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Responsibilities and benefits of lab compliance

Laboratories, Biobanks and other biological sample repositories have to comply with a number of legal and industry controls. These are often seen as a burden. However, if you carefully consider the responsibilities and benefits of lab compliance then the advantages can far outweigh the effort.

Compliance involves you having the required policies and procedures to ensure adherence to the law.

However, recognising that these initiatives are designed to drive quality and improve lab operations, you can change your approach to compliance. Therefore, focusing on gaining optimum benefits through compliance rather than simply going through a tick in the box exercise.

 

Consider your customers when identifying the benefits of compliance

Benefits of lab compliance

Your business goals and objectives will change over time, so it is important to regularly review and update your procedures.  Every lab or biological sample repository has “customers” – those groups and institutes that require your services or outputs. These outputs can include test results, processed specimens, samples for research or documented proof of legal compliance. An effective lab evolves in response to changes in its customers’ needs.  Further your “customers” may require you to comply with certain guidelines or have a particular accreditation.

To facilitate this process, you should consider a feedback loop between your customers and your lab management. This approach will allow you to identify changing needs and implement responses. As you apply the changes, you should monitor the effects to ensure that the expected benefits are actually being realised.

In addition, you should consider any changes in line with accreditation or compliance guidelines.  These can help steer you towards best-practice approaches and instil quality considerations from the beginning.

 

Understanding the different types of lab compliance

The responsibilities and benefits of lab compliance involve legal regulation such as the dreaded acronyms HTA, MHRA and GDPR. They also include formal industry best-practice accreditations such as ISO 17025, ISO 15189 and ISO 20387.  In addition, these may also include guidelines such as the Caldicott principles and ISBER best practices.

 

What do you have to comply with?

Depending on the types of samples or data that you handle in the UK you will need to comply with one or more of the following laws. In other countries there are equivalent regulations.  The legislation you must comply with depends on your type of collection. Human tissue has very specific legislative controls and donor-identifiable tissue even more so. The type of processing of the samples is also relevant, so if it is related to drug or medical device development then MHRA is applicable.

  • Human Tissue Act (HTA) – This is law in the UK although it is enacted via slightly different legislation in Scotland. This controls the tracking and auditing of all human-identifiable cellular tissues. In addition to covering the provision of and the withdrawal of informed consent. Each licence has a Designated Individual named on the licence who is liable by law for the institute’s compliance
  • Medicines and Healthcare products Regulatory Agency (MHRA) – This is law in the UK and is relevant to labs and institutes involved in the production of medicines and medical devices. It is necessarily very stringent and ensures that medicines and medical devices work and are acceptably safe
  • General Data Protection Regulation (GDPR) – This is law in the UK and Europe and covers the appropriate management and safe storage of personal data. It is relevant to all institutes that hold data about people

Industry accreditation and guidelines

In addition to the legal regulations there are several accreditations that you may decide are valuable to achieve. The most relevant standards you may seek to be accredited for depend on your type of lab or collection with diagnostic, calibration and research each having their own accreditations. Finally, there are the “best practice” guidelines that you may decide to adopt.

  • ISO 17025 – This European standard is recognised not just in the UK and Europe but is relevant to labs worldwide. It is a general standard for competence of testing and calibration labs
  • ISO 15189 – This European standard is also in use widely in the UK for medical labs and is a standard for competence of medical diagnostic labs
  • ISO 20387 – This European standard is also in use widely in the UK and is a standard for tissue processing along the lines of HTA safeguarding impartiality and underpinning confidentiality protection. It is sometimes known as “ISO 9001 for labs”
  • Caldicott Principles – These guidelines were commissioned by the UK Government and underpin the ethical usage storage and sharing of patient data in the UK
  • ISBER best practices – The International Society for Biological and Environmental Repositories is a respected body that has produced a very thorough set of recommendations in relation to best practice in the operation of biological sample repositories

When considering the benefits of compliance

Compliance

Naturally you have to comply with the mandatory legislation.  However, for any additional accreditation, you decide which are appropriate for you and which guidelines you want to adopt.  This is all driven by what your customers want and will respect. Those accreditations confirm that your processing is professionally managed and uphold values that your customers will respect. Even the legislative compliance, although mandatory, still supports your reputation and builds trust.

The benefits of your compliance fall into a number of categories:

Reputational benefits 

Those logos you have on your website, publications and paperwork all contribute to your reputation. They show that you adhere to rigorous standards. They often come with affiliations on specialist websites and social media and generally help to get you noticed. All this helps to raise awareness of your services and that helps the inflow of new customers. New and existing customers gain confidence. As a result. this brings in business, which helps with the finances, whether that is cost recovery for a not-for-profit facility or revenue for a self-funded business.

Supporting funding bids

Funding bodies always strive to ensure that their funding is used to maximum benefit. One very important factor in those assessments is the ability to measure outcomes. That measurement relies on robust auditing of procedures. If those procedures are standardised that makes it easier to measure and compare. Accreditations and standards marques all increase the confidence of funders that your services will be professional and efficient.

Internal process efficiency

Standardising your processes according to best-practice allows you to benefit from the years of experience and process development already done by others.  In addition, these processes are designed to be easily audited to prove compliance. Even where you need to develop your own processes the ISO standards indicate clearly what needs to be measured and why.  This allows you to consider this when developing your own processes.

Efficient processes lead to fewer mistakes, require less time to carry out and result in better data quality.

Improved data quality

Standardised processes result in more consistent results and this is because the processes are more easily repeatable.  Their documentation should dictate how measurements are taken, how they are recorded and which units of measure are used. They also help to ensure that all required values are recorded so incomplete data should become less of an issue. Using a computer system that enforces mandatory fields and checks data types and pre-defined lists of allowed values also helps. However, having a process that all staff understand and follow is a necessary first step.

Confidence of study donors and collaborators

Again, accreditations and supported standards add confidence for other parties with whom your lab deals such as tissue donors who make generous commitments to support your aims. That might involve donating tissues or giving access to data and also giving up their time to complete paperwork such as informed consent and questionnaires. Donors should have confidence that their tissues and data are being used and protected in a professional manner to the agreed aims of the project. Collaborators also need that confidence that the time and effort they invest in working with your lab is well spent and that their standards are matched (or exceeded) by your lab’s, to the benefit of both.

Standardising processes

If staff are carrying out the same process in slightly different ways then any discrepancies can cause serious issues. For example, if processed samples are not ready for the next processing step at the same time-point/location or processes stall because of missing paperwork or data updates. These little stall points typically require checks and discussion between staff.  At best, this interrupts them and detracts from what they should be working on. At worst, the process stalls or continues without the required information or approval.

However, if everybody works the same way then you can anticipate confirmation points.  In this way various processes can be optimised to ensure the least interruption for all concerned.

Improved biological sample viability

Whenever a process stalls this can potentially cause issues with sample viability. Any delays to process can lead to biological samples being sat at room temperature for extended periods of time. This is not optimal for their viability and unplanned delays in processing/freezing can have an impact on their quality. Standardised processes, whether by legal requirement, adoption of accreditations or by following industry best-practice, result in clearer flows of lab work, fewer holdups and better quality samples.

 

Challenges with lab compliance and standardisation

There are clearly a lot of benefits, so why isn’t every lab standardised already? There are challenges.

Time to set up and audit

Auditing Laboratory Samples and Processes

Very often lab staff are running at 100% utilisation just keeping up with day-to-day work.  Therefore, taking time out to set up and carry out audits of current processes is a real challenge. Add in absences due to illness and annual leave and it becomes doubly difficult. However, if you cannot break that cycle you will be running flat out indefinitely.  You will just compound the issues that have already been highlighted. You need to make time to do some auditing to identify the issues and then you can go to management with evidence that change is needed. Audit data also helps with the inevitable external audits, whether they be HTA, MHRA or ISO assessments, if you already have evidence it makes the auditing process much less stressful. Finally, when you have optimised your processes you can look back and wonder “How did we manage with the status quo how it was?”.

Inertia and fear of change

Resistance from staff is often a barrier, especially if they have been in post for a long time. The often heard “We’ve always done it like this” can seem to be justified sometimes. If the process has not changed for a number of years that obviously means it is standardised? Well, no. Standardisation is not the same as consistency. It is about having the same process as other teams and institutes and, importantly, between different staff in the same lab. Lab staff should not be working to processes that are just in their heads or individually documented. The documentation should be for all staff and should be available for interrogation by external parties. It can take you time to change your processes in the short-term, however, they should bring big benefits once bedded in and are familiar to all.

Costs of memberships

Accreditations and compliances come at a cost. Even if there is no group membership fee (very few are free), you still have the cost of your team’s time spent auditing and implementing changes. However, it is easier to justify the costs if you are clear on the additional value accreditation will deliver.

 

In summary

The responsibilities and benefits of lab compliance can be expensive in terms of time and money.  However, these should be greatly outweighed by the benefits of having efficient, optimised processes that are clearly documented and periodically tested to evidence that compliance. Your business will be more professional as a result.  Further, you can reinforce your professionalism through accreditation which leads to recognition by your funders, biological sample donors, collaborators and your peers.

More information


Our team is ready to discuss your lab compliance questions and challenges to see how we can help you improve quality across your data and processes