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Inspection Summary


Overall summary & rating

Good

Updated 17 September 2021

This service is rated as

Good

overall.

The key questions are rated as:

Are services safe? – Good

Are services effective? – Good

Are services caring? – Good

Are services responsive? – Good

Are services well-led? – Good

We carried out an announced comprehensive inspection at My Access Clinic as part of our inspection programme.

My Access Clinic (MAC) provide cannabis-based products for medicinal use (CBPMs) to patients with pain, anxiety or depression who have not been successful with conventional treatments.

The clinical director is the registered manager. A registered manager is a person who is registered with the Care Quality Commission to manage the service. Like registered providers, they are ‘registered persons’. Registered persons have legal responsibility for meeting the requirements in the Health and Social Care Act 2008 and associated Regulations about how the service is run.

Our key findings were:

  • There were clear aims, objectives and ethos in place, and this was confirmed by clinicians and staff when we spoke with them.
  • There was a clear process in place which was completed before any medicines were prescribed, which included a full health assessment and questions on what patients wanted the medicine to achieve in reducing symptoms.
  • The provider had access to comprehensive and effective, secure clinical IT system that included both electronic patients records and clinical decision tools.
  • Staff recruitment and training records that we reviewed were well organised and contained all the required information.
  • There were appropriate policies and processes in place and implemented by clinicians, these were updated as needed.
  • Patient were provided with information on the medicines being prescribed and had access to a help line for any queries they may have.
  • The provider acted on feedback from patients and responded openly to any complaints made. Appropriate actions were taken when needed when improvements were needed.

The areas where the provider should make improvements are:

  • Review arrangements for safeguarding training of staff to ensure they are trained to the appropriate level for their role.
  • Clarify arrangements for prescribing decisions when patients are not discussed at meetings.

Dr Rosie Benneyworth BM BS BMedSci MRCGP

Chief Inspector of Primary Medical Services and Integrated Care

Inspection areas

Safe

Good

Updated 17 September 2021

We rated safe as Good

Safety systems and processes

The service had systems to keep people safe and safeguarded from abuse.

  • The provider conducted safety risk assessments. It had appropriate safety policies, which were regularly reviewed and communicated to staff including locums. They outlined clearly who to go to for further guidance. Staff received safety information from the service as part of their induction and refresher training. The service had systems to safeguard children and vulnerable adults from abuse. Staff knew how to identify and report concerns. Staff who acted as chaperones were trained for the role and had received a Disclosure and Barring Service check. (DBS checks identify whether a person has a criminal record or is on an official list of people barred from working in roles where they may have contact with children or adults who may be vulnerable).

  • The service worked with other agencies to support patients and protect them from neglect and abuse. Staff took steps to protect patients from abuse, neglect, harassment, discrimination and breaches of their dignity and respect.
  • The provider carried out staff checks at the time of recruitment and on an ongoing basis where appropriate. DBS checks were undertaken where required.
  • Not all staff had received up-to-date safeguarding and safety training to their role. We reviewed training records for staff. We found that some had not received safeguarding training in the past 12 months. Three clinicians had not received safeguarding training to level three for children. Intercollegiate guidance indicates that this is not required for staff who have limited or no contact with patients aged under 18 years old. The guidance states that all clinicians should be trained in safeguarding level three for children by August 2021. The service did not provide treatment for patients aged under 18 years old. We requested the service’s training policy which showed staff should be trained to an appropriate level for their role, but the level was not specified.
  • There was an effective system to manage infection prevention and control. The infection control policy covered COVID-19, handwashing and used of personal protective equipment. Cleaning of the premises was the responsibility of the landlord. The consulting room used by the service was visibly clean and tidy. Cleaning schedules were available and seen to be completed.
  • The landlord carried out regular testing for Legionella (Legionella is a term for a particular bacterium which can contaminate water systems in buildings which can cause illness) and shared the results with the service. There were no issues with Legionella being present in water systems.
  • Health and safety of the whole building was the responsibility of the landlord and documentation showed that appropriate checks had been carried out on electrical wiring safety and gas installations. Appropriate arrangements were in place for fire safety; including a risk assessment; and a fire safety policy; and procedures to take in the event of a fire. Fire drills were carried out every six months.
  • The provider ensured that facilities and equipment were safe, and that equipment was maintained according to manufacturers’ instructions.

Risks to patients

There were systems to assess, monitor and manage risks to patient safety.

  • All appointments were booked at a time suitable for patients and information on when a particular clinician was available was displayed on the service’s website. There were appropriate indemnity arrangements in place.
  • All patients received online or telephone consultations and suitable arrangements were in place should a clinician be concerned about a patient.

Information to deliver safe care and treatment

  • Before providing treatment, doctors at the service ensured they had adequate knowledge of the patient’s health, any relevant test results and their medicines history. We saw examples of patients being signposted to more suitable sources of treatment where this information was not available to ensure safe care and treatment.
  • The service prescribed CBPMs that are Schedule 2 controlled drugs (medicines that have the highest level of control due to their risk of misuse and dependence).
  • The medicines prescribed were unlicensed. Treating patients with unlicensed medicines is higher risk than treating patients with licensed medicines, because unlicensed medicines may not have been assessed for safety, quality and efficacy. Therefore, they must be prescribed and supplied in line with the Medicines and Healthcare products Regulatory Agency (MHRA) guidance for the prescribing and supply of unlicensed medicines. Patients were given information on what this meant in the patient information leaflet.

  • Clinicians made appropriate and timely prescribing decisions in line with organisational protocols and up to date evidence-based guidance. For example, the cannabis-based products for medicinal use CBPMs should only prescribed where there is evidence of unmet clinical need such as unsuccessful conventional treatments.
  • Current guidance for settings which prescribe CBPMs, is that decisions on what CBPMs to prescribe should be agreed through peer review or multi-disciplinary team discussion.. My Access Clinic’s process for reviewing of prescribing decisions for CBPMs did not always include a peer review by another clinician with the appropriate scope of clinical practice.
  • My Access Clinic ensured that when a new clinician started to prescribe CBPMs, then this was always discussed with a peer and taken to a clinical meeting. Established prescribers had access to a database of over 120,000 patients who were actively being prescribed CBPMs. The database also included a similar number of patents who had been discharged from being prescribed CBPMs and over 500 peer reviewed clinical studies and 30 validated assessment tools. This information was used in clinical assessments to assist with prescribing decisions. The clinic was also had 24-hour to access national and European networks for advice and best practice guidance in prescribing.
  • If a patient assessment showed that they had complex needs then their cases were peer reviewed and taken to a clinical meeting to be discussed, these meeting were planned on a regular basis and were also carried out when needed. Clinical meetings also showed that patient cases were discussed when a clinician considered it was appropriate. Only when this process had been followed was a prescription issued for complex cases.
  • Prescribing decisions could also be discussed with the Medical Cannabis Clinicians’ Society.
  • For other prescribing decisions the provider had set up a secure chat function on mobile telephones, which enabled clinicians to seek advice and discuss patients at any time and if needed get real time feedback.
  • When we undertook a review of service provision in October 2020 we recommended that the provider followed published guidance on prescribing CBPMs. The provider had reviewed this guidance. This process had not been risk assessed or formally documented in a protocol to demonstrate how prescribing decisions were managed.
  • There were effective protocols for verifying the identity of patients, all of whom were adult.
  • All patients received information on the CBPMs that was prescribed and a dosing and titration plan to enable them to receive the optimum treatment. Follow up consultations were used to check on whether this was effective.

Staff had the information they needed to deliver safe care and treatment to patients.

  • Individual care records were written and managed in a way that kept patients safe. The care records we saw showed that information needed to deliver safe care and treatment was available to relevant staff in an accessible way.
  • The service had systems for sharing information with staff and other agencies to enable them to deliver safe care and treatment.
  • The service had a system in place to retain medical records in line with Department of Health and Social Care (DHSC) guidance in the event that they cease trading.

Safe and appropriate use of medicines

The service had reliable systems for appropriate and safe handling of medicines.

  • My Access Clinic did not keep any CBPMs on site.
  • The clinic did not use a designated pharmacy to dispense prescriptions. They worked with multiple pharmacies who guaranteed prescription charges and ensured there were appropriate patient consent and identity checks in place, to prevent unauthorised use.
  • If a patient’s CBPMs changed then they were informed of the new dosage and how to titrate to get to a therapeutic level. Withdrawing from the previous product was managed as part of this process.
  • The service kept prescription stationery securely and monitored its use.

Track record on safety and incidents

The service had a good safety record.

  • There were comprehensive risk assessments in relation to safety issues.
  • The service monitored and reviewed activity. This helped it to understand risks and gave a clear, accurate and current picture that led to safety improvements.

Lessons learned and improvements made

The service learned and made improvements when things went wrong.

  • There was a system for recording and acting on significant events. Staff understood their duty to raise concerns and report incidents and near misses. Leaders and managers supported them when they did so.
  • There were adequate systems for reviewing and investigating when things went wrong. The service learned and shared lessons identified themes and took action to improve safety in the service. My Access Clinic had had no significant events or incidents in the past 12 months.
  • The provider was aware of and complied with the requirements of the Duty of Candour. The provider encouraged a culture of openness and honesty. The service had systems in place for knowing about notifiable safety incidents

When there were unexpected or unintended safety incidents:

  • The service gave affected people reasonable support, truthful information and a verbal and written apology.
  • They kept written records of verbal interactions as well as written correspondence.

The service acted on and learned from external safety events as well as patient and medicine safety alerts. The service had an effective mechanism in place to disseminate alerts to all members of the team including sessional and agency staff.

Effective

Good

Updated 17 September 2021

We rated effective as Good

Effective needs assessment, care and treatment

The provider had systems to keep clinicians up to date with current evidence-based practice. We saw evidence that clinicians assessed needs and delivered care and treatment in line with current legislation, standards and guidance (relevant to their service)

  • Clinicians had enough information to make a prescribing decision. The service had access to a clinical database of over 120,000 patients who have received medicinal cannabis care and treatment. This anonymised information was used to underpin clinical decisions on the most appropriate product to be prescribed. The system provided both a secure electronic patient record and clinical decision tools.
  • Patients’ immediate and ongoing needs were fully assessed. Where appropriate this included their clinical needs and their mental and physical wellbeing. Patients were only prescribed cannabis-based products when they had tried at least two licensed medicines to treat their condition. This was in line with NHS Guidance.
  • Eight cannabis-based products for medicinal use (CBPMs) were available from My Access Clinic and were prescribed to meet the individual needs of each patient. Each medicine had a different ratio of active ingredients. The clinical assessment tool identified the most appropriate ratio of active ingredients to treat patients needs and provided recommendations of which medicines to prescribe. Choice of medicine was discussed with patients and an agreement reached of what medicine might meet their needs.
  • We saw no evidence of discrimination when making care and treatment decisions.

Monitoring care and treatment

The service was involved in quality improvement activity.

  • At the time of inspection work was in progress to refine their current system of audits have an overarching schedule for audit and quality improvement activity. This was due to be presented at the next governance meeting.
  • Clinicians and staff of My Access Clinic were involved in educating doctors who worked for other services, as well as the clinic and other staff who undertook cannabis prescribing.
  • The service was carrying out an audit on patient notes and level of details to ensure sufficient information to enable continuity of care.

Effective staffing

  • My Access Clinic employed its own specialist doctors to provide medicinal cannabis care to patients with pain, anxiety and depression. These prescribing consultants were on the General Medical Council’s Specialist Register and included a pain specialist and anaesthetist; a neuro-rehabilitation specialist; and a specialist psychiatrist. Other recently recruited doctors were undergoing induction training, one of whom was a pain specialist. Nurses employed by the service triaged patients and ensured all information required by a prescriber was available before a patient attended for a consultation. Nursing staff we spoke with confirmed they had received induction training which was clear on the duties they were employed to carry out.

Staff had the skills, knowledge and experience to carry out their roles.

  • All staff were appropriately qualified. The provider had an induction programme for all newly appointed staff.
  • Relevant professionals (medical and nursing) were registered with the General Medical Council (GMC)/ Nursing and Midwifery Council and were up to date with revalidation
  • The provider understood the learning needs of staff and provided protected time and training to meet them. Up to date records of skills, qualifications and training were maintained. Staff were encouraged and given opportunities to develop.
  • Regular appraisal sessions were carried out which also provided opportunities for staff to comment on the running of the service and request support for development opportunities.

Coordinating patient care and information sharing

Staff worked together, and worked well with other organisations, to deliver effective care and treatment.

  • Patients received coordinated and person-centred care. Staff referred to, and communicated effectively with, other services when appropriate. One example concerned a patient who was being provided with support from a service based in another country, therefore the prescribing clinician liaised with this service to ensure safe and effective treatment. Other examples related to patients who were not suitable for medical cannabis and the service contacted mental health services or drug misuse services for ongoing care and treatment for patients.
  • Before providing treatment, doctors at the service ensured they had adequate knowledge of the patient’s health, any relevant test results and their medicines history. We saw examples of patients being signposted to more suitable sources of treatment where this information was not available to ensure safe care and treatment.
  • All patients were asked for consent to share details of their consultation and any medicines prescribed with their registered GP on each occasion they used the service. If consent was withheld then My Access Clinic would not provide care.
  • Patient information was shared appropriately (this included when patients moved to other professional services), and the information needed to plan and deliver care and treatment was available to relevant staff in a timely and accessible way.
  • The service monitored the process for seeking consent appropriately.

Supporting patients to live healthier lives

Staff were consistent and proactive in empowering patients and supporting them to manage their own health and maximise their independence.

  • Where appropriate, staff gave people advice so they could self-care.
  • Risk factors were identified, highlighted to patients and where appropriate highlighted to their normal care provider for additional support.
  • Where patients needs could not be met by the service, staff redirected them to the appropriate service for their needs.

Consent to care and treatment

The service obtained obtain consent to care and treatment in line with legislation and guidance.

  • Staff understood the requirements of legislation and guidance when considering consent and decision making. All patients who used the service, did so on the understanding that they must consent to have their treatment details shared with their own GP practice where they were registered.
  • Consent was also obtained from the patient for the service to work with the pharmacies they used to dispense medicines.
  • Staff supported patients to make decisions. Where appropriate, they assessed and recorded a patient’s mental capacity to make a decision. If needed the service obtained copies of Lasting Powers of Attorney to ensure that relevant people were involved in decision making.

Caring

Good

Updated 17 September 2021

We rated caring as Good

Kindness, respect and compassion

Staff treated patients with kindness, respect and compassion.

  • The service sought feedback on the quality of clinical care patients received. Following each consultation, patients were sent a feedback form, questions included patients views on their consultations and consent processes.
  • Feedback from patients was positive about the way staff treat people. Patients considered that staff involved them in decisions and explained treatment options clearly.
  • Staff understood patients’ personal, cultural, social and religious needs. They displayed an understanding and non-judgmental attitude to all patients.
  • The service gave patients timely support and information. Examples included patient information leaflets and information via the service’s website.

Involvement in decisions about care and treatment

Staff helped patients to be involved in decisions about care and treatment.

  • Interpretation services were available for patients who did not have English as a first language. Patients were also told about multi-lingual staff who might be able to support them. Information leaflets were available in easy read formats on request, to help patients be involved in decisions about their care.
  • For patients with learning disabilities or complex social needs family, carers or social workers were appropriately involved.
  • Staff communicated with people in a way that they could understand, for example, communication aids and easy read materials were available.

Privacy and Dignity

The service respected patients’ privacy and dignity.

  • Staff recognised the importance of people’s dignity and respect.

All consultations were carried out in private and patients were able to discuss their needs openly. This was demonstrated by information contained in records of consultations.

Responsive

Good

Updated 17 September 2021

We rated responsive as Good

Responding to and meeting people’s needs

The service organised and delivered services to meet patients’ needs. It took account of patient needs and preferences. During the COVID-19 pandemic, appointments were conducted over the telephone or through video calls. Only when necessary were home visits undertaken.

  • The provider understood the needs of their patients and improved services in response to those needs. They had developed their website in response to patient feedback and introduced a self-booking appointment system on the site.
  • The service had a phoneline that was open from 9am to 5pm Monday to Friday for patients to call with any queries. There was the facility for patients to leave a voice message out of hours.
  • Reasonable adjustments had been made so that people in vulnerable circumstances could access and use services on an equal basis to others. For example, where needed arrangements were in place to enable relevant people to support patients with their care and treatment.

Timely access to the service

Patients were able to access care and treatment from the service within an appropriate timescale for their needs.

  • Patients had timely access to initial assessment and treatment.
  • Waiting times, delays and cancellations were minimal and managed appropriately.
  • Patients reported that the appointment system was easy to use.
  • Referrals and transfers to other services were undertaken in a timely way.

Listening and learning from concerns and complaints

The service took complaints and concerns seriously and responded to them appropriately to improve the quality of care.

  • Information about how to make a complaint or raise concerns was available. Staff treated patients who made complaints compassionately.
  • The service informed patients of any further action that may be available to them should they not be satisfied with the response to their complaint.
  • The service had a complaint policy and procedure in place. The service learned lessons from individual concerns, complaints and from analysis of trends. It acted as a result to improve the quality of care. For example, there were issues with refunding patients, so My Access Clinic changed their payment system.

Well-led

Good

Updated 17 September 2021

We rated well-led as Good

Leadership capacity and capability

Leaders had the capacity and skills to deliver high-quality, sustainable care.

  • Leaders were knowledgeable about issues and priorities relating to the quality and future of services. They understood the challenges and were addressing them.
  • Leaders at all levels were visible and approachable. They worked closely with staff and others to make sure they prioritised compassionate and inclusive leadership.
  • The provider had effective processes to develop leadership capacity and skills, including planning for the future leadership of the service.

Vision and strategy

The service had a clear vision and strategy to deliver high quality care and promote good outcomes for patients.

  • The service had a realistic strategy and supporting business plans to achieve priorities.
  • The service developed its vision, values and strategy jointly with staff and external partners (where relevant). Clinicians described good communication and peer support was in place; and there was a clear focus on patient centred care, including appropriate follow up arrangements for patients.
  • Staff were aware of and understood the vision, values and strategy and their role in achieving them.
  • The service monitored progress against delivery of the strategy.

Culture

The service had a culture of high-quality sustainable care.

  • Staff felt respected, supported and valued. They were proud to work for the service.
  • The service focused on the needs of patients and tailored their service to their needs, for example, by offering a manned telephone line during working hours for any queries patients may have.
  • Leaders and managers acted on behaviour and performance inconsistent with the vision and values.
  • Openness, honesty and transparency were demonstrated when responding to incidents and complaints. The provider was aware of and had systems to ensure compliance with the requirements of the duty of candour.
  • Staff told us they could raise concerns and were encouraged to do so. They had confidence that these would be addressed.
  • There were processes for providing all staff with the development they need. This included appraisal and career development conversations. All staff received regular annual appraisals in the last year. Staff were supported to meet the requirements of professional revalidation where necessary. Clinical staff, including nurses, were considered valued members of the team. They were given protected time for professional development and evaluation of their clinical work.
  • Improvements were needed to ensure safeguarding training to the appropriate level had been completed for staff.
  • There was a strong emphasis on the safety and well-being of all staff.
  • The service actively promoted equality and diversity. It identified and addressed the causes of any workforce inequality. Staff had received equality and diversity training. Staff felt they were treated equally.
  • There were positive relationships between staff and teams.

Governance arrangements

There were clear responsibilities, roles and systems of accountability to support good governance and management.

  • Structures, processes and systems to support good governance and management were clearly set out, understood and effective. The governance and management of partnerships, joint working arrangements and shared services promoted interactive and co-ordinated person-centred care.
  • When we carried out a remote assurance engagement in October 2020, we found some policies and procedures required updating to reflect current practice. This work had been completed by the time we inspected.
  • Staff were clear on their roles and accountabilities and said that they were supported to work in line with their competencies.
  • Leaders had established proper policies, procedures and activities to ensure safety and assured themselves that they were operating as intended.
  • The service used performance information, which was reported and monitored, and management and staff were held to account.
  • The information used to monitor performance and the delivery of quality care was accurate and useful. There were plans to address any identified weaknesses.
  • There were arrangements in line with data security standards for the availability, integrity and confidentiality of patient identifiable data, records and data management systems.

Managing risks, issues and performance

There were clear and effective processes for managing risks, issues and performance.

  • There was an effective, process to identify, understand, monitor and address current and future risks including risks to patient safety.
  • The service had processes to manage current and future performance. Performance of clinical staff could be demonstrated through audit of their consultations, prescribing and referral decisions. Leaders had oversight of safety alerts, incidents, and complaints.

Appropriate and accurate information

The service acted on appropriate and accurate information.

  • Quality and operational information was used to ensure and improve performance. For example, prescribing decisions and treatments were discussed at clinical meetings to assess how effective medicines were in treating patients’ conditions. . Performance information was combined with the views of patients.
  • At each consultation, patients were requested to answer questions on their physical and mental health wellbeing to provide information on how effective their medicines were. Results from reviews of patients showed that treatment were effective in reducing symptoms, such as pain and anxiety and patients felt more able to manage their condition
  • Quality and sustainability were discussed in relevant meetings where all staff had sufficient access to information.

Engagement with patients, the public, staff and external partners

The service involved patients, the public, staff and external partners to support high-quality sustainable services.

  • The service encouraged and heard views and concerns from the public, patients, staff and external partners and acted on them to shape services and culture. For example, My Access Clinic was developing patient education materials in response to questions from patients and other health care professionals about medicinal cannabis prescribing. They had introduced patient information leaflets on the medicines prescribed in response to patient need as p[art of the process. This work would be continued on an ongoing basis and reviewed.
  • Staff could describe to us the systems in place to give feedback. All patients were sent a feedback form electronically after their consultation. Results from these showed that patients were pleased with the service provided and considered that treatment options were explained, and patients were involved in decision making about the most appropriate treatment.
  • We saw evidence of feedback opportunities for staff and how the findings were fed back to staff. We also saw staff engagement in responding to these findings.
  • The service was transparent, collaborative and open with stakeholders about performance.

Continuous improvement and innovation

There were of systems and processes for learning, continuous improvement and innovation.

  • There was a focus on continuous learning and improvement.
  • The service made use of internal and external reviews of incidents and complaints. Learning was shared and used to make improvements.
  • Leaders and managers encouraged staff to take time out to review individual and team objectives, processes and performance.
  • There were systems to support improvement and innovation work, My Access Clinic were working with legal teams to explore the possibility of setting up a charity to support patients who could not afford to pay for the service provided.