Sonic Healthcare USA

Laura Segovia

Laboratories are vital in many research and diagnostic fields, including healthcare, environmental science, and biotechnology.  However, due to regulatory, economic, and other pressures, it’s becoming more and more common for healthcare and other laboratories to relocate, reorganize, downsize, or fully shutdown.  My recommendations could be helpful for laboratory business operations leaders and other impacted stakeholders to evaluate, make strategic decisions, navigate, and execute these types of change initiatives.  It is also essential for laboratory staff and other stakeholders involved to grasp the essential elements of laboratory closure or change plans to comply with federal and state regulations during relocations, reorganizations, or downsizing efforts, or full lab shutdowns.

Planning should begin ideally at least 3 months in advance prior to the lab transition or full shutdown.  A Project Manager should be appointed to assist with the facilitation, planning, and execution of these initiatives. A Project Plan and laboratory transition or closure plan should also be prepared that specifies how to safely transition or shut-down laboratory operations.  They should also include strategic communication, resource, and implementation plans, also address risk management. A solid understanding of applicable federal and state laboratory regulations will also help ensure compliance with environmental safety and other regulations and provide human health protections.

Regulatory agencies include the Food and Drug Administration (FDA), which regulates diagnostic tests and laboratory equipment in the United States; the Clinical Laboratory Improvement Amendment (CLIA), which sets standards for laboratory testing to ensure accuracy, reliability, and timeliness of patient test results; the Occupational Safety and Health Administration (OSHA), which oversees safety practices in medical labs and phlebotomy facilities; and the Centers for Medicare & Medicaid Services (CMS), which oversees laboratory services reimbursement and ensures compliance with federal regulations to protect patient safety and prevent fraud and abuse in the healthcare system. Properly managing and disposing of chemicals and other hazardous wastes is also crucial and should include knowledge of and adherence to established hazardous materials transfer and disposal methods. Non-compliance can result in injuries, even death, or at a minimum, fines and legal troubles. Compliance consultants can also lend support in developing tailored lab transition or closure plans specific to the laboratory needs.

“Properly managing and disposing of chemicals and other hazardous wastes are crucial and should include knowledge of and adherence to established hazardous materials transfer and disposal methods.”

Other ‘Best Practices’ for lab relocations, reorganizations, downsizing, or full lab shutdowns include collaboration of interdependent teams such as Project Management Office (PMO), executive, medical, scientific, legal and compliance, and other leadership, IT, finance, operations, marketing and sales, and relevant vendors to assess and manage inventory, ensure protocols development like creating specific protocols for handling and disposing of materials safely, properly train all staff involved, complete any necessary technical and network deprovisioning, timely communicate with impacted stakeholders, also transfer or terminate payor, vendor, and other product or service contracts, and assess value, transfer, and dispose of equipment, furniture, and other items. Throughout the change process, there should also be routine status/check-in meetings and thorough documentation.

Laboratory, and especially patient data, should also be backed-up and secure. Continued customer service and the ability to access patient historical records, slides, and other materials for the last 10 years should also be arranged, and communication and operations processes established. If the property or space is leased or owned and no longer needed, arrangements need to be made to immediately sub-lease or sell the existing property or move into a new space.

If a Reduction in Force (RIF) occurs, fair and competitive compensation packages should also be timely issued, also human and other resource arrangements made if terminated staff leave prematurely to ensure continued lab quality and safety until the research and testing initiatives officially transition or cease.

If Lab Operations are expected to continue without interruption, any new construction or procurement of required diagnostic and other equipment or materials should also be coordinated to align with the scheduled move or downsize date.  It’s also especially important to timely communicate with and discontinue or transfer any connectivity with vendors and clients, such as hospitals and outreach clients, to maintain security.  Also, these requirements, processes, and timeline may differ, depending on the client, vendor, and resources available.  Business financial reconciliations post-closure also need to take place and be accounted for in terms of invoices, asset transfer valuations, change of address, or other.