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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.


Biologic Materials

Entry level

Midlevel

Senior level

1. Describe the concept of biohazardous materials

  1. List biohazardous materials present in the laboratory

1. Distinguish biohazardous from nonhazardous materials

  1. Ensure that a comprehensive list of biohazardous materials is present in the laboratory

1. Ensure personnel's knowledge of biohazardous materials

  1. Ensure personnel have knowledge of biohazardous materials handled in the laboratory

2. Recognize potential hazards associated with biohazardous materials handled in the laboratory

  1. Describe association of infectious agents and toxins to disease
  2. Describe the virulence and pathogenicity of the organisms
  3. Describe the principal exposure routes of laboratory-acquired infections
  4. Recognize potential hazards of unknown/nonroutine samples

2. Explain the potential hazards associated with the biologic materials handled in the laboratory

  1. Ensure understanding of the association of infectious agents and toxins to human disease
  2. Same as entry level
  3. Same as entry level
  4. Mitigate hazards of unknown/nonroutine samples

2. Manage biohazardous materials

  1. Assess personnel's knowledge of infectious agents and toxin risk-group classifications
  2. Assess personnel's knowledge of the virulence and pathogenicity of the organisms handled in the laboratory
  3. Assess personnel's knowledge of the principal exposure routes of laboratory-acquired infections
  4. Manage mitigation of hazards of unknown/nonroutine samples

3. Utilize control measures and work practices with biologic materials

  1. Describe personal protective equipment (PPE) that should be used when handling biologic materials
  2. Describe work practices that reduce or control biologic exposure risks (e.g., practice universal precautions)
  3. Explain storage and handling requirements for biologic materials
  4. Recognize when biologic materials should be considered for transfer to a different type of hazard control (e.g., should go from BSL-2 to BSL-3 facility and practices, or transfer from bench to the biological safety cabinet)
  5. Demonstrate response procedure after suspected exposure.

3. Ensure utilization of established hazard controls for biologic materials used in laboratory procedures

  1. Demonstrate correct use of PPE when handling these biologic materials
  2. Ensure implementation of work practices that reduce or control biologic exposure risks (e.g., compliance with universal precautions)
  3. Implement storage and handling requirements for biologic materials
  4. Implement procedures for appropriate transfer of biologic materials to a different type of hazard control
  5. Explain response procedure after suspected exposure

3. Establish hazard controls for biologic materials used in laboratory procedures

  1. Evaluate PPE that should be used when handling biologic materials
  2. Determine work practices that reduce or control biologic exposure risks (e.g., universal precautions)
  3. Formulate storage and handling requirements for biologic materials
  4. Evaluate laboratory's procedures for transfer of biologic materials that require a different type of hazard control
  5. Establish response procedure after suspected exposure

4. Recognize hazards associated with various procedures

4. Discuss hazards associated with various procedures

4. Assess procedures for hazardous components


Research Animals

Entry level

Midlevel

Senior level

1. Describe inherent hazards associated with research animals

  1. Describe hazards associated with the animal species to be handled
  2. Describe hazards associated with experimentally infected animals

1. Identify inherent hazards associated with research animals

  1. Identify hazards associated with the animal species to be handled
  2. Assess hazards associated with experimentally infected animals

1. Assess the inherent hazards associated with research animals

  1. Assess hazards associated with the animal species to be handled
  2. Same as midlevel

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

  1. Adhere to occupational health requirements for treatment of exposures
  2. Adhere to animal facility's policies and procedures manual
  3. Describe PPE that should be used when handling animals
  4. Describe limits to control measures
  5. Example of a control measure: describe the Laboratory Animal Allergy (LAA) protocol
    i. Recognize signs and symptoms of animal allergens
    ii. Report suspected LAA to supervisor

3. Implement control measures and work practices to mitigate risks associated with research animals

  1. Same as entry level
  2. Ensure adherence to animal facility's policies and procedures manual
  3. Demonstrate proper use of PPE that should be used when handling animals
  4. Ensure limits to control measures are understood
  5. Example of a control measure: ensure implementation of the LAA protocol
    i. Same as entry level
    ii. Ensure reporting of suspected LAA to supervisor

3. Develop control measures and work practices to mitigate risks associated with research animals

  1. Ensure occupational health requirements for treatment of exposures are known and met
  2. Implement animal facility's policies and procedures manual
  3. Evaluate PPE that should be used when handling animals
  4. Establish limits to control measures
  5. Example of a control measure: establish the LAA protocol
    i. Same as entry level
    ii. Ensure reporting of suspected LAA to supervisor

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

  1. Explain the use of material safety data sheets (MSDS) and other sources of information regarding chemicals used in laboratory procedures
  2. Demonstrate ability to use MSDS and other sources to determine physical hazards, health hazards, and routes of exposures for chemicals
  3. State the hazard represented by the information on a chemical container's label

2. Explain hazards associated with chemicals used in the laboratory procedures

  1. Ensure MSDS are available for all chemicals used in the laboratory
  2. Ensure personnel can use MSDS and other sources to determine physical hazards, health hazards, and routes of exposures for chemicals
  3. Ensure chemical container labeling requirements are maintained and understood

2. Assess personnel's knowledge of hazards associated with chemicals used in laboratory procedures

  1. Ensure MSDS are available and kept updated for all chemicals used in the laboratory
  2. Same as midlevel
  3. Establish specific labeling practices to meet regulatory and institutional requirements

3. Recognize control measures and work practices to be used when working with chemicals

  1. Adhere to established work practices
  2. Describe personal protective equipment (PPE) needed when working with specific chemicals
  3. Describe engineering controls (e.g., chemical fume hood) needed when working with specific chemical
  4. Explain correct storage location for each chemical
  5. Demonstrate understanding of response protocols if exposure is suspected

3. Implement control measures and work practices to be used when working with chemicals

  1. Implement compliance with established work practices
  2. Explain how PPE selection provides protection from a specific chemical's hazards and routes of exposure
  3. Explain how engineering controls provide protection when working with specific chemicals
  4. Ensure chemicals are stored according to physical hazard properties
  5. Ensure prompt compliance with response protocols if exposure is suspected

3. Establish control measures and work practices to be used when working with chemicals

  1. Ensure compliance with established work practices
  2. Determine appropriate PPE needed when working with specific chemicals
  3. Determine appropriate engineering controls needed when working with specific chemicals
  4. Determine proper storage location for each chemical
  5. Establish response protocols for suspected exposures

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

  1. Describe sources of information regarding physical and health hazards (including routes of exposures) of radiologic materials
  2. Describe the meaning of information on the container labels

2. Explain hazards associated with use of radiologic materials

  1. Same as entry level
  2. Same as entry level

2. Assess hazards associated with use of radiologic materials (collaborate with radiation safety personnel, as needed)

  1. Ensure sources of information regarding physical and health hazards (including routes of exposures) to radiologic materials are available
  2. Ensure labeling information is understood

3. Recognize control measure and work practices to be used when working with radiologic materials

  1. Describe concept of ALARA (as low as reasonably achievable)
  2. Describe personal protective equipment (PPE) needed
  3. Describe engineering controls needed (e.g., bench shields)
  4. Demonstrate knowledge of proper storage requirements
  5. Describe inventory and survey requirements
  6. Describe training requirements

3. Implement control measure and work practices to be used when working with radiologic materials

  1. Implement ALARA practices
  2. Explain how PPE selection provides protection from radioactive hazards and routes of exposures
  3. Describe how special engineering controls (e.g., bench shields) provide protection
  4. Ensure radiologic materials are stored and secured according to regulations
  5. Same as entry level
  6. Demonstrate knowledge of training requirements

3. Establish control measure and work practices to be used when working with radiologic materials (collaborate with radiation safety personnel, as needed)

  1. Ensure compliance with ALARA
  2. Determine appropriate PPE selections on the basis of hazards and routes of exposure
  3. Determine appropriate engineering controls
  4. Establish correct and secure storage locations in compliance with regulations
  5. Establish inventory and survey requirements
  6. Develop laboratory-specific training requirements

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. Describe proper use and disposal of laboratory sharps
  2. Describe hazards associated with compressed gases, pressure, and vacuum
  3. Describe hazards associated with temperature extremes
  4. Describe hazards associated with specific instruments and equipment
  5. Describe ergonomic hazards
  6. Describe nonionizing radiation (e.g., UV light, lasers)
  7. Describe slips, trips, and fall hazards

1. Explain physical hazards present in the laboratory (including, but not limited to):

  1. Explain proper use and disposal of laboratory sharps
  2. Explain hazards associated with compressed gases, pressure, and vacuum
  3. Explain hazards associated with temperature extremes
  4. Explain hazards associated with specific instruments and equipment
  5. Explain ergonomic hazards
  6. Explain nonionizing radiation (e.g., UV light and lasers)
  7. Explain slips, trips, and fall hazards

1. Ensure identification of physical hazards present in the laboratory

  1. Establish correct use and disposal of laboratory sharps
  2. Identify hazards associated with compressed gases, pressure, and vacuum
  3. Identify hazards associated with temperature extremes
  4. Identify hazards associated with specific instruments and equipment
  5. Identify ergonomic hazards
  6. Identify nonionizing radiation (e.g., UV light and lasers)
  7. Identify slips, trips, and fall hazards

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. Provide input about user preference regarding selection of required PPE
  2. Describe safety practices to be used in conjunction with PPE

1. Monitor availability of PPE for general laboratory entry

  1. Same as entry level
  2. Implement safety practices to be used in conjunction with PPE

1. Determine PPE required for general laboratory entry

  1. Ensure (with institutional professionals) that PPE meets regulatory standards and policies
  2. Ensure that appropriate safety practices are used in conjunction with PPE

2. Describe specific PPE to be used for each laboratory procedure

  1. Not applicable
  2. Participate in evaluation of new PPE
  3. Cite location of all required PPE

2. Demonstrate use of specific PPE required for each laboratory procedure

  1. Not applicable
  2. Same as entry level
  3. Demonstrate location of all required PPE

2. Determine procedures (with institutional professionals) for use of specific PPE

  1. Develop PPE hazard assessment to be reviewed and updated at least annually
  2. Evaluate regularly the availability of new PPE
  3. Ensure that location of all required PPE is clearly designated

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

  1. Demonstrate donning (placement) and doffing (removal) sequence for PPE
  2. Describe limitations of PPE
  3. Demonstrate cleaning, disinfection, and disposal procedures for PPE

4. Implement correct use of PPE

  1. Same as entry level
  2. Same as entry level
  3. Implement cleaning, disinfection, and disposal procedures for PPE

4. Ensure personnel's compliance with correct use of PPE

  1. Develop procedures for personnel to comply with PPE donning and doffing sequence
  2. Ensure personnel's knowledge of limitations of PPE
  3. Develop cleaning, disinfection, and disposal procedures for PPE

5. Assess integrity and functionality of all PPE in use

  1. Describe pre- and post-use inspection protocol for PPE
  2. Identify compromised PPE

5. Implement assessment procedures for integrity and functionality of all PPE in use

  1. Implement pre- and post-use inspection protocols for PPE
  2. Monitor personnel's ability to identify compromised PPE

5. Establish assessment procedures to maintain integrity and functionality of all PPE in use

  1. Establish pre- and post-use inspection protocols for PPE
  2. Assess personnel's ability to identify compromised PPE

6. Describe appropriate reporting and response to compromised PPE

  1. Not applicable

6. Implement appropriate reporting and response procedures to compromised PPE

  1. Not applicable

6. Develop procedures for appropriate reporting and response to compromised PPE

  1. Ensure personnel's knowledge of 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

  1. Demonstrate correct use of laboratory equipment with engineering controls to ensure safety
  2. Describe methods to verify that equipment with engineering control is functioning properly to ensure safety
  3. Describe limitations of equipment with engineering controls to ensure laboratory safety
  4. Be aware of inspection and certification status of all laboratory equipment with engineering controls for safety
  5. Recognize when engineering controls for safety on laboratory equipment are compromised, malfunctioning, or nonfunctioning

2. Demonstrate proper functioning of laboratory equipment with engineering controls

  1. Same as entry level
  2. Demonstrate methods to verify that equipment with engineering control is functioning properly for safety
  3. Same as entry level
  4. Monitor status of inspection and certification of all laboratory equipment with engineering controls for safety
  5. Implement methods for ongoing assessment of whether engineering controls for safety on laboratory equipment are compromised, malfunctioning, or nonfunctioning

2. Ensure proper functioning of laboratory equipment with engineering controls

  1. Ensure that personnel has required knowledge regarding correct use of equipment with engineering controls for safety
  2. Establish methods to verify that equipment with engineering control is functioning properly to ensure safety
  3. Ensure that personnel who are using equipment with engineering controls are knowledgeable about limitations in ensuring laboratory safety
  4. Ensure that inspection and certification of all laboratory equipment with engineering controls for safety are completed as required
  5. Establish response protocols to address situations in which engineering controls on equipment for laboratory safety are compromised, malfunctioning, or nonfunctioning

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

  1. Describe preuse, use, and postuse protocols for laboratory equipment with engineering controls for safety
  2. Describe cleaning and disinfection procedure for 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

  1. Monitor staff adherence to preuse, use, and postuse protocols for laboratory equipment with engineering controls for safety
  2. Monitor staff adherence to cleaning and disinfection protocols procedure for laboratory equipment with engineering controls for safety

4. Establish appropriate work practices for all staff working with laboratory equipment with engineering controls for safety

  1. Establish preuse, use, and postuse protocols for laboratory equipment with engineering controls for safety
  2. Establish cleaning and disinfection protocols for 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. Describe the design and operation controls of the laboratory facility pathogen containment areas
  2. Not applicable
  3. Not applicable

1. Demonstrate knowledge of the laboratory facility engineering controls designed to prevent exposure or release of hazardous materials

  1. Same as entry level
  2. Identify need for upgrades in the laboratory facility engineering controls to prevent release of hazardous organisms
  3. Not applicable

1. Ensure that laboratory personnel have appropriate knowledge about facility engineering controls designed to prevent exposure or release of hazardous materials from the laboratory

  1. Ensure that laboratory personnel have appropriate knowledge about the design and operation controls of the facility's pathogen containment areas
  2. Collaborate with institutional safety and facility professionals to ensure that upgrades of facility engineering controls are appropriate for overall system and meet all regulations and policies
  3. Ensure facility safeguards that prevent accidental release of an infectious agent from the laboratory function properly

2. Recognize when facility engineering controls are compromised or not functioning properly

  1. List specific procedures that must cease or begin if facility engineering controls are not functioning properly
  2. Adhere to all required response procedures when facility engineering controls are compromised

2. Coordinate response to any compromise in facility engineering controls

  1. Implement specific procedures that must cease or begin if facility engineering controls are not functioning properly
  2. Same as entry level

2. Develop response procedures to address any compromise in facility engineering controls

  1. Collaborate with institutional safety and facility professionals to identify specific procedures that must cease or begin when facility engineering controls are compromised
  2. Ensure that laboratory personnel adhere to response procedures when facility engineering controls are compromised

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. Recall containment facility design and operation controls
  2. Describe BSL-4 facility design and operational controls

1. Demonstrate knowledge of engineering controls to prevent release of hazardous materials

  1. Describe containment facility design and operation controls
  2. Identify need for upgrades in engineering controls

1. Ensure personnel's knowledge of engineering controls to prevent release of hazardous materials

  1. Ensure personnel's knowledge of containment facility design and operation controls
  2. Ensure upgrades of engineering controls are appropriate

2. Describe process for routine monitoring of engineering controls

  1. Describe pre-entry verification procedures
  2. Describe verification of engineering controls
  3. NA

2. Implement routine monitoring of engineering controls equipment and facilities

  1. Demonstrate proficiency in pre-entry verification of facility functionality
  2. Demonstrate knowledge of unique engineering controls
  3. Ensure maintenance and recertification of engineering controls

2. Ensure engineering controls are adequate and functioning properly

  1. Same as midlevel
  2. Same as midlevel
  3. Develop protocol for ensuring maintenance and recertification of engineering controls

3. Recognize when secondary barriers are compromised or not functioning properly

  1. Describe reporting procedures
  2. Describe procedures that must cease when secondary barriers are compromised

3. Coordinate response to any compromise in engineering controls

  1. Implement proper reporting procedures
  2. Implement cessation of laboratory procedures with exposure potential when secondary barriers are compromised

3. Develop response procedures to any compromise in secondary barrier

  1. Ensure personnel's knowledge with proper reporting procedures
  2. Ensure that all personnel know which procedures should be stopped when engineering controls are compromised

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

  1. Describe proper disposal of different types of biologic waste
  2. Describe packaging procedure for transport to remote treatment location

2. Monitor adherence to laboratory waste management procedures for biologic materials

  1. Demonstrate proper disposal of different types of biologic waste
  2. Implement packaging procedures for transporting waste to remote treatment location

2. Establish facility waste management procedures for biologic materials

  1. Develop protocols for biologic waste disposal
  2. Establish packaging procedures for transporting waste to remote treatment location

3. Describe disinfection, decontamination, and sterilization methods

  1. Describe how to prepare items for decontamination
  2. Describe proper disposal of laboratory sharps
  3. Describe proper use of any specific equipment (e.g., autoclave, vapor phase decontamination equipment)
  4. Describe process validation procedures
  5. Describe routine surface decontamination procedures
    i. List name and correct use of surface disinfectants and chemical sterilants

3. Implement disinfection, decontamination, and sterilization methods

  1. Demonstrate preparation of items for decontamination
  2. Demonstrate proper disposal of laboratory sharps
  3. Implement procedures for proper use of specific equipment (e.g., autoclave and vapor phase decontamination equipment)
  4. Implement process validation procedures
  5. Implement routine surface decontamination procedures
    i. Demonstrate correct use of surface disinfectants and chemical sterilants

3. Establish methods of disinfection, decontamination, and sterilization

  1. Ensure correct preparation of items for decontamination
  2. Ensure proper disposal of laboratory sharps
  3. Establish procedures for use of specific equipment (e.g., autoclave and vapor phase decontamination equipment)
  4. Ensure compliance with process validation procedures
  5. Develop routine surface decontamination procedures
    i. Determine surface disinfectants and chemical sterilants to be used

4. Describe procedures for hazardous chemical waste collection and disposal

  1. Describe satellite accumulation area requirements
  2. Describe waste container labeling requirements
  3. Describe routine surface decontamination protocols

4. Monitor compliance with procedures for hazardous chemical waste collection and disposal

  1. Ensure satellite accumulation area protocol is followed
  2. Ensure waste containers are properly labeled
  3. Implement routine surface decontamination protocols

4. Establish regulatory compliant procedures for hazardous chemical waste collection and disposal

  1. Establish satellite accumulation area protocols
  2. Establish waste container labeling requirements
  3. Establish routine surface decontamination protocols

5. Describe procedures for radioactive waste collection and disposal

  1. Describe security requirements for radioactive waste
  2. Describe waste container labeling requirements
  3. Describe routine surface decontamination protocols

5. Monitor compliance with procedures for radioactive waste collection and disposal

  1. Ensure that radioactive waste is secured
  2. Ensure that waste containers are properly labeled
  3. Same as entry level

5. Collaborate with radiation safety professionals to acquire required licensing and establish procedures for radioactive waste collection and disposal

  1. Establish security protocol for radioactive waste
  2. Establish waste container labeling requirements
  3. Develop protocols for routine decontamination of laboratory surfaces

6. Adhere to procedures for safely removing equipment and instruments from the laboratory

  1. Adhere to procedures for discarding, servicing, or transferring equipment and instruments

6. Monitor compliance with procedures for safely removing equipment and instruments from the laboratory

  1. Implement procedures for discarding, servicing, or transferring equipment and instruments

6. Establish procedures for safely removing equipment and instruments from the laboratory

  1. Establish procedures for discarding, servicing, or transferring equipment and instruments in compliance with regulations and policies

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. Adhere to safety signs, labels, and posted information as described by operating procedures
  2. Not applicable

1. Implement safety signs, labels, and posted information

  1. Monitor adherence to safety signs, labels, and posted information, as described by operating procedures
  2. Evaluate effectiveness of safety signs, labels, and posted information

1. Determine required safety signs, labels, and posted information

  1. Ensure adherence to safety signs, labels, and posted information
  2. Implement changes to safety signs, labels, and posted information, as needed

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)

  1. Not applicable
  2. Describe procedures to identify hazardous materials in the laboratory

3. Implement process to communicate sample-specific hazard information according to SOPs

  1. Convey information regarding potential hazardous materials in nonroutine specimens brought into the laboratory
  2. Apply procedures to identify hazardous materials in the laboratory

3. Develop procedures to communicate sample-specific hazard information according to SOPs

  1. Advise laboratory staff regarding potential hazardous materials in nonroutine specimens brought into the laboratory
  2. Ensure personnel's knowledge of procedures to identify hazardous materials in the laboratory

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. Adhere to procedures of the records management system
  2. Adhere to applicable guidelines and regulations for laboratory procedures

1. Implement current regulatory requirements and applicable guidelines

  1. Implement the records management system
  2. Implement applicable guidelines and regulations for laboratory procedures

1. Ensure personnel have knowledge of current regulatory requirements and applicable guidelines

  1. Develop the records management system
  2. Ensure compliance with applicable guidelines and regulations for laboratory procedures

2. Follow laboratory manuals and plans

  1. Identify location of required laboratory manuals and plans
  2. Not applicable

2. Implement laboratory manuals and plans

  1. Same as entry level
  2. Not applicable

2. Develop and maintain laboratory manuals and plans to comply with current regulatory requirements and applicable guidelines

  1. Same as entry level
  2. Ensure manuals and plans are current

3. Describe applicable institutional committees

  1. Not applicable

3. Same as entry level

  1. Not applicable

3. Ensure compliance with applicable institutional committee requirements

  1. Communicate with applicable institutional committees

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. Adhere to work practice requirements
  2. Adhere to safety practices and SOPs
  3. Describe safety information resources
  4. Describe occupational health plan

1. Implement institution's safety and occupational health programs

  1. Implement work practice requirements
  2. Monitor compliance with safety practices and SOPs
  3. Same as entry level
  4. Monitor compliance with occupational health plan

1. Collaborate in the development of the institution's safety and occupational health programs

  1. Determine work practice requirements
  2. Ensure compliance with safety practices and SOPs
  3. Ensure access to safety information resources
  4. Ensure compliance with occupational health plan

2. Complete required safety training

  1. Not applicable
  2. Not applicable
  3. Not applicable

2. Monitor site-specific safety training program

  1. Ensure that required safety training is completed
  2. Mentor introductory staff on established safety procedures
  3. Not applicable

2. Develop site-specific safety training program

  1. Ensure compliance with safety training requirements
  2. Develop mentoring program on established safety procedures
  3. Assess effectiveness of 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

  1. Recognize deviations that lead to unsafe work practices and conditions
  2. Recognize deviations that lead to safer work practices and conditions

4. Investigate deviations from normal operations and procedures

  1. Implement reporting of deviations that lead to unsafe work practices and conditions
  2. Implement deviations that lead to safer work practices and conditions

4. Resolve investigation of deviations from normal operations and procedures

  1. Assess response to deviations that lead to unsafe work practices and conditions
  2. Assess response to deviations that lead to safer work practices and conditions

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. Not applicable

1. Implement the medical surveillance plan

  1. Not applicable

1. Collaborate in the development of the medical surveillance plan

  1. Assess medical surveillance plan periodically

2. Describe the benefits for monitoring personal health status changes

  1. Describe how to report personal health status changes

2. Same as entry level

  1. Same as entry level

2. Ensure personnel's knowledge of the benefits for monitoring personal health status changes

  1. Ensure personnel's knowledge on procedures to report personal health status changes

3. Describe incident exposure reporting procedures

  1. Describe signs and symptoms following incident exposure
  2. Not applicable

3. Implement procedures for incident exposure reporting

  1. Same as entry level
  2. Not applicable

3. Collaborate in the development of incident exposure reporting procedures

  1. Develop intervention procedures for incident exposures
  2. Develop list of infectious disease, radiation, and chemical experts to be contacted in event of an unintentional exposure

4. Describe signs and symptoms in humans following exposure to hazardous materials

  1. Not applicable

4. Same as entry level

  1. Initiate the intervention for a person demonstrating symptoms apparently resulting from exposure

4. Ensure personnel's knowledge of signs and symptoms after exposure to hazardous materials

  1. Ensure the intervention for a person demonstrating symptoms apparently resulting from exposure

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. Recognize significance of alarms

1. Same as entry level

  1. Same as entry level

1. Ensure personnel's ability to recognize emergencies and other incidents that should be reported

  1. Ensure personnel's knowledge of alarm significance

2. Describe reporting requirements for emergencies and other incidents according to institutional plans and policies

  1. Not applicable

2. Implement institutional plans and policies for reporting emergencies and other incidents

  1. Not applicable

2. Collaborate with appropriate persons and agencies to develop plans and policies for reporting emergencies and other incidents

  1. Be aware of the incident command structure

3. Describe assigned role in responding to emergencies and other incidents

  1. Recall emergency response plan
  2. Describe emergency disinfection and exposure prevention procedures
  3. Describe procedures for responding to spills or potential exposures
  4. Describe emergency evacuation routes and assembly areas
  5. Not applicable
  6. Not applicable

3. Implement required response actions for emergencies and other incidents

  1. Same as entry level
  2. Demonstrate emergency disinfection and exposure prevention procedures
  3. Demonstrate procedures for responding to spills or potential exposures
  4. Demonstrate emergency evacuation routes and assembly areas
  5. Not applicable
  6. Not applicable

3. Develop procedures to respond to emergencies and other incidents according to institutional plans and policies

  1. Collaborate in developing emergency response plans
  2. Ensure that emergency disinfection and exposure prevention procedures are performed
  3. Ensure proper response to spills or potential exposures
  4. Ensure personnel's knowledge of emergency evacuation routes and assembly areas
  5. Implement developed plans
  6. Maintain developed plans

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

  1. Not applicable

2. Report effectiveness of response to senior level

  1. Implement corrective actions

2. Assess effectiveness of response to incident

  1. Ensure implementation of corrective actions

Emergency Response Exercises and Drills

Entry level

Midlevel

Senior level

1. Comply with personnel emergency response training requirements

  1. Participate in entry-level personnel training
  2. Not applicable
  3. Not applicable

1. Conduct required emergency response training of laboratory personnel

  1. Demonstrate ability to train entry-level staff
  2. Not applicable
  3. Not applicable

1. Develop required emergency response training

  1. Evaluate ability of mid-level staff to train all laboratory personnel
  2. Ensure adherence to laboratory's emergency response training requirements
  3. Evaluate effectiveness of the laboratory's emergency response training

2. Participate in drills and exercises for laboratory personnel

  1. Not applicable
  2. Not applicable

2. Implement drills and exercises for laboratory personnel

  1. Not applicable
  2. Not applicable

2. Collaborate in the development of drills and exercises for laboratory personnel

  1. Assess effectiveness of drills and exercises
  2. Incorporate lessons learned into training program


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