Archived: Airedale Allergy Centre

We carried out an unannounced responsive inspection at Airedale Allergy Clinic on 12 March 2018, following concerns which were raised with the Care Quality Commission. During the March 2018 inspection a breach of the regulations was identified in relation to the management of medicines, equipment and assessing and responding to patient risk. A warning notice was issued and the provider was told to improve.

This inspection was an announced comprehensive inspection carried out on 16 October 2018 to check that the clinic had responded to the warning notice dated 20 March 2018 and had made the required improvements.

The responsive report for the March 2018 inspection can be found by selecting the ‘all reports’ link for Airedale Allergy Clinic on our website at www.cqc.org.uk.

During this comprehensive follow up inspection on 16 October 2018 we asked the service the following key questions; Are services safe, effective, caring, responsive and well-led?

Our findings were:

Are services safe?

We found that this service was not providing safe care in accordance with the relevant regulations.

Are services effective?

We found that this service was not providing effective care in accordance with the relevant regulations.

Are services caring?

We found that this service was not providing caring services in accordance with the relevant regulations.

Are services responsive?

We found that this service was not providing responsive care in accordance with the relevant regulations.

Are services well-led?

We found that this service was not providing well-led care in accordance with the relevant regulations.

We carried out this inspection under Section 60 of the Health and Social Care Act 2008 as part of our regulatory functions. This inspection was planned to check whether the service had carried out the improvements required to comply with the warning notice dated 20 March 2018. Airedale Allergy Centre had failed to comply with Regulation 12 (1) Safe care and Treatment of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

At the March 2018 inspection, a number of concerns had been identified with regards to the safe management of medicines. This included compliance with Human Medicines Regulations (2012) and Nursing and Midwifery Council guidance. There were omissions in relation to the storage, labelling, manufacturing and administration arrangements for vaccines and infusions provided to patients. We were not assured all patients were appropriately assessed prior to receiving treatment. In addition, processes for gaining consent from patients did not follow best practice guidance. Staff training and competence showed a number of gaps and we were not assured that staff skills and knowledge were up to date. At the March 2018 inspection we had also identified a number of sterile items which had passed their expiry date; and electronic equipment testing had not taken place since 2013. Hand wash facilities were not available in the consulting or treatment room; although alcohol gel was available.

Airedale Allergy Centre is operated by Thames Allergy Centre Limited. The service investigates and aims to identify dietary, environmental or nutritional factors related to health problems. It also offers advice and treatment, including dietary modification and desensitisation. The service also manufactures, supplies and administers vaccines and intravenous infusions to patients.

At the time of our inspection this service was registered with CQC under the Health and Social Care Act 2008 in respect of some, but not all, of the services it provides. There are some general exemptions from regulation by CQC which relate to particular types of service and these are set out in Schedule 2 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. At Airedale Allergy Centre, services are provided to patients regardless of where they live. Patients who are seen in the clinic, but do not reside in England are out of CQC scope of registration.

At the time of our inspection the clinic was registered with the CQC for the regulated activity of Treatment of Disease, Disorder or Injury only. During our inspection it was highlighted that the clinic was also undertaking the regulated activity of Diagnostic and Screening Services. The provider is registered for the provision of this regulated activity, but not as a condition of registration from Airedale Allergy Centre.

The clinic administrator 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.

During the inspection feedback was obtained through completed CQC comment cards and by speaking with one patient on the day. We received four comment cards on the day of inspection, and were shown one email sent by a patient. Seven patients contacted CQC through the ‘share your experience’ form on the CQC website, prior to the inspection. The majority of feedback from patients was positive. Patients told us they were treated with dignity and respect and that the staff were caring and listened to their concerns. Patients said they felt involved in decisions about their treatment. One patient told us that they had used two different clinics run by the provider, the patient stated there were inconsistencies in the information given and that they were unsure if the doses of medicines they were receiving were correct.

During our inspection on 16 October 2018, we identified a number of significant concerns which posed a serious risk to the life, health or wellbeing of patients at Airedale Allergy Centre. On the 19 October 2018, the Care Quality Commission applied to the Magistrates Court for an urgent cancellation of the registration of the service provider and the registered manager at Airedale Allergy Centre under section 30 of the Health and Social Care Act 2008.

The order was granted on 19 October 2018 and the registration of Thames Allergy Centre, in respect of the regulated activity of Treatment of disease, disorder or injury and that of the registered manager were cancelled at the Airedale Allergy Centre location with immediate effect. The provider was allowed 28 days to make an appeal against this decision. The provider appealed the decision to the First Tier Tribunal. The tribunal dismissed the appeal, therefore this service remains closed and is no longer registered with the Care Quality Commission.

Our key findings were:

• At this inspection we found that the provider had failed to respond appropriately to the warning notice issued on 20 March 2018. The provider had failed to ensure that under Regulation 12(1) of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014; Safe Care and Treatment, was provided in a safe way for service users.
• There were serious deficiencies in the manufacturing, safe storage, quality control and record keeping arrangements for medicines.
• The provider failed to comply with legal requirements for the management of controlled drugs because they did not have appropriate record-keeping and safe custody arrangements in place. We saw that Morphine and Fentanyl which are both controlled drugs in Schedule 2 of the Misuse of Drugs Act 2001, were stored on the premises.
• During the inspection we found stock solutions used to prepare vaccines which had been produced up to 22 years ago. There was no scientific justification available to confirm the stability and sterility of these solutions or to confirm the effectiveness of the preservative used.
• The provider had failed to act on the advice of the Medicines and Healthcare Products Regulatory Agency (MHRA) regarding safety concerns with their manufacturing processes.
• The provider had failed to acquire a Manufacturer’s ‘Specials’ Licence to carry out manufacturing activities as required by the MHRA.
• The clinic confirmed that a concentrated potassium chloride injection was used to make up intravenous infusions and had been administered to at least one patient. This medicine was the subject of a national patient safety alert issued in 2002 and can be fatal if administered inappropriately.
• The clinic offered face to face consultations for adults and children. In addition, telephone and Skype consultations were available for adults, and Skype consultations for children of any age. The clinic director told us there were no systems in place to confirm the identity of patients during remote consultations; nor were there systems to confirm parental identity or responsibility when consulting with children. They told us these issues had not been considered.
• The clinic did not respond appropriately to concerns raised by other health professionals or assess the capacity of patients when concerns were evident.
• The systems in place to manage infection prevention and control at the clinic were inappropriate and ineffective.
• The provider had not given due regard to the health and safety of patients using the clinic; including in respect of fire safety, the calibration of medical equipment, legionella checks, electrical safety and emergency procedures.
• Staff training did not follow the clinic’s own policy, and gaps were identified.
• Recruitment procedures at the clinic did not keep people safe.
• The provider did not undertake any quality improvement activity.
• The provider and the registered manager demonstrated a lack of insight and oversight as to the requirements of managing the work to be performed.

Professor Steve Field CBE FRCP FFPH FRCGPChief Inspector of General Practice

Airedale Allergy Centre is operated by Thames Allergy Centre Limited. The service is an independent clinic with a consulting and treatment room on the ground floor. Upstairs is a clinical room where vaccines are manufactured.

The service provides treatment for allergies and conditions caused by environmental and nutritional factors for children, young people and adults.

To get to the heart of patients’ experiences of care and treatment, we ask the same five questions of all services: are they safe, effective, caring, responsive to people's needs, and well-led? Where we have a legal duty to do so we rate services’ performance against each key question as outstanding, good, requires improvement or inadequate.

The inspection was a responsive inspection following some concerns raised. We looked at the safe and well led domain. We carried out this inspection on 12 March 2018. We inspected the service on a day when we could observe vaccines being produced.

Throughout the inspection, we took account of what people told us and how the provider understood and complied with the Mental Capacity Act 2005.

Services we do not rate

We regulate Independent clinics but we do not currently have a legal duty to rate them when they are provided as a single specialty service. We highlight good practice and issues that service providers need to improve and take regulatory action as necessary.

We found the following issues that the service provider needs to improve:

• A number of concerns were identified with regards to the safe management of medicines. This included compliance with Human Medicines Regulations (2012) and Nursing and Midwifery Council guidance, with regards to the storage, labelling and manufacturing and administration of vaccines and infusions provided to patients.
• We lacked assurance that all patients were appropriately assessed prior to receiving treatment and processes for gaining consent from patients did not follow best practice guidance.
• Information we were provided with regarding staff training and competence showed a number of gaps. We could not be assured that staff skills and knowledge were up to date with recent guidance and best practice.
• We found a number of sterile items past their expiry date and electronic equipment testing had not taken place since 2013.
• Hand wash facilities were not available in the consulting or treatment room; although alcohol gel was available.

However, we found the following areas of good practice:

• The team worked well together and were clearly focused on providing patient focused care.
• Incidents were reported and learning shared with the team.
• The clinic was visibly clean and tidy and free from clutter.

Following this inspection, we told the provider that it must take some actions to comply with the regulations and that it should make other improvements, even though a regulation had not been breached, to help the service improve. We also issued the provider with a warning notice.

Ellen Armistead

Deputy Chief Inspector of Hospitals, on behalf of the Chief Inspector of Hospitals