Elements Medical

On this page

• Overview
• Learning culture
• Safe systems, pathways and transitions
• Safeguarding
• Involving people to manage risks
• Safe environments
• Safe and effective staffing
• Infection prevention and control
• Medicines optimisation

We assessed a total of 7 quality statements from this key question. We have combined the scores for these areas with scores based on the rating from the last inspection, which was good. Our rating for this key question has deteriorated to inadequate. We found concerns in all 7 quality statements which included learning culture, safe systems, pathways and transitions, safeguarding, involving people to manage risks, safe environments, safe and effective staffing, and medicines optimisation. We found 7 breaches of the legal regulations, specifically 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 they involved people in managing risks. People were not always made aware of potential risks they were being exposed to or given the option to make an informed decision about whether to use the service; there was a poor culture of safety and learning which was not based on openness, transparency and learning from events which put people and staff at risk of harm. Risks were overlooked or ignored; there was an ineffective approach and a lack of regard for identifying and managing risks to people as they moved between services. There was no collaborative, joined-up approach to safety because information about assessments, treatment and aftercare was not shared with other stakeholders and partner organisations; there was a lack of effective systems, processes and practices to make sure people were protected from abuse and neglect; there were significant safety concerns with the environment; systems were not in place to ensure staff were recruited safely, were appropriately trained and received effective support and supervision and there were significant safety concerns with the management of medicines and treatments.

This service scored 31 (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 learning culture.

There was a lack of evidence that discussions occurred when things went wrong, or that learning from incidents was embedded at the service. Some staff described it as a safe place to make mistakes but could not describe how that contributed to a culture of continuous improvement. When asked, the provider confirmed they did not keep a record of significant incidents as there had not been any incidents to record. However, we were told of examples of events, by staff, which ought to have constituted being recorded as a significant incident (for example, a potential allergic reaction). The provider told us a log of complaints was kept by a lead member of staff. The staff member could not provide evidence of this.

There was a poor culture of safety and learning which was not based on openness, transparency and learning from events. This had put people and staff at risk of harm. Risks were overlooked or ignored, for example, risks related to fire safety and medicines. The provider did not have a process for staff to report incidents, near misses and safety events. There was an absence of evidence that significant events were being dealt with sufficiently. We were made aware of at least two incidents that had not been recorded and therefore we could not be assured what action the provider had taken. This posed a potential risk for clinical errors to recur because recording, learning, and dissemination of serious events were not undertaken. The provider’s website outlined its complaints procedure in considerable detail, but we found no evidence during the assessment that a policy existed to support people to complain. The provider had arrangements in place to allow people using the service the opportunity to provide feedback on the service received. However, there was no evidence that the views of people were listened to, recorded, or considered. This was not in line with the provider’s own complaints policy. The policies, procedures and templates provided to us by the provider on the day of the assessment were not service specific and did not contain the level of detail we would expect to see.

Our assessment found care and treatment people received did not meet the expected standards relating to safe systems, pathways and transitions.

The provider told us they did not have a system for sharing and receiving information from a person’s GP practice for the medical regulated activities. There was a process for The Virtual Slimming Clinic, however, we saw that this was optional, and the provider told us most people selected not to inform their GP.

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 safe systems, pathways and transitions.

There was an ineffective approach and a lack of regard for identifying and managing risks to people as they moved between services. Safety and continuity of care was not prioritised. There was no collaborative, joined-up approach to safety because information about assessments, treatment and aftercare was not shared with other stakeholders and partner organisations. Whilst The Virtual Slimming Clinic had a process for contacting the GP to inform them of the prescribing of slimming medicines, we were not assured of the effectiveness of this. Most people did not select the option to share information with their GP. The provider did not take further steps to explain to people why it was important to share this information with their GP. In addition, The Virtual Slimming Clinic used a community pharmacy to dispense the slimming medicines and as part of this process the community pharmacy was asked to access the person’s summary care record for additional clinical checks such as allergies and interactions between medicines. Elements Medical Ltd itself is out of scope for access to summary care records. NHS Digital guidance states that to access a person's summary care record then permission from the person is required. Once accessed, the pharmacy ticked a box on the prescribing platform used by The Virtual Slimming Clinic, however, there was no process in place to ensure information of concern was passed between the services. The policies, procedures and templates provided to us by the provider on the day of the assessment were not service specific and did not contain the level of detail we would expect to see.

Staff we spoke to were not able to describe the provider’s safeguarding arrangements. There was a lack of understanding of safeguarding and how to take appropriate action. Staff could not describe safeguarding arrangements, what being safe meant to them, or how to raise concerns when they did not feel safe, or if they had concerns about the safety of other people. People were not supported to understand their rights under the Mental Capacity Act (MCA) 2005. Staff we spoke to had little awareness of these rights and there were no systems in place to support people’s rights.

The provider did not have effective safeguarding systems, processes and practices which meant that people’s human rights were not upheld, and they were not protected from abuse, neglect and discrimination. For example, we saw that people were covertly filmed at the premises including while receiving treatment, without their knowledge or consent. In addition, the provider told us that the closed-circuit television monitoring (CCTV) was monitored and managed by a third-party provider which posed a safeguarding risk. Some records we looked at did not include a date of birth of the person using the service. This meant that care and treatment could not be delivered in a way that met people’s needs and kept them safe. This contravened the need to maintain an accurate, complete, and contemporaneous record in respect of each service user. The provider could not evidence that staff had completed safeguarding training as detailed in the Royal College of Nursing Intercollegiate guidance. The safeguarding policies provided to us by the provider on the day of the assessment were not service specific and did not contain the level of detail we would expect to see. There was no system or process for using incidents or complaints to identify potential abuse. This meant the provider could not take preventative action, including escalation where appropriate. Records up to 7 days before our assessment could not be accessed internally, (or externally by other authorised agencies). This posed a risk to people’s ongoing care and treatment and prevented information sharing.

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

Staff we spoke to told us the service had no system to enable them to identify and assess risks to the health, safety and welfare of people using the service.

The provider did not have systems in place to ensure they involved people in managing risks. People were not always made aware of potential risks they were being exposed to or given the option to make an informed decision about whether to use the service. For example, significant risks in relation to medicines and treatment, fire safety, CCTV monitoring, consent, staff training, staff recruitment and safeguarding were not communicated to people using the service.

Staff were unsure of their responsibilities in the event of a fire, infection prevention and control or a medical emergency. The staff we spoke to could not recall having practised a fire evacuation.

Fire safety was a significant concern. All fire extinguishers had been removed and placed in the staff room on the top floor, which was only accessible via steep, narrow stairs. There was no safe means of escape from the top floor. Records showed the fire alarm was last serviced in 2021. The ground floor stairwell, leading to the basement fire exit, was obstructed by building materials and the fire exit in the basement was at the back of a cluttered room that housed unused furniture and cardboard boxes. There were lit candles in clinic and waiting rooms, which were unattended for significant periods of time. Medical oxygen was available, however this was not appropriately signposted. This means that there could be a delay in locating the oxygen cylinder in the event of a fire. No evacuation chair was available, which meant evacuation from the four-storey building would be seriously hampered. General evacuation plans were not in place, and we found no evidence of staff training for fire safety. Items were not stored securely or appropriately, including needles, syringes, and medicines. None of the rooms within the building were locked when not in use. Sharps bins were overfilled and there was no policy in place for the safe disposal and handling of clinical waste. Premises were visibly clean, however there was no schedule or oversight of the cleaning of clinical areas and clinical equipment between appointments. This meant that staff and patients could not be assured that clinical areas were safe from the potential risks of infection. Facilities, equipment and technology were in some instances well-maintained, for example, some equipment had been tested for electrical safety in May 2023. However, the environment did not consistently support staff to deliver safe and effective care.

Systems were not in place to detect and control potential risks in the care environment. There was a lack of oversight relating to health and safety. Some required health and safety checks were carried out, however others were not. For example, there was no routine checking of emergency safety equipment, such as burns, eye wash or bodily fluid disposal kits. Equipment used to deliver care and treatment was not always suitable for the intended purpose, which meant people using the service were not always cared for in safe environments. Arrangements to ensure emergency equipment and medicines were maintained were not in place. For example, we found some emergency medicines and equipment had expired and had not been replaced. There was no risk assessment in place to determine which medicines the service required, and some emergency protocols required staff to use medicines the service did not stock. A defibrillator was available, however there were no pads, which meant the defibrillator was not usable in the event of an emergency. Records did not show the defibrillator as being checked. Oxygen was not stored safely, as there was no signage to alert people to its location. There was not a system in place to ensure clinical waste, including used sharps, were disposed of appropriately and in line with national guidance

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

The provider confirmed formal clinical supervision or competency assessments were not carried out. Professional revalidation was managed within the service. We were told staff met daily as a group to share information and that nurses would block out time in their schedules if they needed to discuss something that concerned them. We did not see evidence of this. Staff told us they had the opportunity to attend courses when they requested this. The provider told us that plans were in place for the rollout of a new training package soon and that currently, they did not have a system for managing staff training and they relied on staff completing mandatory training in their other places of employment.

Systems were not in place to ensure staff were recruited safely, were appropriately trained and received effective support and supervision. We reviewed 4 staff files and found gaps in all areas of recruitment including appropriate DBS checks, identification verification, references or equivalent, full employment history, staff immunisations status and medical history. There were no recruitment records available for a recently appointed nurse prescriber who had commenced work for The Virtual Slimming Clinic. Recruitment and capability processes were not robust and therefore we were unable to be assured that there was no discrimination based on any specific protected equality characteristic. Staff did not always receive training appropriate and relevant to their role. A system for ensuring training to equip staff to carry out their role was not in place. Staff had not completed training in a range of areas, including (but not limited to) safeguarding at any level, basic first aid, anaphylaxis, infection prevention and control, fire safety, learning disability and autism. There was no evidence of supervision, appraisal, or competency assessments for staff to show they received the support they needed to deliver safe care. The policies and procedures provided to us by the provider on the day of the assessment were not service-specific and did not contain the level of detail we would expect to see. There was evidence that clinicians had appropriate indemnity insurance in place.

We did not look at Infection prevention and control during this assessment. The score for this quality statement is based on the previous rating for Safe.

Our assessment of the way medicines were managed meant that the care and treatment people received did not meet the expected standards. Some of the medicines the provider prescribed were unlicensed. Treating people with unlicensed medicines poses greater risk than treating people with licensed medicines, because unlicensed medicines may not have been assessed for safety, quality, and efficacy. These medicines are not currently recommended by the National Institute for Health and Care Excellence (NICE). Some information was available to people regarding unlicenced medicines, however information was not clarified before procedures took place and no consent from people regarding the use of the unlicensed medicine was documented. We could not be assured that medicines for aesthetically regulated activities or medical regulated activities were prescribed for the individual person prior to the treatment taking place. There was no prescribing data available during the assessment due to the provider moving to a new clinical system and not completing a hard download or maintaining access to the old system after the 1 October 2024 when the new system was introduced. There was no clinical auditing of prescribing that was focused on improving outcomes, care, and treatment.

Feedback from staff was not consistent with our findings. Staff told us that they checked emergency medicines and equipment, however we found that the checks were not always recorded, and they did not include all items that required checking. In addition, there was a lack of awareness of the differences between anti-wrinkle treatments, Botox and Dysport (a prescription medicine neuro-muscular blocker (Abobotulinum toxin A) which meant that staff were not able to support people to make informed choices.

Checks on the stock levels and expiry dates of medicines stored did not take place, including for emergency medicines. Not all medicines fridges were fit for purpose, as some were not lockable or had no thermometers. Temperature monitoring records were not in place for any medicine fridges, which meant staff could not be assured medicines were safe and fit for use. For example, 1 medicine fridge was turned off during clinic times due to its noise, however we found a large quantity of Dysport (a type of muscular injection) was stored in it. This medicine required storage between 2 and 8 degrees, however we did not find appropriate temperature monitoring in place. Staff told us this medicine had been imported from Turkey, and we found labels on the medicine were not in English, however the provider did not have a licence to import any medicines to England. Turkey is also not an approved country for the purposes of supplying medicines for use in England by the Medicines Healthcare products Regulatory Agency (MHRA). Failure to obtain medicines from a licensed source exposes people to a significant risk of harm because there is no assurance the medicines are safe to use. We also found the provider was using this injection in place of Botox, however people using the service had not been informed of this. We saw evidence that vials which were meant for single use only were being shared between multiple patients, which posed a significant infection risk. The provider purchased Bacteriostatic Sodium Chloride 0.9% online to use as a diluent to reconstitute medicines used for injection. The website stated “all products listed on this website are for research purposes only, we do not advocate or advise human use, and any such use is entirely at your own risk”, however no risk assessment had been completed by the provider for the use of this product. No information was provided to patients, which placed patients at significant risk of harm.

Systems were not in place to ensure that medicines and treatments were safe and met people’s needs.There was no in-date medicines policy. There were no clinical protocols or treatments plans for the use of medicines in either the slimming or aesthetic parts of the provider’s services. The provider did not have a system for obtaining medicines for stock use within the service. Stock items were obtained by prescribing them for staff members. The supplied medicines were then used in the clinic. The Nursing and Midwifery Council have adopted the Royal Pharmaceutical Societies document “A Competency Framework for all prescribers” which details the standards for non-medical prescribers. Failure to follow prescribing standards and failure to ensure emergency medicines are in stock and fit for use puts people who use the service at unnecessary risk of harm. The provider did not have an effective system to manage and respond to safety alerts and medicine recalls.