Biological Agent Risk Assessment

Attachment A-1

BIOLOGICAL AGENT RISK ASSESSMENT

Risk Assessment: The purpose of this risk assessment is to identify possible causes of harm and measures needed to avoid an accident before it occurs. A hazard is anything with the potential to cause harm to humans and risk is the likelihood that someone will be harmed by the hazard and the severity of the harm caused. This document will include strategies to mitigate risk, inadvertent exposure, and outline response measures in an event an exposure occurs.

Instructions: This risk assessment form is to be completed by the Principal Investigator (PI) or designee in consultation with the BioSafety Officer, site specific Safety Officer, Infection Prevention Director, department leadership and health care personnel (HCP) involved in daily operations, plus others such as Engineering, etc.

Please submit completed form to David Smith, Ph.D., Biosafety Officer

Email:

ADMINISTRATIVE USE ONLY:

Registration#: / Requires IBC Review
Clinical / Pre-Clinical
Date Reviewed: / Date Approved:

SECTION I - CONTACT INFORMATION

Name of Principal Investigator (PI):

/

Name:

Office #:

Cellular#:

Email:

Name of Study/Research Coordinator (if applicable):

/ Name:
Office #:
Cellular#:
Email:

Study Trial/Research Project Title:

Site of Study Trial /Research Project (list department and all areas where the biological agent(s) will be in)

/

Facility:

Floor:

Suite/Room Number:

Please provide a brief summary of the Study Trial/Research Project

/

SECTION II - BIOLOGICAL AGENT INFORMATION

Name of Biological Agent:

/

Agent Information Attached (i.e. Agent Safety Data Sheet (SDS)/ Investigator brochure)

Other Pertinent References Attached: Document(s):______

National Institute of Health (NIH) Guidelines are available and are followed? Yes No

Is the biological agent known to cause infection via the following routes of exposure?
Inhalation Ingestion Injection / sharps injury Skin Eyes
Unknown Other:

Can the biological agent cause injury or disease in healthy adult humans? Yes No

If yes, identify the injury or disease:

Can the biological agent produce toxins? Yes No

If yes, identify the toxin:

Is prophylaxis available? Yes No

If yes, identify the prophylaxis:

Is there a group of health care personnel (HCP) who are at increased risk and should be restricted from a work environment with this biological agent(s)? Yes No

If yes, identify: Pregnant Woman Immunocompromised Chronic Respiratory Illness
Other:

Work Practice BSL: BSL1 BSL2 BSL3 BSL4

*If the Study Trial/Research Project falls under BSL1 guidelines, STOP here and proceed to SECTION IV-Signatures
*If the Study Trial/Research Project falls under BSL2 or above guidelines, PROCEED to SECTION III-Risk Assessment

SECTION III - RISK ASSESSMENT

Please fill out each section in detail, or write N/A where applicable to ensure no steps were missed.

1.  RECEIPT & STORAGE OF AGENT(S)

Is the agent being shipped to a Northwell site? Yes No

If yes, location of agent to be received:

Location where agent is being shipped from:
Site specific biosafety policies and procedures in place? Yes No
Identify location:
Individual(s) to be notified and receive the agent upon arrival at the site location [list name(s)]:
Receipt of agent documented: Yes No
If yes, explain method for documentation:

Type of container agent will be received in:

Individual(s) responsible for placing/maintaining agent in storage:

What type of storage is required until the time of administration (i.e. freezer or refrigerator and the temperature parameters)?

Storage location:

How will the temperature parameters be monitored? Please describe:
How will storage area be secured?
Who will have access to secured storage area/facility?
Engineering Controls based on agent(s):

Administrative Controls:

Specific training requirements? Yes No

If yes, list the required training:

Required OSHA Blood-Borne Pathogen Training for involved staff has been completed and records of the training are available for review?
Yes No

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:

Risk Exposure: Low Medium High

2.  PREPARATION OF AGENT(S)

Where will agent be prepared?
The following are provided in the preparation area:
Sink Eye wash Shower Hood/biosafety cabinet Mechanical ventilation (negative pressure) Sharps container Medical waste containers Spill kits Other:

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:
Are appropriate warning and biohazard signs posted?
Yes No
All staff involved in preparation are properly trained and educated on the following procedures for agent preparation:
Cleaning, decontamination and spill procedures
Disposal protocol
Design and construction of preparation area (conducive to cleaning, has adequate space)
Eating, drinking, smoking, cosmetic application prohibited in preparation area
Disinfecting solution to be used to clean area

3.  TRANSPORTATION OF AGENT(S)

Outline chain of custody from point of receipt to storage location (include the name(s) of who will be transporting the agent):
Outline chain of custody from storage location to administration location (identify the administration location):
Describe mode of transportation (how the agent will be transported) from the storage location to point of use:
Engineering Controls:
Is there a secondary container used for transport? Yes No
If yes, describe:
Additional engineering controls? Yes No
If yes, describe:

Administrative Controls: Changes in work procedures that have a goal of reducing the duration, frequency, and severity of exposure to hazardous materials, i.e. written safety policies, rules, training, etc.

Staff transporting agent were trained, including emergency spill procedures? Yes No

Other specific training requirements? Yes No

If yes, list the required training:

Specific labelling requirements? Yes No

If yes, list the required labels:

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:

Risk Exposure: Low Medium High

4.  BIOLOGICAL AGENT ADMINISTRATION

Site specific biosafety policies and procedures in place? Yes No
Area/Location where agent will be administered:
Administration Area includes:
Hand washing facilities
Mechanical ventilation
Sharps container
Easily cleanable surfaces
Accessible eyewash
Provisions for medical waste
Properly labelled signs including Biohazard
Other:
Describe biological agent transfer from manufacturers container to the device used to administer:
Describe the preparation, transfer and administration of biological agent(s):
Engineering Controls:
Transfer devices required? Yes No
If yes, please describe:
Biosafety cabinet required? Yes No
If yes, please describe:
Additional engineering controls Yes No
If yes, describe:
Administrative Controls: Changes in work procedures that have a goal of reducing the duration, frequency, and severity of exposure to hazardous materials, i.e. written safety policies, rules, training, etc.
Staff involved in administration of agent(s) was trained on hazards, precautions, emergency situations? Yes No

Other specific training requirements? Yes No

If yes, list the required training:

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:
Risk Exposure: Low Medium High

5.  AGENT & DEVICE MANAGEMENT & DISINFECTION

If you will be packing and/or shipping unused biological agents, infectious substances, diagnostic samples, you must be trained and certified and comply with IATA (International Air Transport Administration) and DOT (Department of Transportation) requirements
Current Individual IATA certification is on file
Current Individual DOT certification is on file
N/A
Describe disposal of biological agent(s):
Regulated Medical Waste, describe:
Other, as per manufacturer’s guidelines, describe:
Describe disposal of device(s) used:
Regulated Medical Waste
Other, as per manufacturer’s guidelines, describe:

Decontamination or sterilization of waste prior to disposal required?

Yes No

If yes, describe:

Decontamination with and Environmental Protection Agency (EPA) approved disinfectant:
Reprocess of surgical instruments with:
High-level disinfection Sterilization Other:
Reprocessing location:
Engineering Controls? Yes No
If yes, please describe:

Administrative Controls: Changes in work procedures that have a goal of reducing the duration, frequency, and severity of exposure to hazardous materials, i.e. written safety policies, rules, training, etc.

Specific training requirements were outlined and staff was properly trained to prevent exposure?

Yes No

If yes, list the required training:
Who is responsible for waste disposal?

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:

Risk Exposure: Low Medium High

6.  ENVIRONMENTAL CONSIDERATIONS

List EPA-approved disinfectant(s) that are effective against the biological agent(s) that will be used:
Cleaning/disinfection of area- process in place? Yes No
Describe cleaning and decontamination of contaminated surfaces procedures:
Location waste is held until time of pick up?
Describe waste disposal procedures:
Regulated Medical Waste Other as defined by the manufacturer
If other, describe:
Who is licensed biohazard waste hauler?
Who is responsible for manifesting waste?
Engineering Controls? Yes No
If yes, describe:

Administrative Controls: Changes in work procedures that have a goal of reducing the duration, frequency, and severity of exposure to hazardous materials, i.e. written safety policies, rules, training, etc.

Specific training requirements? Yes No

If yes, list the required training:

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:

Risk Exposure: Low Medium High

7.  HAZARDS MANAGEMENT

Signage: Signs are placed on:
Reception Area
Access way/door were biological agent(s) are used
Storage area
Labelling:
Transport container has the warning sign/labels affixed, including Biohazard label?
Yes No
Appropriately designed and labelled waste receptacles (if applicable), including sharps containers?
Yes No
Environmental hazard mitigation:
Biosafety cabinet
Biohazard label on storage refrigerator
Eye wash accessible
Safety Data Sheet, if applicable
Describe emergency procedures in case of spillage (include protective equipment needed, decontamination procedures etc.):
Hazard Communication Process: Describe process and include contact name and information (telephone number and e-mail address) for reporting incidents/spills/emergencies:
/ Name / Telephone number / Email
Biological Safety Officer /

David Smith

/

516-725-0333

/ Site Safety Officer / / /
Site Infection Prevention / / /
Employee Health Services / / /
Other / / /
Engineering Controls? Yes No
If yes, describe:

Administrative Controls: Changes in work procedures that have a goal of reducing the duration, frequency, and severity of exposure to hazardous materials, i.e. written safety policies, rules, training, etc.

Specific training requirements? Yes No

If yes, list the required training:

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:
Risk Exposure: Low Medium High

8.  OTHER CONSIDERATIONS

Special consent needed? Yes No
If yes, describe:
Post procedure precautions for follow-up care for this patient on admission beyond standard precaution (i.e. airborne, contact, or droplet precaution): Yes No
If yes, describe:
List any other considerations for follow-up care for this admission:
Follow-up care delivered to the patient on subsequent admission: Yes No
If yes, describe:
Engineering Controls: Yes No
If yes, describe:

Administrative Controls: Changes in work procedures that have a goal of reducing the duration, frequency, and severity of exposure to hazardous materials, i.e. written safety policies, rules, training, etc.

Specific training requirements? Yes No

If yes, list the required training:

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:

Risk Exposure: Low Medium High

9.  OCCUPATIONAL/EMPLOYEE HEALTH

Describe and list persons at risk (complete the attachment in appendix)
Employee assessment and clearance required?
Yes No
If yes, describe:
Will health surveillance be required?
Yes No
If yes, describe:
Vaccination required?
Yes No
If yes, describe:
First aid provision?
Yes No
If yes, describe:
Post-exposure follow-up?
Yes No
If yes, describe:
Engineering Controls?
Yes No
If yes, describe:

Administrative Controls: Changes in work procedures that have a goal of reducing the duration, frequency, and severity of exposure to hazardous materials, i.e. written safety policies, rules, training, etc.

Specific training requirements? Yes No

If yes, list the required training:

Personal Protective Equipment (PPE) is available and appropriate to minimize exposure?

Yes No

None Gloves Eye Protection Face shield Mask N95 Respirator

Impervious gown/Laboratory coat Other:

Risk Exposure: Low Medium High

SECTION IV– PERSON(S) COMPLETING THIS RISK ASSESSMENT IN CONSULTATION WITH BIOSAFETY OFFICER

Title / Name
Title / Print Name
Department Director/Administrator
Site Safety Officer
Site Medical Director
Site Infection Prevention

APPENDIX

Instructions: List all persons involved with the work detailed in this risk assessment

Print Name
Title
Department
Contact information / Telephone #: / Email:
List tasks involving biological agents
Health Clearance?
Training Completed / 1.  Regulatory Training NIH Guidelines (CITI)
2.  BSL2 (iLearn)
3. Agent and site specific training
4. Other: / Date:
Date:
Date:
Date:
Print Name
Title
Department
Contact information / Telephone #: / Email:
List tasks involving biological agents
Health Clearance?
Training Completed / 1.  Regulatory Training NIH Guidelines (CITI)
2.  BSL2 (iLearn)
3. Agent and site specific training
4. Other: / Date:
Date:
Date:
Date:
Print Name
Title
Department
Contact information / Telephone #: / Email:
List tasks involving biological agents
Health Clearance? / Yes No
Training Completed / 1.  Regulatory Training NIH Guidelines (CITI)
2. BSL2 (iLearn)
3. Agent and site specific training
4. Other: / Date:
Date:
Date:
Date:

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