ATTACHMENT S - Research Service -EM-COOP.pdf

Service/Program: Research Service

Letter/Number: 151 Date Effective: 09/30/2025

Interdisciplinary:

Principle Investigators, Clinical Research Asst, Research Spec., Lab Technicians, Administration, Budget

Affected Units/Clinics:

VA Medical Center, San Diego

Review/Revision Date:

09/03/2025

VA San Diego Healthcare System (VASDHS)

Service/Program/Clinic-Specific Emergency Management Plan (EMP) and Continuity of Operations (COOP) Plan

1. PURPOSE: To ensure resiliency and readiness throughout the VA San Diego Healthcare System, the Research Service has reviewed and identified critical needs as it pertains to the safety of its patient population(s) and employees during an emergency and/or disaster. This Service/Program/Clinic-Specific Emergency Management (EM) and Continuity of Operations (COOP) plan could be activated at any time in response to a wide range of disruptive events or situations. Many of these are outlined in the VASDHS Hazard Vulnerability Analysis (HVA) to include an earthquake, wildfire, bomb threat, epidemic/pandemic, or terrorist attack.

However, any event that makes it impossible for employees to work in their regular capacity or cause significant loss of life or property could result in the activation of the EM-COOP plan.

A. Essential Functions of Research Service: VA research is designed to yield knowledge, information, products, and technologies that advance the understanding of health and disease, and the development of treatments that improve the wellbeing of Veterans. VA research is research that is conducted by VA investigators (serving on compensated, without compensation (WOC), or Intergovernmental Personnel Act (IPA) appointments) while on VA time or VA property. The research may be funded by VA, by other sponsors, or be unfunded. VA research must have R&D Committee approval. VA research laboratories are research laboratories under the control of VA and/or used for VA research within VA facilities or a space occupied by VA under a legal agreement (e.g., lease). Medical and Prosthetics Research and Development (R&D) in VHA is an intramural program administered by the VHA Office of Research and Development (ORD) in support of research conducted at VA facilities. Research service provides space and resources for non-VA funded research (such as NIH, DoD etc.) that is administered by Veterans Medical Research Foundation (VMRF), a not-for profit organization. Research service, in accordance with VHA policy safeguards the safety of personnel, the public and the environment, and the security of research laboratories and other applicable research space in compliance with all applicable VA policies, Federal statutes and regulations from OSHA, EPA, NRC, NIH and CDC guidelines, and State and local requirements. This is accomplished by establishing and implementing Research Safety and Security Program as per VHA directive (1200.08).

2. DEFINITIONS:

A. CEMP: Comprehensive Emergency Management Plan establishes mitigation, preparedness, response, and recovery processes for the VASDHS to effectively manage events as identified in a Hazard Vulnerabilities Analysis, or those incidents which may cause major disruption to the environment of care. Specific procedures are outlined in Annexes, Appendices, and a Continuity of Operations Plan. The CEMP also provides an all-hazards approach to emergency management with the goal of protecting the life and safety of all patients, employees, and visitors within VASDHS.

B. COOP: Continuity of Operations plan is an effort within individual organizations to ensure that Mission Essential Functions continue to be performed during a wide range of emergencies, including localized acts of nature, accidents, and technological or attackrelated emergencies. This is typically from 12 hours to 30 days, or until resumption of normal operations is reached.

C. Disaster: Any internal or external emergency incident generated accidental or uncontrollable events, actual or threatened, that are concentrated in time and space, in which it endangers the well-being and safety of medical center patients, visitors, employees, property or records.

D. Emergency: An unexpected or abrupt incident, serious and escalating occurrence or situation urgently requiring prompt action.

E. Emergency Code Internal: Any impending or actual emergency incident on the grounds or in the facility, generated by a force or an event that significantly endangers the wellbeing and safety of patients, visitors, employees, property, or records. Leads to possible activation of VASDHS CEMP/COOP and coordinated response from the Hospital Incident Command System (HICS) Leadership Team.

F. Emergency Code External: Any impending or actual emergency incident outside the facility grounds, generated by a force or an event that could cause our system to receive injured persons or substantially impact the delivery of patient care. Leads to possible activation of VASDHS CEMP/COOP and coordinated response from the Hospital Incident Command System (HICS) Leadership Team.

G. Emergency Code Internal/External Code Levels:

1) Level 1 = Complete Activation: Activates Comprehensive Emergency Management

Plan (CEMP) and Full Hospital Incident Management System (HICS) Incident Management Team (IMT).

2) Level 2 = Modified Activation: Increase/Decrease Level or Impact to Community Based Outpatient Clinic or Administrative Annex.

3) Level 3 = Minimum Activation: Situational Assessments with Preparatory Response.

H. Employees: All full/part time paid personnel, licensed dependent practitioners, licensed independent practitioners, without compensation, and volunteers or any individual under the regular supervision of paid personnel.

I. Four Phases of Emergency Management:

1) Mitigation: Preliminary activities undertaken to lessen the severity and impact of a potential disaster or emergency on operations and allow for the recovery of mission essential capabilities as quickly as possible.

2) Preparedness: Activities undertaken to build organizational capacity and identify those resources that may be utilized should a disaster or emergency occur. This also involves testing and drilling plans and procedures to ensure capabilities are adequately met.

3) Response: Activating pre-identified processes and procedures during a time of emergency/disaster and to address the incident specific medical, psychological, security and functional needs of employees and patient population(s).

4) Recovery: Activities taken to assess, manage, and coordinate the recovery from a disaster/emergency in order to return to the operational level existent prior to the disaster/emergency. This includes the replenishment and reconstitution of supplies, equipment and required maintenance, and required staffing levels to resume normal operations. Access to emotional, psychological, and spiritual care should be provided and/or made available to those impacted by the incident(s).

J. Service/Program-Specific Emergency Management Planning (EMP) and Continuity of Operations Plan (COOP): Methodology to ensure delivery of the most critical services even when personnel, equipment and resource are unavailable, not working and/or relocated. Framework based in the Four Phases of Emergency Management (Planning, Mitigation, Response and Recovery) and Continuity of Operations Activation (readiness and preparedness of employees; activation of plans, procedures, and schedules to transfer activities personnel, records, and equipment to alternate facilities; continuity operations to execute essential operations at alternate operating facility; and reconstitution of operations at alternate facility are terminated and normal operations resume).

3. PROCEDURES: The following emergency/disaster readiness elements will describe how Research Service will address the implementation of its EM and COOP plan. These operational procedures will address all-hazards’ assumptions specific to employees and patient populations enrolled in our research studies.

A. Activation and response (with 96-hour capability):

a. Notification of an emergency normally will be received over the paging system, by telephone or by messenger notification from the command post. The person receiving the notification of the alert will immediately advise the Research and Development Safety Officer (RDSO). RDSO will notify the ACOS (R&D) and the Administrative Officer (AO; R&D) of Research Service.

b. Upon plan activation, under Emergency Code Internal/External, the RDSO or the ACOS (in the absence of RDSO) will report to a Command Center briefing or as designated. During normal business hours the Command Center is in the Computer Lab room 4078B. During non-business hours the Command Center will be in Conference Room 1, 4 East (or as designated), until moved by the Director or Incident Commander.

c. The RDSO will maintain communication with the ACOS R&D and the Command Post. The RDSO will contact the Veterinary Medical Officer (VMO) and VMU Facility Manager and VMRF CEO to coordinate responses and procedures as applicable to the incident(s).

d. The Floor Captain(s) and members of the Emergency Team will report to the 6S conference room or as designated. If the situation warrants or if evacuation becomes necessary, the Floor Captain will direct Emergency Team members and/or Research Administration personnel to the wings to notify lab personnel who may not have heard the alarm or overhead announcement.

e. Appropriate personnel will be dispatched by the AO/RDSO to the personnel pool for assignment. The location for the personnel pool will be announced by the Command Post.

f. Service personnel will continue to function under emergency situations that do not involve their immediate area as under normal conditions, except they will be emergency-oriented and responsive to the total situation. If directed, they should be prepared to shut down all unnecessary operations.

g. Employees will be cognizant of fire escape routes, alarm locations, placement, and use of fire extinguishers in the service, location of flashlights, lanterns and procedures relating to utility failure.

h. In an emergency the need to evacuate may be required. If a horizontal evacuation is necessary, staff should proceed to a safe area on the floor.

i. If evacuation from the facility is required, the service safe area will be behind the parking garage 2 between posts 19 and 20. A head count or roll call will be conducted in order to account for everyone.

j. Research Service Specific Incident Response Plan for biological hazards and chemical hazards that details issues and processes in case of an incident are available in each laboratory for reference (Refer to attachment A).

k. Our research service has been provided with a list of chemicals and hazardous agents and these are shared under “W drive.” If the emergency is due to exposure to any of the specific hazards, appropriate interventional measures including moving staff to a safe location will be instituted immediately to mitigate the exposure.

l. If disaster/emergency is an infectious disease pandemic, staff may be allowed to telework if it is part of the medical center plan. However, all staff will always be instructed to maintain all ethical principles of research, even under reduced staffing situations that are essential in management of pandemic transmission. When resuming research operations, guidelines provided by State and Local Public Health determinations, as well as national guidelines from the Office of Research & Development, and VA San Diego Facility policies and safety requirements will be strictly followed in progressing though different phases (red, orange, yellow and green) of ramp up of research activity. On-site staff density will be restricted to avoid spread of infectious disease and to maintain essential research activities.

m. Within 30 minutes of plan activation or when safe to do so an Operating Status and Capabilities Report (OSCAR) will be submitted as indicated on form or as directed.

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n. A Vivarium Disaster Plan details the special procedures to be followed for research animals in case of emergencies or disasters (Refer to Attachment B).

B. Employee roles and succession of authority:

Service level order of succession to take command is as follows: (Primary and secondary numbers will be listed for each person below in the Research Service Cascade List.

When the ACOS/deputy ACOS/AO/RDSO are not present, an Acting ACOS/AO/RDSO will be designated):

a. ACOS (R&D), (office: (858) 642-3657; Cell: (858) 249-9806)

b. Deputy ACOS (R&D), (office: (858) 642-1240; Cell: (858) 692-4057)

c. AO, R&D: (office: (858) 642-3657; cell: 858-354-7088)

d. Research Safety Coordinator office: (858-642-3396; cell: 858-218-5973): The RDSO is designated as the Research Safety Coordinator and is responsible to:

establish an emergency response team and designate its leader; participate in scheduled disaster drills; and maintain the Service Emergency Cabinet supplies.

e. Floor Captains (at least two to be assigned by AO/RDSO and trained by the facility emergency manager; they are the space and safety manager and project support to the space and safety manager). If Floor Captains are unavailable the RDSO will be the acting Floor Captain. It is the responsibility of the appointed and/or alternately appointed Floor Captain(s) to:

i. Take and retain control of 6th floor emergency situations until relieved by a higher authority or until the arrival of the appropriate outside agency;

and

ii. Act as liaison between Medical Center Incident Commander and Police Service during 6th floor research areas during emergencies and nonemergencies.

f. Emergency Team Members (to be assigned from the research labs by AO/RDSO;

they include 2 senior laboratory technicians from each wing): Emergency Team members will assist the Floor Captains during disaster drills and/or emergencies by following all policies and procedures and complying with any directives given to them by the Floor Captain or the Emergency Team Leader during an emergency.

g. Research Staff: If requested, the AO/RDSO will be adding administrative staff to the Personnel Pool along with other members of the service. Research Investigators and the lab managers will ensure to secure the labs, research data, chemicals, flammable agents, and equipment during the emergency before leaving the lab.

C. Critical resources and assets:

a. Water: Use of toilet facilities allowed only when necessary. They will be flushed only when solid material is introduced into the system. Hard flushes with nonpotable water may also be required. Hand sanitizer will be distributed to the toilet facilities and available at distribution stations.

b. Sewer Failure: If notified of a sewer failure, personnel will refrain from discharging effluent into the system, except when required for public health reasons. Hard flushes with non-potable water may be required.

c. A listing of all hazardous agents in VASDHS research laboratories and hard copies will be available in the AO’s office and RDSO’s office (in the drawer labeled with Chemical Inventory).

d. A response cascade with contact names, phone numbers, and other contact information listed will also be kept ready and hard copies will be available in the AO’s office and RDSO’s office (in the drawer labeled with Response Cascade).

e. The Research service will follow the facility lock-down procedures to protect patients, and personnel; and prevent theft or destruction of equipment, computers, and sensitive materials. All data for the Research Service is stored electronically and accessible via VA computers. Personal Protective Equipment (PPE) and other equipment necessary for potential hazardous environment responses are kept in the storage closet near the service elevators on the 6 th floor.

D. Data support systems/vital records: Research use of CPRS/VISTA is not critical for patient care during an emergency. E. Communication:

a. Emergency communication normally will be received over the paging system, by telephone or by messenger notification from the command post. The person receiving the notification of the alert will immediately advise the ACOS (R&D), and the deputy ACOS and the RDSO. When the ACOS or deputy ACOS of Research Service are not present, an Acting Chief will be designated.

b. The RDSO will maintain communication with the AO and the Command Center.

The RDSO will contact the Veterinary Medical Officer (VMO) and VMU Facility Manager and VMRF CEO to coordinate responses and procedures as applicable to the incident(s).

c. If the telephone service is unavailable, and if there is a need for more two-way radios, a staff person will be sent to the HICC to request emergency communication equipment.

d. Each employee is responsible to ensure that the service has a current cell or home telephone number for use in emergency staff callback (cascade list). Service Chief will activate cascade list in an emergent situation.

e. The cascade list will be updated annually and whenever personnel actions occur, affecting current cascade list.

f. For mass notification purposes, all employees are required to routinely review and update, as necessary, their work and personal contact information under the VA Emergency Alert and Accountability System (EAAS):

https://alerts7.athoc.com/selfservice/vaeaas and respond to issued alerts as instructed.

g. Staff may be allowed to telework if it is part of the medical center plan and approved by the service chief. Facility approved remote teleworking system will be required to perform the work.

F. Recovery and reconstitution of services:

a. The Research service has an inventory list of equipment and chemicals and as each item is used, it will be logged. Any supplies and/or equipment used will be tracked and procurements made to restock or to provide required maintenance to ensure operational readiness status.

b. Staff will be assessed for distress for the event and resources will be provided.

Staff that are experiencing physical and/or mental health issues should contact their supervisor immediately and be directed to the appropriate clinical care. Early intervention by supervisors is essential to ensure that the safety and well-being of staff is provided.

c. Research leadership will conduct an after-action review of exercised or actual event processes to ensure response actions met service requirements and plan expectations. Document and track action plans to resolution.

i. a. Modify EMP-COOP as needed and retest. G.

Reinforce plan:

a. The RDSO is assigned the responsibility to observe and critique the service’s participation in the drill. RDSO and the research staff will participate in different emergency exercise drills at least once a year. RDSO will hold emergency preparedness discussions with research staff at least twice annually which will include response and continuity activities associated with EMP and COOP and related educational topics. A test of the research service cascade roster will be conducted at least twice annually.

b. The Research service will ensure readiness of the HVAC and emergency electrical system in the research labs and animal areas is on Emergency/Back-up power to maintain the required temperature and temperature sensitive equipment such as deep freezers etc. to preserve research samples.

c. The Research service will also ensure readiness of protocols to establish coordination with the facility's Emergency Manager and local first responders.

d. RDSO will test and evaluate the effectiveness of the Research Emergency Preparedness and Response Plan at least annually.

e. RDSO will present an evaluation report of all exercises and actual emergencies to the Subcommittee on Research Safety and Security (SRSS) in the Research Service including the identification of deficiencies and opportunities for improvement. This evaluation report will be documented.

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VA San Diego Healthcare System Incident Response Plan

Attachment A

151 SOPP

August 2025 Chemical and biological hazards INCIDENT RESPONSE PLAN

1. Introduction: The purpose of this plan is to establish policy and procedures to ensure appropriate responses to incidents involving chemical and biological hazards in laboratories in accordance with the Department of Veterans Affairs policy as set forth in Veterans Health Administration (VHA) Handbook

1200.08. The scope of this policy includes R&D laboratories located within the VA San Diego Healthcare System.

1a. Hazardous Agent. A hazardous agent by VA definition is a biological material including the CDC list of select agents and toxins (42 CFR Part 73), and APHIS biological agents (7 CFR Part 331, and 9 CFR Part 121). For the purposes of this plan, the term also includes excluded select agents, highly toxic chemicals, exempt quantities of toxins, or gases that have the potential for being used as weapons by terrorists, as well as radioactive materials and/or radioactive sources (see Attachment.

A). When additional agents are added to, or deleted from, the hazardous agent list that are not contained in the CDC or APHIS list, the new list is posted on VA ORD’s website, and a notice is sent to all facilities. The terms select agents and toxins in this plan refer to both the CDC select agents and toxins and the APHIS biological agents and toxins.

1b. Toxin. According to 42 CFR 73.1, a toxin is the toxic material or product of plants, animals, microorganisms (including, but not limited to: bacteria, viruses, fungi, rickettsiae, or protozoa), infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production. It includes any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism, or any poisonous isomer of biological product, homolog, or derivative of such a substance.

2. Incident Response

a. In the event of a fire or explosion, occupants will, if safe to do so, assure that all hazards are secured within their cabinets, immediately leave the lab, pull fire alarm and follow the Code Red emergency evacuation procedures.

b. Evacuation Procedures: If evacuation is necessary, lab occupants should attempt to secure all hazards by locking them up inside storage cabinets, if safe to do so. They need to follow the Research Service Emergency Plan. Exit the building via the closest emergency exit door and move away from the building to a secure location.

At this time, representatives from the lab should ensure that a headcount is taken and that all personnel are accounted for. Missing persons should be reported to the Research and Development Safety Officer (RDSO) or the Administrative Officer (AO) immediately.

c. For small spills or releases that can be managed by laboratory personnel, emergency response will be provided in accordance with the Chemical Hygiene Plan.

d. For larger spills or releases that require a coordinated emergency response, the procedures set forth in the “Hazardous Materials” section of the VASDHS Emergency Management Plan are to be followed. The RDSO and/or the investigator for the affected lab will provide consultation and guidance to the HAZMAT Team Incident Commander with respect to the hazards and

VA San Diego Healthcare System Incident Response Plan 151 SOPP

August 2025 precautionary measures required to protect the responders, contain the agent, prevent or minimize contamination, and decontaminate, as necessary. The Medical Center has and will continue to coordinate with the San Diego HAZMAT Team for emergency response, including participation in planned drills.

e. In the event severe weather is forecast, lab occupants are to implement measures to secure the contents of the lab, particularly hazards and toxins. Response to, severe weather and natural disasters will be in accordance with procedures established by the Medical Center Emergency Management Plan with consultation and guidance provided by the RDSO and/or lab head, as appropriate.

f. Workplace violence, bomb threats, suspicious packages, sabotage or terrorist activity or other such events are to be reported immediately to the lab head, RDSO and Police Service. Police Service is to respond and handle the situation based on procedures established by the Medical Center Security Management Plan. The RDSO and/or the lab head will be consulted to ensure any necessary safety precautions are implemented, e.g., containment, decontamination, and/or the use of appropriate personal protective equipment.

g. Power outages, heating, ventilation or air conditioning (HVAC) system failures, water supply disruptions, gas leaks, and or any other utility system problems are to be immediately reported to Engineering Service by calling ext. 3301 at all times. The Research lab is provided with emergency power to minimize the potential loss of power, thus preserving a disruption of operations.

h. Emergency rescue and medical treatment will be provided by the Medical Center by calling ext.

3333 to report a CODE BLUE. For other emergency medical treatment, report or transport person directly to Occupational Health or Urgent Care. A hose that can be used for an emergency shower and eyewash are also provided in the lab for emergency flushing of the entire body or eyes and face, in the event of a chemical splash.

i. Code Blue: When a Code Blue is called for, Police Service will work with Rapid Response Team to give them access.

j. In the event of exposure to a large spill there are no first aid measures that are effective. The spill should be contained and decontaminated as described below. Within the next 24 to 48 hours decisions about the use of anti-fungal therapy can be made after consultation with the laboratory director and/or other infectious disease experts on station about the risks and benefits of such therapy.

k. Victim(s) requiring decontamination should be decontaminated on site, if at all possible, using soap and water, as well as disinfectant solution, to wash the affected areas. A hose that can be used as an emergency shower and eyewash are also provided in the trailer for emergency flushing of the entire body or eyes and face, in the event of a chemical splash.

l. Decontamination. The need for decontamination of the laboratory, laboratory surfaces, and equipment will be reviewed by the principal investigator of the laboratory after any incident.

Small spills will be decontaminated using the procedures described in the Biosafety Plan using an effective disinfectant together with absorbent materials. Decontamination after larger spills or other events will be carried out in consultation with the Laboratory Director, RDSO and San Diego HAZMAT Response Team. Gas decontamination of the entire laboratory, if necessary, will be arranged with the assistance of an outside contractor.

m. Biosecurity Incident Response

The following must be reported immediately to the Lab Director, RDSO and VA Police Service:

(1) Any loss or compromise of keys, passwords, lock combinations, etc.,

(2) Any suspicious persons or activities,

(3) Any loss or theft,

(4) Any unauthorized computer accesses.

All suspicious persons will be challenged and asked to leave the area.

Any discovery of loss or theft shall be immediately reported to the ACOS R&D.

3. Annual Review: An annual review of this plan will be conducted by the RDSO, Laboratory Manager and the Subcommittee on Research Safety. This plan will also be reviewed after any employee exposure or incident and after each annual drill.

4. Preservation of records. All records related to inventory, including access, training, reports, and protocols will be preserved for a period of at least three years after the closure of the protocol, and will be available for review upon request.

5. References:

(1) VASDHS Emergency Preparedness Resource Manual

(2) Research Service Emergency Preparedness Procedures

(3) 151 SOPP 01, “Biosecurity Plan”

(4) 151 SOPP 02, “Biosafety Plan’

Review Date: Annually

Follow-Up Responsibility: Research & Development Safety Officer

Rescission: 151 SOPP , Chemical and biological hazards Incident Response Plan, February 2025

Date Approved by SRS Committee: February 2025

Personnel Roles and Lines of Authority and Communications Immediately call: Laboratory Director/ Principal Investigator A. Lab Director will call: RDSO Chitra Mandyam

Cell: 858-218-5973 B. RDSO will call: Carl Stepnowsky, PhD, Deputy ACOS R&D

Cell: 858-692-4057 Cell2: 760-877-3986 C. Activation of the Medical Center Emergency Cascade as required.

Further reporting may be required depending upon the incident. Refer to the above and Biosecurity Plan.

Police Service Extension 3931 (24hrs. /7days)

Quick Reference Emergency Procedures in case of:

Earthquake:

All Personnel exit building immediately.

Do not attempt to save cocci stocks or animals at this time. Re-assess situation (concerning animals and stocks) after clearance to enter the room is given. Follow notification procedures per Biosecurity Plan.

Fire:

All Personnel exit building immediately. Secure room by closing door.

PULL ALARM. Call CODE RED ext. 3333.

Spills in Biological Cabinet or Animal Box:

Cover spill with absorbent towels.

Spray towels with one of the approved disinfectants.

Wait 30 minutes before cleaning up.

Autoclave all contaminated waste and clean up materials.

Spills other than above (floor, bench top, sink, centrifuge, incubator, etc.):

All Personnel exit building immediately.

Call Biosafety Officer and call Lab Director, or Alternate.

Method of clean up will then be determined.

Ventilation Power Failure (Strobe light activates):

Personnel in building should call Engineering at ext. 3301.

Personnel in building assess safe exit procedures.

Call Biosafety Officer and call Lab Director, or Alternate.

Biological Safety Cabinet Power Failure:

Close Sash. All Personnel exit building immediately. Call Engineering at ext. 3301 to determine cause.

VA San Diego Healthcare System Veterinary Medical Unit

Vivarium Disaster Plan

Vivarium Disaster plan 1 of 15

Attachment B

INTRODUCTION

Animal facilities may be subject to unexpected conditions that result in the catastrophic failure of critical systems or significant personnel absenteeism or other unexpected events that severely compromise ongoing animal care and well-being (ILAR 2010). The Veterinary Medical Unit (VMU) has very special needs in the case of emergencies, due to the fact they are responsible for the humane care and use of live animals. All live animals are housed in VA San Diego healthcare System (VASDHS) 6th floor, and because of this, this facility is recognized as having high priority for disaster assessment in case of emergencies.

The animal facility is equipped with 100% emergency generator power. These generators can run 2-7 days before refueling is necessary, depending on use. They supply power to HVAC and lighting systems as well as to all emergency power outlets (over 90% of outlets in the VMU are on emergency power). Emergency power outlets are red or marked as emergency power.

Key members of the staff have undergone additional training and have been given necessary access to the animal facility for evaluation of animal health and welfare, and facility condition as soon as possible after an emergency.

COMMUNICATIONS

Radio: Tune in to Emergency Broadcast System (EBS) for updates on situation

Phone: Check phones - voice mail may be functional. On-site phone number: 3647 Off-site phone number - if able to dial out: 911

PRESERVATION OF ANIMALS

Investigators must consider how they will preserve animals that are necessary for critical research activities or are irreplaceable. PI’s are encouraged and reminded regularly to have embryos or sperm of vital strains of mice or rats frozen and stored offsite, preferably in two areas of the country, to ensure these lines are not lost in case of a disaster.

The Veterinary Medical Officer (VMO) holds regular meetings to discuss options and assist with planning for the preservation of these animals. In addition, a contract is in place to begin cryopreservation of sperm. This contract will offset the initial costs of this process. Sheltering in place for the animals will be the most likely scenario unless there is significant damage to the building and the building is unsound. If animals escape, and personnel cannot catch them immediately, live traps will be set to re-capture animals. Emergency personnel, such as animal control and police, will be notified that there were escapees and provided a description of the escaped animals. Currently, laboratory rodents and rabbits are the only species housed in the VMU.

FOOD AND WATER SUPPLIES

The laboratory animal facilities will be prepared to provide support to a limited animal population for up to 7 days without utilities. We have sources of water for the animals. Water will be retrieved from their source in a large underground holding tank. There is a one-week supply of food for all species in the facilities at all times. In the event of an anticipated disruption in service (e.g. pandemic), the VMU will make all efforts to order a 3-to-4-week supply of food and bedding and submit reorders biweekly thereafter. Alternate food and bedding vendors may be considered, however, Vivarium Disaster Plan

Vivarium Disaster plan 2 of 15 use would only occur in an emergency, because the diet formulations are different and changing diets could affect ongoing or future research

Rodent feed rationing:

• All animals must have continuous access to food and water; however, animal care staff will use professional judgement in assessing whether hoppers will be fully replenished (based on cage density, breeding, etc.).

• Investigator staff are requested to label any cages that will be euthanized within the week to ensure that hoppers are not unnecessarily topped off.

The shelf-life of Envigo food is 9-12 months (https://www.envigo.com/p/teklad/resources/diet-faqs/); food will continue to be stored and used in a manner that ensures the oldest food gets used first. Food past its determined shelf life will be labeled and stored separately from in-date food until normal operations resume.

• Should feed supply become critically low, investigators may be requested to save and reuse feed for use with other animals within the same colony when cages are removed/euthanized. The re-use of food (collected and used from other cages in the same animal room) is not practical and poses cross-contamination issues. This would be a last-resort scenario.

HVAC FAILURE

The VMU HVAC system is on emergency power. Therefore, if there is a regular power outage it will run on the emergency power.

In cases of failure of the HVAC unit, the outgoing air will still run, creating a negative pressure flow of air. The animals are in cages that are HEPA filtered and positive pressure to the room and on emergency power. The flow of air should prevent any rapid rise in temperature; however, if the temperature should rise, the VMU has 5 portable cooling units, several fans and extension cords (if needed) available to cool the rooms.

For catastrophic electrical failure involving regular and emergency power, the scenarios listed below will be followed.

SECURITY

VA police are to be contacted immediately if there is a potential threat, such as a break-in, intruder, bomb threat, etc. In addition, as part of ongoing security, there are cameras in the VMU that are monitored and checked regularly by VMU staff. There are additional cameras monitored by VA police throughout the hospital. All personnel that enter the 6th floor must be employees or have a visitors’ badge given to them by police service. All employees, including WOC’s undergo fingerprinting and full background checks prior to hire and every 2-3 years thereafter.

SCENARIOS

The type of action taken depends on the extent of damage sustained within the facility.

PANDEMIC

Pandemics can create personnel shortages at the VASDHS, as well as with suppliers of animals, feed, bedding and other supplies. In these situations, a code external is activated by the hospital. To prepare for this, it is best to have strains of mice or rats that are bred in-house and are not readily available from the vendor frozen down. In addition, these situations are generally highly dynamic, with constant federal and state guideline updates. The steps below are considered basic information for general pandemic conditions, but it is likely that policies specific to the incident will continue to evolve on a regular basis, and further restrictions may occur over time. Personnel are encouraged to check https://www.envigo.com/p/teklad/resources/diet-faqs/ https://www.envigo.com/p/teklad/resources/diet-faqs/ https://www.envigo.com/p/teklad/resources/diet-faqs/ https://www.envigo.com/p/teklad/resources/diet-faqs/ https://www.envigo.com/p/teklad/resources/diet-faqs/

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Vivarium Disaster plan 3 of 15 their email regularly for updates. The following are examples of steps that may be taken, based on Institute, local, regional, state and national requirements. See also appendix 1 for an overview.

For Research Study Personnel (VA-Paid, WOCs, IPAs, Contractors):

• VA San Diego Facility Policy on screening, social distancing where possible, and proper hygiene practices to minimize spread of a pandemic disease are always to be followed by ALL STAFF in Research.

• For asymptomatic staff reporting to work and cleared through screening, hygiene practices are to include regular handwashing and use of hand sanitizer, as well as frequent wiping (especially between users) of all common surfaces and shared equipment.

Considerations for social distancing should include remaining 6 feet apart from co-workers and other staff/visitors/subjects, minimizing direct skin-to-skin contact, holding meetings by conference calls where feasible, etc. Where feasible (see details below on telework options at present), allowing work remotely for functions that can be accomplished that way is advisable to minimize on-site personnel.

• Where on-site work is needed (e.g. ongoing animal studies, timed wet lab/bench studies in progress), Principal Investigators should work with their staff to most effectively utilize assigned research space which is conducive to social distancing practices. Staggered shifts may be advisable, as are assigned knee hole/work surfaces with minimization of crossover of staff into other staff assigned areas where possible.

• For areas and equipment requiring shared use, regular disinfection with 60% or greater alcohol-containing products between users should be implemented and wearing of gloves even for procedures not otherwise requiring them is advised when handling common equipment, supplies, or samples.

• In a pandemic situation, HR and hospital administration will communicate with personnel about additional precautions and work duties.

CONTINUITY OF OPERATIONS PLAN FOR VETERINARY MEDICAL UNIT DURING PANDEMIC

To ensure continuous operations of the VMU during ta pandemic, the following actions will take effect based on the determined level of emergency:

• Storage: Existing administrative storage space located in the VASDHS basement will be made available to store additional food and bedding.

Husbandry duties:

• Normal operations, including cage changing and routine sanitation in accord with the applicable SOP/s for the species will continue if there are no critical shortages of staff or supplies and regional situations permit normal operations.

• With staffing shortages or commute restrictions, VMU may institute limited husbandry practices in accord with Holiday and Weekend maintenance. This may include extended cage-changing intervals beyond approved SOP intervals to maximize husbandry resources (labor, food, bedding).

• VMU staff will decrease the amount of food and bedding added to each cage to minimize waste and extend the use of existing supplies.

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• Minimal VMU operations require staffing of 1-3 people onsite to facilitate health checks, perform spot cage changes, address facility issues, wash/fill cages. No additional services, such as autoclaving enrichment devices, will be provided until further notice.

• Animal Care Coordinator will be integrated into routine husbandry assignments as needed.

• Research staff may be asked to assist with cage changing in their colonies.

• The VMO may also elect to euthanize animals if the entire lab is unable to continue the study.

Temporary cessation of services: VMU will halt the following until further notice.

• Animal Orders and Animal Receiving: During emergent situations, no new animal orders will be placed or accepted. The VMU will continue to receive animal orders already in place, but actual availability and delivery are subject to vendor regulations. VMU will advise lab staff when orders can resume.

Animal Transfers: All pending transfer requests will remain in the queue until further notice; incoming shipments will be delayed to the extent possible. No new transfer requests will be accepted.

• VMU Surgical Suite: The VMU surgical suite is closed until further notice.

• VMU Procedure Room: The VMU procedure room can continue to be used for procedures that are mission critical, such as genotyping and completing current ongoing studies. However, it is critical that research staff thoroughly clean the area when they are done.

Experimental Procedures – ongoing studies and new research:

• Experimental animals: Without exception, post-procedural care and recordkeeping must continue according to policy. Animal welfare must remain a priority. Animals must receive appropriate pain management and documented care. If a single lab is unable to provide adequate care to their post-procedural animals, VMU staff availability permitting, VMU staff may provide care. This cannot be assumed and the VMO must be notified in advance. The VMO may also elect to euthanize animals if the entire lab is unable to continue the study.

• Investigators may be asked to prioritize ongoing studies and consider delaying time-sensitive and new studies to evaluate what the impact of supply or staff disruptions could have on the research. Research efforts could focus on tissue analysis on banked samples, or data analysis, instead of new live-animal studies. Investigators may be directed to complete studies or shorten survival times to accommodate interruptions in care or supplies. New studies and new survival surgeries may be suspended until stability of operations resumes.

• Breeding colonies: Investigators must scale back breeding to colony maintenance and preservation.

Investigators are encouraged to contact the VMO to initiate cryopreservation. This includes strains/lines not currently being used and other valuable lines to reduce risk of loss of valuable VA resources.

• Lab staff is advised to flag cages of animals with the planned date of euthanasia, so that VMU staff can prioritize food and bedding for these cages. While all animals will have food and water, the VMU will not top-off food for animals that will be euthanized soon.

Veterinary Medical Care:

• The Veterinary Medical Officer and Animal Care Coordinator must be consulted regarding any animal health concerns. Routine clinical rounds will continue in accord with standard or weekend/holiday care procedures.

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• There is a backup veterinarian designated in case the VMO should become unavailable. This information will be sent to research staff if necessary. Should need arise, FaceTime or WhatsApp can also be used for consultation for animal health issues.

New Personnel and Training: In the event of a coded emergency, new personnel will not be approved to work with animals in the VMU or in the labs, nor granted VMU access. In-person training, such as New Animal User Orientation and Recordkeeping will be suspended.

STAFF SHORTAGES FOR OTHER THAN PANDEMIC

There are times when staff shortages can occur within the VMU (e.g., illness + vacation + staff leaving). Should this occur, and there are delays in obtaining new personnel, a contract will be put in place for obtaining temporary already trained personnel. If delays occur in getting these people on-site, the following husbandry changes may be implemented

• Animal Orders and Animal Receiving: During emergent situations, no new animal orders will be placed or accepted. The VMU will continue to receive animal orders already in place, but actual availability and delivery are subject to vendor regulations. VMU will advise lab staff when orders can resume.

Animal Transfers: All pending transfer requests will remain in the queue until further notice; incoming shipments will be delayed to the extent possible. No new transfer requests will be accepted.

• With staffing shortages or commute restrictions, VMU may institute limited husbandry practices in accord with Holiday and Weekend maintenance. This may include extended cage-changing intervals beyond approved SOP intervals to maximize husbandry resources (e.g., delay room sanitation, do spot-changing only, weekend do only health checks and no husbandry, etc.).

PHYSICAL DISASTER

I DISASTER OCCURS DURING REGULAR BUSINESS HOURS

Immediately following an event (earthquake, explosion, or fire, e.g.) all staff are expected to assemble outside of the building in the parking lot area assigned to research (see map, attached). A member of the Veterinary Medical Unit – Emergency Response Team (VMU-ERT) will use our staff checklist to account for all staff members at work that day. If anyone is missing, the Emergency team for the VASDHS will be notified immediately to assist in locating the missing person(s). We expect the VASDHS emergency team to grant us access within 4 hours of determination that the building is safe. Information between the Site emergency response command post and the VMU will be delivered via messenger.

II. DISASTER OCCURS DURING NON-BUSINESS HOURS

Once families and personal property have been secured, key VMU staff are expected to report to work as soon as possible following a disaster. The first VMU-ERT member to arrive on scene shall initiate a sign-in/out notice for VMU staff to sign upon arrival. It should be posted on the loading dock door with instructions for staff members who arrive later. Secondly, establish contact with the site emergency command post in order to gain access to the building. VMU staff must be granted access to the building within 4 hours of determination that the building is safe. Some of our emergency equipment may be obtained through the site emergency command post. Information between the Site emergency response command post and the VMU will be delivered via messenger.

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HUMAN LIFE SAFETY AND MEDICAL CARE

The site emergency command post will be located in a safe, secure area, headed by security. Each floor has its own floor captain that coordinates the response team for that floor. All floors are equipped with emergency two-way radios and contact is established with site command and orders are given via floor captains. All search and rescue will be provided by the VASDHS emergency team or by the San Diego County Fire Department, who will be dispersed as needed. Trained teams from each floor will also provide all human life safety and medical attention. The medical triage area will be located in a safe and secure area, depending upon location of injured. If sheltering-in-place is required of personnel, the hospital has sufficient food and water to maintain personnel for an extended time (at least a week).

RESPONSIBILITY OF VMU STAFF FOR RECOVERY

The primary role of the VMU staff will be to assess the health and welfare of the animals within the building.

Once the VMU staff has received approval to enter the building the team captain shall give assignments to VMU personnel, who will be paired with a buddy, to go into the building to make their animal assessments. Each pair will be given a specific area of the facility to check. Initially staff will go to their assigned areas, make a visual and mechanical assessment of the area, then immediately report their findings to the team captain. Once reports from all sections of the facility have been received, the team captain will prioritize the order of action that will be taken to bring recovery of the facility. Staff will be expected to work until the team captain has determined that all animals have been secured, provided with adequate food and water, treated if necessary or euthanized.