Elements Medical

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• Overview
• Assessing needs
• Delivering evidence-based care and treatment
• How staff, teams and services work together
• Supporting people to live healthier lives
• Monitoring and improving outcomes
• Consent to care and treatment

We assessed all 6 quality statements from this key question due to the provider’s previous rating from 2021 being requiring improvement. Our rating for this key question has deteriorated to inadequate. We found concerns in all 6 quality statements which included assessing needs, delivering evidence-based care and treatment, how staff, teams and services work together, supporting people to live healthier lives, monitoring and improving outcomes and consent to care and treatment. We found 7 breaches of the legal regulations relating to dignity and respect, safe care and treatment, safeguarding service users from abuse and improper treatment, staffing, fit and proper persons employed, need for consent and good governance. The provider could not demonstrate that their systems and processes ensured that people who used the service had their care needs fully assessed. Staff did not have access to the information they needed to appropriately assess, plan, and deliver people’s care and treatment; systems and processes were not in place to ensure people received care and treatment that was evidence based and in line with good practice standards; effective systems and processes to support people to manage their health and wellbeing were not in place. Assessments did not adequately consider the person’s health, care, or wellbeing to enable them to receive care or treatment that has the best possible longer-term health outcomes; the service was not actively involved in quality improvement activity and did not have a clinical audit system in place. The service had no system in place to use information about care and treatment to make improvements; and significant concerns were identified in the way the provider managed consent and the respect offered to persons receiving care and treatment.

This service scored 25 (out of 100) for this area. Find out what we look at when we assess this area and How we calculate these scores.

Our assessment found care and treatment people received did not meet the expected standards relating to assessing people’s needs.

Some staff told us that they would not always carry out a regulated activity if they did not feel that the assessment of the person showed it was safe to do so, however there was no system for recording this and no evidence to show that treatment was refused or postponed. For people who used The Virtual Slimming Clinic we were told that when the assessment showed the person was not within scope for prescribing, the person would be refunded, and the prescribing would not take place. However, we asked how the service audited that people did not reapply with different answers, and we were told there was no audit to prevent this occurring. Staff told us that they made people aware of some potential risks and side effects when assessing and delivering treatment, however they did not routinely record this by way of safety netting. (Safety netting involves ensuring that systems are in place to provide safe monitoring and follow-up, as well as the specific advice given to individual people). Records that we looked at corroborated this.

Systems and processes were not in place to ensure that people who used the service had their care needs fully assessed to enable the provider to provide people with the services they required. People provided information to the practitioner delivering their treatment. However, the information requested from the person having treatment was limited to lifestyle questions, in the main. There was a lack of evidence of thorough and effective assessment. For example, in 3 out of 10 records that we looked at, the person’s date of birth had not been recorded. Assessments did not consider the person’s health, care, wellbeing, and communication needs. Where mental health needs had been identified there was no evidence of support or signposting to other services. Information and assessment outcomes pertinent to people’s treatment were not shared with the GP or other relevant health and social care agencies. This posed a risk as it had the potential to inhibit communication between health professionals. The provider used two systems for managing people's clinical records. For the regulated activities that were not slimming-related, the provider was unable to access clinical records for its existing people who used the service since the move over to a new records system, 7 days before our visit. This meant that the service could not confirm when the last medicine was administered and their medical history which placed people at risk of unsafe prescribing. The Virtual Slimming Clinic used an electronic assessment and prescribing system which was access restricted. The system enabled prescribers to look back at a person’s prescribing history, however this was not actively looked at or reviewed as we saw 3 people who had been prescribed a higher dose of medicine even though, they had not received a prescription from the service in the 3 months prior to the request.

Our assessment found care and treatment people received did not meet the expected standards relating to delivering evidence-based care and treatment.

Staff we spoke to were not familiar with changes in clinical guidelines. There was no system in place to cascade or disseminate this information to clinical staff who may have needed it.

Systems and processes were not in place to ensure people received care, treatment and support that was evidence-based and in line with good practice standards. For example, we identified medicines used within the service that were not always fit for purpose (or had the potential to be unfit for purpose) because the medicines were not purchased from an approved country for the purposes of supplying medicines for use in England by the Medicines Healthcare products Regulatory Agency (MHRA) which placed people who use the service at significant risk of harm. Medicines and Healthcare products Regulations Agency (MHRA) alerts were not always followed as the provider had not taken steps to sign up for alerts. For example, the MHRA issued a notice in August 2022 for prescription-only medicine (Kenalog) the notice advised providers to not directly or indirectly advertise to the public Kenalog for the treatment of hay fever in the UK. However, at the time of the assessment this was advertised on the provider’s website. Following our assessment the provider removed the specific reference to the medicine ‘Kenalog’ but continued to indirectly advertise treatment for hay fever. Medicines were prescribed for slimming online using the website The Virtual Slimming Clinic. There were no prescribing policies, slimming formulary, or guidance documents to support new prescribers to safely prescribe.

Our assessment found care and treatment people received did not meet the expected standards relating to how staff, teams and services work together.

The service was set up in a way that meant each practitioner saw their own person who used the service and there was rarely any crossover of lists. An encrypted social media messaging platform was used by staff at the service. They told us this was how they kept up to date with important information or changes implemented by the provider.

We were unable to gain feedback from partners as part of this assessment. However, our assessment found care and treatment people received did not meet the expected standards relating to how staff, teams and services work together.

Staff did not have access to the information they needed to appropriately assess, plan, and deliver people’s care, treatment, and support. For example, assessments were limited in scope, and there was no request for consent to the sharing of information between professionals or stakeholders (except for The Virtual Slimming Clinic). People treated for obesity were asked on the first contact for consent to share details of their consultation and any medicines prescribed with their registered GP, however, we did not see evidence that this was revisited on subsequent contacts. Our review of people's records did not evidence letters sent to the person’s registered GP in line with Nursing and Midwifery Council guidance. This was optional as part of the templates for online prescribing of slimming medicines. In both parts of the provider’s service, there was no evidence available to show that the risks of not sharing this information were explained to people. When people received care, it was not coordinated effectively. For example, we saw written records that did not adequately describe the treatment or intervention (regulated activity) that had been carried out. This meant that only the individual practitioner had knowledge of the person and the treatment they had received. This posed a risk if a different practitioner was to be allocated the person to treat, due to staff absence or their leaving the service. Staff did not work collaboratively to understand and meet people's needs because there was no evidence of effective clinical supervision.

Our assessment found care and treatment people received did not meet the expected standards relating to supporting people to live healthier lives.

The provider informed us that no further action or signposting for a person using the service would be undertaken if an assessment of a person to carry out a regulated activity was deemed unsafe. Some staff told us that they would not always carry out regulated activity if they did not feel that the assessment of the person showed it was safe to do so. However, there was no system for recording this and no evidence to show that this treatment was refused or postponed.

Effective systems and processes to support people to manage their health and wellbeing and, where possible, to live healthier lives were not in place. Assessments did not adequately consider the person’s health, care, or wellbeing to enable them to receive care or treatment that had the best possible longer-term health outcomes. The service did not focus on the early identification of risks to people’s health and wellbeing or on how to support people to prevent deterioration. For example, where a person reported low mood and requested a vitamin B12 injection there was no signposting on to other services that could support emotional wellbeing. There was no safety netting recorded. (Safety netting involves ensuring that systems are in place to provide safe monitoring and follow-up, as well as the specific advice given to individual people). There was no evidence of reassessment of any reported deterioration in mental health. For people who received slimming medicines the provider demonstrated a variety of resources that were available to people such as healthy diet plans and other resources.

Our assessment found care and treatment people received did not meet the expected standards relating to monitoring and improving outcomes.

Staff we spoke to told us they were not involved in clinical audit because they had not been trained how to undertake it. They told us they would be interested in learning how to undertake clinical audit in the future.

The provider was not actively involved in quality improvement activity. There was no clinical audit system and no system in place to use information about care and treatment to make improvements. The provider could not provide evidence of guidance documents used by staff for the regulated activities people were treated for. There was no evidence of monitoring in terms of the outcome of using the medicines we identified concerns with.

Our assessment found care and treatment people received did not meet the expected standards relating to consent to care and treatment.

The provider told us that the management of CCTV monitoring used inside the building (including in clinical rooms) was outsourced to a third-party company. People using the service could not consent to this as they had not been made aware of the situation. For people who did not speak English as a first language and needed interpretation services, this was not provided by Elements Medical Ltd. Staff had no system of assurance for checking that the correct information was being relayed to the person, or that the person understood and was happy for the treatment to commence. Staff we spoke with had a limited understanding of the Mental Capacity Act (MCA). They could not describe a chaperone policy, or any chaperone training they had received. There was a lack of understanding as to why a chaperone may be offered or required.

Systems were not in place to ensure people were told about their rights around consent and to ensure these rights were respected when care and treatment was delivered. The provider did not have risk assessments or policies in place to support a range of decisions relating to consent. For example, no risk assessment was in place in respect of their decision for people who were being continually monitored and recorded by CCTV inside the building, including in clinical areas, without being informed of this. Patients had not consented to this. The provider did not have a risk assessment in place or evidence to show they obtained the person’s consent for a third party such as the pharmacy supplying the slimming medicine to access their personal summary care record. No effective system was in place to ensure that people understood the care and treatment being offered or recommended to help them make an informed decision. From records we looked at 2 out of the 10 people using the non-slimming services did not have a consent for treatment form recorded in their record, but care and treatment appeared to have been initiated despite this. For people who accessed treatment through The Virtual Slimming Clinic consent to treatment was built into the online forms completed before prescribing. There were some systems to ensure that people understood the care and treatment as part of this process, however, this information was limited in scope and did not promote the persons’ fully informed decision. There were no supporting policies or procedures for obtaining consent to care and treatment. Staff training records were not available. Staff had not completed chaperone, MCA and Learning Disability and Autistic people Support Training.