equipment has electronic access controls tied to the entering person; for example, a personal identification number to be entered or biometric like a signature or finger print Do intrusion detection systems exist in the areas where agents are used or stored? 4= No intrusion detection 3= Detection is staff working in area trained to report anything unusual 2= Detection based on observations by personnel, including roving guard patrols 1= Local notification of alarms only 0= Alarms for intrusion detection are reported to a central alarm station Are all doors and windows (or other potential entry points) alarmed? 4= No controls/alarms (access controls and/or intrusion detection) on any entry points 2= Controls/alarms on some but not all entry points 1= Controls/alarms only on doors 0= Controls/alarms on all possible entry points, including windows and doors

14 When alarms are activated, how are they assessed? 4= No plans for alarm assessment 3= Alarm assessment is staff working in area trained to report 2= Guards sent to assess alarms 1= Alarm assessed by camera 0= Alarm assessed by camera that records brief time before alarm and then afterwards How are alarms responded to? 4= No plans for alarm response 2= Local law enforcement is initial response and Memorandum of Understanding (MOU) is in place for this 1= Local law enforcement is initial response, MOU in place, and this is exercised regularly OR onsite guard response 0= Onsite guard response and local law enforcement back-up with MOU and regular exercises Could a loss of electrical power present a risk of accidental release due to loss of directional air flow or other function loss? 4= Yes 0= No Is backup power available for critical processes (fume hoods, biosafety cabinets, freezers, etc.)? 4= No 0= Yes Is emergency lighting present at all entrances and exits at all times? 4= No 0= Yes

15 Likelihood of theft from facility Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. Potential of Facility to be Targeted Are the biological agents used during your project also used in other laboratories in your country? 4= Agent not in other labs in country and/or facility and is only found in very few labs globally 3= Agent rarely found in laboratories within the country and/or facility 0= Agent common in other laboratories within the country and/or facility What is the level of security required in your country for facilities where the same biological agent(s) are regularly used? 4= Agent not subject to biosecurity regulations in the country 2= Agent rarely subject to biosecurity regulations in the country 0= Agent is highly regulated in the country Threat Attributes Please assess the level of knowledge that possible threatening groups may have about your facility. 4= Possible group posing threat has extensive operational skills and knowledge and all of the necessary tools to execute a theft 2= Possible group posing threat has incomplete operation skills, knowledge, and tools necessary to execute a theft or the adversary means are unknown 0= Possible group posing threat has no means to execute a theft Please assess the level of opportunity that such groups may have to steal from the facility. 4= Possible group posing threat has authorized access to the facility 0= Possible group posing threat does not have authorized access to the facility

16 Material Control and Accountability Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. How does the laboratory determine which materials are subject to material control and accountability (MC&A) measures? 4= No materials are subject to MC&A measures 3= Individuals/lab owners make decisions about which material requires MC&A measures 2= Laboratory relies on regulatory or international lists (e.g. agent list) to determine which material at their facility needs MC&A measures 1= Laboratory risk assessment is utilized to identify and categorize materials and forms of materials that require MC&A measures 0= Where applicable, proactive measures towards the reduction of risk through elimination, substitution or minimization of volumes/quantities of agents, and the type and number of manipulations conducted Are there clearly defined procedures for material control and accountability (MC&A)? 4= No procedures for MC&A exist 2= Some MC&A procedures are in place but they are not comprehensive and/or are not fully implemented 0= Written procedures are in place and implemented to ensure timely and accurate recording, reporting and auditing of materials subject to MC&A measures Which materials are inventoried? 4= No material catalogued 3= Seed stock inventory managed 2= Seed stock inventory actively managed and working stocks, including infected animal status, tracked though laboratory notes 1= Seed stock inventory managed using a secure system and includes tracking of samples that have been transferred into and out of the lab, source, strain, controlled substance identification, form, responsible individual, etc. 0= Seed and working stock containers bar coded or otherwise identified, marked and catalogued for inventory tracking purposes What is the level of control of agents while in use (working stocks, infected animals, etc)? 4= No controls in place when materials are in use 2= Controls in place when materials are in use (e.g. working tissue cultures, animals subjected to challenge experiments, in equipment such as incubators and centrifuges, etc.) but at lower level than controls for material in storage 0= Controls in place when materials are in use at equivalent level to controls for material in storage Are there clearly defined roles and responsibilities for accountability? 4= No designation of responsibilities 2= PI aware of each agent used within their laboratory 1= A responsible individual is designated to oversee the control of protected agents 0= A qualified and vetted individual is designated to oversee the control of protected agents (agent-by-agent basis, on a per-laboratory basis, etc.)

17 Waste Management Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. Is biological waste decontaminated (autoclave, disinfectant, etc.) prior to disposal? 4=Biological waste is not decontaminated prior to disposal 2=Biological waste is decontaminated, but not checked for inactivation of waste 0=Biological waste is decontaminated prior to disposal and checked for inactivation prior to disposal Are procedures in place to monitor the decontamination process of biological waste? 4=No procedures are in place 2=Procedures are in place but are not consistently followed 0=Procedures are in place and are consistently followed Are there protocols for reporting any accidents and/or injuries? 4=Accidents and/or injuries are not reported or documented; no protocol in place 3=Accidents and/or injuries are documented but not reported; and/or there is no protocol in place 2=Accidents and/or injuries are documented but not reported; and/or there is protocol in place but not consistently followed 0=There are protocols in place for reporting and documenting accidents and/or injuries and it is consistently followed Is there a disposal procedure in place for mixed hazards (materials containing both biological and chemical hazards, etc.)? 4=There is no disposal procedure in place for mixed hazards 2=There is a disposal procedure in place but it is not followed consistently 0=There is a disposal procedure in place for mixed hazards and it is followed consistently Are waste containers and systems properly labeled and secured, and routinely inspected for integrity (leaks, cracks, etc.)? 4=Waste containers and systems are not properly labeled and secured, nor are they routinely inspected 2=Waste containers and systems are properly labeled and secured but are not routinely inspected 0=Waste containers and systems are properly labled and secured and are routinely inspected Are waste storage and processing systems placed in a way that they are not visible from outside the facility? 4=Waste storage and processing system is outside and/or visible from outside of the facility 0=Waste storage and processing system is not outside or visible from outside of the facility Are staff trained to clean up any spills of hazardous materials? 4=Staff is not trained to clean up spills of hazardous materials 0=Staff is trained on procedures for cleaning up spills of hazardous materials

18 Transport Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. What is the level of control of materials moving between laboratories or while in shipping/receiving areas? 4= No controls during internal transport 3= Agent transported by authorized individual(s) but may be left unattended in unsecured areas 1= Agent not left outside of custody of authorized individual(s) during transit unless secured but level of security is lower than how it is secured in storage 0= Agent not left outside of custody of authorized individual(s) during transit unless secured in a manner equivalent or better to how it is secured in storage What type of vetting is required for personnel transporting material within the facility? 4= Facility personnel who have access to materials during internal transport are not vetted 2= Facility personnel who have access to materials during internal transport are vetted but to a lower degree than those who handle the agent in the laboratory 0= Facility personnel who have access to materials during internal transport are vetted to the same degree or better than those who handle the agent in the laboratory What type of administrative approvals are required for external transport? 4= No approvals or documentation required for external transport 3= Pre-approval is not required for external transport but is documented in laboratory records 1= Pre-approval by a responsible individual at the facility required prior to shipping to external recipient 0= A material transfer agreement is required prior to final approval or an external regulatory body must approve the transfer prior to shipment What is the required biosecurity level for the receiving facility when sharing an agent? 4= No biosecurity (or biosecurity status is unknown) at receiving facility 2= Receiving facility may have lower level of security than at shipping facility 1= Receiving facility has equivalent or better biosecurity 0= Receiving facility has equivalent or better biosecurity, AND notifications between shipping and receiving facilities at time of dispatch and receipt are required How are agents packaged for external transport? 4= Agent can be identified by examining labels on outside of the package 0= Conforms to infectious substance shipping labeling requirements but does not identify the specific agent on the outside of the package How are external carriers selected? 4= Any carrier is allowed, regardless of security 2= External carriers with good reputation for security of commercial shipments are utilized only 0= Carriers have a security plan in place that covers shipments of dangerous biological agents

19 Is spill containment provided for all containers? 4= Spill containment is not provided for any containers 4= Spill containment is not provided for some containers 0= Spill containment is provided for all containers

20 Information Security Enter the value of the best answer to each question in the corresponding cell of column B below. Responses will range from 4 to 0, fill in the blank and select all that apply. Has information which is considered sensitive been clearly identified, marked, and protected at a level equivalent to the assessed risk of loss or release? 4= No identification and classification of information in place 1= Sensitive and security related information is identified, marked, and classified at a level equivalent to the assessed risk Is information which is considered sensitive protected from release or loss? 4= No protection of information 2= Some information protection procedures are in place but they are not comprehensive and/or are not fully implemented 0= Protective sensitive (security related) information is protected at a level equivalent to the risk (e.g. information considered a valuable asset is held redundantly by the institution. Information is accessed on a need-to-know basis, by pre-approved/screened authorized individuals. Procedures for handling, storing, transmitting, and destroying sensitive information) Are there clearly defined communication policies regarding sensitive information? 4= No communication policies 2= Staff is trained on communication policies 0= Means of communicating sensitive information is controlled (e.g. encryption for electronic transmission, no cellular discussions or communication/viewing sensitive materials) Are electronic critical infrastructure systems (including inventory databases, alarm control stations, access control systems, building monitoring systems, etc.) protected from attack? 4= No protection (can access the systems through the internet) 2= Basic good practices are in place (firewalls, desktop security) 0= Comprehensive information technology security infrastructure in place or not applicable because no sensitive information is stored Are there clearly defined policies for public disclosure of information? 4= No public disclosure procedures/policies in place 2= Some procedures/policies regarding public disclosure are in place but they are not comprehensive and/or are not fully implemented 0= Potentially sensitive (security-related) information is screened prior to public release by an established review and approval process. Modification of information to make it appropriate for public release