Laboratories are full of hazardous materials such as precursors, lead, benzene, and other chemicals, indicating regulatory compliance is a must for all laboratories. Not only does compliance help to mitigate unnecessary risks of working in such an environment, but any violation can attract a fine of more than $30,000 per day per violation, along with criminal penalties.
Every institution will have different regulations depending on the type of work and hazards in that environment; however, here are six ways to ensure employee health and safety with regulatory compliance can be achieved in your preclinical laboratory.
Delegate an institutional system or a department that will solely focus on complying with the laboratory’s Environmental Health and Safety (EHS) needs. The department will feature health and safety specialists and inspectors who will ensure compliance within the lab.
Depending on your location and lab operations, there will be different statutes and regulations to comply with. Health and Safety Personnel, Compliance, and EHS leaders must focus on these significant federal agencies:
Having a separate department dedicated to regulatory compliance and risk management will help your lab maintain its regulatory compliance during regulatory audits provided by the agencies that deal with the regulation of workforce safety and associated handling and storage of laboratory chemicals.
Enforcing regulatory compliance within lab operations is only as good as the compliance of its personnel. All employees must receive direct and detailed training on the tasks and performance requirements of the job. You can appoint a staff whose responsibility will be staff training, document control and assessment of personnel, and sensitization of good clinical laboratory practices.
Such training should include courses and in-house training on proper laboratory practices and compliance requirements. Furthermore, the appointed staff or compliance department should inform employees of updates regarding regulations and standard operating procedures as policies evolve in relation to the pivotal stances of regulatory bodies.
All laboratory equipment must function effectively and efficiently, as per the manufacturer’s specifications. To ensure compliance, the staff must inspect preventive maintenance and service on the equipment as per the company’s program, either daily, weekly, monthly, or annually. Ensuring proper maintenance and calibration of equipment not only maintains compliance, but it maintains a safer working environment for the entire workforce.
The lab must document all preventive maintenance, service records, and calibrations on the equipment, after which the lab director must review, sign, and date all documentation for accountability purposes. The lab should also maintain records of monitored conditions and temperatures to be compared against other reports. In case of changes, the lab must perform corrective actions.
Lastly, the lab should have Standard Operating Procedures (SOPs), which shall guide laboratory activities on the quality and integrity of lab standards. These SOPs will help test performance laboratory processes.
OSHA and EPA standards often influence the design and construction of laboratory buildings, whether it is regarding storage, workers’ safety, or the efficiency of the laboratory tools and equipment. Therefore, here are a few regulatory requirements your laboratory must follow:
OSHA also quotes, “It’s the laboratory manager’s responsibility … to apply scientific knowledge in safeguarding workers against risks, even though there may be no specifically applicable OSHA standard.” Therefore, implement additional guidelines that will protect your personnel’s’ health and safety.
Besides the significant federal agencies stated above, some other organizations and societies could guide you towards compliance and other laboratory health and safety issues. You can join such institutions to benchmark and learn about assessment, implementation, and program development.
Examples of such professional societies include:
These societies often discuss proposed regulations and compliance procedures that could help your laboratory as well.
Lastly, you can create system analysis programs to ensure seamless compliance through organizational structuring, training, and assessing. A unified compliance, predictive risk, and quality management system (QMS) such as CQRM XD will ensure maintenance and quality of laboratory operations by planning out lab objectives, recording lab procedures, and assigning responsibilities to laboratory staff.
The Quality Manager will work with the lab’s quality control (QC) and quality assurance (QA) programs to evaluate the lab’s performance and enhance its functions, such as inventory control, parallel testing, review of data, and quality control logs. Furthermore, such programs can also help with documentation and resolution of issues within the lab.
The importance of employee health and safety for laboratories is crucial because there are many risks associated with employee health and the potential consequences of regulatory violations. Therefore, to ensure workforce safety in your preclinical laboratory, you must create and maintain good clinical laboratory practices that will ascertain all personnel’s proper health and safety. Emidence XD helps employers minimize risks and manage compliance to create safer workplaces. With Emidence XD, you can manage incidents, workers’ compensation cases, industrial hygiene, safety investigations and audits in a comprehensive unified system.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.
Head of Sales: APAC | Head of Operations: India
Priya is responsible for Xybion business growth in APAC region. She brings over two decades of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.