Natural and manmade disasters can strike at any time or place. To weather any kind of disaster, clinical laboratories need to develop comprehensive disaster preparedness plans to provide the best possible safety and security for the laboratory, staff, and the patients they serve.
By Jennifer MacCormack
Natural and manmade disasters can affect large areas of the country, damaging homes and businesses and disrupting the delivery of goods and services. Clinical laboratories are a critical component of the healthcare system, and having them inoperable for long periods is detrimental to patient care, particularly in the wake of natural or manmade disaster. While a laboratory may need to close or evacuate when danger is imminent, thoughtful and proactive disaster planning can help to prevent damage, loss of records and equipment, and ensure that operations can resume as soon as it is safe for staff to return.
Be Disaster-Ready
A well-thought-out safety plan for the laboratory, and staff adequately trained on the plan, goes a long way toward simplifying disaster preparation and recovery. All laboratories should have a fire safety plan, and a plan for coping with sustained power outages. Depending on the laboratory’s geographic location, other disasters may also need to be considered: wildfires, floods, extreme temperatures, hurricanes, blizzards, tornadoes, earthquakes, and tsunamis can all require evacuations and interrupt laboratory operations. As we have experienced over the past two years, pandemics can also disrupt operations if staff are sick or quarantined, or if supply chains are strained.
Knowing your area’s biggest disaster risks is important when developing safety and disaster plans for your laboratory. Different types of danger require different measures. For example, if the laboratory is in a flood-prone area, it may be best to store reagents and equipment on shelving and countertops, but if the area is prone to earthquakes, keeping supplies closer to the floor, or behind closed, latched doors may be a better strategy.
Keeping Personnel Safe
The safety of laboratory personnel should always be the primary concern in an emergency. All staff should be familiar with evacuation procedures, shelter-in-place procedures, and the location of all safety equipment in and near the laboratory. Regular safety and planned evacuation drills can help ensure that staff will act immediately and appropriately in the case of a real emergency.
Laboratory leadership should have contact information, and secondary emergency contact information, for all laboratory staff. If the laboratory must be closed in advance of an impending weather event, scheduled staff can be instructed to stay home. Having this list will also make it easier to contact them after a disaster to confirm their safety.
With most weather-related disasters, there is advance warning of impending dangerous conditions. Be sure to have weather and emergency alerts set up on mobile phones, so staff can act quickly to secure the laboratory and take shelter if necessary. If evacuation is required, it is helpful to have a designated emergency “captain” to take charge and delegate tasks. This person should be chosen ahead of time, and their responsibilities listed in the laboratory’s safety plan. In the case of their absence, designate backups. Post-disaster communication is equally important to communicate to staff when the laboratory can resume operations and who is allowed access to the laboratory to reestablish critical functions. Emergency contact numbers should be posted throughout the laboratory for quick access by staff.
Have a Laboratory Evacuation Plan
If it is likely that the laboratory will be left empty for a week or more due to evacuation orders or damage, develop an “extended closure” checklist of required tasks to be performed before evacuating. Depending on your circumstances the list could include:
- Shut down instruments appropriately
- Backup all possible data
- Unplug electronics susceptible to power surges
- Close all biological safety cabinets or fume hoods
- Ensure all chemical containers are closed and secured
- Move items to higher ground and/or cover instruments with waterproof tarps
- Move paper records to safe area or into waterproof plastic bins
- Call staff to inform them of closure
- Change telephone message and/or website to tell patients and clients you are closing
In cases of fire or an immediate emergency, there may not be time to perform appropriate shutdowns or move items to safety. However, before leaving, always shut off sources of heat or flame, such as hotplates or Bunsen burners, and shut the hoods of biological safety cabinets or fume hoods. Leaving them open can cause fire to spread more quickly through the building. Check all rooms before exiting the building, and close all doors behind you once you are certain that nobody has been left behind.
Pathology laboratories should consider how tissue specimens will be managed during a potential closure. Left in a processing instrument, tissue specimens may be subjected to prolonged exposure to heat, processing chemicals, and hot paraffin, which would compromise the end quality of the specimen. If the laboratory is aware of a likely closure or delay, they may choose to hold tissues in formalin in a secure location within the laboratory, rather than starting a processing program.
Preserving Documents and Records
Paper records are at serious risk of damage or destruction by fire and water. The best way to avoid losing important documents is to maintain electronic copies of records and be as “paperless” as possible, especially if electronic backups of data can be stored offsite or in a cloud data storage service.
If time and the volume of paper records allows, move them off-site to a secure storage facility. Use caution if bringing records to a staff member’s home for safekeeping—the laboratory is still responsible for those records and any HIPAA violations that may occur. If anything is removed from the premises for storage, keep a detailed list of what has gone, where, and with whom, to ensure recovery of all records later.
In some cases, records can be reprinted or recreated. Many instruments keep quality control and patient data in on-board memory, and copies of previous proficiency testing (PT) records can be requested from the laboratory’s PT provider. If personnel competency records are lost, perform new competency assessments as soon as possible.
Keep in mind, however, that it is never acceptable to back-date or otherwise falsify documentation. While signatures and dates will be missing on any reprinted records, it is better to review and re-sign documents on the present date and to write up an incident report documenting what was lost and how the problem was handled. When those records aren’t available for review, your surveyor will want to see a written explanation.
Protecting Instrumentation and Supplies
If possible, have critical equipment such as refrigerators or freezers plugged into outlets that are powered by building generators in case of a total loss of power. Note that portable generators should never be used indoors, because carbon monoxide levels in an unventilated area can quickly become fatal. In the case of an extended power outage, the laboratory should have a plan for preserving reagents and other temperature-sensitive supplies. This can include use of coolers filled with ice or dry ice, or a refrigerated vehicle, depending on the circumstances. If temperatures exceed acceptable ranges, in most cases the stored reagents and materials cannot be used for patient testing. Consult with the manufacturer and with your regulatory agency to determine what can be done in the event of reagents being subjected to high temperatures.
If the laboratory is being evacuated and there is a chance that staff will not return for several days, refer to instrument manuals for appropriate shutdown procedures and be sure to unplug them, if recommended, to avoid damage from power surges.
Maintain a list of all current hazardous chemicals in the laboratory and where they are stored. Keep a copy of this list posted outside of the laboratory entrance so that first responders can access it quickly. Be sure that all hazard labeling is accurate and clear, as emergency responders will need this information when they enter the laboratory space. In the case of an evacuation of the laboratory, secure all chemicals in their appropriate storage spaces.
Data Recovery Planning
The laboratory IT department should have a disaster plan and disaster recovery plan to protect, maintain, and recover all laboratory systems, data, electronic documents, communications, instrument interfaces, software, hardware, and other critical components, should there be interruptions.
Returning to the Laboratory
Once local authorities declare the emergency over and it is safe to return to the laboratory, perform an initial damage assessment. Are instruments still operational? Does the building have water and power? Have temperatures exceeded the allowed ranges in storage areas?
There may be limited resources, such as staff and supplies, during the recovery period. It is important to identify the operations that are the most vital to the institution to prioritize scarce resources to those operations during initial recovery. Cross-training staff is key to maintaining continuity with critical functions when the laboratory experiences staffing shortages due to a disaster. Remember that training must be documented prior to someone performing patient testing that they have not done before.
Contact your accreditation organization (AO) or state CLIA office to notify them about what has happened in your laboratory. They may need to reschedule a planned survey or provide an extension on corrective action documentation that may have been owed to them. They will provide guidance on documenting any damaged or destroyed records, or deviations from normal procedure that occurred because of the disaster event.
Some testing may not be able to be brought back online immediately, either due to instrument damage, loss of reagent or quality control material integrity, or lack of available personnel to perform the testing. The laboratory may also be unable to obtain reagents, personal protective equipment (PPE), and other necessities because of supply chain problems or delayed shipments due to weather conditions or damage to the surrounding infrastructure. If this is the case, assess inventory and determine what testing can be safely and accurately performed given the constraints, and what should be prioritized to be brought back online. Consider other vendors and suppliers; however, keep in mind that changes in reagents or specimen collection tubes or swabs may change a test’s complexity or necessitate a new validation of the test.
Consult with your AO or state CLIA office before moving forward with any such changes.
Be sure that all providers who use the laboratory’s services know how testing capacity is affected by the disaster. They will need to know what tests can still be performed in-house, what must be sent out to a reference laboratory, and what the new turnaround times are.
If there will be a long delay in repairing or replacing instrumentation, or if the decision is made to temporarily cease testing in certain specialties, contact the laboratory’s proficiency testing provider to let them know what testing is not being performed. If you receive a Proficiency Testing shipment and cannot perform the event due to your circumstances, call the PT provider as soon as possible to learn how to officially report that you were unable to complete the testing. Simply skipping the event and reporting nothing will result in a failure for that event, which can have serious consequences. Be sure to contact the laboratory’s AO or state CLIA office to inform them of the temporary changes to the test menu of the laboratory. Also notify them of the expected timeline for resuming testing; if the changes to the test menu or test complexity are permanent, the laboratory may need to change its CLIA certificate type to accurately reflect the current testing.
Planning for Disaster
State and Federal agencies1 have checklists and other useful information online about how to plan for natural disasters. These can be a good place to start when developing disaster plans, as they will address the most frequent dangers in the area.
Remember that the best way to handle an unexpected disaster is to expect it, and to prepare well ahead of time. Over the course of the next year, review your safety plan with your locality’s most common natural disasters in mind. Discuss “what-if” scenarios with staff, management, and providers, and decide now what actions can be taken in each situation. Put your action plans in writing and be sure that staff are trained on what do to.
Of course, during a crisis, it may be necessary to deviate from the plan. If this happens, be sure to document what decisions were made and the rationale behind them. These will be important for your AO or CLIA surveyors to see, and will also be a valuable resource for learning as you continue to refine your disaster plans to provide the best possible safety and security to your laboratory, staff, and the patients who rely on you.
ABOUT THE AUTHOR
Jennifer MacCormack is COLA’s technical writer, developing webinars, technical bulletins, and educational materials, as well as articles for external publication. Prior to joining COLA as a technical advisor, she had more than 15 years of experience as a medical laboratory scientist, working in hospital core laboratories and transfusion services in both the U.S and Canada. She also worked in development and manufacturing of blood typing antisera. Her work has been featured in several industry publications and science communication blogs.
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