As laboratories are highly specialised commercial and industrial spaces, facility managers and their teams are required to abide by all the regulations relevant to their industry and locality.
The regulatory requirements for ethical laboratory management and maintenance are interconnecting, with dynamic standards being developed and updated routinely to ensure laboratory operating practices stay up-to-date with consumer laws, healthcare industry regulations, and Australian OHS regulations.
Here are just some of the key regulatory requirements that laboratory facilities all across Australia must abide by to ensure they’re operating legally, comply with all relevant regulations, and thus, ensure they’re still eligible to receive funding and grants across both governmental and non-governmental supporters.
OHS for Laboratory Workers
From ensuring the responsible and safe disposal of hazardous chemicals to keeping flooring and work surfaces sanitised and free of obstructions, OHS requirements for laboratories must naturally cover an extensive range of criteria.
Thankfully, facility managers and staff can meet this extensive criteria more readily by securing ISO 15189 for medical laboratories and ISO 17025 accreditation for calibration and test laboratories. Using the frameworks outlined across these internationally recognised standards, laboratories can also implement OHS policies within a wider operational management system. These management systems effectively integrate safety management processes into daily operational processes for laboratories.
Worker Accreditation Standards
Worker accreditation is another evergreen concern when it comes to laboratory regulations worldwide. Ensuring laboratory workers all possess the right qualifications, licenses, training and experience to work across different equipment and technologies is foundational for maintaining regulatory compliance.
As accreditation is tricky to standardise internationally due to variations in tertiary courses across different regions and markets, worker accreditation standards are set by local regulatory bodies. For instance, in Australia the worker accreditation standards for medical pathology services are established by the Australian Commission on Safety and Quality in Health (ACSQH).
For other industries (food packaging and production, consumer technology, automotive engineering etc.), accreditation standards are established and upheld by relevant governmental and industry bodies. A good example here is ANCAP.
In Australia and New Zealand, the Australasian New Car Assessment Program (ANCAP) acts as a vehicle safety advocate, providing vehicle safety ratings determined by thorough vehicle testing processes. As an independent body, ANCAP sets their own standards for NCAP (New Car Assessment Program) testing procedures, but their position as an industry voice ensures that ANCAP safety ratings hold a certain level of weight with consumers. In fact, poor ABS testing or crash test results are enough to turn Aussie car shoppers off models and even manufacturers entirely.
This prompts vehicle manufacturers to design car models with respect to ANCAP safety benchmarks. Over time, ANCAP’s work and the work of other vehicle safety advocates globally, work to standardise automotive safety in the consumer auto industry.
Risk Assessment & Quality Assurance
Risk management is always likely to be a foremost priority for facility managers for a range of different reasons (i.e. insurance, liability management, employee and consumer satisfaction rates, etc.). Outside of legal considerations, risk management is also essential for reputation management. As laboratories often produce media releases for public announcements, reputational damage can greatly impact the authority of future media stories in the long term, and affect facility eligibility for funding in the short term.
The key here is of course, upholding operational practices that not only aid in identifying risks but also mitigating them. These same operational practices utilise standards (like the aforementioned ISO standards or even standards developed by local industry bodies) to support facility managers across both risk mitigation and quality assurance.
For example, the ACSQH plays a vital role in supporting the quality of medical pathology services in Australia. The regulatory frameworks provided by this government agency is also foundational to medical laboratories being eligible to receive funding from within the public sector.
Equipment & Facility Requirements
Working with corrosive chemicals? Then you’ll need a safety shower installed in your laboratory? Working with hazardous waste? Then you’ll need clearly labelled waste bins and waste disposal partners.
In this regard, different types of laboratories naturally have their own equipment and facility requirements. For instance, the ACSQH outlines that chemistry labs must include designated areas for different processes (i.e. testing, specimen collection, storage). These different areas must also only be accessed by authorised personnel and no laypersons who may disrupt facility operations or tamper with the outcomes of chemical testing.
Data Privacy Considerations
As we transition further into the digital age, data management has become an increasingly important consideration for laboratories. Data privacy policies naturally vary from industry to industry, with medical laboratories investing heavily in patient file management.
Contrastingly, research and development laboratories are more likely working across managing data-based results (i.e. the results of product testing processes). It can take months or even years of testing before some consumer tech or other products are given the green light for commercial development. And for in-demand products like new gaming consoles, data leaks may result in test results (that potentially outline operational faults) to be made publicly available prior to the product’s commercial launch.
In much the same way that patient file leaks can put individuals at risk, leaking data relating to faults surrounding consumer goods, grocery store items like canned or packaged foods or even medical products (like vaccines), can have longstanding consequences, including the development of unfounded claims and consumer biases. Simply put, data leaks from laboratory facilities have the potential to result in tens of thousands if not hundreds of thousands of dollars’ worth of damage.
Ethical Conduct Policies
Depending on the nature of the work being carried out, some laboratory personnel may be required to sign non-disclosure agreements to safeguard data or results that are yet to be made publicly available.
However, there are other ethical conduct considerations that laboratory workers must make depending on their industry or sector. For instance, medical laboratories must abide by healthcare sector ethical conduct policies, whereas consumer ethics are more likely to be a concern across research and development or food science laboratories.
Ethical conduct policies for laboratories typically also cover the misuse of laboratory equipment and facilities or even the misappropriation of laboratory funding. For laboratories seeking government funding for research purposes, there are likely to be very strict guidelines in place covering the utilisation of those financial resources to ensure that taxpayer dollars aren’t being needlessly spent.
Preparing Australian Labs for a Future of Homegrown Innovation
From calibration and testing facilities to medical, ecological, and bioscience laboratories, the tireless work done by laboratory technicians across the country help to drive Australia forward.
ISO 15189, ISO 17025 and other international standards provide frameworks that support facility managers and their staff in upholding ethical practices across laboratory environments. Similarly, Australia’s state and federal industry regulatory bodies like the ACSQH also support management teams in integrating practices that comply with industry regulations.
With the tireless efforts of these industry bodies and the commitment of facility managers and their teams, Australian laboratories can continue to deliver results that go on to benefit not only local communities but global populations as well.
