So, how safe is your freezer?

This year as a direct result of an un-expected freezer failure, a laboratory lost 1/3 of their collection of autistic brain samples after a freezer failure. To put this into context, their collection is the world’s largest and therefore, the autistic research community now has a massive gap in their research continuity.

In this case, as so often, there were no clues of potential failure. No performance temperature data was being collected, examined or checked for variations in performance.

This sad example highlights how low-cost automated monitoring systems alone are not the answer. In the case of the lost brain samples, it is possible the automated system did sense the rising internal temperatures. But it could only send out automated phone calls or texts to a list of employees and go down the list until someone acknowledges the call. It’s possible that someone got a call over the weekend, but decided to wait to check it when they arrived Monday morning. But whatever the reason, it was too late!

The health of a freezer is critical to the safe storage of samples; a deviation of temperature, no matter how brief or how small, may ruin one’s life’s work or that of a team.

Could monitoring data have spotted the failure in time?

In the retail sector, where the potential loss of stock and margin erosion is a constant issue, the widespread use of real time monitoring means they are safeguarding not only valuable inventory in their fridges and freezers, but also simultaneously improving customer experience and reducing their energy consumption. The wealth of data collected provides critical insight to empower informed decisions, at all management levels, to reduce risk.

The Tutela monitoring system is currently protecting fridges and freezers in pharma, biotech, and academic labs, as well as over 1000 sites around the NHS, every minute of every day. We have uncovered valuable insights into the behaviour of these fridges and freezers, discovering performance differences by usage; even supplier. The effects of ambient temperatures, doors left open or poor seals, can all be monitored, and data collected and benchmarked to enable best practice over large sites; even purchasing policy.

The potential to save money and reduce loss is enormous, but automated calling systems can give a false sense of security.

We all prefer talking to real people

I started this article with the example of the automated system calling notification that was ignored and the substantial loss that can occur as a result.

The simple fact is not only do we prefer talking to real people, we also take this sort of contact more seriously than an automatically generated text for example. Tutela provide a fully trained alarm response team, who can contact your employees personally, clearly describing the problem in clear easily-understood language. The potential seriousness of the excursion is then acknowledged, an incident report is raised and a follow up action emailed. This kicks off the audit trail and lessons for the future can be learned.

What is temperature mapping?

Why can’t I just trust the digital display on my freezer?

Back to frozen samples, almost always we rely on the marked digital display to reassure us that our samples are still frozen. However the displayed temperatures does not reflect the variances of actual internal temperature from location to location within your freezer. This inconsistency is due, in part, to the position of the temperature sensors inside the freezer, but how the freezer is loaded can also have an effect.

Typically, sensors are positioned at the top, middle and bottom of the inner compartments. It’s worth reviewing the manufacturer’s test data for your freezer to learn of the temperature lag and precisely where the temperature sensors are positioned. Temperature mapping services provide a highly accurate picture of temperature gradients and behaviour within the unit.

Tutela offer a full, on-site automated solution for mapping temperature excursions, in conjunction with Tutela Monitoring Systems ISO17025 accreditation for calibration.

Because the wireless data loggers are sited internally within the device being mapped, no cables protrude through fixture seals, providing a real situation mapping report.

This is less disruptive, compliant to the Orange book (MHRA) and detailed to meet rigorous certification needs.

Our goals are simple

With clear leadership and independent temperature and data monitoring of healthcare Biotech and Pharma biology assets, together Tutela aim to partner and Improve health outcomes, protect reputations and support the researcher and his team.

We protect your businesses and organisations from catastrophic loss and damage which cannot be recovered and provide auditable data for future trending and preventable loss.

The post How a Lab lost 33% of the world’s largest collection of autistic brain samples. appeared first on Tutela Monitoring Systems.

Manual recording – just a waste of skilled resource?

The method recommended by the GPhC of manually checking fridge temperatures twice a day is no longer fit for purpose for the modern pharmacist. It’s simply not manageable, cost effective and importantly, fails to add any value. It’s become a tick box exercise, and with no checks and balances, open to abuse and ‘retrospective’ inputs.

This almost Dickensian methodology, now in its 50th (yes 50th) year means writing recorded temperatures of the medicine and vaccine fridges on paper, stuck to the fridge door. These days, everything we do must add value, but the GPhC insist that this manual written recording methodology is appropriate to ensure storage temperatures are within the often-tight parameters needed for the safe storage of modern medicines. But is it really? Surely its time to update the official advice?

Within every pharmacy exists the need to demonstrate safe medicine management, and so proper processes need to be in place for the storage and access-control of temperature-sensitive medicines and restricted medicines respectively.

To quantify this, we are talking about basic fridges and freezers and door locks, except the content cost and risk to patients is far higher and the need to monitor these fridges and freezers for temperature stability and access control is far more important. Perhaps more important than you think!

Manual recording – just snapshots with huge data gaps

These twice daily manual checks, typically performed just before the start of business and at the end of the day, cannot take into account any temperature variations, thermostat swings, doors left open, potential predictive failure and alarm calling when failures occur. The existing GPhC and CQC recommended record requirement is simply record keeping and, providing evidence forms filled out are supplied, that’s it. Effectively a twice daily chore – a cost with zero added value!

Even inspection visits are based largely around written forms and to assess how the pharmacy operates with the aim of ensuring that the supply of medicines and the provision of pharmacy services to patients from a registered pharmacy are safe and appropriate.

Manual recording – means patients and/or the community at risk

We have all had experience with a sudden fridge or freezer failure at home, and we have to make choices about what we can save and what we dispose of. If you are a pharmacist or an assistant, how do you know if your vaccines or medicines are safe or not without continuous monitoring? A simple air temperature sensor is not necessarily the best indicator of product temperature and good stock may be wasted. The opposite problem could be that bad stock being kept and risking patient’s health.

Doors not being shut properly is also an extremely common issue leading to a rise in internal temperatures and stock loss, a simple door switch monitor could solve all this.

What’s needed is a truly independent continuous monitoring system with proper audit trails, not paper records where ‘gaps’ can be re-created or records lost, and where texts cannot be deleted and emails erased accidentally in simple automated systems.

Do we need independent pharmacy temperature monitoring?

The simple answer is yes, but not just monitoring on its own. Pharmacy temperature monitoring supported by actively contacting the Pharmacist in person, to bring to their attention a failing fridge or freezer and by a trained independent member of staff. The storage of vaccines, bloods, insulin and a range of medicines don’t just become inactive, they can become outright dangerous if used, putting lives at risk.

The modern Pharmacist needs to remove unnecessary costs and this means streamlining manual processes which add no value. In terms of pharmacy temperature monitoring, the ‘quill pen’ process needs to be updated with an advanced digital temperature and data monitoring system, so the pharmacist can to be alerted to temperature excursions and possible threat to stock – adding real, measurable value to his activity.

It’s therefore important that an alert or alarm is raised which triggers a corrective action report which requires a proper audit trail. The system will not allow this to be avoided, and investigating the cause is mandatory as well as detailing the corrective action. All these processes are trackable and auditable for the sort of quality control processes required to maintain patient safety and to provide healthy outcomes, 24 hours 365 days of the year.

What role can technology play in supporting the Pharmacist?

With a new Secretary of State for Health and Social Care in post, Matt Hancock, it can be expected there will be a renewed focus on technology and the role of the Pharmacist in supporting community patient care and Pharmacists up down the country become more centric to our healthcare requirements, supporting GPs and nurses.

Tutela is the world’s largest independent healthcare and life science temperature monitoring and data insights platform for critical process control of temperature sensitive biological inventory and products.

Tutela’s monitoring technology can remotely monitor every pharmacy fridge or freezer door, temperature, ambient and humidity. In every room, ward, department, hospital or remote clinic all under one account. Protected, secure with full reporting and action audit trail.

Our goals are simple, with independent monitoring of the healthcare and drug development activity, we aim to Improve health outcomes, protect reputations and support your team

The post Why Community Pharmacies need to engage with technology appeared first on Tutela Monitoring Systems.

Many Biotechnology companies today are unwittingly exposed to unnecessary risk of losing valuable reference materials as a result of outdated and manual temperature monitoring processes.

Without being dramatic, the prospect of a catastrophic loss of important reference materials is very real and could have unforeseen commercial implications. Loss of reference material would delay launch to market, slow the pace of future developments, impact investment returns, not to mention value to the business.

There’s no doubt Biotech research offers value and contribution to drug development and can deliver simply because they are more agile and responsive than their goliath Pharmaceutical colleagues. But are Biotech companies gambling with investors’ money by missing the opportunity to manage comprehensively the risk to their temperature sensitive stored materials?

Changing market dynamics mean more outsourced expertise

Biotech’s research groups are today focused on many aspects of drug development, but none more so than the rise of personalised medicines. These targeted forms of medicines require that the genetic code of many cancers are better understood, stored and held for reference and study.

These frozen libraries of tissue samples must be stored at -180 to preserve genetic material, but should a freezer fail, and temperatures rise, the potential for loss of these valuable reference materials is a genuine nightmare.

This genetic material is in the form of cell lines, human tissue, bio-makers and diagnostic reference materials and are all held and stored in large laboratory-grade fridges, freezers and cryogenic tanks. To say they have no commercial value is naïve, it is the very core of the business. Any due diligence from a potential investor will highlight this risk and need it corrected.

Short cuts and cheap solutions could be disastrous!

When a biotech company decides to manage research inventory risk to avoid the potential loss, its important to choose a partner with a robust temperature monitoring solution. A temperature sensor coupled to a blue tooth app is unlikely to provide effective cover. In fact, it could lead to a false sense of security.

Tutela have seen that simple text and email systems fail to convey to the member of staff the seriousness or urgency of the situation. Texts and emails can be lost, and if a 3rd party account is not topped up from a credit card, then the service is stopped, removing all cover.

The trained support team call clients from Tutela’s UK office HQ in Fleet, asking for a name seals in the importance and responsibility of the call. Real people notifying clients’ staff, taking their details and opening an incident report, backed up with an email confirming the call.

The difference in urgency is huge, and the member of staff on site becomes 100% clear of what their responsibility is. Tutela’s role as a partner is to remove the burden of administration, while providing piece of mind that often priceless research materials are under constant digital surveillance, and protection.

The Tutela temperature monitoring system also ensures compliance to Biotech’s regulatory requirements are met with an unparalleled audit report trail for inspectors and auditors alike. Incidents are listed, together with actions taken, and that the required corrective action and recommendations were implemented and finally signed off.

Case Study – The benefits of flexibility and experience

By implementing a Tutela temperature monitoring system, customers such as the APHA (Defra) have minimised their risk, protected their material 24/7/365 continuous, uninterrupted monitoring in near real-time of their valuable tissue, pathogen and virus reference materials.

Many of these samples are stored in Cryo, ultra low freezers, -20 freezers, fridges, and working ambient and pressure sensitive laboratories as well as incubators and ovens.

All of these temperature-controlled environments needed careful monitoring to remain compliant at all times and to manage risk. With over 40 years of reference materials, these assets need safeguarding with a proven cost effective system with clear benefits.

Staff at APHA use the Tutela web-based interface. This powerful graphical user interface (GUI) is is provided for an unlimited number of staff and is specifically set up by the site administrators to allow users access to their departments and probes.

Refined built-in administrator options ensure that users are allocated the correct permissions. The web interface allows multiple site viewing for central QA reporting, as well as individual local view for system operators

Unrivalled compliance coverage

Tutela was chosen as a trusted partner by APHA (DEFRA) partly because of our ability to support reliably the scale of installation and also because of adherence to calibration standards such full UKAS ISO17025 which allows onsite calibration, further minimising risk to interruption to stored materials.

In addition, Tutela’s quality standards comply with ISO 9001 – 2015, and all electronic records are fully FDA 21 CFR part 11 compliant, securely stored on mirrored servers in two different geographical locations for up to 30 years. All this this provides a highly secure, robust and backed up service.

Tutela understands the importance of reacting quickly and clients will be notified of alarms by our trained operators within minutes of an alarm to a pre-agreed response procedure and contact list, to ensure absolute viability of your valuable inventory.

Our goals are simple

With clear leadership and independent monitoring of the Biotech and Life science industry, Tutela protect your investors interests and the potential of future investment when clinical trials show positive results.

Together, Tutela aim to partner and reduce the risk, protect reputations and support the Life science industry in its research goals.

Tutela protect your business or organisation from catastrophic loss and damage which cannot be recovered and provide auditable data for future trending and preventable loss, reducing administration and running costs.

The post Biotech stored research material – risking investor relations? appeared first on Tutela Monitoring Systems.

Beyond best practice

Attending a recent pharmacy safety conference in Cardiff, I and others were looking for the guiding lights and best practice recommendations on this important subject. Safety and best practice are in no way mutually exclusive.

We all heard a patient story, powerfully delivered by Donna Dunn, of her inspirational daughter who sadly lost her fight to blood cancer. The story contained many heart wrenching aspects about her daughter’s care, but we learned how a Pharmacist obtained and delivered important eye drops mandatory for the daughter to be allowed home. He liaised with doctors, and delivered them to her door, out of hours, to enable the daughter to spend another precious night at home, before being re-admitted to hospital.

This selfless action of the Pharmacist wasn’t best practice, but it was exceptional, kind and empathetic and removed significant barriers to allow the family to spend valuable time together. It was only a year later the Pharmacist learnt the significance of his actions; it was her last night at home with her family.

Balancing care obligations with commercial pressures

For the Pharmacist of the future to survive, clinical care and patient trust will be paramount, but with ever increasing commercial pressures does that mean safe processes designed to protect the quality of care we expect will skipped in favour of commercial bottom line and profits?

Organisations such as Well Pharmacy are demonstrating strong commercial leadership, investing in the use of technology and automation, and have created a network of pharmacy outlets with a new smart professional look.

It will be interesting to see how their strategy develops but early signs look positive.

Are the regulators letting down Pharmacists?

The role of the retail pharmacist is very unlike your GP, or NHS Hospital because the pharmacist is often employed by a large corporate. Income is subject to the employer, and often performance-related. The equipment and facilities are supplied by the retailer, and fittings and storage of refrigerated medicines are all investments and a capital cost. Investment is commercially-lead and affected by the pressures on high street retail today.

However, compliance and safety is placed fairly and squarely on the Pharmacist by the regulators, and not the employer’s responsibility. That’s a difficult balance, and one where advice and guidance would be very welcome.

Best practice and safety are not choices, they are a compulsory requirement laid down in GPhC regulations. Compliance with these regulations are extremely important to protect standards and practices. So, you would think when it comes to implementing these regulations, GPhC auditors (with all their experience and exposure to Pharmacists up and down the country) could offer advice and guidance?

Sadly that’s not the case, when challenged representatives of the GPhC said…”its not our place to offer guidance or advice, our role is to implement the standards”. Big stick approach!

Have industry bodies caught up with new pharmacy technologies?

Safety can be now supported with automation and technology. Technology reduces human error, labour, time and mistakes. Automation reduces errors, saves cost and helps the commercial pressures on the hard-pressed retail pharmacist and provides insights to communicate to his employer. It would seem that the logical step that the professional body in the form of the Royal Pharmaceutical Society (RPS) would supposedly support and provide leadership to their pharmacy members, in order to help them manage the retail pressures placed on them.

Sadly, very little evidence can be found of this. It seems that the RPS will not engage with technology providers, no evaluation programs exist, technology pages on their website are absent, guidance or advice on using non-specific technology to improve compliance missing.

In Europe or the USA a very different scenario emerges. Pharmacists pay subscriptions as a member of the industry body and receive advice, insights and regular training and education programmes. So why is so hard for technology to be incorporated into retail pharmacy support in the UK?

Create an embedded safety culture

Creating an embedded safety culture within an organisation is all about people. This culture needs to ensure staff feel safe to report potential risk, without fear of reprisal or impacting on their working environment negatively. Staff need to anticipate and combat risk, learning from mistakes openly and to be empowered to implement changes. An environment of teamwork and processes designed to remove human error. If manually recording the temperature on a medicine fridge once a day holds no value, then its little wonder that it gets missed or not done.

Activity without value risks complacency and increases risk. The correct management of medicines and controlled drugs, such as vaccines and temperatures sensitive drugs as regulated in section 4.3, is the number 1 out of compliance issues as recorded by the GPhC.

Is this where the PDA can help? As a union they can support, protect and advise members on best practice; its early days for the PDA but the signs look positive. They are certainly acting in the best interests of their members and challenging big corporates on safety and practices.

Could the PDA be the answer, to fill the current industry leadership vacuum, and supply the guidance so desperately needed?

Case Study – multisite pharmacy temperature monitoring

By implementing a Tutela monitoring system, customers such as Royal Berkshire NHS Foundation Trust have minimised their risk, protected their material 24/7/365 continuous, uninterrupted hospital refrigerator temperature monitoring in near real-time of temperature-sensitive medicines. With Royal Berks’ commitment to quality and efficiency, they sought to acquire a pharmacy temperature monitoring system that was capable of providing integrated monitoring of medicines from central Pharmacy through those stored on the ward. Key objectives were meeting the compliance requirements of MHRA, free up resources and reduce cost..

Staff at Royal Berks use the Tutela web-based interface. This powerful graphical user interface (GUI) is provided for an unlimited number of staff and is specifically set up by the site administrators to allow users access to their departments and probes. Refined built-in administrator options ensure that users are allocated the correct permissions. The web interface allows multiple site viewing for central QA reporting, as well as individual local view for system operators

The role of monitoring technology in retail pharmacy

Tutela is the world’s largest independent pharmacy temperature monitoring and data insights platform providing critical process control of temperature sensitive biological inventory and products.

Tutela have supplied 1000’s of systems to the NHS, Biotech and Pharmaceutical industries as well as research facilities such as the APHA (Defra).

Tutela’s technology can remotely monitor every fridge or freezer door, temperature, ambient and humidity. In every room, ward, department, hospital or remote clinic all under one account. Protected, secure with full reporting and action audit trail.

Our goals are simple

With clear leadership and independent monitoring of the Pharmacist is protected, patient trust is strengthened and your corporate owners reputation remains intact. Tutela embed safety into your everyday process to protect your name.

Together, Tutela aim to partner and reduce the risk, protect reputations and support the Pharmacists, who else can say that?

The post Medicine Management in Retail Pharmacy – A Leadership Vacuum? appeared first on Tutela Monitoring Systems.

The NHS Long Term Plan defines how technology will be seamlessly integrated and used to help healthcare professionals act and communicate better to enable patients to receive quality assured care. New technology systems must provide greater connectivity providing staff with greater confidence in test results, history and evidence they need to make the best decisions for patients.

Here at Tutela, we support these fundamental goals across all healthcare settings, expanding connectivity to a range of systems and information.

Proven Track Record in Data and Insight

As the NHS digital business plan expands, Tutela Monitoring Systems continue to harness the power of information and technology to make healthcare better and improvement patient health outcomes.

Here are the 8 ways that Tutela have already been mirroring the NHS digital plan:

1. Solid Trusted Platform

Tutela have built a reliable IT service with solid infrastructure over the last 25 year that health and care professionals rely on every day. Tutela monitoring systems continue to provide the data services that are essential for building medicine and biology asset protection which is more efficient, better connected and smarter than the manual inspection unconnected systems.

2. Digital connectivity

For improved efficiency and transference of best practice, multiple sites both in acute but also primary and community can be joined up, freeing up front line staff and removing this labour resource requirement to focus patient care. Data on the correct condition and storage of medicines is essential to support people in making the correct health and care choices.

3. Better use of skilled healthcare Professionals

All too often valuable GP and staff time is expending on temperature and data management of medicines. Tutela are working to free GPs and their staff from time-consuming admin and offer patients better self-care through performance optimisation of stored medicines.

4. Accredited Partner

With Tutela as a preferred NHS Supply Chain partner we are making sure patients and the NHS get the best value from investment in medicines and pharmacy. By making prescribing and dispensing safer and more efficient, the supports the integration of pharmacy into the wider NHS and making the most of medicines data and eliminates waste.

5. Data-driven Insight

Tutela’s temperature monitoring systems and wealth of priceless data is supporting the NHS Digital strategy and equips the health and care system with world-class technology. This ensures the workforce has the skills to get the most out of this management data.

6. Improving Health Outcomes

The wealth of data and insight available from a Tutela Monitoring System is already used and analysed extensively to make incremental changes to the healthcare system, for better prevention and improving health outcomes.

7. Compatibility and Installation

The Tutela solution is fully compatible with the NHS infrastructure (including N3), linking health and social care organisations together – enabling information to move frictionlessly and securely to be accessible from different locations. Tutela supports and maintains strong and future-proof national systems and networks.

8. Data Security Assured

Tutela Monitoring Systems are designed to meet and exceed the needs of the NHS to ensure it delivers on its 2019 Digital Plans for the future.

The post 8 ways that Tutela is already supporting staff deliver the NHS Digital Business Plan appeared first on Tutela Monitoring Systems.

Once in a while you meet an exceptional leader who can truly inspire and acts as a role model to others. I am privileged to have met such a person, who’s energy, enthusiasm and sheer drive and determination has shattered the typical NHS barriers thrown in their way.

Meet Mrs Michelle Martin for she is an extraordinary leader hidden within the NHS corridors driving improvement, compliance and reducing risk. Her role of Quality and Governance Manager at Barking Havering and Redbridge, does not define or place her. She is also the Training Manager, a senior specialist and a Biomedical Scientist in Haematology and Blood Transfusion.

A role model to others, meeting the needs of the staff around her, she has achieved amazing things.

So much so that In 2016 NHS England commended her as one of a few inspiring female healthcare scientists to be selected for, and was invited to join, the 2016 fellowship program. Michelle was subsequently awarded the fellowship in 2017.

Building a team to gets things done!

Before Michelle worked at BHR she worked at The Royal Marsden for 3 years specialising in Haematology and Blood sciences, before heading off to Barts for 2 years as a training officer.

This rare individual understands the importance of structure and providing clear areas of responsibility, with easy to understand reporting lines. These provides the platform to empower her staff and make them feel valued and supported. Michelle can foresee emerging skills gaps as experienced staff leave. Recruitment is difficult, so training and staff development are a key driver for her and her team, investing in people and providing confidence to others to put themselves forwards.

Temperature monitoring risk

When UKAS issued a non-compliance for fridge and freezer monitoring within the Haematology Department at BHR, Michelle recognised the importance and acted immediately. Driven by the fact that blood was donated by patients seeking to save lives, this precious commodity could not be exposed to un-necessary risk, and so the need to assure compliance became a top priority.

Smashing Barriers with Innovative Thinking

Within the NHS, finding money to invest in new systems is a constant battle. This is exacerbated by a lack of the business acumen needed to create the case to justify investment against the backdrop of a heavily bureaucratic system; slow, tangled and multifaceted.

But not for Michelle who, with a supportive line manager quickly saw an opportunity. By combining the efforts of two valued suppliers of Siemens and Tutela, she enabled them to work in collaboration to resolve this non-compliance of their temperature monitoring. Helping them to create a fully managed service contract, she was able to acquire this necessary systems and spread the cost of many years, providing a fully manageable and planned expenditure over 5-10 years.

Leadership with vision

Leadership often means thinking differently from others around you, and can prove both exciting or a threat depending upon your values and standing. Michelle is on the move constantly, but even she admits that the mental cuts and bruises on the way can drain personal energy levels. Often others around you can view you as a role model, and this adds extra weight and responsibility to her role; not easy when also bringing up her 5 year old son with her husband’s full support.

In Summary

Her story might not be unique and her role within the NHS, like many other roles can seem mundane, but her attitude and relentless energy and enthusiasm to improve processes and patient health outcomes around her, say a lot for her style of leadership and in our experience, this is genuinely remarkable. Staff and colleagues now look to her for guidance and advice. I suspect her wise words and wider view of healthcare can change lives.

The post CASE STUDY | Inspirational leadership Drives Change in the NHS appeared first on Tutela Monitoring Systems.

In a briefing paper the King’s Fund, the Health Foundation, and the Nuffield Trust predict that NHS staff shortages in England could increase from 100 000 at present to almost 250 000 by 2030 if not dealt with.

With no clear idea of what Brexit will bring, other than further uncertainty, staffing levels are not set to improve any time soon. The CQC continues relentlessly month after month to uncover yet more poor medicine management, or control of biological assets, so it’s no wonder that when Trusts rely on manual processes, staff shortages lead to these failures.

So why are so many Trusts are so slow to recognise that investment in automation releases pressured front line staff, it reduces errors in medication and prevents the loss of medicines and valuable stock? Sometimes it’s as simple as creating a simple business case.

But when was the last time someone trained NHS staff how to create a compelling business cases to support the investment in an automated solution?

Let us help you with some useful pointers from our experiences.

Making a start

First, recognise the issue. This could be a CQC non-compliance related to medicine management, or a UKAS audit that flags up that your monitoring systems are not meeting the regulatory minimum requirements.

Or an MHRA inspection identifies areas which are not considered under control and auditable. Whatever the issue of compliance, quality or efficiency is, it will certainly have a cost implication and needs to be detailed and costed to support your case.

Look for those hidden costs

Calculating the cost of the current process should include not just the manual time absorbed but also the cost of failure and your exposure to risk. Any manual process requires the consistent attention of full-time front line staff, or issues will be missed and mistakes will be made. This might be a fridge full of medicines and their associated commercial cost. It could be litigation cost should a patient become unwell, or cost of corrective action, disposal, re-ordering, shortages, reports, re-training staff, integration with Pharmacy. All these areas have a cost implication and when examined the money potentially wasted is eye watering.

What does a fully automated data and temperature monitoring service really cost?

Firstly, front line staff are no longer needed to record data; the additional costs of bank or temp staff is immediately reduced. The monitored data is collected, saved and backed up continuously for you – while you and your qualified staff get on with your real jobs. The significance of this improvement in efficiency cannot be under-estimated

Perfectly formatted, auditable reports arrive at a push of a button when required, not after hours of painful spreadsheet analysis.

You now also have a wealth of historic data to learn from, that will underpin and improve processes. Data you can totally trust because an automated monitoring system is calibrated and maintained by qualified engineers, UKAS Certified on site.

Further cost efficiency through Managed Service Contracts

Supplied as a managed service, the VAT normally applied to the costs of a system is refundable. Costs can be planned with certainty and budgeted over time – typically 5 – 10 years, with regular maintenance, updates, calibration and training all included. See how the Barking and Havering NHS Trust negotiated to achieve this.

What do you get in return?

The upsides from investing in an automated data and temperature monitoring system are obvious but the big one is total security; because your inventory is being monitored 24/7/365.

In the event of any excursion, such as a temperature failure (maybe door left open) or 02 levels fall, being detected, you are contacted immediately via a Tutela trained representative. They will describe the issue, where to find it and open a corrective action report.

All records are stored, backed up and secure for 30 years meaning you can effectively forget about them and concentrate on moving forwards and not looking backwards.

The additional power of connectivity with Tutela

Because Tutela was designed from the ground up for medical and scientific applications, we saw connectivity between sites, departments, floors and even other hospitals and Trusts where close working relationships exist, as highly empowering. You can manage multiple sites through one interface, and the analytics available to compare site performance, even down to equipment supplier means you can identify further process improvements.

Total trust in Tutela

Don’t take our word for it, speak to some of our 1000’s of customers and inspirational leaders involved in day to day medicine management who have written business cases and have won the investment to make patient health outcomes, safer, more consistent and have protected their reputation without the need for additional staff and are seen as “World Class”. Or read some of our great testimonials

The post Helping Front-line Medicine Management Meet Future Staffing Challenges appeared first on Tutela Monitoring Systems.

Love them or not the CQC is instrumental in ensuring we receive a safe standard of care and they are to be applauded for the difficult task they have. Their reports good and bad are in the public domain for all to read and learn from and for failing departments they are an uncomfortable read.

Repetitive Manual Processes Fail to Add Value

What is clear is that manual activities that do not add value, such as recording temperature, humidity or air quality, are not perceived as an urgent role for hard-pressed front-line staff.

And why should it be? Attention to an ever-growing number of patients needs comes first, providing care, comfort and safe treatment. Reliance on manual processes using qualified staff who have other demands, often means that medicine safety, that should be prioritised from the leadership team can be compromised and compliance is put at risk.

Automate for “Fix and Forget” Compliance

At Tutela we embed the safety culture, we follow the CQC closely for our customers and see it as an important part of our service. Why? Because it ensures that no Tutela customer is ever highlighted for failing to monitor and manage medicines, bloods, diagnostic material or human cells/tissue correctly.

Our passion is to ensure all biological materials are stored at the optimum condition and not effected by poor storage conditions or environment. Our belief is that safety should be at the centre of everything. In removing risky non-value-added activities by automating the quality audit trail, compliance is maximised by ensuring no alarm is ever missed.

A New Focus on Ward-Based Medicine Storage

The CQC follow certain trends and the focus on ward-based medicine management is one of it’s long term goals. The responsibility for medicine compliance now lies with the wards, and not just the Pharmacist. But as is so often the case, our observation is that the adoption of automated digital solutions is slow at ward level. We expect that ward compliance will improve with the roll-out of the latest NHS Digital Plan.

The High Cost of Using Skilled Resources for Repetitive Admin

The irony is that the cost of resourcing manual monitoring has been proven to be in excess the cost of automated system. Add to that, the value of spoiled or non-compliant medicines and/or the cost of the cheap “throw away” monitoring systems. Risk can be managed and driven down cost-effectively with automated digital solutions. The CQC publishes details of countless stories of expensive fridge contents lost, or patient recalls for compromised diagnostic results (in the news only last week), or the loss of years of research.

Auto-diallers are not 100% failsafe

What is very clear, that an automated call, email or SMS text just does not have the impact it needs on busy lives. The only way of guaranteeing an incident is dealt with is by a trained caller from a monitoring bureau.

A Tutela trained caller can identify the issue, its value, its trend and location of the asset and helps the recipient of the call to understand the gravity of the alarm. With a Tutela trained caller the recipient name will be on the incident report, thus guaranteeing an audit trail to assess how the incident was managed and corrected. It’s a game changer and something that automated calling and SMS can never replicate.

So, ask your yourself when you are caring for a someone or working on new drug developments – who’s watching out and caring for you?

The post Driving Positive Change in the NHS – The CQC appeared first on Tutela Monitoring Systems.

Health and Social Care Act 2008 published guidance for healthcare providers. This guidance describes how providers and managers can meet the regulations. These include the fundamental standards – the standards below which care must never fall.

Once this is clearly understood – why the regulation is required, then meeting it becomes far easier to grasp. Here is Tutela’s take on how best to meet the CQC regulation as it relates to the safe storage of medicines.

CQC seek to prevent avoidable harm or risk

Our focus is on Regulation 12 and is the most relevant to those involved in medicine management, for example the temperature controlled storage of drugs. The intention of this regulation is to prevent people from receiving unsafe care and treatment and prevent avoidable harm or risk of harm. This is covered in detail in Part G “the proper and safe management of medicines”.

From our perspective as leading temperature monitoring providers to the NHS, we see 5 simple steps to ensure that your facility can meet CQC requirements.

1. Never Underestimate CQC’s Powers

CQC can and will prosecute for a breach of this regulation or a breach of part of the regulation. This is triggered if a CQC audit identifies that a failure to meet the regulation has resulted in ‘avoidable harm’ to a person using the service or if a person using the service is exposed to significant risk of harm.

They do not have to serve a warning notice before prosecution, so prosecution can come out of the blue. Additionally, CQC may also take other regulatory action.

That’s pretty serious because they monitor, inspect and regulate services to make sure they meet fundamental standards of quality and safety. A failed audit will end up in the public domain. CQC will publish what they find, including performance ratings. The sole reason for this is to help people choose the right place to have their care.

When they identify poor practice, they record and highlight the area for improvement and if it is serious will down grade the area of care for improvement.

So, in these digitally enlightened times, negative findings will always be visible on the internet and social media – even in general searches.

2. Understand the Regulations

The regulation states that care and treatment must be provided in a safe way for service users and, in section G the proper and safe management of medicines and covered in specific detail. Have a written policy for each section and stick to it.

Section G covers:

Staff responsible for the management and administration of medication must be suitably trained and competent and this should be kept under review.
Staff must follow policies and procedures about managing medicines, including those related to infection control.
These policies and procedures should be in line with current legislation and guidance and address:
- supply and ordering
- storage, dispensing and preparation
- administration
- disposal
- recording.

3. Understand the Need for Proper Resourcing of Monitoring and Compliance Function

In order to ensure that medicines perform as required by then they must be stored and handled in accordance with the manufacturer’s instructions. This requires many medicines to be stored at specific temperatures in fridges or freezers until required.

Highly qualified front line staff are busy doing their day job, and manually checking fridge temperatures by hand is a poor use of skilled resource, and a bad return on investment. As such, a manual monitoring process often has data gaps because log sheets are not filled in.

This ensures that the facility has failed to meet the CQC standard of care expected. And it is totally avoidable.

4. Automate – Implement a Fail-Safe Method for Compliant Management of Medicines

Temperature monitoring systems exist to remove this particular CQC threat. To have complete peace of mind, simple automated monitoring is not sufficient.

An integrated system of digital technology, allied to a 24/7 alarm bureau of trained independent staff that actively contacts the point of care provider in person and bring to their attention a failing fridge or freezer, will meet the CQC needs 100%.

Stored poorly and not monitored correctly, vaccines, bloods, insulin and a range of medicines don’t just become inactive, they can become outright dangerous if used, putting lives at risk.

It’s therefore important that an alert or alarm is raised to trigger a corrective action report, which requires manual intervention to correct. This is unavoidable and investigating the cause is mandatory as well as detailing the corrective action. In a good temperature monitoring system, all these processes are track-able and auditable for quality control processes to maintain patient safety and provide healthy outcomes.

5. Adopt Compliance and Safety-Centred Partners

Our goals are simple, with independent monitoring of the healthcare and drug development activity, we aim to Improve health outcomes, protect reputations and support your team because as healthcare specialists, Tutela understand the need to deliver on the proper and safe management of medicines.

The post How to Guarantee Long Term CQC Compliance in 5 Steps appeared first on Tutela Monitoring Systems.

Cold chain temperature monitoring specialists Tutela appoint Tony Lester to expand Tutela’s business within the Biotech and Pharmaceutical Industry.

Tony joins the Tutela team bringing a wealth of experience in the Biotechnology and Pharmaceutical sector with a BSc (Hons) in Biochemistry. Having worked within the drug development and cell culture industry with large corporations for over 30 years, Tony is therefore well equipped to support our Pharma/Biotech customers’ needs for temperature and storage monitoring of their drug pipeline and safe delivery of their cold chain plans.

Tony has a strong scientific background and has worked in a diverse range of areas such as microbiology, clinical sciences and tissue culture. As our Biotech and Pharmaceutical customers seek to meet the changes in compliance, risk and deliver quality processes that ensure compliance with GxP and GmP requirements,Tony is ideally placed to support them with monitoring solutions from Tutela.

Welcome aboard Tony!

About Tutela Monitoring Systems

Tutela Monitoring Systems works with partners in the NHS, private healthcare, pharmaceuticals and life sciences, and retail healthcare sectors to provide real-time monitoring and alarms, capturing environmental data which can provide insights to support improved quality, regulatory safety and compliance.

Tutela Monitoring Systems are part of Next Control Systems, an ISO9001:2015company that has been successfully marketing medical monitoring and recording systems for Pharmaceutical, Biotechnology, Academic & Clinical Research, Laboratories & Blood Banks, worldwide for over 20 years.

For more information, contact:

Email: TutelaUKsales@tutelamedical.com

93 Fleet Road
Fleet
Hampshire
GU51 3PJ UK

Tel: +44 1252 406398

www.tutelamedical.com

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When considering a temperature and data monitoring system in a regulated healthcare facility, it’s critical that Safety and Risk are the drivers when considering systems to manage and comply with the above.

How do you need to treat risk according to the ACT?

To do this let’s look simply at section 12(2)(b). To summarise this clause, this means doing all that is “reasonably practicable” to mitigate any such risks.

In legal terms, “all that is reasonably practicable” means that the degree of risk in a particular situation can be balanced against what would be deemed acceptable in terms of the time, trouble, cost and physical difficulty of taking measures to avoid the risk.

How does this translate within the Healthcare Sector?

Incidents that affect the health, safety and welfare of people using services must be reported internally and to relevant external authorities/bodies. Such incidents must be reviewed and thoroughly investigated by competent staff and monitored to make sure that action is taken to remedy the situation.

What we should reasonably expect thereafter is a process implemented that prevents further occurrences and make sure that improvements are made as a result. Staff who were involved in incidents should receive information about them, and this should also be shared with others to promote learning. Incidents include those that have potential for harm.

How does this specifically impact the Temperature Monitoring of medicines and other regulated products?

In our experience, we find two typical approaches to monitoring solutions which totally fail to mitigate risk:

A manual temperature data recording system. These “quill-pen” processes are reliant on often highly qualified front line staff busy with their day job. This implies competing priorities and risks recording errors and/or gaps in data,
Budget automated systems. These being cheap are fully automated and reliant on digital communication methods such as text or email communication. Being machine driven, these systems rely on busy staff to read and respond to automatically generated messages. There are no checks and balances.

Have you genuinely taken “all reasonable practicable steps” to reduce risk if it can be shown that reporting excursions are not in real time, relying on error-prone manual recording; or automated systems that use purely texts or emails which do not report excursions directly to staff on site?

Mitigating Risk and Compliance with the Act

Incidents like excursion events must be reviewed and thoroughly investigated by competent staff and monitored to make sure that action is taken to remedy the situation, prevent further occurrences and make sure that improvements are made as a result.

To meet these requirements: –

Do you have an incident report which is raised independently?
Are they recorded, investigated and record the corrective action?
Who signed if off to demonstrate learning for corrective action?

Staff who were involved in incidents should receive information about them and this should be shared with others to promote learning. Incidents include those that reasonably be expected to have potential for harm.

Therefore, against the “all that is reasonably practicable” test, generic communication may not be considered as “mitigating risk”, but a system that responds to named specific staff, which are nominated to receive direct communication to take responsibility most definitely does.

The post Temperature monitoring systems and meeting the needs of the Health and Social Care Act 2014: Regulation 12 (2)(b) appeared first on Tutela Monitoring Systems.

So, how safe is your freezer?

In this case, as so often, there were no clues of potential failure. No performance temperature data was being collected, examined or checked for variations in performance.

The health of a freezer is critical to the safe storage of samples; a deviation of temperature, no matter how brief or how small, may ruin one’s life’s work or that of a team.

Could monitoring data have spotted the failure in time?

The potential to save money and reduce loss is enormous, but automated calling systems can give a false sense of security.

We all prefer talking to real people

I started this article with the example of the automated system calling notification that was ignored and the substantial loss that can occur as a result.

What is temperature mapping?

Why can’t I just trust the digital display on my freezer?

Tutela offer a full, on-site automated solution for mapping temperature excursions, in conjunction with Tutela Monitoring Systems ISO17025 accreditation for calibration.

Because the wireless data loggers are sited internally within the device being mapped, no cables protrude through fixture seals, providing a real situation mapping report.

This is less disruptive, compliant to the Orange book (MHRA) and detailed to meet rigorous certification needs.

Our goals are simple

We protect your businesses and organisations from catastrophic loss and damage which cannot be recovered and provide auditable data for future trending and preventable loss.

The post How a Lab lost 33% of the world’s largest collection of autistic brain samples. appeared first on Tutela Monitoring Systems.

Its not often that a study day should be received so positively but, on the occasion, Tutela held it’s “Achieving Excellence in Compliance and Monitoring Insights” at the beautiful location at Coombe Abbey in Coventry, it was a day I will remember fondly. Here’s my thoughts from the day. You’ll find a link to the presentations at the bottom of the page!

Making Light Work of Compliance

We heard from Wayne Goddard who was in good form, his humour shone throughout his presentation. Wayne is the Laboratory manager at Stockton Quality Control Laboratory, with his 20 years of experience he shared his first hand experiences with inspections and compliance requirements to meet GmP compliance and the demands of MHRA.

Thermal Profiling and Ensuring Quality of Service

We then listened to Michelle Evans who is head of Quality Assurance Laboratory at the Welsh Blood Service. Again with 30 years’ experience she knew all the stumbling points to avoid, and how to ensure your temperature monitoring requirements are accurately recorded and applied to ensure quality of service was never in doubt. The validation of storage systems which surround blood is so important to providing a trusted service, it was fascinating to hear her accounts and stories.

From the Regulators Point of View

Chris Robbie from the MHRA joined the event. It was fascinating to hear his understanding from the regulator’s perspective, not something you hear that often. As member of SHOT (Serious Hazard of Transfusion), working as part of a larger team on steering groups such as the National Blood Transfusion Committee Lab Managers Group, ensuring lessons in the past are applied and ensuring that safety to the public is paramount.

Driving Change in the NHS through Leadership

A new edition to the team was Michelle Martin, the Pathology Quality and Governance Manager & Lead for Scientific training at Barking, Havering and Redbridge. She is also a CSO WISE Fellow 2016-17. This hidden leader within the NHS is driving change with an open mind and challenging the norms, shaking up old thinking with fresh ideas and great communication. Michelle spoke about leadership and it’s many forms, and put us all to the test (literally) to discover what kind of leaders we were.

Managing the Unthinkable – What to do When the Auditors Arrive

Jackie Peck (a pharmacist by profession) has managed pharmacies in all parts of the country opening at one time thirty four Pharmacists within Sainsburys. With all that experience she knows what it means to be audited and how to be prepared for it. Today she is the CEO of Pharmacy Consulting and offers her clients a personal, informative and collaborative training for her clients to ensure they embed safety and systems in the roles and to ensure quality audits are managed effectively and managed correctly.

Chaired by Biomedical Scientist of the year – Malcom Robinson

The whole event was rounded off with our old friend Malcolm Robinson, a biomedical scientist who despite retiring never stops caring for others. During his time at Western Sussex Hospitals NHS Trust delivered 5 x CQC Outstanding rating. When Harvey Buster Baldwin came into his life the impact that was to come could never have been predicted. The inspiration of this poorly young man pushed Malcolm to launch the Charity Harvey’s Gang which was awarded the NHS70 award for children and young people presented to Malcolm by the BBC. Malcolm was also awarded the honour of Biomedical Scientist of the year 2018, after his talk there were many tears secretly being wiped away.

In Summary

Well I wish you could have been there what an event it was, but if you think you’d like to come to the next meeting and meet the team above just get in touch…. follow this link for the presentations

The post Achieving Excellence in Compliance and Monitoring Insights | Tutela Study Day ’19 appeared first on Tutela Monitoring Systems.

Three steps for driving hospital improvement

Tutela’s wireless temperature and data monitoring system provides a world-renowned interface for the correct management and compliant storage of medicines, vaccines and bloods. This is something we are proud to have been providing for over 20 years. Over that time, we have supported many healthcare and life science professionals to deliver improvements, after all our reputation is your reputation.

With this in mind, and with the recent CQC publication of Driving Improvement – Case Studies from 8 Independent Hospitals, this article draws on some of the projects Tutela have delivered, highlighting some key take-aways, inspiration that you too could apply to help drive improvement. Whether this be achieving the correct storage of medicines to CQC standards or for achieving MHRA temperature monitoring guidelines.

1 – Strong visible leaders

The NHS faces ever challenging resourcing issues, finding and keeping valuable staff is a constant battle. The CQC recognise that strong, visible leaders is one of the factors in achieving a good or outstanding rating.

“Strong, visible, local leadership is needed to drive improvement. Most of the hospitals featured made changes to leadership teams, or the way that leadership teams worked at the start of their improvement journey”

Tutela recently heralded Michelle Martin, Quality and Governance Manager at Barking Havering and Redbridge. Presenting at our recent Study Day on Leadership and Challenges in the NHS, Michelle understands the importance of structure and providing clear areas of responsibility, with easy to understand reporting lines. Recruitment is difficult, so training and staff development are a key driver for her and her team.

When UKAS issued a non-compliance for fridge and freezer monitoring within the Haematology Department at BHR, Michelle recognised the importance and acted immediately. By combining the efforts of two valued suppliers of Siemens and Tutela, she enabled them to work in collaboration to resolve this non-compliance of their temperature monitoring. Read Michelle’s Story

2 – An honest approach to reporting

“Leadership also needs to be inclusive, with senior leaders bringing more people into discussions about changes and improvements”. Say the CQC

They do say that information is power. Yet sharing of information is key when developing an inclusive, team driven environment. Tutela can support your improvement plan by providing transparent, granular data, that your team can access.

Through a series of powerful yet intuitive web-based interfaces, performance information can be used to support decision making to improve processes, purchasing and efficiency.

Staff need to be freed up to provide quality patient led service, yet also need to provide the level of reporting detail needed for regulatory compliance. When it comes to the correct management and compliant storage of medicines, vaccines and bloods then an automated monitoring system provides many benefits.

The Pennine Acute Trust, when they approached Tutela Monitoring Systems, already had built in monitoring that met MHRA standards. Yet they were seeking greater granularity of information about monitored inventory and temperature variances. They were seeking to achieve compliance to EU transfusion guidelines and monitoring to ISO15189. The Tutela systems were able to meet this requirement but was also able to provide rich data and presentation specified by the users. Download the Pennine and Acute NHS Trust case study

3 – Learning from incidents

The CQC state that “Failure to learn from incidents or share learning is a common issue with under-performing hospitals.”

Tutela monitoring systems, being in the cloud, means data can be accessible from any location, it is also scalable. Tutela enables you to monitor across multiple sites in your Trust, in fact installation of multi-site monitoring is something that Tutela takes in its stride. As well as end-to-end cold chain management. This empowers you to share data, share learning in real time and maintain high standards of monitoring Trust wide. Backed up with NHS HSCN approval and ISO27001 data security.

The Royal Berkshire Hospital is committed to quality and efficiency. They approached Tutela as they were seeking to acquire a pharmacy monitoring system capable of providing integrated tracking of temperature sensitive medicines from central Pharmacy through to patients on the ward.

The Trusts’ Quality Control department is centralised, so it was important that the system offered scalability and future proofing, but importantly the ability to display all hospital site data onto a single web user interface centrally. Additionally, in terms of alarming functionality, QC required notification calls, SMS and email notifications be delivered to the correct personal responsible at each individual monitored location, so that action to resolve any temperature or system breaches could be taken accordingly. Download the Royal Berkshire Hospital case study

Accreditations:

Compassionate, high quality care is at the centre of what we do. Fully compliant with ISO27001 and UKAS 17025 accreditation, the Tutela interface allows comprehensive access to customer data at anytime, anywhere through the use of Smartphone, Tablet or Laptop or any device able to support a web browser.

Tutela are accredited to the following relevant standards:

ISO17025 Laboratory Calibration accreditation
ISO9001:2008 Quality Management System
ISO27001 Data management and Storage
MHRA and FDA Compliant

Learn more about accreditations

The post Driving Improvement via Temperature Monitoring – learning from those that are doing it appeared first on Tutela Monitoring Systems.

Medicines must be prescribed, dispensed and administered safely and effectively. Safe storage of medicines is something we all expect. With Vaccine and medicine storage having to meet pharmacy temperature monitoring guidelines issued by the MHRA. Yet public confidence in vaccination programs is being shaken.

In June 2019 it was reported that two Sydney GP’s had administered poorly stored vaccines to patients, including infants and young children. This was thought to go as far back as 2010, affecting more than 3000 patients. Investigators found vaccines were incorrectly stored or out-of-date at the practice. The vaccines included measles mumps and rubella (MMR), the seasonal flu formulations and a range of vaccines on the National Immunisation Program.

Closer to home the Care Quality Commission in July 2018 rated a health clinic in London as inadequate. With the report highlighting two pharmaceutical refrigerators, for the storage of patient vaccines, had been recorded as out of range, over numerous occasions, since 2017.

This comes at the same time the BBC reported on the Low Trust in Vaccination, calling it ‘a global crisis’. Quoting figures from the Wellcome Global Monitor they also state that the World Health Organization lists vaccine hesitancy as one of the top 10 threats to global health.

Three questions to ask when verifying the safe storage of your Vaccines.

It’s more important than ever that trust in Vaccine quality is assured. The most overlooked and undervalued area is the correct storage conditions to ensure Vaccine efficacy is maintained.

Put simply, if a Vaccine is stored at a temperature above the manufacture’s recommended temperature then it’s shelf life can be dramatically reduced. If stored at too low a temperature or if it freezes then the vaccine can be unstable and breakdown and even produce a cloudy or separated appearance. In both cases the result is a non-effective Vaccine.

Just when the public are super sensitive to bad press.

This is not the time to lose patient trust – so what can you do to ensure your Vaccines are stored correctly?

1. Have you a culture of safety first?

Remember safety is an attitude, embedding safety in all aspects of your day to day work is extremely important. Safety means you value your staff, your clinic, your patients and your reputation. The regulators are not there to police safety, they are here to ensure the minimum standards are followed, to ensure trust is never broken…. Ask yourself is the minimum enough?

2. What would it mean to your clinic if you lost patient trust?

Often staff are short on time, under pressure and so safety procedures can be overlooked or incomplete. With manual temperature monitoring it’s also not possible to determine how long stock has been exposed to the out of spec temperature. So, the only safe option is to bin the stock – an added cost to the NHS or pharmacist. The safe storage and delivery of medicines is an area The Kings Fund report highlights for achieving significant cost efficiencies. Can you confidently demonstrate compliance and so maintain patient trust?

3. When was the last time you audited your Vaccine storage?

Can you confidently say your Vaccine storage is meeting current standards? If not what simply steps can you take to meet standards? What resource do you need to put this in place?

Tutela Monitoring – who are we

Our goals are simple, with independent monitoring of the healthcare and drug development activity, we aim to Improve health outcomes, protect reputations and support your team

The post Trust me! I’m a Vaccine appeared first on Tutela Monitoring Systems.

With manual medical temperature monitoring it’s not possible to determine how long stock has been exposed to the out of specification temperature. So, the only safe option is to bin the stock. Every fridge may have its own thermostat, yet these are not reliable or independent. And busy medical staff, under pressure, may overlook manual monitoring duties, or fail to address an out of range temperature notification. These challenges can be overcome by using an automated, calibrated temperature monitoring system. But how do you present the case for the automation of your temperature monitoring? How do you get buy in from colleagues and budgetary sign off?

What to consider – presenting the case for the automation of temperature monitoring for healthcare and life sciences

1. What would it mean to your clinic if you lost patient trust?

Take a moment to audit your current systems. Consider the staffing and processes currently in place, where there is room for improvement and what you need to do to meet or exceed regulatory compliance? Importantly, consider what you need to do to confidently demonstrate compliance and so maintain your patients’ trust.

2. What is the labour requirement to perform temperature monitoring manually?

Consider putting together some simple figures, where you evaluate the cost of staff time, and the potential level of risk to loss of stock. Ask yourself is it acceptable to expect staff to complete these processes manually? Can they consistently meet CQC standards with the time and resources they have? This can then be compared against the risk appetite for your department. With this information you can build a business case for automation.

3. What is the value of the stock you are protecting?

With manual systems it’s not possible to determine how long the stock was exposed to the out of spec temperature. So, the only safe option is to bin the stock – an added, preventable cost. With an automated notification, you can take action to save the stock, in little to no time by: closing an open door, re-packing the fridge with proper circulation and space to allow the fridge to operate properly, or relocating.

4. Do you need to put the contract out for tender?

Gaining budgetary sign off, particularly in a healthcare setting can be a complicated and dauting task. Thankfully Tutela Monitoring and Mapping systems are listed on the NHS Supply Chain Medical National Framework Agreement. We are also fully versed in the tendering process. Once you have gathered together your case for automation, you can then justify the expenditure against the savings, in terms of staff time and stock protected.

What do you want from the temperature monitoring system you choose?

5. How should you or your staff be notified of a temperature alarm?

With an automated system, you will need a call or notification rota to be in place. A rota for day or night, bank holidays and vacations, so vital medicines can be saved and managed effectively 24/7. What’s the best way to be notified? In our experience it is by a person. When a person calls you to let you know that your vaccine fridge is over temperature you understand timely action is needed. And when your name is attached to that call and incident report then you have a responsibility to act immediately.

6. Is the monitoring system scalable, is it simple to manage multiple sites?

You will more than likely have more than one storage location you want monitored. Consider whether the monitoring system you are choosing is able to report clearly across multiple sites. With monthly reports you can see patterns emerge, certain sites will have more failures than others, stock loses can be allocated to clinics, asset performance can be monitored, fridge manufacturer claims can be verified. This allows you to investigate the causes.

7. How simple is it to install and train staff?

Consider what your provider is offering in terms of of the installation, training, setup and monitoring for you. For example, Tutela is fully integrated with the NHS N3 Cloud, so implementation is seamless, and will not burden the local IT department. We are happy to provide a demonstration of the interface, with its intuitive dashboards and clear reporting mechanisms. We also provide face to face training and ongoing support. In addition calibration is carried out by our engineers, on-site, so there is not disruption to you, your staff, or the monitoring of your valuable stock.

With a calibration contract you can be sure you are never out of compliance. In summary – By investing in your clinic and your staff you are also investing in the trust you want to build with your patients.

Find out more:

View our case studies

NHS Supply Chain

Contact Tutela for an independent reference you can speak with.

The post Automating your Temperature Monitoring in 7 simple steps appeared first on Tutela Monitoring Systems.

The guidelines for temperature monitoring systems for hospitals are becoming increasingly robust. And critical to the success of clinical trials in medical research is the stability of the storage and research environment.

In Life Sciences, Tutela monitoring systems protect often years of priceless research work. And the rising value of inventory in a hospital pharmacy, refrigerated warehousing, plasma centres or blood banks is such that a fail-safe remote monitoring system is needed to ensure that you prevent loss at all points in the cold chain management.

This is a particular challenge when we see fluctuations in seasonal temperatures outside of the norm. Automated remote temperature monitoring provides a true value add. With manual systems it’s not possible to determine how long the stock was exposed to the out of spec temperature. Automated monitoring, backed by real time excursion alarms from real people, can save your valuable stock and help you remain compliant.

Delivering cool customer service on the hottest day

Last week, as summer temperatures peaked, the team at Tutela kept their cool, as a significant number of alarms were triggered. Summer temperatures rose to a high of 98.4F (36.9C) at Heathrow on Thursday 25^th July, making it the hottest July day since records began. The support team coped admirably, calling out on average 426 alarms per hour.

The 17 strong team of support operators, over the course of the day, alerted a total of 10238 contracted customers via phone of temperature variances. They also responded to a staggering 36248 alarms received by customers. The split of these being 56% for the built environment, with 44% for Tutela Monitoring Systems.

Darren Baker, National Support Manager for Next Control Systems & Tutela Monitoring said “The support hub rose to the occasion, working hard in the hot conditions to protect customers valuable stock. Demonstrating professionalism and the robust service we have in place here.”

Temperature Monitoring with a manned alarm calling service 24/7

Automated temperature monitoring means you can be sure you are never out of compliance.

Tutela provides real-time monitoring and manned alarm calling service 24/7 all year, come rain or shine. Last week proved, as summer temperatures peaked, the value of this service.

What’s the best way to be notified? In our experience it is by a person. When a person calls you to let you know that your vaccine fridge is over temperature you understand timely action is needed. And when your name is attached to that call and incident report then you have a responsibility to act immediately.

The post Temperature monitoring for healthcare and life sciences during the summer heat appeared first on Tutela Monitoring Systems.

Overview of Requirement

Royal Berkshire Hospital required rigorous pharmacy temperature monitoring to ISO15189 standards. This needed to be implemented across multiple sites where drugs are required to meet MHRA regulatory guidelines. Locations included Reading, Newbury, Thatcham, Windsor and Bracknell.

Objectives

Deliver outstanding patient safety
Meet MHRA compliance requirements
Free up resources
Reduce cost

The Site

Royal Berkshire NHS is one of the largest general hospital foundation trusts in the country. While the main site is based in Reading, the Trust also specialise in providing:

Acute medical and surgical services to Reading, Wokingham, West Berkshire, Windsor, and Slough
Specialist services such as cancer, dialysis and eye surgery across Berkshire and its borders
Specialist centre for cancer, eye and renal (kidney) care for Berkshire and south Oxfordshire
Outpatient services at Townlands Hospital in Henley
Cancer and renal centre at the Royal Berkshire Bracknell Clinic

What was Needed – Targeting Enhanced Compliance

The system needed to integrate with existing central pharmacy temperature monitoring hardware and monitor temperature-controlled medicines on the wards. The new system also needed to manage a number of local and central geographic sites, offer scalability, future-proofing, and display all hospital site data onto a single and central web user interface.

In terms of alarm functionality, Quality Control required calls, SMS and email notifications to be delivered to the correct personnel responsible at each individual monitored location, so action to resolve temperature or system breaches could be taken accordingly.

Why Tutela Was Chosen

Competitive cost
24-hour call centre facility
The benefits of 24/7 advanced real-time alarm coverage
Good experience with their existing Tutela system
Easy integration with central pharmacy monitoring

What was Delivered – Highly Secure Data Transmission and Storage

The sites are connected via dedicated IPSEC to IPSEC VPN for two-way data and alarm traffic. Because Tutela are licenced to VPN tunnel via the NHS network (BT-N3) Cat 5 cable is hardwired directly into the facilities ethernet ports. All data to and from the site travels directly through the secure VPN and is encrypted on both ends for ultimate lockdown.

The system is connected via the various trust networks back to the Tutela off-site server centre based in Fleet UK. From the Tutela server centre, all aspects of alarming, data gathering, audit trails and system data backup is managed.

Multi-Site Delivery and Roll Out

The Tutela Projects team carried out ISO17025 calibration, commissioning and QQ validation during each installation phase.

Comprehensive training was provided onsite to administrator-level access. Online training videos are also available to support more infrequent users of the monitoring system.

What were the Results

130 drug fridges in wards across the estate are now monitored, alarmed, and serviced by Tutela Systems.
The website users interface is the standard platform allowing multi-user, multi-tasking and simultaneous access to users assigned to the system.
A total of 13 WARPs with Ethernet Repeaters were installed across all the sites
Because Tutela is licensed to use the NHS N3 network for VPN connectivity, The Trust saved a large unnecessary cost by using Genesis 3 Ethernet repeaters rather than adding more WARP units

For further information, read the full case study here.

The post Pharmacy Temperature Monitoring at Royal Berkshire NHS appeared first on Tutela Monitoring Systems.

In a briefing paper the King’s Fund, the Health Foundation, and the Nuffield Trust predicts that NHS staff shortages in England could increase from 100 000 at present to almost 250 000 by 2030 if not dealt with.

Figures report that the NHS employed 1,239,631 staff across England in May, with a significant drop of 1,695 compared to April. It is becoming more apparent that the NHS doesn’t have enough staff to fulfil its increasing demand. The NHS is in desperate need of qualified and experienced clinical and operational staff, including Paramedics, mental health practitioners, and primary care doctors, nurses and midwives.

With no clear idea of what Brexit will bring other than further uncertainty, staffing levels are not set to improve any time soon. The CQC are, month after month, uncovering yet more poor medicine management, and control of biological assets. Is it any wonder, when such a manual process is employed by Trusts, that staff shortages lead to failures? So, what is the solution?

Recognising the value of automated temperature monitoring:

Automated temperature monitoring provides a tried and trusted solution. Yet why are so many trusts slow to recognise the value of automation investment? It releases front line staff, reduces errors in medication and prevents the loss of medicines and valuable stock. The value of the service can justify the investment.

Sometimes it’s as simple as creating a basic business case. But when was the last time someone trained NHS staff on creating a business case for investment in an automated solution? Let us help you.

Understanding the challenge of meeting medicine compliance:

First recognise the issue, it could be a CQC non-compliance related to medicine management, or a UKAS audit recognising that your monitoring systems are not meeting the regulatory minimum requirements. Or MHRA inspection identifies areas which are not considered under control and auditable. Whatever the issue of compliance, quality or efficiency is, it will certainly have a cost implication.

What are the hidden costs of manual temperature monitoring for medicines?

Calculating the cost of the current process should include not just the manual time absorbed but also the cost of failure and your exposure to risk. Any manual process requires consistent full-time staff or it will be missed and mistakes will be made. This might be a fridge full of medicines and their associated commercial cost. It could be litigation cost should a patient become unwell, or cost of corrective action, disposal, re-ordering, shortages, reports, re-training staff, integration with Pharmacy. All these areas have a cost and when examined the money wasted is eye watering.

What does a fully automated data and temperature monitoring service provide?

Firstly, front line staff are no longer needed to record data, so no additional cost of bank or temp staff required, it’s collected, saved and backed up continuously for you. Auditable, reports at a push of a button when required. Data to learn from, correct and improve processes. Calibrated and maintained by qualified engineers, UKAS Certified on site. VAT is refundable with a fully managed service and costs can be planned and budgeted from 5- 10 years with certainty, including maintenance, updates, calibration and training.

What do you get in return?

The big one is total security, items are monitored 24/7/365. And when any excursion such as a temperature failure or door left open is detected or 02 levels fall, you are contacted immediately via a Tutela trained representative. The Tutela trained member of staff will describe the issue, where to find it and open a corrective action report. The records are stored, backed up and secure for 30 years. Connectivity is possible between sites, departments, floors and even other hospitals and Trusts, where close working relationships exist, allows for data exchange, so identifying further process improvements.

Tutela Monitoring Systems – learn from our customers

Speak to some of our 1000’s of customers and inspirational leaders who have written business cases and have won the investment to make patient health outcomes, safer, more consistent and have protected their reputation without the need for additional staff and are seen as “World Class”.

Contact us and we will put you in touch with one of our customers, so you can learn from their experience of investing in automated temperature monitoring.

Further reading:

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Technology provides a great opportunity for improving how the NHS delivers its services. And this has been recognized in the NHS Long Term Plan, published on 7 January 2019, with a whole chapter of the plan dedicated to digitally-enabled care.

Technology can provide a new and modern way for providing faster, safer and more convenient care. Digitally-enabled care can empower healthcare staff to act and communicate better. By providing greater connectivity, providing staff with greater confidence in test results, history and the evidence they need to make the best decisions for patients.

The digital transformation of the NHS is being driven by NHSX, and is set to be the largest digital health and social care transformation programme in the world. The NHSX have five missions, which are focused on how to make things better for patients and staff.

How Tutela Monitoring Systems supports the NHSX digital transformation programme

Here at Tutela Monitoring Systems, we are proud that our temperature monitoring can support the fundamental goals set by the NHSX. Below we have detailed how our technology aligns to the NHSX five missions, demonstrating how our automated alarm monitoring can support staff in providing quality assured care for patients:

Reducing the burden on clinicians and staff, so they can focus on patients

Our automated temperature monitoring replaces paper and manual processes with quick, secure, connected systems. Freeing up time to spend on patient critical tasks. Through automated monitoring and 24/7/365 alarming, health care staff can be assured of maintaining compliance for the safe storage of medicines, bloods and patient samples.

Giving people the tools to access information and services directly

Data gathered by Tutela Monitoring Systems can be accessed securely via any device that has internet connectivity. The Tutela customer interface utilises ‘https’ electronic banking standard data encryption protocols. This provides the highest level of security to our customers. The user interface is also easy to configure and easy to use. Multiple sites in acute and also primary and community can be monitored via Tutela Monitoring Systems. Presenting data for all, allowing for improved efficiency and transference of best practice.

Ensuring clinical information can be safely accessed, wherever it is needed

Building public trust and confidence in how health and care services look after confidential information and use it to benefit health and care is of paramount importance, Tutela is ISO27001 data security compliant. Data on the correct condition and storage of medicines is essential to support people in making the correct health and care choices. Not only does the Tutela tracking data platform give advanced warning of any potential threats to the compliance of the inventory, it provides unparalleled insight into the whole monitored environment.

Improving patient safety across the NHS

Providing patient lead care is paramount and when it comes to the safe storage of medicines, bloods and samples an automated monitoring system can provide real value. With manual systems it’s not possible to determine how long the stock was exposed to the out of spec temperature. So, the only safe option is to bin the stock. Yet with our automated monitoring, supported by 24/7/365 alarmed notification, valuable stock is protected. Making sure patients and the NHS get the best value from investment in medicines and pharmacy, whilst making prescribing and dispensing safer.

Improving NHS productivity with digital technology

Tutela have built a reliable IT service with solid infrastructure over the last 25 year that health and care professionals rely on every day. Tutela complies with and is approved for the NHS network protocol for security N3 / HSCN. With Tutela as a preferred NHS Supply Chain partner we offer value in terms of protecting stock and value in terms of admin time saved, so contributing to greater productivity.

In conclusion

Tutela monitoring systems provide the data services that are essential for building medicine and biology asset protection. This protection is more efficient, better connected and smarter than manual inspection. Tutela’s temperature monitoring systems, and wealth of priceless data, is supporting the NHS is delivering digitally-enabled care, by equipping the health and care system with world-class monitoring technology.

Contact us and we will put you in touch with one of our customers, so you can learn from their experience of investing in automated temperature monitoring.

The post How Tutela Temperature Monitoring supports Digitally-enabled Care in the NHS appeared first on Tutela Monitoring Systems.