Business Continuity in Environmental Contract Testing Labs

The goal of business continuity is to ensure the health and safety of all employees, to protect company assets and minimize negative impacts of a potential interruption to normal business functions. A business continuity plan helps to ensure a facility can return to normal operations as quickly as possible after a crisis. Minimizing a potential impact to customers by maintaining business operations prioritizes the business and customer partnership and protects the businesses financial interest. The proactive planning and ongoing activities associated with a business continuity plan ensure business units can continue to support operations in the event that something interrupts the standard business routine.

PART 1: Business Interruptions and Major Risk Areas

There are a variety of business interruptions that can emerge from minor instances including power outages or an inclement weather event, to those more severe including natural disaster, fire, workplace violence, economic or political situations or unrest, terrorist attacks, infrastructure failings or a global pandemic. Depending on the type of event, different challenges may arise. If inclement weather closes the business, usually operations can resume within a day to a few days. If the event is of limited duration, work can be resumed upon opening, and catching up on a back-log may be easily remedied. If severe weather occurs such as a hurricane or tornado, and there is resulting infrastructure failings, more substantial challenges may need to be navigated at a rapid pace. Environmental laboratories do not close for any length of time due to their continued brick and mortar operations requirements. Depending on the type of crisis, the impact on workflow and the ability to maintain standard processes can vary significantly.

Major risk areas associated with environmental laboratories can include:

• Issues with access to LIMS and other critical IT platforms
• Inability to operate and maintain instrumentation
• Supply chain interruptions (necessary consumables for analytical testing, PPE for scientists and technicians)
• Inability to analyze (or process) time-sensitive samples
• Sample chain of custody broken (or loss of integrity)
• Loss of or inability to access sample data/results

IT problems even in the short term can have devastating effects on the productivity of a laboratory. For environmental labs to comply with chain of custody requirements set by environmental regulatory and accreditation agencies, a digital or hard copy (paper) must be maintained. If LIMS access limitations surface due to a disaster event, accessing important data may be a concern. Often, this data is stored or replicated in several places so that there is redundancy.

Customer sample results and reports are documents that must be provided to demonstrate compliance with permit terms, for regulation maintenance and to validate sufficient remediation has been performed after spills. Redundant systems can also act as a back-up including servers and redundancy in the data itself.

Laboratories require a variety of consumables for performing analysis of environmental samples. The consumables can be PPE, but it can also be septa, needles, vials as well as chemical standards and reagents. Some reagents require temperature-controlled environments therefore power interruptions can be detrimental. If temperature control is not maintained, reagents may need to be discarded.

As the world has observed with COVID-19, supply chain interruptions have the potential to immediately prevent work from continuing. PPE is critical to keep laboratory staff safe under regular conditions, and supply chain interruptions that slow or prevent PPE shipments from arriving to laboratory staff can be debilitating. Finding alternative supply chains to ensure required consumables and materials allow for a lower potential impact if a preferred vendor is unable to deliver on purchase order requests.

Laboratory equipment and instruments are highly specialized and need periodic maintenance performed and occasional vendor support. If travel restrictions are in place, service specialists may not be able to physically reach the site for routine or unplanned maintenance. Ensuring labs have redundancy in one or more of the following is critical to keep the lab and instruments operating: instruments, laboratory testing analysts, and skilled service and maintenance resources. This critical aspect keeps instruments running, especially when the typical resources are not available for calibration, maintenance, and servicing.

For equipment that is temperature-sensitive, ensure that an alarm system is in place to alert an individual or team of out of range of pre-set temperature parameters.

Local, state, federal or global travel restrictions may result in difficulties in sample collection and transport, therefore complicating the ability of the laboratory to effectively receive and process samples and related documentation. Adjustments to processes pertaining to sample receipt and chain of custody are also important to ensure that samples are received and tested without breaking the chain of custody within the designated timeframe per the specifications associated with each different sample type.

Documentation of all risk areas with secondary and even tertiary plans for adjustments to workflow and processes should be put in place preemptively to avoid significant interruption to the standard business operations. The quicker the laboratory can return to normal business operations, the better the financial and business outlook as well as limiting the impact to customers.

PART 2: Creating a Continuity Plan

The intent of developing a plan in anticipation of a disruptive event is to ensure the contract laboratory maintains the capability of performing critical operations, e.g. analytical testing during an unplanned crisis. By investigating which applications and processes play key roles in the maintenance of business operations, a robust plan can be generated to guide and support in times of crisis.

The process of developing a plan allows business continuity team members to investigate and evaluate current processes at a granular level not only in terms of preparedness planning but can also be used to highlight inefficiencies or gaps in processes for corrective action. A business continuity plan can include sections pertaining to communications with internal and external clients and vendors, technology workaround processes, staffing measures, training and preparation, documentation steps and actions to ensure regulatory compliance.

The goal of business continuity planning is to isolate key business functions, services or activities which are required to sustain ongoing business operations. Highlighting these main areas of focus will help to guide restarting operations following a major crisis. It is important to isolate the necessary functions from supportive functions. Necessary functions are the most impactful, and if stopped in the short or long-term would pose a substantial threat to the well-being of the business. Supportive functions are those that can be suspended in the short term to conserve and pool resources for the maintenance of essential areas of focus.

Business continuity team members often include laboratory management, IT managers, operations management, quality directors, and lab directors. These key roles maintain business functionality under normal circumstances. Keen insights gathered from expertise and knowledge of the intricate details of day to day operations, quality control, and management should be combined to create a robust and comprehensive risk mitigation strategy in the event of a disaster. In times of crisis, the efforts of operations, quality, and laboratory management are critical to the well-being and success of the business. Laboratories core functions may include conducting research, communicating data testing and delivery timelines with clients, maintaining supply lines to receive consumables, sample receipt and documentation, and staff management.

When determining what resources are required to maintain operations, focus on how many staff are required, what consumables or equipment are needed to allow staff to complete their daily tasks, and an accessible safe physical location in order to perform essential work duties. Assessing minimum set limits for staff, consumables, and instruments uses risk mitigation planning to build a framework capable of withstanding business interruptions with as limited impact as practically and financially feasible.

PART 3: COVID Vigilance

The global COVID-19 pandemic has affected businesses across all industries. With shelter-in-place orders forcing many job roles to transition to remote-based communication, the ability to maintain brick and mortar operations has grown increasingly difficult. COVID has presented an array of challenges to essential laboratory businesses, with trained personnel required to receive sample shipments, run tests, and process data while maintaining social distance protocols, and adhering to local and state-level travel or employment restrictions.

Business continuity team members including laboratory management, operations managers, quality directors, and lab directors have had to adjust workflows in order to accommodate COVID-19 specific guidelines to include measures for social distancing, workforce availability, cleaning and sanitization, and COVID-vigilance. Protecting the health and hygiene of employees, visitors, and vendor support is the main goal of COVID-19 laboratory measures.

Adjustments to signage throughout the building can assist in controlling the flow of essential personnel to limit access and clustering. Ensuring a point-of-contact responsible for site-wide communication and notification is imperative to ensure that both remote and on-site employees have the most current and pertinent information available to maintain the health and safety of essential personnel.

Adjustments to the usage of common spaces such as hallways, conference rooms, designated workspaces such as desk cubicles, and laboratory space can be implemented to control for flow of traffic and social distancing. The addition of another working shift, having remote access to instruments for their status, conditions and/or running batch samples overnight can further support the productive but remote or scaled down staffing due to social distancing requirements. Regulations limiting what personal items may be brought from home into the office can prevent cross contamination or possible exposure to other employees. Increased cleaning and sanitization of spaces both inside and out of the lab can help limit potential exposure. Mandates for wearing masks while in the building, temperature monitoring, and ensuring 6-feet social distancing is practiced can also help to prevent the spread of COVID-19.

Implementation and Maintenance

Developing and implementing a business continuity plan in the environmental laboratory setting takes time, effort, and critical planning through cross-collaboration with a multi-dimensional team of laboratory managers and directors, operations directors, and quality management.

After isolating key risk areas, developing rigorous alternative workflows and processes, and ensuring all adjustments are documented within regulatory guidelines, maintenance of the plan is required. As businesses evolve and change, the business continuity plan needs to be updated with pertinent and critical information to ensure it is a living document reflective of the most current business practices and needs. Adjustments to include more extensive risk mitigation strategies can work to improve the document and protect against potential business threats.