Biologic Materials |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe the concept of biohazardous materials
|
1. Distinguish biohazardous from nonhazardous materials
|
1. Ensure personnel's knowledge of biohazardous materials
|
2. Recognize potential hazards associated with biohazardous materials handled in the laboratory
|
2. Explain the potential hazards associated with the biologic materials handled in the laboratory
|
2. Manage biohazardous materials
|
3. Utilize control measures and work practices with biologic materials
|
3. Ensure utilization of established hazard controls for biologic materials used in laboratory procedures
|
3. Establish hazard controls for biologic materials used in laboratory procedures
|
4. Recognize hazards associated with various procedures |
4. Discuss hazards associated with various procedures |
4. Assess procedures for hazardous components |
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APPENDIX B
Biosafety Laboratory Competency Guidelines
I. SKILL DOMAIN: POTENTIAL HAZARDS
Purpose statement: This skill domain is focused on the competencies involved with understanding the hazards in a given laboratory setting. The ability to recognize hazards is the first step in preventing occupational and environmental exposures. The five subdomains are biologic, chemical, and radiologic materials, research animals, and physical environment.
Research Animals |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe inherent hazards associated with research animals
|
1. Identify inherent hazards associated with research animals
|
1. Assess the inherent hazards associated with research animals
|
2. Describe possible route of exposures to personnel in relation to the animal procedures used |
2. Assess possible route of exposures to personnel in relation to the animal procedures used |
2. Same as midlevel |
3. Describe control measures and work practices to mitigate the risks associated with research animals and report on effectiveness to supervisors
|
3. Implement control measures and work practices to mitigate risks associated with research animals
|
3. Develop control measures and work practices to mitigate risks associated with research animals
|
Chemical Materials |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Identify chemicals used in the laboratory |
1. Ensure chemical inventory is complete |
1. Establish chemical inventory |
2. Describe hazards associated with chemicals used in laboratory procedures
|
2. Explain hazards associated with chemicals used in the laboratory procedures
|
2. Assess personnel's knowledge of hazards associated with chemicals used in laboratory procedures
|
3. Recognize control measures and work practices to be used when working with chemicals
|
3. Implement control measures and work practices to be used when working with chemicals
|
3. Establish control measures and work practices to be used when working with chemicals
|
Radiologic Materials |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Identify radiologic materials used in the laboratory |
1. Ensure list of radiologic materials used in the laboratory is complete |
1. Establish inventory of radiologic materials used in the laboratory |
2. Describe hazards associated with use of radiologic materials
|
2. Explain hazards associated with use of radiologic materials
|
2. Assess hazards associated with use of radiologic materials (collaborate with radiation safety personnel, as needed)
|
3. Recognize control measure and work practices to be used when working with radiologic materials
|
3. Implement control measure and work practices to be used when working with radiologic materials
|
3. Establish control measure and work practices to be used when working with radiologic materials (collaborate with radiation safety personnel, as needed)
|
4. Describe monitoring devices (e.g., Geiger counters and dosimetry badges) |
4. Demonstrate proper operation and use of monitoring devices |
4. Evaluate monitoring devices for suitability in detecting radioisotopes to be used (collaborate with radiation safety personnel, as needed) |
Physical Environment |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe physical hazards in the laboratory (including, but not limited to):
|
1. Explain physical hazards present in the laboratory (including, but not limited to):
|
1. Ensure identification of physical hazards present in the laboratory
|
2. Describe control measures and work practices to be used when physical hazards are present |
2. Implement control measures and work practices to be used when working with physically hazardous materials |
2. Establish control measures and work practices to be used when working with physically hazardous materials (collaborate with safety professionals, as needed) |
II. SKILL DOMAIN: HAZARD CONTROLS
Purpose statement: This skill domain provides guidance for development of competencies associated with the use of primary and secondary barriers to prevent exposure to hazardous materials as well as competencies related to decontamination and management of hazardous waste. Primary barriers include personal protective equipment and specialized laboratory equipment with engineering controls designed to protect against accidental exposures. Secondary barriers include actual design and construction features of the laboratory facility to prevent exposure both within and outside laboratory areas. Competencies for waste management include guidelines related to biologic, chemical, and radiologic hazardous, including decontamination, sterilization, and safe removal of potentially contaminated laboratory equipment.
Personal Protective Equipment (PPE) (Primary Barriers) |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. List PPE required for general laboratory entry
|
1. Monitor availability of PPE for general laboratory entry
|
1. Determine PPE required for general laboratory entry
|
2. Describe specific PPE to be used for each laboratory procedure
|
2. Demonstrate use of specific PPE required for each laboratory procedure
|
2. Determine procedures (with institutional professionals) for use of specific PPE
|
3. Describe respiratory protection program |
3. Implement respiratory protection program |
3. Develop a respiratory protection program to include fit testing for all staff using respiratory protection devices |
4. Perform correct use of PPE
|
4. Implement correct use of PPE
|
4. Ensure personnel's compliance with correct use of PPE
|
5. Assess integrity and functionality of all PPE in use
|
5. Implement assessment procedures for integrity and functionality of all PPE in use
|
5. Establish assessment procedures to maintain integrity and functionality of all PPE in use
|
6. Describe appropriate reporting and response to compromised PPE
|
6. Implement appropriate reporting and response procedures to compromised PPE
|
6. Develop procedures for appropriate reporting and response to compromised PPE
|
Engineering Controls --- Equipment (Primary Barriers) |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe laboratory equipment used with engineering controls to contain hazardous materials |
1. Monitor availability of laboratory equipment with engineering controls used to contain hazardous materials |
1. Determine correct equipment to use with engineering controls in order to contain hazardous materials worked with in the laboratory |
2. Describe proper functioning of laboratory equipment with engineering controls
|
2. Demonstrate proper functioning of laboratory equipment with engineering controls
|
2. Ensure proper functioning of laboratory equipment with engineering controls
|
3. Describe procedures to immediately report compromised, malfunctioning, or nonfunctioning engineering controls on laboratory equipment |
3. Implement procedures required to report improperly functioning engineering controls to Senior level |
3. Ensure timely remediation of improperly functioning engineering controls on laboratory equipment |
4. Adhere to appropriate work practices when using laboratory equipment with engineering controls for safety
|
4. Monitor adherence to appropriate work practices by staff who are using laboratory equipment with engineering controls for safety
|
4. Establish appropriate work practices for all staff working with laboratory equipment with engineering controls for safety
|
5. Not applicable |
5. Monitor adherence to procedures that verify hazard awareness notification, training, and lock-out procedures for primary engineering control maintenance staff or contractors |
5. Collaborate with institutional safety professionals to establish procedures to ensure hazard awareness notification, training, and lock-out procedures for primary engineering control maintenance staff or contractors |
Engineering Controls --- Facility (Secondary Barriers) BSL-2 & BSL-3 |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. List the laboratory facility engineering controls designed to prevent exposure or release of hazardous materials
|
1. Demonstrate knowledge of the laboratory facility engineering controls designed to prevent exposure or release of hazardous materials
|
1. Ensure that laboratory personnel have appropriate knowledge about facility engineering controls designed to prevent exposure or release of hazardous materials from the laboratory
|
2. Recognize when facility engineering controls are compromised or not functioning properly
|
2. Coordinate response to any compromise in facility engineering controls
|
2. Develop response procedures to address any compromise in facility engineering controls
|
3. Adhere to correct reporting procedures when facility engineering controls are compromised |
3. Implement required reporting procedures when facility engineering controls are compromised |
3. Ensure correct reporting procedures are followed by all laboratory personnel when facility engineering controls are compromised |
4. Describe process for routine monitoring of facility and facility engineering control systems |
4. Implement process for routine monitoring of facility and facility engineering control systems |
4. Ensure continuous maintenance and required recertification of facility and facility engineering control systems |
5. Describe laboratory facility's controlled access system |
5. Same as entry level |
5. Collaborate with institutional safety and facility professionals to develop the laboratory's controlled access system |
6. Adhere to facility security rules |
6. Same as entry level |
6. Ensure adherence to facility security rules |
7. Describe facility design differences between BSL-2 and BSL-3 laboratories |
7. Same as entry level |
7. Advise personnel on facility design differences between BSL-2 and BSL-3 laboratories |
8. Not applicable |
8. Monitor adherence to procedures for cleaning of laboratory containment areas |
8. Collaborate with institutional safety and maintenance professionals to determine appropriate procedures for cleaning of laboratory containment areas |
Engineering Controls (Secondary Barriers) BSL4 |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe facility engineering controls to prevent release of hazardous materials
|
1. Demonstrate knowledge of engineering controls to prevent release of hazardous materials
|
1. Ensure personnel's knowledge of engineering controls to prevent release of hazardous materials
|
2. Describe process for routine monitoring of engineering controls
|
2. Implement routine monitoring of engineering controls equipment and facilities
|
2. Ensure engineering controls are adequate and functioning properly
|
3. Recognize when secondary barriers are compromised or not functioning properly
|
3. Coordinate response to any compromise in engineering controls
|
3. Develop response procedures to any compromise in secondary barrier
|
Decontamination and Laboratory Waste Management |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe laboratory waste segregation procedures for biologic, chemical, and radiologic materials |
1. Implement laboratory waste segregation procedures for biologic, chemical, and radiologic materials |
1. Establish facility waste segregation procedures for biologic, chemical, and radiologic materials in compliance with all required regulations and policies |
2. Describe laboratory waste procedures for biologic materials
|
2. Monitor adherence to laboratory waste management procedures for biologic materials
|
2. Establish facility waste management procedures for biologic materials
|
3. Describe disinfection, decontamination, and sterilization methods
|
3. Implement disinfection, decontamination, and sterilization methods
|
3. Establish methods of disinfection, decontamination, and sterilization
|
4. Describe procedures for hazardous chemical waste collection and disposal
|
4. Monitor compliance with procedures for hazardous chemical waste collection and disposal
|
4. Establish regulatory compliant procedures for hazardous chemical waste collection and disposal
|
5. Describe procedures for radioactive waste collection and disposal
|
5. Monitor compliance with procedures for radioactive waste collection and disposal
|
5. Collaborate with radiation safety professionals to acquire required licensing and establish procedures for radioactive waste collection and disposal
|
6. Adhere to procedures for safely removing equipment and instruments from the laboratory
|
6. Monitor compliance with procedures for safely removing equipment and instruments from the laboratory
|
6. Establish procedures for safely removing equipment and instruments from the laboratory
|
III. SKILL DOMAIN: ADMINISTRATIVE CONTROLS
Purpose statement: This skill domain describes competencies associated with a variety of administrative controls that can be used to reduce the duration, frequency, and severity of exposure to hazardous materials or situations. These controls include: hazard communication, signage, institutional guidelines, regulatory requirements, the overall safety program, occupational health and medical surveillance, and the management of risk. Each facility should tailor its safety program to its mission and facilitate meeting the requirements and adherence to guidelines. These minimum competencies only serve as a basis for individual facilities to build upon.
Hazard Communication and Signage |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Explain safety signs, labels, and posted information
|
1. Implement safety signs, labels, and posted information
|
1. Determine required safety signs, labels, and posted information
|
2. Describe labeling of samples, containers, and cultures according to appropriate regulatory requirements |
2. Implement labeling of samples, containers, and cultures according to appropriate regulatory requirements |
2. Ensure the implementation of labeling of samples, containers, and cultures is compliant with appropriate regulatory requirements |
3. Describe process to communicate sample-specific hazard information according to standard operating procedures (SOPs)
|
3. Implement process to communicate sample-specific hazard information according to SOPs
|
3. Develop procedures to communicate sample-specific hazard information according to SOPs
|
4. Describe communication processes for applicable regulatory requirements |
4. Implement communication processes for applicable regulatory requirements |
4. Ensure personnel's knowledge of communication processes for applicable regulatory requirements |
5. Describe methods of internal communication (BSL-3 and BSL-4 only) |
5. Demonstrate methods of internal communication (BSL-3 and BSL-4 only) |
5. Ensure personnel's knowledge of internal communication methods (BSL-3 and BSL-4 only) |
6. Recognize signals and alarms |
6. Explain signals and alarms |
6. Ensure personnel's knowledge of signals and alarms |
Guideline and Regulation Compliance |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe current regulatory requirements and applicable guidelines that govern appropriate laboratory procedures
|
1. Implement current regulatory requirements and applicable guidelines
|
1. Ensure personnel have knowledge of current regulatory requirements and applicable guidelines
|
2. Follow laboratory manuals and plans
|
2. Implement laboratory manuals and plans
|
2. Develop and maintain laboratory manuals and plans to comply with current regulatory requirements and applicable guidelines
|
3. Describe applicable institutional committees
|
3. Same as entry level
|
3. Ensure compliance with applicable institutional committee requirements
|
4. Adhere to security requirements |
4. Adhere to communication processes in compliance with regulatory requirements |
4. Advise regarding regulatory communications requirements |
Safety Program Management |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Comply with institution's safety and occupational health programs
|
1. Implement institution's safety and occupational health programs
|
1. Collaborate in the development of the institution's safety and occupational health programs
|
2. Complete required safety training
|
2. Monitor site-specific safety training program
|
2. Develop site-specific safety training program
|
3. Describe routine monitoring process of equipment and facilities |
3. Implement routine monitoring process of equipment and facilities |
3. Develop procedures for routine monitoring of equipment and facilities |
4. Recognize deviations from normal operations and procedures
|
4. Investigate deviations from normal operations and procedures
|
4. Resolve investigation of deviations from normal operations and procedures
|
5. Describe the quality assurance program |
5. Implement quality assurance program |
5. Develop quality assurance program |
6. Describe records management system |
6. Implement records management system |
6. Develop records management system |
Occupational Health --- Medical Surveillance |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe the medical surveillance plan
|
1. Implement the medical surveillance plan
|
1. Collaborate in the development of the medical surveillance plan
|
2. Describe the benefits for monitoring personal health status changes
|
2. Same as entry level
|
2. Ensure personnel's knowledge of the benefits for monitoring personal health status changes
|
3. Describe incident exposure reporting procedures
|
3. Implement procedures for incident exposure reporting
|
3. Collaborate in the development of incident exposure reporting procedures
|
4. Describe signs and symptoms in humans following exposure to hazardous materials
|
4. Same as entry level
|
4. Ensure personnel's knowledge of signs and symptoms after exposure to hazardous materials
|
Risk Management |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe the differences in work practices between biosafety levels |
1. Explain the differences in work practices between biosafety levels in regards to potential hazard |
1. Ensure personnel have knowledge of the differences in work practices between biosafety levels |
2. Recognize potential hazards associated with laboratory materials and procedures |
2. Assess the ability to identify potential hazards associated with laboratory materials and procedures |
2. Ensure that potential hazards associated with laboratory materials and procedures are identified |
3. Describe the risk assessment process on identified hazards |
3. Demonstrate the ability to conduct a risk assessment on identified hazards |
3. Ensure risk assessment is performed in accordance with institutional policy |
4. Describe control measures identified in the risk assessment, including communication |
4. Implement control measures identified in the risk assessment, including communication |
4. Ensure that control measures identified in the risk assessment are implemented, including communication |
5. Recognize effectiveness and noneffectiveness of new control measures |
5. Assess effectiveness of control measures |
5. Determine if controls have reduced the risk to an acceptable level |
IV. SKILL DOMAIN: EMERGENCY PREPAREDNESS AND RESPONSE
Purpose statement: This domain consists of competencies to manage emergency preparedness and response. Institutions are responsible for referencing applicable standards of practice for their operations and for the development of response plans for incidents that affect them. This domain does not include emergency response to security, biosecurity, and biosurety events.
Emergencies and Incident Response |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Recognize emergencies and other incidents that should be reported
|
1. Same as entry level
|
1. Ensure personnel's ability to recognize emergencies and other incidents that should be reported
|
2. Describe reporting requirements for emergencies and other incidents according to institutional plans and policies
|
2. Implement institutional plans and policies for reporting emergencies and other incidents
|
2. Collaborate with appropriate persons and agencies to develop plans and policies for reporting emergencies and other incidents
|
3. Describe assigned role in responding to emergencies and other incidents
|
3. Implement required response actions for emergencies and other incidents
|
3. Develop procedures to respond to emergencies and other incidents according to institutional plans and policies
|
Exposure Prevention and Hazard Mitigation |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Describe laboratory's incident follow-up process |
1. Implement laboratory's incident follow-up process |
1. Develop laboratory's incident follow-up process to include the following: review of incident report, initiation of investigation process, conducting of root-cause analysis, development of an action plan to mitigate root causes, and reporting after taking action |
2. Not applicable
|
2. Report effectiveness of response to senior level
|
2. Assess effectiveness of response to incident
|
Emergency Response Exercises and Drills |
||
---|---|---|
Entry level |
Midlevel |
Senior level |
1. Comply with personnel emergency response training requirements
|
1. Conduct required emergency response training of laboratory personnel
|
1. Develop required emergency response training
|
2. Participate in drills and exercises for laboratory personnel
|
2. Implement drills and exercises for laboratory personnel
|
2. Collaborate in the development of drills and exercises for laboratory personnel
|
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